Monthly Archives: July 2021

Nova Scotians fighting some types of lymphoma will soon be able to receive a potentially life-saving therapy in their home province.

A new CAR T-cell treatment program is being made possible through $18 million in investments in cancer careannounced Monday by the provincial government.

CAR T-cell therapy is a method of immunotherapy that modifies a person's immune cells or T-cells in a way that the cells are able to detect the cancer and fight it within the patient for the rest of their lives.

About $6.7 million of that funding will be spent annually on the new therapy.

"This will literally be the difference between life and death for patients diagnosed with certain types of cancer," said Dr. Helmut Hollenhorst,the senior medical director of Nova Scotia Health's Cancer Care Program.

Hollenhorstsaid that non-Hodgkin's lymphomas are the fifth most common cancers in Canada and advances in treatment can now cure the illness in about two-thirds of patients.

But the remaining third are only expected to survive for about six monthswhen cancer recurs, he said.

"The CAR T-cell is a type of personalized medicine that has the potential to cure non-Hodgkin's lymphoma when other treatment methods are not available," saidHollenhorst.

The therapy has been approved by Health Canada but specialist staff and equipment are needed, so the proposal for the new program took a couple of years to come to fruition.

About eight patients every year travel from Nova Scotia to Boston for the treatment but others decide not to go due to extra financial costs and added stress to their families.

It's expected now the treatment will be available in Halifax that double that number will take what Hollenhorst describes as a last chance treatment.

"We are committed to providing Nova Scotians with the cancer care and support they need, closer to home," said Health and Wellness Minister Zach Churchill. "These changes add another treatment option not previously available in Nova Scotia and will expand eligibility and ensure patients pay less for travel, accommodations, supplies and cancer drugs."

Churchill said conversations will happen with other Atlantic provinces about the possibility of residents from neighbouring provinces being able to access the treatment.

The Nova Scotia government will also spend $11.1 million in the next three years to reduce out-of-pocket costs for travel, accommodations, supplies and cancer drugs for patients.

About $225,000 of that money will go to the Canadian Cancer Society's Dr. Susan K Roberts Lodge That Gives, which provides free accommodations for people who live outside Halifax while they undergo cancer treatment.

Churchill said the new funds being announced are the result of the 2018 review of cancer services in Yarmouththat included input from patients, physicians, staff and people in the community.

The new CAR T-cell therapy is expected to be available in six months at the QEII Health Sciences Centre.

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N.S. to become first Atlantic province to offer potentially life-saving cancer treatment - CBC.ca

SOUTH SAN FRANCISCO, Calif., June 30, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ALLO-605, the Companys next-generation AlloCAR T therapy targeting BCMA for the treatment of relapsed or refractory multiple myeloma. The FDA granted Fast Track designation based on the potential of ALLO-605 to address the unmet need for patients who have failed other standard multiple myeloma therapies. The Phase 1 dose escalation portion of the IGNITE trial evaluating ALLO-605 was initiated in Q2 2021.

ALLO-605 is the Companys first TurboCAR clinical candidate. TurboCAR is a proprietary, next generation platform technology based upon programmable cytokine signaling designed to improve the function and potency of AlloCAR T cells. These properties may also enable CAR T therapy to succeed in solid tumors and increase efficacy in hematologic malignancies. Preclinical results from the ALLO-605 study were presented in a poster session at the American Society of Hematology (ASH) annual meeting in December of 2020.

We are very pleased with the continued momentum of our anti-BCMA portfolio for patients with multiple myeloma and look forward to making allogeneic CAR T therapy a potential option for these patients, said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. With studies now underway for ALLO-715 alone and in combination with a gamma secretase inhibitor, as well as ALLO-605 as our next generation CAR T, we are taking an aggressive three-pronged approach aimed at exploring the unique attributes of AlloCAR T therapies for patients with rapidly progressing disease.

Initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma were presented at an oral session of the ASH annual meeting in December 2020. In April 2021, ALLO-715 was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA. Separately, the UNIVERSAL study began enrolling patients in the first half of 2021 to evaluate ALLO-715 in combination with SpringWorks Therapeutics investigational gamma secretase inhibitor, nirogacestat.

Fast Track is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may be better than what is currently available.

About ALLO-605ALLO-605 is a next-generation AlloCAR T investigational therapy that targets the B-cell maturation antigen (BCMA) for the treatment of patients with relapsed/refractory multiple myeloma and other BCMA-positive malignancies. This study uses ALLO-647, Allogene's proprietary monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen. ALLO-605 incorporates Allogenes proprietary TurboCAR technology, which allows for cytokine activation signaling to be engineered selectively into CAR T cells. Preclinical results with ALLO-605 were presented at the American Society of Hematology (ASH) annual meeting in December 2020. In June 2021, ALLO-605 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed/refractory multiple myeloma.

About Allogene TherapeuticsAllogene Therapeutics, with headquarters inSouth San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visitwww.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to progress the Phase 1 IGNITE trial of ALLO-605; the ability of ALLO-605 and other TurboCAR candidates to improve the function and potency of AlloCAR T cells, enable success in solid tumors and increase efficacy in hematologic malignancies; and the potential benefits of AlloCAR T therapy. Various factors may cause differences between Allogenes expectations and actual results as discussed in greater detail in Allogenes filings with the SEC, including without limitation in its Form 10-Q for the quarter ended March 31, 2021. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

AlloCAR T and TurboCAR are trademarks of Allogene Therapeutics, Inc.

ALLO-605 and ALLO-715 utilize TALEN gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at BCMA and holds all global development and commercial rights for this investigational candidate.

Allogene Media/Investor Contact:Christine CassianoChief Communications Officer(714) 552-0326Christine.Cassiano@allogene.com

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Allogene Therapeutics Granted FDA Fast Track Designation for ALLO-605, the First TurboCAR T Cell Therapy, for the Treatment of Relapsed/Refractory...

Each Monday, CancerNetwork highlights the most important content from the previous week in oncology news.

This week, the recap is headlined by an article investigating the differences in genetic risk for breast cancer in Black and non-Hispanic White women. Then, a pair of thought leaders share their thoughts on research presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

Black and non-Hispanic White Women Found to Have No Differences in Genetic Risk for Breast Cancer

Differences in frequency of germline pathogenic variants were not seen in patient subsets by ethnicity when comparing 12 genes linked with breast cancer.

At a time when Black men and women are more likely to be diagnosed with cancer at later stages when it is less treatable, [the Black & BRCA initiative] seeks to empower people to understand their family health history and take action to prevent cancer from one generation to the next, said first author Susan Domchek, MD, executive director of the Basser Center for BRCA.

Navigating an Optimal Treatment Course for Advanced Kidney Cancer

Benjamin A. Teply, MD, considers the optimal treatment of renal cell carcinoma in a peer perspective accompanying an article by Tiffany Y. Shaw, MD, and colleagues.

A remarkable sea change has occurred over the past 3-plus years, as the results of 5 separate positive phase 3 studies have demonstrated superiority of immunotherapy-containing regimens over monotherapy with the anti-VEGF tyrosine kinase inhibitor (TKI) sunitinib (Sutent) in the first-line setting.

Neal D. Shore, MD, on the Importance of Multidisciplinary Care in Advanced Prostate Cancer

At the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, CancerNetwork spoke with Neal D. Shore, MD, FACS, regarding the importance of multidisciplinary care for patients with advanced prostate cancer.

Incorporating a multidisciplinary approach for patients with advanced prostate cancer is essential in order to provide patients with further therapeutic benefit and improve quality of life.

Friendly Competition Fosters Progress in Hematologic Malignancies

With options for transplant, chimeric antigen receptor T-cell therapy, tyrosine kinase inhibitors, and immunotherapy in most tumor types, appropriate therapy selection for a given patient is far from straightforward or standard.

To discuss this and emerging breakthroughs, Elias Jabbour, MD, a professor of medicine in the Department of Leukemia, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center in Houston, reflected on his body of work and how competition among colleagues motivated his contributions to the field of medicine.

Stephen Liu, MD, on How Targeted Therapy Results in Significant Efficacy for RET-Altered Tumors

CancerNetwork sat down with Stephen Liu, MD, of the Georgetown Lombardi Comprehensive Cancer Center in Washington, DC, at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to discuss what multidisciplinary providers can learn from outcomes of the phase 2 ARROW trial (NCT03037385) of pralsetinib in patients with RET fusionpositive nonsmall cell lung cancer.

For more updates from CancerNetwork, make sure to follow us on Facebook, Twitter, and LinkedIn to stay up to date on the latest in oncology.

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CancerNetwork's Week in Review: July 5th, 2021 - Cancer Network

American Gene Technologies is celebrating a milestone in its HIV Cure Program, which is currently in Phase 1 human trial. The first participant, an unidentified man.

ROCKVILLE, Md. At a biotechnology company in Rockville, Md., a team of molecular biologists is working to develop cures for cancer, HIV and a range of other diseases.

American Gene Technologies (AGT) is celebrating a milestone in its HIV Cure Program, which is currently in Phase 1 human trial. The first participant, an unidentified man, was treated in late May.

Now, the Food and Drug Administration (FDA) is reviewing the safety of AGTs new cell therapy product, AGT103-T, which is intended to cure HIV.

Were putting viruses in their bodies that are going to specific cells and that are making very, very specific changes in a targeted way, said American Gene Technologies CEO, Jeff Galvin.

The first patient was stellar, Galvin said. Initial safety data is cause to celebrate because what it says is that the process by which we are doing a cell modification for these patients seems to be showing safety.

Galvin is expecting a decision this month, from the Data Safety and Monitoring Board to find out if his team can move forward with treating additional patients.

Most drugs fall out of the development process because of adverse events, so in other words, the drug itself might work on the disease, but the problem may be, people cant tolerate the treatment itself.

With the FDAs approval, Galvin said his team took blood from a man with HIV, to extract his infected T-cells.

HIV is known for hijacking the bodys T-cells, which are cells that fight off some viral infections, thus, weakening the immune system.

Galvins team modified those extracted T-cells from the first participant, to make them resistant to HIV. The reprogrammed cells were infused back into the patient, which, if all goes as planned, would keep the virus from spreading.

We have learned so much about viruses, specifically about HIV, that we can now crack them open, scoop out their disease software, Galvin said. We are so excited at the company and we are trying to contain our excitement because the HIV community has been waiting for a cure for so long.

If AGT gets the green light to move forward with other patients this month, Galvin said, by years end, theyll take blood samples from those participants to see if the modified T-cells are healthy and working as intended. Galvin called it an efficacy signal that will be convincing to the scientific community that the cure for HIV has been achieved or is tremendously close.

This year, we may prove that a functional cure is possible and see the end of HIV in our lifetime, Galvin said.

From that point, and with additional approval from the FDA, researchers would ask some of the participants to stop taking their antiretroviral medication to see what happens to the virus in their bloodstream. After 21 days, Galvin said, theyd have clear indicators revealing the effectiveness of this treatment.

There have been promises of a cure since the first cases of what would later be known as HIV/AIDS.

The Centers for Disease Control and Prevention (CDC) published a report on June 5, 1981, describing a Pneumonia-like disease discovered in five previously healthy gay men in Los Angeles.

Since that study, millions of people have died from HIV/AIDS globally.

What was once a virtual death sentence, is now a manageable disease for some, because of the development of antiretroviral treatments.

In the immediate Washington metropolitan area, 26,824 people are living with HIV, including 39-year-old, Dr. Ravi Perry.

Ive lived far longer than I ever thought I would on the day I was diagnosed, Dr. Perry said. "I genuinely treat every day as a blessing. My immune system still is somewhat compromised. When I get a cold, my colds used to last for a day or two, now it may last four to six days. Your body has a slower response."

Dr. Perry was a junior in college when he was diagnosed on September 4, 2003. While antiretroviral medicines were available at the time, he said, some were too toxic. Dr. Perry was in the hospital consistently because his immune system was weakening and his mental state, waning.

"I certainly remember thinking that I would never be in a relationship, never thought that I would get married, never thought I would have sex again and thought that my life was on its way to its expiration date, Dr. Perry recalled.

For the last 15 years, Dr. Perry said, hes been undetectable.

Ive been able to live a mostly normal life, even with HIV. Its not something I expected to get, but I was 21 when I was diagnosed. Ive grown accustomed to telling that story because I think its important for younger people, Perry said.

As Chair of the Political Science Department at Howard University, Dr. Perry reminds students on campus about the seriousness of this virus. He also tells his story at local churches and community events.

My hope is that people realize the seriousness of HIV, but that people are living with HIV and not dying as much from AIDS anymore. The stigma associated with it, I think, certainly has no place in society, Dr. Perry added.

While Dr. Perry doesnt expect a cure to be developed in his lifetime, he said there are steps to take to eliminate HIV. First, with equal emphasis on prevention and intervention.

We seem to be focused on prevention because of course, most of the world is negative, Dr. Perry said. We all can be doing more to help ensure this disease doesnt ravage another generation. We can be donating our time to HIV/AIDS organizations. We can be lobbying the Red Cross to lift their ban on gay men not being allowed to give blood. We can be lobbying our congress members to eliminate these HIV criminalization laws that are abhorrent and from another era. We can of course in our own personal and private lives be ensuring we are having conversations with our nieces, our nephews, our cousins about HIV and sexual health."

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'We're in it to win it' | Maryland company progresses with development of HIV 'functional cure' - WUSA9.com

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Chapter 1: T-Cell Therapy Overview, Product Overview, Market Segmentation, Market Overview of Regions, Market Dynamics, Limitations, Opportunities and Industry News and Policies.

Chapter 2: PEST (Political, Economic, Social and Technological) Analysis of T-Cell Therapy Market.

Chapter 3: Value Analysis, Production, Growth Rate and Price Analysis by Type of T-Cell Therapy.

Chapter 4: Downstream Characteristics, Consumption and Market Share by Application of T-Cell Therapy.

Chapter 5: Production Volume, Price, Gross Margin, and Revenue ($) of T-Cell Therapy by Regions.

Chapter 6: T-Cell Therapy Production, Consumption, Export, Market Trends and Competitive Landscape.

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Chapter 10: Market Analysis and Forecast by Regions.

Chapter 11: Industry Characteristics, Key Factors, New Entrants SWOT Analysis, Investment Feasibility Analysis.

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T-Cell Therapy Market Reviewed for 2019 with Industry Outlook to 2027 The Manomet Current - The Manomet Current