Monthly Archives: December 2020

Flavors added to vaping devices damage the heart, vanilla custard the most toxic of all – Study Finds

Posted: December 23, 2020 at 11:58 am

TAMPA, Fla. While health officials and lawmakers continue trying to steer young people away from vaping, the wide variety of enticing flavors added to these products make that a tough task. Although most of the worry over vaping comes from the risk of addiction, lung damage, and threat of switching to conventional cigarettes, a new study finds the flavoring chemicals these products use may be just as harmful as anything else. Researchers from the University of South Florida Health say vaporized flavoring molecules are toxic to the heart and damage the organs ability to beat correctly.

While other studies find that vaping is generally less harmful than smoking traditional tobacco products, the nicotine and other chemicals in e-cigarettes still damages the heart and lungs. Until now however, researchers say the impact of flavoring additives inhaled into the bloodstream remained unclear.

The flavored electronic nicotine delivery systems widely popular among teens and young adults are not harm-free, says principal investigator Dr. Sami Noujaim in a university release. Altogether, our findings in the cells and mice indicate that vaping does interfere with the normal functioning of the heart and can potentially lead to cardiac rhythm disturbances.

Dr. Noujaims study is one of the first to investigate the cardiotoxic effects of flavoring chemicals added to the e-liquids in electronic nicotine delivery systems (ENDS). ENDS include a variety of different vaping products like vape pens, mods, and pods.

Researchers define vaping as inhaling aerosols (tiny droplets) which e-cigarettes create by heating liquid nicotine and solvents like propylene glycol and vegetable glycerin. A vaping devices battery-powered heater converts this liquid into a smoke-like mix, or vapor.

The study tested how three popular e-liquid flavors fruit, cinnamon, and vanilla custard affect cardiac muscle cells (HL-1) of mice. After being exposed to e-vapor in a lab dish, the results reveal all three flavors are toxic to HL-1 cells.

The USF team also examined what happens to cardiac cells grown from human stem cells that are exposed to three types of e-vapors. The first substance containing only solvents interfered with the cells electrical activity and beating rate. The second substance, containing both nicotine and solvents, proved to be even more toxic to the heart cells.

The third substance however, containing nicotine, solvents, and vanilla custard flavoring, caused the most damage to the heart and its ability to spontaneously beat correctly. Researchers also determined that vanilla custard flavoring is the most toxic of the varieties tested.

This experiment told us that the flavoring chemicals added to vaping devices can increase harm beyond what the nicotine alone can do, Dr. Noujaim says.

The study also tested flavored vapings impact on live mice. Researchers implanted each subject with a tiny electrocardiogram device before exposing them to 60 puffs of vanilla-flavored e-vapor five days a week for 10 weeks.

Study authors looked at how this exposure impacted heart rate variability (HRV), which is the change in time intervals between successive heartbeats. The results show that HRV decreased in vaping mice compared to those only exposed to puffs of clean air.

The USF team finds vaping interferes with normal HRV by disrupting the autonomic nervous system and its control over heart rate. Mice exposed to flavored vaping are also more prone to a dangerous heart rhythm problem called ventricular tachycardia.

Researchers say they still have to confirm these results in humans. Dr. Noujaim urges policymakers to continue looking at the growing evidence that vaping is not a particularly safer alternative to smoking.

Our research matters because regulation of the vaping industry is a work in progress, Dr. Noujaim explains. The FDA needs input from the scientific community about all the possible risks of vaping in order to effectively regulate electronic nicotine delivery systems and protect the publics health. At USF Health, in particular, we will continue to examine how vaping may adversely affect cardiac health.

The study appears in the American Journal of Physiology- Heart and Circulatory Physiology.

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Jim McMahon broke his neck playing for Vikings, and found out about it 17 years later – TwinCities.com-Pioneer Press

Posted: December 23, 2020 at 11:56 am

In 2010, Jim McMahon was getting results from what he thought was a routine examination for workers compensation. The doctor asked him, When did you break your neck?

Suddenly, the former quarterbacks mind shot back to when he played one season for the Vikings in 1993. In a 17-10 playoff loss to the Giants in New York on Jan. 9, 1994, McMahon was battered and knocked out of the game twice but returned each time.

I said, I have a pretty good idea, McMahon said in a phone interview.

On the second play of the third quarter, with the Vikings leading 10-3, McMahon was sandwiched by defensive linemen Mike Fox and Keith Hamilton, the latter belting him in the head. McMahon was down on the field for nearly two minutes, and CBS play-by-play announcer Pat Summerall later said on the air he had been diagnosed with a mild concussion.

I believe thats the game that I broke my neck, McMahon said. I remember lying on the field for quite a while. I had all my senses but I was like, Dont touch me. I cant feel my legs.

McMahon eventually was able to get up and slowly walked off the field. He was replaced by Sean Salisbury but returned on Minnesotas next series.

I remember rolling out to throw a pass and (Fox) jumped up to block the pass, McMahon said of a play late in the third quarter. He brushed against my helmet, and then my legs went numb again.

McMahon was down again for more than a minute, and again was replaced by Salisbury. But McMahon returned with five minutes left in the game after CBS analyst John Madden had said on the air he should sit out the rest of the afternoon.

McMahon went on to play three more NFL seasons.

After that game, you go back to Minnesota and you see the coach (Dennis Green), and he says, Have a good summer, and then you leave, McMahon said. I guess they never caught (the neck injury) with any X-rays the next three years because I passed every physical. They told me (in 2010) that the C6 and C7 vertebrae were cracked and compressed, which means they were squished together and cracked at the ends.

McMahon was beaten up plenty while playing in the NFL from 1982-96, suffering other neck injuries, numerous concussions and shoulder injuries. He had 12 knee surgeries and suffering bruised ribs and a lacerated kidney. In 2012, McMahon, who now lives in Scottsdale, Ariz., was diagnosed as being in the early stages of dementia but said he has felt better in recent years.

McMahon, 61, goes to a chiropractor in New York every three months to have his neck aligned to help the flow of spinal fluid. And last December he went to Columbia University Irving Medical Center in New York to have 275 million stem cells added into both shoulders, both elbows, both knees, and his neck, spine and brain.

McMahon helped lead the Chicago Bears to a 15-1 record in 1985, and a resounding 46-10 win over New England in Super Bowl XX. Had he not been sidelined by injuries in three Chicago seasons after that, the Bears might have won another Super Bowl or two.

McMahon doesnt watch the NFL much now. The Bears will face the Vikings on Sunday at U.S. Bank Stadium, and McMahon isnt expected to watch. But he likely will check out the score.

Even though he played just one season with the Vikings and it didnt end well, McMahon has fond memories of Minnesota. He has returned to the Twin Cities twice in the past two years for autograph shows and to play golf.

I enjoy Minnesota, he said. I like to go up there and see some old teammates and have a beer and have some laughs.

McMahons latest visit was in September, when he stayed at the Blaine home of Buddy Becker, a friend and real-estate agent. Becker is friends with Tommy Kramer, a Vikings quarterback from 1977-89 who has been living at his home. Former NFL quarterback Jim McMahon, right, who played with the Minnesota Vikings in 1993, visits with Tommy Kramer, a Vikings quarterback from 1977-89, at an autograph signing at Route 47 Pub & Grub in Fridley in September 2020. (Courtesy of Buddy Becker)

McMahon and Kramer got to know each other a bit when their teams faced each other twice a season in the old NFC Central Division. A few years ago, they started tweeting at one another, and since have become much closer.

Theyre golf, drinking and singing buddies, Becker said. When Jim was here in September, I have a video of him and Tommy singing the Waylon Jennings song, Good Hearted Woman. They were singing to their exes.

McMahon and Kramer faced off in what was perhaps the most memorable regular-season game of McMahons career. Entering the Sept. 19, 1985, game at the Metrodome, the Bears and the Vikings were both 2-0.

The game was played on a Thursday night and televised nationally by ABC with its Monday Night Football broadcasting team of Frank Gifford, Joe Namath and O.J. Simpson. McMahon had been in the hospital for two days during the week with a pinched nerve in his neck and head coach Mike Ditka had announced that Steve Fuller would start at quarterback.

I had been in the hospital in Chicago in traction, and Ditka told me I wasnt going to play, McMahon said. The night before the game, I was sitting in my (Twin Cities hotel) room icing my shoulder, my back and my neck. Then one of the coaches comes up and says, Ditkas ticked off. Why arent you at (a team) meeting? So, I had to go down and listen to Ditka rant and rave about me, and I said, Why do I have to be here? You told me Im not playing.

McMahon said he was given painkillers before the game, and that once the game got underway, he started bugging Ditka the whole first half that you better let me play.

With the Bears trailing 17-9 midway through the third quarter and Fuller ineffective, Ditka finally inserted McMahon. The quarterback joked that he probably did so because Ditka was tired of being pestered on the sideline.

On the first play, a screen pass was called, McMahon said. I was a little wobbly when I dropped back because of all the painkillers I had taken. But I saw a blitz, and downfield Willie Gault was 10 yards past his man, so I threw it to him instead.

The speedy wide receiver scored on a 70-yard reception to cut the deficit to 17-16. But Ditka wasnt happy.

When I came off the field, he grabbed me and said, What play did you call? Why did you throw it to (Gault)? I said, Because he was open.

On Minnesotas next possession, Kramer threw an interception. On the next play, McMahon tossed a 25-yard touchdown pass to Dennis McKinnon for a 23-17 Bears lead.

Later in the third quarter, McMahon threw a 43-yard touchdown pass to McKinnon for a 30-17 lead. That made it three TD passes in a span of 6 minutes, 40 seconds, and the Bears were on their way to a 33-24 win.

We should have won that game, Kramer said. McMahon hadnt even been on the field and then comes in and nobodys guarding Willie Gault. Willie Teal was supposed to be on him.

The win helped springboard the Bears to a 12-0 start before they lost their only game of the season, 38-24 at Miami. McMahon completed 8 of 15 passes for 236 yards.

It was a fun third quarter, McMahon said. It was awesome. People got to see that we were more than just a defensive football team.

Between 1985-88, McMahon was 29-3 as Chicagos starting quarterback but missed about as many games as he played. So, the Bears traded him to San Diego, where he played one forgettable season.

McMahon then went to Philadelphia to serve as Randall Cunninghams backup from 1990-92 but had 12 starts. Then it was on to Minnesota in 1993. There, he started a career-most 12 games and went 8-4. He missed four games due to a dislocated shoulder, and the Vikings finished 9-7. Minnesota Vikings quarterback Jim McMahon reacts after a third-down pass intended for Quadry Ismail falls incomplete, forcing Minnesota to punt in an NFL football game against the Green Bay Packers at the Metrodome in Minneapolis on Sept. 26, 1993. Vikings placekicker Fuad Reveiz kicked a 22-yard field goal his fifth of the game with four seconds left to lift Minnesota to a 15-13 victory. (Jean Pieri / Pioneer Press)

We had a pretty good defense, and offensively we had some weapons in Cris Carter and Anthony Carter, McMahon said. My biggest memory that season was beating the Packers twice and the Bears twice.

The Vikings beat the Bears 10-7 at the Metrodome in Week 2 and 19-12 in Week 8 on Monday Night Football at Chicago. It marked the only times in McMahons career he defeated the Bears as a starter.

It was nice to play back home, McMahon said of the win at Soldier Field. They gave me a nice ovation. The fans always treated me well in Chicago. But the sweetest revenge was getting a victory.

During his 1982-88 Chicago tenure, McMahon had the image of being a punk rocker, which he attributed to one bad haircut. He said he didnt write any lyrics for The Super Bowl Shuffle video in which he sang, Im the punky QB known as McMahon. And he said the sunglasses he regularly wore were for medical reasons.

McMahon said his image with the Bears was a media creation, and Minnesota teammates never saw it.

He had that image of wearing sunglasses and the headband and all those kind of things, but he was just a normal guy, said Brad Johnson, Minnesotas third-string quarterback in 1993. Wed go over to his house and play darts and cards. I remember him as just a really good guy, a good teammate.

That season marked the only time McMahon led a team other than Chicago to the playoffs. He completed 60.4 percent of his passes, a career best as a starter, and threw for 1,968 yards with nine touchdowns and eight interceptions.

He was tough, like a Scott Studwell playing quarterback, said former Vikings cornerback Carl Lee, referring to the rugged former linebacker. He got beaten up a lot, but he never wanted to miss a play.

That attitude was on display to start the playoffs at Giants Stadium, when the temperature was 20 degrees with a 21-mph wind that made the wind-chill factor 4 degrees. Going against a rugged defense that featured legendary linebacker Lawrence Taylor, McMahon completed 12 of 25 passes for 145 yards and a touchdown.

He got knocked around a lot in that game, but I didnt know he broke his neck, said Roger Craig, then a Vikings running back. Thats crazy. Thats wild. He was a tough, tough guy, and he was great leader. If I broke my neck, man, that would have made me retire right away.

Of course, McMahon didnt know it then and played three more seasons.

After the Vikings opted to bring in quarterback Warren Moon in 1994, McMahon spent that year as backup in Arizona. He then moved on to Green Bay to serve as Brett Favres backup in 1995 and 1996. In his final NFL game, he watched from the sidelines as the Packers beat New England 35-21 in Super Bowl XXXI, earning McMahon a second championship ring.

McMahon still keeps up with Favre. He reached out to him when he saw that Beckers home has a urinal in a basement bathroom with a Packers logo at the bottom of the bowl.

Jim got a kick out of it, and the first thing he did was send a picture of it to Brett Favre, and Brett sent a text back laughing, Becker said. Former NFL quarterback Jim McMahon, who played with the Minnesota Vikings in 1993, on the beach in Cabo, Mexico on Dec. 17, 2020. (Courtesy of Jim McMahon)

McMahon spends much of his time now at his Arizona home, and recently bought a house in Mexico. He said he still at times gets bad headaches because the spinal fluid is acting up and must go into a dark room for relief. But hes been able to keep that mostly under control by going regularly to Rock Hill, N.Y., to have adjustments made by chiropractor Scott Rosa.

McMahon said he also has been helped by the visit to a clinic last December in Medellin, Colombia, when the stem cells were added, and by having a medical prescription for marijuana. McMahon said hes looking himself to get into the cannabis business.

My body is actually feeling a heck of a lot better now, he said.

McMahon was battered plenty in the NFL, most famously when Packers defensive end Charles Martin body slammed him to the turf in Week 12 in 1986. That ended his season due to a shoulder injury.

Not as well documented has been the beating he took seven years later with the Vikings in the playoffs. Any regrets?

I went back in, like an idiot, he said.

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Stem Cell Therapy Shows 2-year Benefit for Progressive MS Patients in Phase 1 Trial – Multiple Sclerosis News Today

Posted: December 22, 2020 at 7:59 am

Lesser or stable disability over two years was evident in most progressive multiple sclerosis (MS) patients given a stem cell treatment in a small Phase 1 clinical trial, supporting a larger study now underway, researchers report.

These results suggest that a treatment using mesenchymal stem cell-derived neural progenitors (MSC-NPs) can safely and effectively ease inflammation in progressive MS.

But for a subset of patients, particularly those with more advanced disease and greater disability, this treatment did not sufficiently counter a continued inflammatory response in the brain.

The study, Mesenchymal stem cell-derived neural progenitors in progressive MS: Two-year follow-up of a phase I study, was published in the journal Neurology: Neuroimmunology and Neuroinflammation.

MSC-NPs are seen as a possible way of treatingpeople with progressive MS, who have few effective disease-modifying treatments available. They are essentially stem cells collected from a patients bone marrow that are expanded and matured to produce factors involved in modulating the immune response and innervous tissue growth and survival.

An open-label Phase 1 trial (NCT01933802) investigated this stem cell treatment in 20 adults with stable primary(four PPMS patients) or secondary progressive MS(16 SPMS patients) and significant disability.

All received a total of three injections of MSC-NPs, given directly into the spinal canal three months apart. They were then evaluated at three and six months, and again at two years, after the final treatment to determine its long-term safety and tolerability, and for signs of potential effectiveness.

An initial analysisat six months post-treatment found lesser disability in most trial participants (15 of the 20) andbetter muscle strength in 14 of them. Greater exercise capacity was also seen in four of the 10 patients able to walk at the studys start, and two nonambulatory patients gained an ability to walk using assistive devices.

Researchers now reported clinical findings at two years after treatment. All 20 completed two-year follow-up assessments, buttwo who were severely disabled could not do a final in-person visit. They were examined via telemedicine and did not provide biomarker samples.

Disability was evaluated using the Expanded Disability Status Scale (EDSS), in which a higher score indicates more severe disability. The two who moved to telemedicine had EDSS scores of 8.0.

At six months, eight participants had an EDSS reduction of at least 0.5 points, including four with disability reductions of two or more points. At the two-year follow-up, seven of these eight people continued to show improvements in their EDSS scores, including two who showed a sustained 2.0 or more point reduction.

The eighth patient, whose disability had initially improved by one point, showed a worsening in disability at two years.

Of the 10 patients without initial improvements in EDSS scores, six had no evidence of disease progression throughout the study and follow-up. Two others worsened at each follow-up, and two showed worsening disease between the six-month and two-year examinations.

Of the 10 nonambulatory patients at the trials start, four showed improvements in walking speed greater than 20% at three months post-treatment. At two years, three had maintained these walking speed gains, while one fell just below the 20% improvement mark.

One of the two people unable to walk at the beginning of the study completed the walking test at both the three-month and two-year exams. One other patient, with an initial normal walking speed, maintained that speed throughout the trial and follow-up periods.

These results indicate that multiple MSC-NP treatments led to disability reduction for most progressive patients with long-standing disease. But those who sustained these gains at two years after treatment had lower EDSS and ambulatory status at baseline or the studys start, the researchers wrote.

A subset of patients with initial improvement failed to maintain shown benefits, while others showed no disease progression throughout the follow-up.

Cerebrospinal fluid (CSF) levels of CCL2, a pro-inflammatory factor, were lower following treatment, while levels of the anti-inflammatory TGF beta 2 rose post-treatment, consistent with previous studies of similar treatments.

Interestingly, no difference here was observed between patients whose disability improved in response to the treatment (responders) and those who failed to improve (non-responders).

However, some inflammatory factors were seen to rise after treatment in non-responders, but not among those who responded to treatment. This suggests that a continued inflammatory response may hinder clinical response to MSC-NP use.

Neurofilament light chain (NfL) levels in the CSF, a marker of nerve cell degeneration and damage, can be elevated in MS patients. Among a small number of trial patients with high NfL levels prior to treatment, these levels rose further in nonresponders after treatment while they declined among responders.

We observed that most subjects who received repeated [MSC-NP] injections exhibited either a reversal in disability or lack of disease progression that was sustained for 2 years after treatment, the researchers wrote.

The impact of any efficacy conclusion, however, are severely limited by the very small number of patients in the study and the lack of blinding and placebo controls, they added.

An ongoing and placebo-controlled Phase 2 clinical trial (NCT03355365), which opened last year, is now investigating the safety and efficacy of repeat MSC-NP injections in progressive MS patients. The study is expected to have enrolled50 adults with progressive MS (40 SPMS and 10 PPMS), being given a total of six injections of either MSC-NPs or a placebo every other month for a first year.

In its second year, those in the MSC-NP group cross to the placebo group and those previously on a placebo move to treatment again for six total injections given every two months. This single-site trial at the Tisch MS Research Center of New Yorkwill run for three years, and is expected to finish in late 2023.

Aisha Abdullah received a B.S. in biology from the University of Houston and a Ph.D. in neuroscience from Weill Cornell Medical College, where she studied the role of microRNA in embryonic and early postnatal brain development. Since finishing graduate school, she has worked as a science communicator making science accessible to broad audiences.

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Physio Logic Brings Cutting-edge Regenerative Treatments for Sport Injuries and Arthritis to New York City – PRNewswire

Posted: December 22, 2020 at 7:59 am

NEW YORK, Dec. 17, 2020 /PRNewswire/ -- Physio Logic, a leading provider of integrated health services in New York City and surrounding areas, continues to demonstrate its commitment to excellence in the field of Regenerative Medicine and Stem Cell Therapy by entering into a collaboration with Regenexx, a worldwide network of specially trained physicians providing the world's most advanced, research-driven, regenerative medicine and stem cell therapy treatments. The partnership brings cutting-edge regenerative treatments to New York City residents suffering from sports injuries or degenerative diseases.

The Regenerative Medicine division of Physio Logic is led by Dr. Tanuj Palvia, MD, a specialist in regenerative medicine and interventional orthopedics focused on the treatment of musculoskeletal injuries and degenerative orthopedic conditions.

"Stem Cell Therapy is one of the most innovative treatments available today but, being so new, patients need to know they're receiving the best possible care. As a physician, I hold myself and my practice to the highest standards and, being aligned with Regenexx adds that extra assurance patients need to know they're in good hands. Whether it's a nagging sports injury or slow degeneration, you're going to get the highest quality of integrated care right here at Physio Logic," said Dr. Palvia.

Interventional Orthobiologics is a specialty that focuses on using your body's natural healing agents to treat orthopedic injuries with the goal of reducing pain and improving joint function. The variety of orthobiologics available to Regenexx physicians, such as bone marrow stem cells and platelet-rich plasma (PRP), allow them to create a treatment plan to best support your recovery. It can be used in the treatment of conditions such as arthritis and injury to ligaments, tendons, cartilage, or bone.

"Being selected to represent the Regenexx brand in New York City speaks to the quality of our facility, our providers, and the care we give our patients," said Dr. Rudy Gehrman, CEO & Founder of the Brooklyn based clinic. "Physio Logic is raising the standard of healthcare in New York and our partnership with Regenexx is an extension of the quality, integrative care we provide to every patient that walks through our door."

Regenexx physicians are required to have thousands of hours of experience performing precise, injection-based treatments using image guidance for a range of body parts and injuries. Their strict acceptance criteria means that Regenexx only chooses the most qualified physicians to join their network. Physio Logic's Interventional Pain Specialist, Dr. Tanuj Palvia, MD, is ranked among them.

To learn more about Physio Logic and Regenerative Medicine, go to https://physiologicnyc.com/regenerative-medicine/

About Physio LogicPhysio Logic brings together an expert team of open-minded medical doctors, physical therapists, chiropractors, acupuncturists, massage therapists, nutritionists, health coaches, biohackers, and Pilates instructors. Our unique collaborative approach, coupled with our ability to assess patients holistically, is used to create a custom care plan tailored to patients' needs. For more information on Physio Logic, visit https://physiologicnyc.com or call (718) 260-1000.

About RegenexxRegenexx is a nationwide network of physicians who practice Interventional Orthopedics, a new specialty that focuses on using the most advanced regenerative protocols available as an alternative to many orthopedic surgeries. Regenexx has published roughly half of the research worldwide on the use of orthobiologics for treating orthopedic injuries, and our patented treatment lab-processing and treatment protocols allow us to achieve unmatched results. Our procedures use your body's natural healing agents including blood platelets and bone marrow concentrate to repair damaged bone, muscle, cartilage, tendons and ligaments. For more information on Regenexx, visit https://regenexx.com.

Media contact:Alan Sott[emailprotected](718) 260-1000

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http://www.physiologicnyc.com

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New Combination Therapy Tested By Children’s May Offer Hope For Leukemia Patients – WVXU

Posted: December 22, 2020 at 7:59 am

Cancer cells pose an uncanny ability to make new cells and dodge drugs, "somewhat like would-be robbers hacking the bank's alarm code," one doctor explains. But researchers at Cincinnati Children's Hospital Medical Center have figured out how cancer cells rewire themselves and, in turn, how to possibly overcome drug resistance.

This drug resistance may explain why some acute myeloid leukemia (AML) and other cancer patients suffer fatal relapses despite many improvements in leukemia outcomes over the years, according to a Children's news release.

"Overcoming resistance to therapy remains a holy grail of leukemia treatment," says Yi Zheng, Ph.D., director, experimental hematology and cancer biology at Cincinnati Children's. Zheng and his colleagues have now discovered a way to boost the effectiveness ofmTOR inhibitors, which prohibit unwanted cell proliferation.

"While the latest study is based on mouse models, building upon the findingspublished Dec. 21, 2020, in PNASeventually could improve outcomes for people with AML, and possibly other forms of cancer," a release says.

What Happens When Treatments Target mTOR?

"Using a novel mouse model, we have learned that deleting the mTOR gene prompts blood stem cells to multiply rapidly to open other pathways to continue producing new blood cells," says Zheng, the study's senior author. "We also found that leukemia cells use a similar response to continue multiplying despite mTOR-inhibiting treatments."

He says attacking mTOR essentially sets off alarms among hemopoietic stem cells (HSCs), which act like blood cell factories deep in bone marrow. Then the cells themselves produce a flood of new, re-wired blood cells. These re-wired stem cells, treated with mTOR inhibitors, can begin multiplying, rendering mTOR inhibitor drugs useless.

The co-authors say mTOR treatment resistance can be counteracted by inhibiting activity of the MNK, CDK9 or c-Myc genes. So-called BET inhibitors can act against c-Myc activity. Other inhibitors that are in clinical trials can act against CDK9.

Next Steps

Scientists at Cincinnati Childrens have already launched some of the research needed to prepare the combination therapies for in vivo test leading to human clinical trials, the news release says. That process will take time, but since mTOR inhibitors have been widely tested in clinical trials, investigators have a head start on exploring combination therapies.

Longer term, the findings may extend beyond AML, Zheng says, because mTOR has been a recognized target in most human cancers, including solid tumors like brain tumors.

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For Patients With HMA-Resistant MDS, What Are Their Options? – AJMC.com Managed Markets Network

Posted: December 22, 2020 at 7:59 am

Although hypomethylating agents (HMAs) are a cornerstone of treatment for the majority of myelodysplastic syndrome (MDS) cases, there are patients who are resistant to such treatment, representing a need for other treatment options, reports the study in Therapeutic Advances in Hematology.

Both azacitidine (AZA) and decitabine (DEC) are HMAs approved in the United States for all patients with MDS, and most patients who respond to the treatments will do so within the first 6 cycles. With this threshold, its recommended to complete 6 cycles of AZA before considering a patient as HMA refractory.

Since the prognosis of patients failing HMA therapy is dismal except for the small minority of patients eligible for allo-SCT [allogeneic stem cell transplant], there is an urgent need for both prevention of HMA failure by (1) optimization of frontline therapies (eg, adding synergistic agents to HMA therapy) and/or (2) improved salvage therapies for HMA-refractory MDS patients, explained the researchers.

For these patients who are resistant to HMA treatment, there are no formal recommendations, but several options, spanning from novel HMAs to chemotherapy, have been or are currently being studied in the setting.

Outside of AZA and DEC, which have short half-lives potentially limiting their biologic activity, guadecitabine has emerged as a more effective, easier-to-administer option that has also demonstrated tolerability.

Oral ASTX727, a combination of cedazuridine and DEC, has preliminary data from 50 patients with MDS or chronic myelomonocytic leukemia. The data show an overall response rate (ORR) of 62%, and the most common grade >3 adverse events were hematologic (eg, neutropenia, 48%; thrombocytopenia, 38%; anemia, 22%; leukopenia, 20%), febrile neutropenia (38%), and pneumonia (20%). There is currently an ongoing phase 3 trial comparing the oral option with intravenous DEC.

An oral option of AZA, CC-486, is also being tested in clinical trials.

The review, while highlighting promising treatment options for these patients, also offers rationale for not using certain treatment options. For example, although lenalidomide has proven effective in the first-line setting for patients with del(5q), the treatment has a limited benefit in these patients who are refractory to HMAs, leading researchers to recommend against lenalidomide being used outside of the frontline setting for the subgroup of patients.

Chemotherapy, frequently used for medically fit patients as a bridge to allo-SCT, was tested in an international multicenter retrospective analysis of over 300 patients who were refractory to HMA. The study, which used 3 intensive induction chemotherapy regimens, boasted an ORR of 41% and median overall survival of 10.8 months. Forty percent of patients were bridged to allo-SCT, the only potentially curative options for patients with MDS.

Other research has indicated that medically fit should not exclusively qualify patients for chemotherapy treatment, with some data suggesting that the decision should also take into account molecular and cytogenetic features.

Ongoing research is also being targeted at combining HMAs with intensive chemotherapy, other forms of epigenetic therapy, venetoclax, and immune checkpoint inhibitors.

Reference

Bewersdorf J, Carraway H, Prebet T. Emerging treatment options for patients with high-risk myelodysplastic syndrome. Ther Adv Hematol. Published online November 11, 2020. doi:10.1177/2040620720955006

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In COVID-19 Clinical Trials, Experts from Baptist Health’s Cancer Institutes Treat Patients With Mild or Severe Symptoms – Baptist Health South…

Posted: December 22, 2020 at 7:59 am

Offering more hope to patients with COVID-19, cancer experts throughout Baptist Health South Florida are launching new clinical trials. The trials, developed as a result of promising initial emergency and experimental COVID-19 therapies at Miami Cancer Institute on the Baptist Hospital campus in Miami and at the Eugene M. & Christine E. Lynn Cancer Institute at Boca Raton Regional Hospital, span the range of care from the most critically ill to those with mild symptoms.

Guenther Koehne, M.D., Ph.D., director and chief of Stem Cell Transplantation, Hematologic Oncology and Benign Hematology at Miami Cancer Institute.

Its exciting to lead these next-generation clinical trials, said Guenther Koehne, M.D., Ph.D., principal investigator of two of the studies, and director and chief of Stem Cell Transplantation, Hematologic Oncology and Benign Hematology at Miami Cancer Institute. We have learned much about COVID-19 since the pandemic began last winter and our hope is that these trials will lead to tremendous treatment options for patients.

Specialists at both centers are accomplished in many of the techniques and technologies that are doing double-duty as oncology and COVID-19 treatments and pivoted at the start of the pandemic to lead numerous COVID-19 clinical trials.

Trial to Save the Most Critical Patients

Miami Cancer Institute is leading a phase I/IIa clinical trial using mesenchymal stem cells for critically ill patients with COVID-19 induced respiratory failure. Mesenchymal stem cells are derived from umbilical cord lining tissue and aid in healing by regenerating damaged lung tissue. The trial is for hospitalized patients who are receiving oxygen therapy or who are on ventilation support and are not showing improvement.

Early in the pandemic, Miami Cancer Institute treated several patients with mesenchymal stem cells through single-use emergency approval from the U.S. Food and Drug Administration (FDA). The patients, who were among the most ill COVID-19 patients, recovered.

In our early experience with these umbilical cord lining stem cells, we had very promising results, Dr. Koehne said. We are very hopeful that the clinical trial will give us evidence that this treatment can save the lives of those who experience respiratory failure due to COVID-19.

Low-dose Radiation may Reverse Pneumonia

Both Lynn Cancer Institute and Miami Cancer Institute are participating in the PREVENT trial, Low-Dose Radiotherapy for Patients with SARS-COV2 (COVID-19) Pneumonia. With a single, low-dose of thoracic radiation, researchers hope that inflammation in the lungs is reduced and that patients with pneumonia associated with COVID-19 may not need to be placed on a ventilator.

Minesh Mehta, M.D., deputy director and chief of Radiation Oncology at Miami Cancer Institute.

We have seen this treatment option benefit many cancer patients, and the hope is that it also helps those affected by the virus, said Minesh Mehta, M.D., co-principal investigator, deputy director and chief of Radiation Oncology at Miami Cancer Institute.

Patients eligible for the study include hospitalized men and women ages 50 and up who are diagnosed with COVID-19 and pulmonary pneumonia but who are not on ventilators.

This trial gives us the opportunity to administer potentially effective treatment before the need for ICU placement or mechanical ventilation, said Michael Kasper, M.D., co-principal investigator and director of Radiation Oncology at Lynn Cancer Institute.

Radiation therapy has shown a reduction in inflammation in a number of conditions, including viral pneumonia, autoimmune disorders and degenerative joint disorders. At much higher doses, it is also used to treat cancer.

Trial to Shorten Recovery and Reduce Symptoms For Those With Mild Disease

Michael Kasper, M.D., director of Radiation Oncology at Lynn Cancer Institute.

Miami Cancer Institute is also enrolling patients in a phase 2 clinical trial known as BLAZE-4, which continues previous work using a monoclonal antibody, bamlanivimab, to treat patients with milder cases of COVID-19. The Institute participated in the phase 1 study, BLAZE-1, which resulted in Emergency Use Authorization (EUA) status by the FDA.

Bamlanivimab is for patients who are COVID-19 positive but are not hospitalized and have mild symptoms. It must be administered within 72 hours of a positive test result.

The BLAZE-1 study showed a lower subsequent hospitalization rate among those who received the drug versus those who received a placebo, and may reduce the viral load, leading to better outcomes. The BLAZE-4 trial will evaluate the efficacy and safety of bamlanivimab both on its own and in combination with another monoclonal antibody. The drugs work by prohibiting the spread of the virus to additional cells in the body.

We have reached a new level of sophistication trying to treat the virus before it makes you really sick, Dr. Koehne said. Despite the prospect of having COVID-19 vaccines, which are intended to prevent us from getting sick, we need to stay focused on the treatment of those individuals who are symptomatic from the virus.

Tags: COVID-19, Lynn Cancer Institute, Miami Cancer Institute

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In COVID-19 Clinical Trials, Experts from Baptist Health's Cancer Institutes Treat Patients With Mild or Severe Symptoms - Baptist Health South...

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SPONSORED: 12 Charities of Christmas – Anthony Nolan – The Courier

Posted: December 22, 2020 at 7:59 am

In the run-up to Christmas (between 13th and 24th December) we bring you a different charity that needs your help at this time of year, as part of our dedicated 12 Charities of Christmascampaign

Anthony Nolan saves the lives of people with blood cancer and blood disorders.

For someone with blood cancer, a stem cell transplant could be their last chance of survival. Your support could help it give that person, their family and their friends a second chance of life.

Anthony Nolan is the charity that makes lifesaving connections between people with blood cancer and incredible strangers ready to donate their stem cells. It is saving lives right now. Three lives a day, in fact.

By growing the stem cell register, carrying out ground-breaking research and providing the best post-transplant care, it is giving families a future. But it cant do it without you. Without you, there is no cure.

Anthony Nolans vision: To save and improve the lives of everyone who needs a stem cell transplant.

This is a fundamental vision and, if youve known the charity a while, youll notice it hasnt changed. Thats because its cause is as relevant now as it was 45 years ago when Shirley Nolan first started the charity to find a matching stem cell donor for her son, Anthony.

Its aims:

1. Together, we can provide outstanding services to patients and the clinical community

2. Together, we can drive lifesaving research and turn it into action for patients

3. Together, we can harness the collective power of our supporters to champion and enable our lifesaving work

4. Together, we can be a stronger voice for patients to ensure they receive the best possible care

5. Together, we can

Anthony Nolans 2019-2022 Organisational Strategy

In April 2019, it launched our new strategy, Together, we can save lives. This strategy sets out what it wants to achieve in these three years and beyond, as it leads the way into a future of new treatments and new ways of working. For more information or to donate, click here.

This feature is brought to you as part of our 12 Charities of Christmas campaign and has been sponsored by:

William Wallace has been self-employed for 54 years, starting with Braefoot Garage in Methil, with his junior John Stewart, who he is still in contact with today.

Aberhill Metals was created in 1986 and has grown, with his sons Derek and William Jnr joining him, from leaving school. He has always had the loyal and supportive help of his wife Margo, of 58 years, who has endured the pressures of running a business, and his extended family of 5, grandchildren of 16 and great grandchildren of 5

The company is well known throughout North East Fife for Skip Hire.

During the last year with the Covid lockdown, it kept working supplying skips. Even after a major fire at its premises, Aberhill didnt stop. Still up and running with the support of all staff.

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SPONSORED: 12 Charities of Christmas - Anthony Nolan - The Courier

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Robert Gallo of the UM School of Medicine Institute of Human Virology and Global Virus Network Awarded Top Life Sciences and Medicine Prize from China…

Posted: December 22, 2020 at 7:56 am

BALTIMORE, Dec. 21, 2020 /PRNewswire/ --Robert C. Gallo, MD, The Homer & Martha Gudelsky Distinguished Professor in Medicine, co-founder and director of the Institute of Human Virology at the University of Maryland School of Medicine and co-founder and international scientific advisor of the Global Virus Network, was awarded the "VCANBIO Award for Biosciences and Medicine," a significant and authoritative award in the life sciences and medicine field of China. The elite Prize is jointly presented by the University of Chinese Academy of Sciences and the VCANBIO CELL & GENE ENGINEERING CORP, LTD to push forward scientific research, technological innovation and continuous development in the life sciences and medicine field of China.

"The Prize also serves to facilitate the industrial development and application of innovative life science achievements,"said George F. Gao, DVM, DPHIL (OXON), Director General of the Chinese Center for Disease Control and Prevention (China CDC), Director, CAS Key Laboratory of Pathogenic Microbiology and Immunology, Professor, Institute of Microbiology, Dean of the Medical School of the Chinese Academy of Sciences and Director of China's Global Virus Network Center of Excellence. "Dr. Gallo is a pioneer in virus research and most worthy of this Prize. We are pleased to see him recognized by many members of the Chinese Academy of Sciences."

"Hosted by the Medical School of the University of Chinese Academy of Sciences, this award commends outstanding and innovative Chinese and foreign scientists, who have accomplished innovation achievements and breakthroughs in the life sciences and medicine field,"said Yiming Shao, MD, the Chief Expert on AIDS, China CDC, Director of the Division of Research on Virology and Immunology, National Center for AIDS/STD Control and Prevention, China and Member of the GVN SARS-CoV-2 Task Force and China GVN. "I have worked with Dr. Gallo through the decades and admire his intellect and leadership, which have led to discoveries that have broad implications in protecting mankind from viral threats. I am delighted that my Chinese colleagues are recognizing him with this significant honor."

"Prof. Gallo has made a great deal of contribution to promote the Sino-American friendship and collaboration, especially for medical talent training and public health in China,"said Prof. Guanhua Xu, Chairman of the selection committee of the VCANBIO Award for Biosciences and Medicine.

"This is a tremendous and well-deserved honor for Dr. Gallo,"said E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, the John Z. and Akiko K. Bowers Distinguished Professor, and Dean, University of Maryland School of Medicine. "Dr. Gallo has dedicated his career to building international collaborations that have produced major scientific discoveries in human virology, including with leading scientists and academic colleagues in China. As a result, the Institute of Human Virology continues to be recognized as the global leader in the fight against chronic viral diseases."

"I am humbled and honored to receive this esteemed Prize from my colleagues in China,"said Dr. Robert Gallo. "I take this opportunity to stress that it is imperative that government and politics not interfere with science, and that my Chinese and American colleagues, who have a long history of collaborating together and contributing scientific breakthroughs to protect humanity from global health threats, continue to have the freedom to do so and to grow these collaborations."

A Distinguished Scientific Career Advancing Global Health

Dr. Robert Gallo has long believed in the necessity of international cooperation and collaboration in medical sciences in general, and infectious diseases in particular, in part to build global friendships and advance humanitarian principles. Though entertainment and sports facilitate such connections he believes the "knots" are tied best through medical sciences. Throughout his 30 years at the National Institutes of Health (NIH) and more recently his nearly 25 years at Baltimore's Institute of Human Virology (IHV) at the University of Maryland School of Medicine, he has fostered these connections. First, through his pioneering scientific discoveries including his discovery in 1976 of Interleukin-2, the first cytokine, a growth regulating substance now used as immune therapy in some cancers and in autoimmune diseases when suppressive T cells are needed. Then in 1980, the first human retrovirus, HTLV-1, a cause of human leukemia and paralytic neurological diseases as well as severe inflammatory disorders, which is endemic in some regions such as parts of Africa, the Caribbean Islands, Japan, Aboriginal Australians, Iran and South America. Dr. Gallo and his team developed a blood test for HTLV-1 applicable to all countries which protects people receiving blood transfusions that would be contaminated with this virus. Similarly, in 1984, when he and his team co-discovered HIV as the cause of AIDS they also developed the HIV blood test for the world and made their reagents available to all. Dr. Gallo and his team established collaborations in HIV/AIDS research, education, therapy and care for many African countries, particularly in Nigeria and some Caribbean nations. During the current pandemic he quickly became involved in initiating preventive measures against SARS-CoV-2 and COVID-19 disease through the idea of stimulating innate immunity with "live" virus vaccines such as the oral polio vaccine. Dr. Gallo, abetted by his collaborator, Konstantin Chumakov, PhD, Associate Director for Research for the U.S. Food and Drug Administration's (FDA) Office of Vaccines Research and Review and a GVN Center Director and his clinical colleague, Shyam Kottilil, MBBS, PhD, professor of medicine and director of the Clinical Care and Research Division of the Institute of Human Virology at the University of Maryland School of Medicine and senior advisor at the GVN, are advising on trials in India and in discussion about trials in Mexico, Brazil, Uzbekistan and China. He has also fostered the international nature of his research by hosting students beyond the U.S., including post-doctoral senior scientists from Asia, Middle East, Europe, the Americas and many African nations.

However, nothing demonstrates his concern for medical science cooperation more than when he established the idea for the Global Virus Network (GVN), which he co-founded in 2011 with the late Prof. Reinhard Kurth, MD, formerly Director of the Robert Koch Institute in Berlin, and Prof. William Hall, BSc, PhD, MD, DTMH, of University College Dublin. Now, GVN is headed by its President Christian Brchot, MD, PhD. The GVN was formed to advance medical and zoological science without any government influence, giving members of the GVN maximum freedom to speak freely while encouraging all nations to be involved. China, among several dozen other countries, has an active Center of Excellence within the GVN and was the site of the 7th meeting of the GVN in May 2015 held in Beijing and hosted by the late GVN Center Director, Zeng Yi of Beijing University of Technology. Experts shared information on varying viral threats, including those causing hemorrhagic fevers, hepatitis, HIV, measles, influenza, dengue and chikungunya, to name a few. GVN members also reviewed strategies at the center of the organization including the creation of specialized task forces and the launch of training programs to address growing viral threats.

A History with Chinese-American Collaborations

Dr. Gallo had a deep friendship with Dr. Robert Ting who came to the U.S. as a child refugee from Shanghai during the Japanese invasion. As a student, Dr. Ting worked with the famous Italian molecular biologist, Dr. Salvatore Luria at MIT, who won a Nobel Prize. Dr. Ting then went to Caltech to work with another Italian Nobel Prize winner, Dr. Renato Dulbecco and they were joined by two others who were soon to be Nobel Prize winners, Drs. Howard Temin and David Baltimore. Dr. Ting was not just Dr. Gallo's friend but also his teacher by introducing him to Chinese culture and food, tennis, and the field of virology. Soon after meeting Dr. Ting, another Chinese-born and educated young man, Dr. Alan Wu, came to Dr. Gallo's lab from Toronto bringing with him the knowledge and skills of blood stem cells. There were then several other Chinese post-doctoral fellows culminating with Dr. Flossie Wong-Staal from Canton Province and who played a very major role in advancing molecular biology on Dr. Gallo's team for about 15 years. Dr. Nancy Chang, also Chinese, came as a visiting scientist on a few occasions. On one such time she was key to the development of the second-generation HIV blood test used around the world.

In 2009, with the help of a University of Maryland School of Medicine colleague, Dr. Richard Zhao, born in China and educated in the U.S., the Shandong Academy of Medical Sciences (SAMS) announced the establishment of the Shandong Gallo Institute of Virology (SGIV). The announcement was made simultaneously with a ceremony to establish China's first Molecular Diagnostic Center for Personalized Healthcare (MDCPH), which was a joint venture among the University of Maryland, Baltimore, Roche Diagnostics Asia Pacific and SGIV at the Shandong Academy of Medical Sciences. The mission of the SGIV is to promote the basic science of virology especially in the area of HIV/AIDS and other important and emerging viral diseases and to facilitate translational research and clinical trials for related diseases. SGIV also aims to provide molecular-based testing for disease diagnosis, prognosis and treatment in the area of individualized molecular testing for personalized medicine.

Since the founding of the Institute of Human Virology (IHV), Dr. Gallo notes that several of his key science leaders at the Institute of Human Virology came from China, including: Dr. Wuyuan Lu (recent Director of the Division of Infectious Agents and Cancer), Dr. Yang Liu (recent Director of the Division of Immunotherapy), Dr. Pan Zheng (Division of Immunotherapy), Dr. Lishan Su (current Director of the Division of Virology, Pathogenesis and Cancer), Dr. Man Charurat (current Director of the Division of Epidemiology and Prevention and Ciheb) and Dr. Lai-Xi Wang (formerly at IHV and now at University of Maryland, College Park). With each of these leaders also came labs full of Chinese colleagues, who Dr. Gallo states contributed greatly to advancing America's biomedical research. Further, over the past six decades, Dr. Gallo visited China countless times to discuss potential collaborations with public and private sector entities, mentored rising Chinese scientists and facilitated open scientific discussions to advance the field of human virology, among other important things.

About the Institute of Human Virology

Formed in 1996 as a partnership between the State of Maryland, the City of Baltimore, the University System of Maryland, and the University of Maryland Medical System, the IHV is an institute of the University of Maryland School of Medicine and is home to some of the most globally-recognized and world-renowned experts in all of virology. The IHV combines the disciplines of basic research, epidemiology, and clinical research in a concerted effort to speed the discovery of diagnostics and therapeutics for a wide variety of chronic and deadly viral and immune disorders - most notably, HIV the virus that causes AIDS. For more information, visit http://www.ihv.org and follow us on Twitter @IHVmaryland.

About the Global Virus Network (GVN)

The Global Virus Network (GVN) is essential and critical in the preparedness, defense and first research response to emerging, exiting and unidentified viruses that pose a clear and present threat to public health, working in close coordination with established national and international institutions. It is a coalition comprised of eminent human and animal virologists from 59 Centers of Excellence and 11 Affiliates in 33 countries worldwide, working collaboratively to train the next generation, advance knowledge about how to identify and diagnose pandemic viruses, mitigate and control how such viruses spread and make us sick, as well as develop drugs, vaccines and treatments to combat them. No single institution in the world has expertise in all viral areas other than the GVN, which brings together the finest medical virologists to leverage their individual expertise and coalesce global teams of specialists on the scientific challenges, issues and problems posed by pandemic viruses. The GVN is a non-profit 501(c)(3) organization. For more information, please visit http://www.gvn.org. Follow us on Twitter @GlobalVirusNews

SOURCE Global Virus Network

gvn.org

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Robert Gallo of the UM School of Medicine Institute of Human Virology and Global Virus Network Awarded Top Life Sciences and Medicine Prize from China...

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Follow the Money: Spatial Omics, CAR-NK Cells, AI-Powered Biology – Bio-IT World

Posted: December 22, 2020 at 7:56 am

December 21, 2020 | Funding updates around the life sciences including cash for a handheld mass spec device, Series D for oncolytic immunotherapy, a new company launch in allogenic CAR-NK cells, AI-powered cell classification, a 3-D sequencing platform, and more.

$170M: Israeli Digital Health First VC Firm

OTV (formerly Olive Tree Ventures), Israels digital health first venture capital firm, today announced the closing of a fund with a total value of $170M. OTV also announced their new name and the appointment of a new Head of Asia Pacific to spearhead the funds expansion into the regions market. OTV is the only venture capital fund in Israel whose primary focus is digital health, specializing in supporting their portfolio companies reach maturity, refine execution, tackle regulatory hurdles and ensure a global imprint on validated products. Over the course of the past five years, OTV has prioritized investment in digital health companies that develop cutting-edge solutions to todays most pressing healthcare problems. OTVs portfolio includes some of the worlds highest-profile digital health leaders, including TytoCare, Lemonaid Health, Emedgene, Scopio and Donisi Health.

$116M: Handheld, Desktop Mass Spec

908 Devices, which provides mass spectrometry devices for forensic and scientific research, raised the proposed deal size for its upcoming IPO. The Boston, MA-based company now plans to raise $116 million by offering 6.3 million shares at a price range of $18 to $19. The company had previously filed to offer the same number of shares at a range of $15 to $17. At the midpoint of the revised range, 908 Devices will raise 16% more in proceeds than previously anticipated. 908 Devices provides handheld and desktop mass spectrometry devices that are used to interrogate unknown and invisible materials, providing actionable answers to directly address critical problems in life sciences research, bioprocessing, industrial biotech, forensics and adjacent markets. Since its inception, the company has sold more than 1,200 handheld and desktop devices to over 300 customers in 32 countries, including 18 of the top 20 pharmaceutical companies by 2019 revenue, as well as numerous domestic and foreign government agencies and leading academic institutions.

$91M: Series C for Digital, Decentralized Trials

Medable has announced $91 million in Series C funding to accelerate the life sciences industrys shift to digital and decentralized clinical trials. The round was led by Sapphire Ventures, with follow-on investment from existing investors GSR Ventures, PPD, and Streamlined Ventures. The funding brings Medables total capital raised to more than $136 million. Medables flexible and modular software platform enables clinical leaders to shift from clinic-centric to patient-centric research strategies. The platform provides a unified experience for patients and clinicians, enabling recruitment, remote screening, electronic consent, clinical outcomes assessment (eCOA), eSource, telemedicine, and connected devices. Medable has seen rapid eCOA adoption, driving the field forward with enhancements including connected devices and telemedicine. The COVID-19 pandemic has driven demand for remote clinical trial technologies and Medable is enabling complex research protocols to be conducted remotely through its platform. By minimizing the need for in-person site visits, Medable customers have achieved unprecedented results including 3X faster enrollment and over 90% retention rates.

$58M: Series B for Healthcare Ecosystem Platform

H1, a global platform for the healthcare ecosystem, announced today that it has closed a $58 million Series B round of funding. The round was co-led by IVP and Menlo Ventures, which led the Series A round in April 2020. Transformation Capital, Lux Capital, Lead Edge Capital, Novartis dRx and YC also participated. H1 has created the largest healthcare platform to forge connections in the healthcare ecosystem. The H1 team has taken a unique approach to building the platform that combines AI, human powered engineering, third-party data sources, and government partnerships, to create the largest platform of healthcare professionals, currently spanning over 9 million healthcare professions around the globe.

$50M: Series C for Somatic Cancer, Wellness Platform

Congenica has announced the completion of its Series C funding round, raising $50 million. The round was co-led by Tencent and Legal & General and included other new investors Xeraya, Puhua Capital and IDO Investments. Existing investors Parkwalk, Cambridge Innovation Capital and Downing also participated. The funding is aimed at accelerating international market development and driving further expansion of Congenicas product platform into somatic cancer, wellness and through partnerships with pharmaceutical companies. Furthermore, the company will deliver capabilities including the ability to integrate with existing electronic health systems and deliver automated interpretation.

$47M: Series D for Novel Oncolytic Immunotherapies

CG Oncology has closed a $47 million Series D preferred stock financing led by new investor Kissei Pharmaceutical Co., Ltd., with participation from existing investors ORI Healthcare Fund, Camford Capital and Perseverance Capital Management. The financing will support the advancement of CG Oncologys late-stage clinical programs for its lead oncolytic immunotherapy, CG0070, including an ongoing global Phase 3 trial (BOND3) with CG0070 as a monotherapy for the treatment of BCG-unresponsive, Non-Muscle Invasive Bladder Cancer (NMIBC), and a combination Phase 2 study (CORE1) of CG0070 with KEYTRUDA (pembrolizumab) in the same indication. In addition, a Phase 1b study (CORE2) is currently ongoing with CG0070 in combination with OPDIVO (nivolumab) as a neoadjuvant immunotherapy for Muscle-Invasive Bladder Cancer (MIBC) in cisplatin-ineligible patients.

$42M: Series A for Allogeneic CAR-NK Cell Therapies

Catamaran Bio has launched with $42 million in financing. Sofinnova Partners and Lightstone Ventures co-led the Series A round that is part of the launch financing, with participation by founding investor SV Health Investors, as well as Takeda Ventures and Astellas Venture Management. Proceeds will be used to advance the companys two lead chimeric antigen receptor (CAR)-NK cell therapy programs. In addition, funding will expand the companys TAILWIND Platform, an integrated and proprietary suite of technologies for designing, genetically engineering, and manufacturing allogeneic CAR-NK cell therapies.

$34M: Series B for glycoproteomic powered ovarian cancer diagnostic

InterVenn Biosciences has raised $34M in a Series B fundraising. The latest round was led by Anzu Partners with full participation of Genoa Ventures, Amplify Partners, and True Ventures; Xeraya Capital and the Ojjeh Family joined the syndicate as well. Funds will be used to commercialize the companys High-Throughput-Glycoproteomic powered diagnostic for ovarian cancer; to service increasing partnership platform demand; and to accelerate development efforts for the immuno-oncology treatment response and colorectal cancer indications. InterVenn has demonstrated that analysis of protein glycosylation, the most common and most complex form of post-translational protein modification, is a highly effective way of discovering uniquely informative biomarkers. This breakthrough was made possible given the companys development of its AI neural network for high throughput analysis (PiP) and enabling software that powers the proprietary Vista research product for over a dozen different oncology indications.

$24M: Series A for Molecular Cartography

Resolve Biosciences has completed a $24 million Series A financing round and appointed Co-founder Jason T. Gammack as Chief Executive Officer. The Series A financing round was led by PS Capital Management and MasterMind Advisory Services and included participation from Alafi Capital, John Shoffner, and High Tech Grnderfonds. The company will use the proceeds to accelerate product development and drive industry adoption of its Molecular Cartography technology. The company's Molecular Cartography platform is a groundbreaking multi-analyte and highly multiplex spatial analysis technology that enables scientists to resolve the most daunting biological challenges in areas such as oncology, neuroscience, and infectious disease. It produces deep contextual datasets that illuminate molecular interactions at subcellular resolution, while preserving the sample tissue. The initial applications of Resolve's Molecular Cartography platform deliver the highest-resolution view of transcriptomic activity and provide the ability to interrogate hundreds of genes in a single run. Future solutions will add DNA, protein, and metabolomic data layers. Unlike current approaches, Resolve's technology provides the required sensitivity, specificity, and workflow convenience to elucidate the cell's complex transcriptional landscape.

$23M: Series A for Traumatic Brain Injury Test

BRAINBox Solutions announced the initial closing on a $23 million Series A financing to support the clinical development of the company's BRAINBox TBI (Traumatic Brain Injury) Test to aid both in the diagnosis and prognosis of mild TBI (concussion). BioVentures Investors led the financing round and was joined by the Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon Holdings LLC, Astia Angels and additional qualified investors, including Kevin Love, professional basketball player and mental health advocate. BRAINBox TBI is the first test designed to assist in both the diagnosis and prognosis of concussion. The multi-marker and multi-modality test, which can be used in either point-of-care or clinical laboratory settings, includes a panel of blood biomarkers as well as advanced digital neurocognitive testing in partnership with BrainCheck, Inc. Using proprietary AI algorithms, BRAINBox TBI combines the results of the test components and patient reported outcomes to generate a single, objective score for diagnosis up to 96 hours from the time of injury and a prognosis report for likely injury-related symptoms up to three months post-event.

$23M: Series B for Digital, Computational Pathology Solutions

Proscia has secured $23 million in Series B funding led by Scale Venture Partners, with participation from Hitachi Ventures, the strategic corporate venture capital arm of Hitachi, Ltd., bringing its funding total to $35 million. The company will use the investment to accelerate its global growth and strengthen its position of leadership in transforming cancer research and diagnosis at a time when demand for modernizing pathology is higher than ever. With its Concentriq software platform, Proscia is accelerating the transformation to digital pathology, which centers around high-resolution images of tissue biopsies, as the new standard of care. Concentriq combines enterprise scalability with powerful AI applications to help laboratories, health systems, and life sciences companies unlock new insights, accelerate breakthroughs, and improve patient outcomes.

$21.5M: Series B for Software, Data Products for Biomarker Discovery

Ovation.io has raised $21.5 million in Series B funding led by SignalFire with participation from Madrona Venture Group, Borealis Ventures, StageDotO Ventures and industry veteran David Shaw. Ovations suite of software and data products make it easier for molecular diagnostic labs to bring innovative tests to the patients that need them. Developed by scientists to help laboratories accelerate adoption of molecular diagnostics, Ovation is a turn-key, cloud-based platform with configurable, out-of-the-box workflows for molecular tests and seamless integrations to support the needs of a rapidly growing lab. With this latest round of funding, Ovation will work with its network of participating labs to develop insights that can help life-science companies reduce the time and cost associated with biomarker discovery.

$20M: Series A for AI-Powered Cell Classification

Deepcell has closed its Series A round of financing with $20 million, led by Bow Capital and joined by Andreessen Horowitz, which led its $5 million seed round. The new funding will allow Deepcell to develop its microfluidics-based technology, continue building a cell morphology atlas of more than 400 million cells, and drive a hypothesis-free approach to cell classification and sorting. Spun out of Stanford University in 2017, Deepcell is using deep learning and big data to classify and isolate individual cells from a sample. The technology combines advances in AI, cell capture, and single-cell analysis to sort cells based on detailed visual features, delivering novel insights through an unprecedented view of cell biology. The Deepcell platform maintains cell viability for downstream single-cell analysis and can be used to isolate virtually any type of cell even those occurring at frequencies as low as one in a billion to offer access to rare cells and atypical cell states that will help advance precision medicine research.

$20M: Series B for Spatial Omics

Rebus Biosystems has closed a $20 million Series B financing round, led by Illumina Ventures and joined by Lifecore Partners, Ncore Ventures, Xolon Invest, CTK Investments, Ray Co., Ltd., Seegene Medical Foundation, LabGenomics Co., Ltd., and Timefolio Asset Management. At the heart of the Rebus Biosystems spatial omics solution is the companys patented Synthetic Aperture Optics (SAO) system, which provides the resolution and sensitivity of a 100X oil lens, but with the breadth and depth of a 20X air lens. Data is captured 100 times faster than with other imaging based spatial omics methods that rely on 100x lenses and z-stacking. Speed and ease of use of the system is further improved by integration with custom microfluidics and image processing.

$14.8M: Scaled Up Production of Portable PCR Diagnostic Device

QuantuMDx Group Limited, a UK-based life sciences company, is investing over 11 million to scale up production to mass manufacture its flagship diagnostic device, Q-POC and disposable test cassette. QuantuMDx accelerated development, scale-up and manufacture of Q-POCits rapid point-of-care testing systemearlier this year in response to the COVID-19 pandemic.Q-POC is a portable, PCR device offering rapid, sample-to-answer, molecular diagnostic testing at the point of care, with results in approximately 30 minutes. The Q-POC system comprises a sample collection kit, single-use test cassette and analyzer. The companys first commercial assay for Q-POC will detect SARS-CoV-2, the virus causing COVID- 19, and Flu A & B, providing a powerful rapid PCR diagnostics and surveillance tool for clinicians and public health officials.QuantuMDx has worked with British development partner Cambridge Design Partnership to undertake pilot manufacturing of Q-POCTM, and is now working with Cogent Technology, as the company scales for volume manufacturing.

$14M: Novel Treatment for Ischemic Stroke

BrainsGate has secured $14 million in a new investment round at a pre-money valuation of $147 million. New investor, BNP Joint Capital Fund, and the Impact investment and consulting firm SPERO led the round alongside existing investors, Elron, Medtronic, Agate, Pitango, and Cipio. The new investment is expected to fund BrainsGate through its pre-market approval (PMA) and enable it to achieve volume production readiness and apply for coverage from the Centers for Medicare & Medicaid Services (CMS) for its Ischemic Stroke System (ISS). BrainsGates therapy involves a less than 5 minutes procedure in which a neurostimulator implant is injected into an existing canal. The implant stimulates a nerve center that augments collateral blood flow to improve stroke patients outcomes in a 24-hour window. In May 2020, BrainsGate received marketing approval in Europe (CE marking) of its ISS product. BrainsGates PMA application was filed with the US FDA in February 2020. The company plans to initiate commercialization activities subject to the PMA being approved.

$10.6M: UK Investment Firm for Life Sciences

Intuitive Investments Group, a closed-end investment company focused on the life sciences sector, has raised 7.85 million (before expenses) in its AIM float by placing 39,250,000 new Ordinary Shares at 20p. The net proceeds of the Placing will be used by the Company to invest in fast growing and/or high potential Life Sciences businesses, based predominantly in the UK, wider Europe and the US, chosen from an identified pipeline of investment opportunities. Investments will be focused on diagnostics and healthcare, medical devices, tools and technologies and bio-therapeutics and pharmaceuticals

$7.4M: BARDA Extension For Point-of-Care Infection Diagnostics

Inflammatix has announced a contract extension of $7.4 million from the Biomedical Advanced Research and Development Authority (BARDA) to further develop its point-of-care test and system to diagnose infection by reading the immune system. The contract is part of a BARDA contract worth up to $72 million, if all options are exercised. The new funding will support continued development and commercialization of Inflammatixs sample-to-answer, point-of-care Myrna test system, which is designed to read RNA using machine learning and produce results in under 30 minutes, as well as continued development of the ViraBac EZ test (formerly known as HostDx Fever), which reads gene expression patterns in the immune system to identify whether a suspected infection is bacterial or viral, enabling physicians to quickly and accurately determine when to prescribe antibiotics. The test will use a fingerstick collection and capillary blood sample, and is designed for use in primary care, urgent care and other outpatient clinical settings.

$6.6M: Series A for Robotics, Machine Learning in Biology

Trailhead Biosystems announced its $6.6 million Series A financing. The company has developed a proprietary platform to perform systems-level interrogation of complex biological problems, ranging from the generation of industrially-scalable manufacturing conditions for specialized human cells to combinatorial drug discovery in cancer and anti-viral therapies. Trailhead robotically conducts the largest dimensioned experiments in biology, using machine learning to discover critical process parameters and combinatorial inputs that explain biological responses. Trailhead aims to rapidly develop the capability of creating specialized human cell types at high purity for regenerative medicine and therapeutic purposes at an industrial scale, addressing current industry needs for highly specialized cells used in drug discovery and modeling of human diseases. Through strategic partnerships, the cells provided by the company will be used to address multiple areas of clinical need. The company currently develops products that target type I diabetes, Parkinson's disease, Multiple Sclerosis, Alzheimer's disease, and blood disorders, among others.

$6.1M: 3-D Sequencing Platform

DNA sequencing instigator Single Technologies announced the completion of a heavily oversubscribed 5 million share issue to existing and new shareholders. Among the new investors are Jens von Bahr, Rothesay Ltd, Carl-Henric Svanberg funded Cygnus Montanus Trust, Professor Ulf Landegren and Andreas Ehn. The funds will be used to accelerate development of the companys 3-D sequencing platform. Stockholm Corporate Finance acted as financial advisor. The new funding will enable the company to finalize automating its 3-D sequencing process, make it more robust and improve quality for both Whole Genome Sequencing (WGS) and transcriptomics applications. The ambition is to open the first data sequencing production site in Stockholm by 2022.

$5M: Gates Grant for At-Home COVID-19 Test

Sherlock Biosciences has received a $5 million grant from the Bill & Melinda Gates Foundation to continue to advance INSPECTR, its instrument-free, synthetic biology-based molecular diagnostics platform. In addition to advancing the INSPECTR platform development to be as sensitive as gold-standard PCR tests, the funding will support the development of an over-the-counter disposable product, similar to an at-home pregnancy test, that can be used to detect SARS-CoV-2, the virus that causes COVID-19. Pending approval, the company says they will launch this product in mid-2021. INSPECTR, which stands for Internal Splint-Pairing Expression Cassette Translation Reaction, uses synthetic biology to enable the creation of instrument-free diagnostic tests that can be conducted at home, at room temperature. INSPECTR can be adapted to work on a simple paper strip test or to provide an electrochemical readout that can be read with a mobile phone. It can also be adapted for use in laboratory or point-of-care settings.

$4M: Prostate Health Center at Mount Sinai

Mount Sinai has received a $4 million donation from Lizzie and Jonathan Tisch to support prostate health and the Milton and Carroll Petrie Department of Urology at Mount Sinai. The prostate program will be named The Lizzie and Jonathan Tisch Center for Prostate Health. The medical services provided at the Lizzie and Jonathan Tisch Center for Prostate Center include state-of-the-art prostate cancer screening and imaging technologies, precision urology, focal therapy, targeted biopsies, robotics for prostate cancer surgery, prostate cancer fusion biopsy, and active surveillance. Additionally, prostate cancer experts such as Dr. Tewari; Avinash Reddy, MD; Sujit Nair, PhD; Robert Valenzuela; MD; Michael Palese, MD; and Steven Kaplan, MD, are available to see patients at the newly named Center.

$2.9M: NIH Grant for Human Placental Stem Cells

Human placental stem cells may have the potential to regenerate heart tissue after a heart attack, according to Mount Sinai researchers who have received a $2.9 million grant from the National Institutes of Health to study them. Their findings could lead to new therapies for repairing the heart and other organs. Hina W. Chaudhry, MD, Director of Cardiovascular Regenerative Medicine at the Icahn School of Medicine at Mount Sinai, is the Principal Investigator for this four-year award. Dr. Chaudhry and a team of investigators previously discovered that mouse placental stem cells can help the hearts of mice recover from injury that could otherwise lead to heart failure. They identified a specific type of placental stem cells, called Cdx2 cells, as the most effective in making heart cells regenerate.

$2M: Cryo Solutions for Cell, Gene Therapy

GlycoNet has secured a $2-million USD equity investment for PanTHERA CryoSolutions (PanTHERA), a Canadian biotechnology start-up. The investment came from US-based investor Casdin Capital and bioproduction tools supplier BioLife Solutions Inc. In addition to an up-front investment, subject to closing conditions, BioLife will provide an additional $2 million to support product development over the next 24 months in exchange for exclusive, worldwide marketing and distribution rights to the technology for use in cell and gene therapy applications. The core technology from PanTHERA was created out of an academic research collaboration between the University of Ottawa and the University of Alberta. During cryopreservation of biological materials, the uncontrolled growth of ice causes cell injury and death. PanTHERA's solution is to develop ice recrystallization inhibitors (IRIs) to control the growth of ice and prevent this damage from occurring, ultimately resulting in superior cellular products after thawing.

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Follow the Money: Spatial Omics, CAR-NK Cells, AI-Powered Biology - Bio-IT World

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