Category Archives: Regenerative Medicine

--100% ORR at both dose levels; deep and durable responses observed in patients with poor prognostic factors --

-- 22 of 31 (71%) evaluable patients reached CR/sCR --

-- 13 of 16 patients (81%) dosed more than 12 months ago reached CR/sCR; 8 (50%) with EMD; 9 (56%) remain in ongoing response with a median follow up of 17.7 months --

-- No cases of Grade 3 CRS and no delayed neurotoxicity or parkinsonian-like events observed at RP2D (n=25) --

-- Phase 2 pivotal study on track to initiate by YE 2022 --

-- Management to host live webcast event on Sunday, June 5, 2022, at 7:00 p.m. CDT to discuss new positive CART-ddBCMA data with a panel of clinician experts --

FOSTER CITY, Calif., June 3, 2022 /PRNewswire/ -- Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced new positive clinical data from the ongoing Phase 1 expansion study of its novel, autologous, CART-ddBCMA therapy for the treatment of patients with relapsed or refractory multiple myeloma. The clinical results are being presented during an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

Evaluable for efficacy and safety analysis were 31 patients, based on follow-up of at least one month, following treatment. These evaluable patients comprised the dose escalation cohorts for the first dose level (100 million CAR+ T cells, n=6), the second dose level (300 million CAR+T cells, n=6), and a dose expansion cohort at the recommended Phase 2 dose (RP2D) of 100 million CAR+T cells (n=19). All patients enrolled in the study have poor prognostic factors with 21 of 31 (68%) patients penta-refractory, 12 of 31 (39%) extramedullary disease (EMD), and all 31 patients having had at least three prior treatments.

The interim CART-ddBCMA clinical results (May 3, 2022 cutoff date) demonstrate deep and durable responses in patients with poor prognostic factors.

Matthew J. Frigault, M.D., CART-ddBCMA study investigator and Assistant Director of the Cellular Therapy Service at Mass General Cancer Center and Instructor at Harvard Medical School said, "The demand for clinically meaningful and safe CAR-T therapies outweighs what's currently available to multiple myeloma patients. It is encouraging to see these data continue to demonstrate deep responses and provide a benefit to patients. I look forward to enrolling patients in the Phase 2 pivotal study."

"We're excited by these long-term results, particularly given the challenging patient demographics, and believe these promising results reflect the potential for our lead program, CART-ddBCMA, to be a best-in-class treatment for patients with multiple myeloma," said Rami Elghandour, Arcellx's Chairman and Chief Executive Officer. "We believe there's a significant unmet need for cell therapies and we're committed to providing physicians with a safe and effective treatment option for multiple myeloma patients. We're honored to have our data presented at ASCO by Dr. Frigault and look forward to beginning enrollment in our Phase 2 pivotal study by the end of this year as the next step in the path towards regulatory approval."

The presentation can be accessed on the company's corporate website here.

Oral Presentation Details:

Title:Phase 1 Study of CART-ddBCMA in Relapsed or Refractory Multiple MyelomaSpeaker:Matthew J. Frigault, M.D., Assistant Director of the Cellular Therapy Service at Mass General Cancer Center, and Instructor at Harvard Medical SchoolSession Type/Title:Oral Abstract Session/Hematologic MalignanciesPlasma Cell DyscrasiaSession Date:Sunday, June 5, 2022Session Time: 8:00 a.m. 11:00 a.m. CDTLocation:McCormick Place Convention Center, Chicago, IllinoisAbstract Number:8003

Webcast Event:

Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results on Sunday, June 5, 2022, at 7:00 p.m. CDT. The event will be accessible from Arcellx's website atwww.arcellx.comin the Investors section. A replay of the webcast will be archived and available for 30 days following the event.

About Multiple Myeloma

Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient's immune function. Multiple myeloma is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About CART-ddBCMA

CART-ddBCMA is Arcellx's BCMA-specific CAR-modified T-cell therapy utilizing the company's novel BCMA-targeting binding domain for the treatment of patients with relapsed or refractory multiple myeloma. CART-ddBCMA is currently in a Phase 1 study. Arcellx's proprietary binding domains are novel synthetic proteins designed to bind specific therapeutic targets. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

About Arcellx, Inc.

Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx's mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Arcellx's lead product candidate, CART-ddBCMA, is being developed for the treatment of relapsed or refractory multiple myeloma (r/r MM) in an ongoing Phase 1 study. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration.

Arcellx is also advancing its dosable and controllable CAR-T therapy, ARC-SparX, through two programs: a Phase 1 study of ACLX-001 for r/r MM, initiated in the second quarter of 2022; and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome, expected to enter the clinic in the second half of 2022.

Visitwww.arcellx.comfor more information.

Forward-looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon Arcellx's current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including those set forth in Part I, Item 1A (Risk Factors) of Arcellx's Annual Report on Form 10-K and in other reports, such as Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, that Arcellx may file from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Arcellx assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Contact:Myesha LacyArcellx, Inc.[emailprotected]510-418-2412

Media ContactLaura Morgan Sam Brown Inc.[emailprotected] 951-333-9110

SOURCE Arcellx, Inc

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Arcellx Presents Continued Robust Long-Term Responses from its CART-ddBCMA Phase 1 Expansion Trial in Patients with Relapsed or Refractory Multiple...

A revolutionary theoretical approach of aging that suggests that individuals might gradually turn feeble, following nearing their 70s; has opened the promise of novel medicines for age-related drop and illnesses.

Cambridge scientists concluded a mechanism that causes a fatal shift in hormone levels in old maturity level, raising the likelihood of bleeding malignancies and leukemia as well as reducing the ability of white blood cells to develop resistance, reported The Guardian.

Significant improvements, the experts claim, transpire in body parts across the system, from the epidermis to the nervous system, and might explain why individuals frequently mature decently for years prior to actually undergoing a relatively steep decrease in their 70s and 80s.

While according to Dr. Peter Campbell, corresponding author on the paper and director of the malignancy, ageing, and cancer stem cell project at Cambridge's Sanger Center, what was really intriguing with this research is that there could be a shared key mechanism at action. And the overall purpose is to halt or intervene in the aging phenomenon, although scientists foresee a potential to utilize this to quantify life expectancy.

Furthermore, aging is a complicated phenomenon, numerous researchers assume that the steady accumulation of alterations in tissues diminishes the body's natural capacity to operate effectively. The new study reveals such assumption is incorrect, or at finest partial, and mainly blames selfish genes that become dominant in old life.

Specialists analyzed leukocytes from infants through persons in their 70s and 80s in collaboration with academics from the Wellcome-MRC Cambridge Stem Cell Laboratory.

Researchers discovered that persons around the age of 65 had a diversified populace of 20,000 to 200,000 distinct varieties of progenitor cells in their brain tissue that generated a broad spectrum of red and white blood cells.

The scenario was drastically distinct among the over-65s. Nearly half of their lymphocytes were derived from a mere 10 or 20 unique regenerative medicine, significantly lowering the richness of the individual's blood cells, with negative effects for their wellness.

The authors discussed in Naturethat while stem cells associated with blood production accumulate alterations through history, the majority of these alterations are innocuous.

As per the website Time To Time, as an individual is in their 30s and 40s, the proliferation benefit of the mutant progenitor cells is negligible, however when they attain retirement point of 70, these fast-growing lymphocytes begin to predominate erythrocytes creation.

Also read: Activists Rescue Scared Dog From Meat Shop in China Ahead of the Yulin Festival

The huge increase answers why there is a rapid shift in morbidity beyond the maturity level of 70, why withering strikes at that period. Faster-growing rbcs have been related to blood malignancies and leukaemia, although they potentially render patients more susceptible to illness and experimental interventions like radiotherapy.

"Researchers recognize that all of these facts extend to other body systems," Campbell remarked. The group plans to hunt for the similar system in epidermis to comprehend why creases and delayed injury repair occur with maturity.

According to Dr. Elisa Laurenti, an associate lecturer at the Wellcome-MRC Cambridge Stem Cell Institute and a co-senior investigator on the investigation, systemic inflammatory, tobacco, disease, and medication all could create cancer-causing growth factors.

Researchers anticipate that these variables will similarly hasten the reduction in blood stem cell variety connected with aging.

It's probable that there are other things that could delay this machine down as well. Researchers also have the interesting challenge of determining how these recently found variations influence blood function in the seniors so that we may discover how to reduce illness injury and ensure overall health, as per Flipboard.

Related article: Hepatitis Outbreak in the US Linked to Contaminated Strawberries

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Aging to Your 70s and Above Makes a Catastrophic Change in Your Body, Says Research - Nature World News

BOSTON & ZUG, Switzerland & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (NASDAQ: CRSP) today announced new late-breaking clinical data accepted for oral presentation at the 2022 European Hematology Association (EHA) Congress. Vertex also announced three abstracts accepted for poster presentation at EHA.

Late-breaking abstract #LB2367 entitled Efficacy and Safety of A Single Dose of CTX001 For Transfusion-Dependent eta-Thalassemia and Severe Sickle Cell Disease, will be an oral presentation on Sunday, June 12 at 09:4511:15 CEST. The abstract from Vertex and CRISPR Therapeutics includes data on patients treated in CLIMB111 and CLIMB121 and followed in CLIMB131 with CTX001, now known as exagamglogene autotemcel (exa-cel). This abstract has been selected for the media briefing program and is therefore embargoed until Saturday, June 11 at 09:00 am CEST.

In addition, three real-world evidence and health economics abstracts from Vertex have been accepted for poster presentation.

The accepted abstracts are now available online on the EHA website.

Exacel is being investigated in multiple ongoing clinical trials as a potential one-time therapy for patients with either TDT or SCD.

About exagamglogene autotemcel (exa-cel)

Exacel, formerly known as CTX001, is an investigational, autologous, ex vivo CRISPR/Cas9 geneedited therapy that is being evaluated for patients with TDT or SCD characterized by recurrent VOCs, in which a patients own hematopoietic stem cells are edited to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygencarrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. The elevation of HbF by exacel has the potential to alleviate transfusion requirements for patients with TDT and reduce painful and debilitating sickle crises for patients with SCD. Earlier results from these ongoing trials were published in The New England Journal of Medicine in January of 2021.

Based on progress in this program to date, exacel has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for both TDT and SCD. Exa-cel has also been granted Orphan Drug Designation from the European Commission, as well as Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), for both TDT and SCD.

Among geneediting approaches being evaluated for TDT and SCD, exacel is the furthest advanced in clinical development.

About CLIMB111 and CLIMB121

The ongoing Phase 1/2/3 openlabel trials, CLIMB111 and CLIMB121, are designed to assess the safety and efficacy of a single dose of exacel in patients ages 12 to 35 years with TDT or with SCD, characterized by recurrent VOCs, respectively. The trials are now closed for enrollment. Patients will be followed for approximately two years after exacel infusion. Each patient will be asked to participate in CLIMB131, a longterm followup trial.

About CLIMB-131

This is a longterm, openlabel trial to evaluate the safety and efficacy of exacel in patients who received exacel in CLIMB111, CLIMB121, CLIMB141 or CLIMB151. The trial is designed to follow participants for up to 15 years after exacel infusion.

About CLIMB141 and CLIMB151

The ongoing Phase 3 open-label trials, CLIMB141 and CLIMB151, are designed to assess the safety and efficacy of a single dose of exacel in patients ages 2 to 11 years with TDT or with SCD, characterized by recurrent VOCs, respectively. The trials are now open for enrollment and currently enrolling patients ages 5 to 11 years of age and will plan to extend to ages 2 to less than 5 years of age at a later date. Each trial will enroll up to 12 patients. Patients will be followed for approximately two years after infusion. Each patient will be asked to participate in CLIMB-131, a longterm followup trial.

About the GeneEditing Process in These Trials

Patients who enroll in these trials will have their own hematopoietic stem and progenitor cells collected from peripheral blood. The patients cells will be edited using the CRISPR/Cas9 technology. The edited cells, exacel, will then be infused back into the patient as part of an autologous hematopoietic stem cell transplant (HSCT), a process which involves a patient being treated with myeloablative busulfan conditioning. Patients undergoing HSCT may also encounter side effects (ranging from mild to severe) that are unrelated to the administration of exacel. Patients will initially be monitored to determine when the edited cells begin to produce mature blood cells, a process known as engraftment. After engraftment, patients will continue to be monitored to track the impact of exacel on multiple measures of disease and for safety.

About the VertexCRISPR Collaboration

Vertex and CRISPR Therapeutics entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. Exacel represents the first potential treatment to emerge from the joint research program. Under an amended collaboration agreement, Vertex now leads global development, manufacturing and commercialization of exacel and splits program costs and profits worldwide 60/40 with CRISPR Therapeutics.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) a rare, life-threatening genetic disease and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1mediated kidney disease, pain, type 1 diabetes, alpha1 antitrypsin deficiency and Duchenne muscular dystrophy.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 12 consecutive years on Science magazine's Top Employers list and one of the 2021 Seramount (formerly Working Mother Media) 100 Best Companies. For company updates and to learn more about Vertex's history of innovation, visit http://www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

(VRTX-GEN)

Vertex Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, our plans and expectations to present clinical data from the ongoing exa-cel clinical trials during the EHA Congress, expectations regarding the abstracts that will be made available on the virtual platform and the clinical data that will be presented during the EHA Congress, including anticipated projections and estimates related to the various economic impacts of SCD and TDT, the potential benefits, efficacy, and safety of exa-cel, including the potentially transformative nature of the therapy and the potential of the treatment for patients, our plans and expectations for our clinical trials and pipeline products, the status of our clinical trials of our product candidates under development by us and our collaborators, including activities at the clinical trial sites, patient enrollment and expectations regarding clinical trial follow-up. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from a limited number of patients may not be indicative of final clinical trial results, that data from the company's development programs, including its programs with its collaborators, may not support registration or further development of its compounds due to safety and/or efficacy, or other reasons, that internal or external factors that could delay, divert, or change our plans and objectives with respect to our research and development programs, that future competitive or other market factors may adversely affect the commercial potential for exa-cel, and other risks listed under the heading Risk Factors in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission (SEC) and available through the company's website at http://www.vrtx.com and on the SECs website at http://www.sec.gov. You should not place undue reliance on these statements or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(CRSP-GEN)

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. For more information, please visit http://www.crisprtx.com.

CRISPR Therapeutics Forward-Looking Statement

This press release may contain a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, as well as statements regarding CRISPR Therapeutics expectations about any or all of the following: i) the safety, efficacy and clinical progress of the ongoing exa-cel clinical trials, including expectations regarding the abstract that will be made available on the virtual platform and our plans to present and the clinical data that are being presented during the EHA Congress; and (ii) the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies. Without limiting the foregoing, the words believes, anticipates, plans, expects and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, existing and prospective investors are cautioned that forward-looking statements are inherently uncertain, are neither promises nor guarantees and not to place undue reliance on such statements, which speak only as of the date they are made. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the potential for initial and preliminary data from any clinical trial and initial data from a limited number of patients (as is the case with exa-cel at this time) not to be indicative of final or future trial results; the potential that the exa-cel clinical trial results may not be favorable or may not support registration or further development; that future competitive or other market factors may adversely affect the commercial potential for exa-cel; CRISPR Therapeutics may not realize the potential benefits of its collaboration with Vertex; potential impacts due to the coronavirus pandemic, such as to the timing and progress of clinical trials; uncertainties regarding the intellectual property protection for CRISPR Therapeutics technology and intellectual property belonging to third parties; and those risks and uncertainties described under the heading Risk Factors in CRISPR Therapeutics most recent annual report on Form 10-K, quarterly report on Form 10-Q, and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission, which are available on the SEC's website at http://www.sec.gov. CRISPR Therapeutics disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

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Vertex and CRISPR Therapeutics Announce Acceptance of Late-Breaking Abstract for CTX001 at the 2022 Annual European Hematology Association (EHA)...

Established through a generous $20-million gift from the Larry and Judy Tanenbaum Family Foundation, the Tanenbaum Institute for Science in Sport at the University of Toronto will be a global centre of excellence for high-performance sport science and sports medicine.

The Tanenbaum Institute will yield new knowledge at the intersection of research and practice, translating discoveries into innovations that dramatically impact health and performance across all athlete populations.

The Tanenbaum Institute will bring together the leading sport science research of U of Ts Faculty of Kinesiology & Physical Education, the sports medicine research expertise of the Temerty Faculty of Medicine, and the renowned clinical and research leadership of the Dovigi Orthopaedic Sports Medicine Clinic and the Lunenfeld-Tanenbaum Research Institute at Sinai Health.

Today marks a monumental step forward in support of Canadian high-performance athletics, one that will lead to improved athlete performance, safety and well-being, said U of T President Meric Gertler. Thanks to the extraordinary generosity of Larry and Judy Tanenbaum, the Tanenbaum Institute for Science in Sport will become one of the worlds leading centres in the field. And the Institute will be truly unique, combining the strengths of U of Ts top-ranked research programs and sports medicine departments with leading clinical care centres at Sinai Health, all in the heart of one of the worlds most celebrated sporting cities.

The Tanenbaum Institute for Science in Sport will help model and predict athlete performance and improve health outcomes based on a wealth of data from across the Greater Toronto Area. This new knowledge will support high-performance athletes across a spectrum that includes world-class professional, non-professional and para athletes, including from diverse and underrepresented communities, as well as athletes striving for high-performance optimization in recreational sports.

The institute will catalyze U of T and Sinai Healths sport science and sports medicine expertise, generating novel insights and innovative technologies and interventions that improve athlete performance, health, safety and well-being; reduce risk of injury; accelerate and optimize recovery and rehabilitation; and advance high-performance sport in a manner that is safe, welcoming, inclusive and accessible to all.

To this end, the Tanenbaum Institute will work in partnership with sports clinics, associations and organizations, including Maple Leaf Sports & Entertainment (MLSE) and its teams: the Toronto Maple Leafs, Toronto Raptors, Toronto FC and the Toronto Argonauts, as well as the Toronto Marlies, Raptors 905 and TFC 2.

I truly believe that sport unites us, inspires us, and offers all people a path toward becoming their best selves, said Larry Tanenbaum, chairman of Tanenbaum Family Foundation and MLSE. The Tanenbaum Institute will bring together sports medicine, sport science and data science to encourage athletic engagement, enhance performance and accelerate recovery and rehabilitation. Im proud to join with U of T and Sinai Health in transforming athlete health and well-being.

Larry and Judy Tanenbaums gift will be combined with more than $20 million in additional support from U of T and Sinai Health. This investment will establish a Directorship and Research Acceleration Fund to support bold, innovative research across the institute, the university, and Sinai Health; create a groundbreaking new Chair in Sport Science and Data Modelling, a Chair in Musculoskeletal Regenerative Medicine, and a Professorship in Orthopaedic Sports Medicine; and provide funding for a range of cutting-edge research, innovations and clinical programs.

The Tanenbaum Institute will enjoy a remarkable head start, thanks to the amazing research and clinical sports medicine leadership we have amassed here at Sinai Health through the Dovigi Orthopaedic Sports Medicine Clinic and across U of T, said Dr. Gary Newton, president and CEO of Sinai Health. Establishing this landmark Institute is only the beginning. We look forward to transforming high-performance sport together with our many industry, government, and community partners.

The Tanenbaum Institutes cutting-edge research will play a leading role in advancing high performance sport in a manner that is safe, welcoming, inclusive and accessible to all, said Gretchen Kerr, dean of the Faculty of Kinesiology & Physical Education at U of T. We are so excited to be joining in this important research enterprise by pooling together our academic research, large and diverse athlete base, and training facilities with the world-class clinicians of Sinai Health.

Were incredibly excited by the potential for the Tanenbaum Institute to transform sports medicine across Canada and to train future generations of sport science and sports medicine leaders, said Trevor Young, dean of the Temerty Faculty of Medicine at U of T. By bringing together so many disciplines, the Tanenbaum Institute will make breakthrough big data-driven findings that will lead to better athlete health, safety and performance.

The Institute combines a diverse array of sport science and sports medicine talent. The Institutes research and clinical foci will include mild traumatic brain injuries, orthopaedics, regenerative medicine, biomechanics, wearable physiological and training monitoring technologies, technologies in parasport, mathematical and statistical modelling applied to individual athlete and team analytics, nutrition, individual and team psychology and health, exercise physiology and more.

This latest gift from the Tanenbaum Family Foundation builds on an impressive philanthropic legacy at U of T, Sinai Health and beyond. Larry and Judy Tanenbaum and the Tanenbaum family have been long-time supporters of U of T. In 2014, they helped establish the Anne Tanenbaum Centre for Jewish Studies at the Faculty of Arts & Science, one of North Americas leading programs of its kind. They also have also established several scholarships in support of student athletes.

At Sinai Health, Larry and Judy Tanenbaum have made several transformative investments. In 2013, the Tanenbaums gave $35 million to rename the Lunenfeld-Tanenbaum Research Institute (LTRI), accelerating Sinai Healths biomedical research institute.

Larry and Judy Tanenbaum have also made major gifts in support of cutting-edge physical and mental health research across Canada. Their generosity led to the creation of the Tanenbaum Open Science Initiative at McGill University and the Tanenbaum Centre for Pharmacogenetics at the Centre for Addiction and Mental Health.

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U of T and Sinai Health announce new gift from Larry and Judy Tanenbaum to establish the Tanenbaum Institute for Science in Sport - University of...

New Jersey, United States TheStem Cell Assay Marketreport is the result of extensive and expert research into theStem Cell Assayindustry. TheStem Cell AssayMarketreport explains what the market is all about, the market prognosis, several segmentations, and everything that falls under the markets umbrella. It also looks at major and secondary market drivers, market share, potential sales volume, regional analysis, and the markets key segments. The research also includes key variables that contribute to the markets growth as well as elements that might stifle the markets growth. The professionals at VM Reports applied precise research techniques and other analyses.

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Stem Cell Assay Market Size, Scope and Forecast | Thermo Fisher Scientific, Perkinelmer, Stemcell Technologies, Merck, Bio-Rad Laboratories, Agilent...

CAMBRIDGE, Mass., June 2, 2022 /PRNewswire/ -- Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programing platform, today announced that Mahesh Karande, President and CEO, will participate in fireside chats at the following upcoming investor conferences in June.

Jefferies Healthcare Conference Date: June 10, 2022Time: 9:30 a.m. ET

Goldman Sachs 43rd Annual Global Healthcare ConferenceDate: June 15, 2022Time: 5:40 p.m. ET / 2:40 p.m. PT

Live webcasts of the fireside chats will be available on the Investors & Media section of the Company's website at http://www.omegatherapeutics.com. An archived replay of the fireside chats will be available on the same website for approximately 90 days.

About Omega Therapeutics

Omega Therapeutics, founded by Flagship Pioneering, is a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines. The company's OMEGA Epigenomic Programming platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth, and differentiation to cell death. Using a suite of technologies, paired with Omega's process of systematic, rational, and integrative drug design, the deterministic OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's modular and programmable mRNA epigenetic medicines, Omega Epigenomic Controllers, target specific epigenomic loci within insulated genomic domains, EpiZips, from amongst thousands of unique, mapped, and validated genome-wide DNA-sequences, with high specificity to durably tune single or multiple genes to treat and cure diseases through Precision Genomic Control. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.

For more information, visitomegatherapeutics.com, or follow us onTwitterandLinkedIn.

Contacts

Media contact: Jason BracoLifeSci Communications646.751.4361[emailprotected]

Investor contact: Kevin MurphyArgot Partners212.600.1902[emailprotected]

SOURCE Omega Therapeutics

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Omega Therapeutics to Participate in the Jefferies Healthcare Conference and Goldman Sachs 43rd Annual Global Healthcare Conference in June 2022 - PR...

DUBLIN--(BUSINESS WIRE)--The "Stem Cell Therapy Market Research Report by Cell Source, Type, Therapeutic Application, End-User, Region - Global Forecast to 2027 - Cumulative Impact of COVID-19" report has been added to ResearchAndMarkets.com's offering.

The Global Stem Cell Therapy Market size was estimated at USD 240.88 million in 2021, USD 286.61 million in 2022, and is projected to grow at a Compound Annual Growth Rate (CAGR) of 19.16% to reach USD 689.69 million by 2027.

Competitive Strategic Window:

The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth during a forecast period.

FPNV Positioning Matrix:

The FPNV Positioning Matrix evaluates and categorizes the vendors in the Stem Cell Therapy Market based on Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Market Share Analysis:

The Market Share Analysis offers the analysis of vendors considering their contribution to the overall market. It provides the idea of its revenue generation into the overall market compared to other vendors in the space. It provides insights into how vendors are performing in terms of revenue generation and customer base compared to others. Knowing market share offers an idea of the size and competitiveness of the vendors for the base year. It reveals the market characteristics in terms of accumulation, fragmentation, dominance, and amalgamation traits.

The report provides insights on the following pointers:

1. Market Penetration: Provides comprehensive information on the market offered by the key players

2. Market Development: Provides in-depth information about lucrative emerging markets and analyze penetration across mature segments of the markets

3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments

4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, certification, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players

5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and breakthrough product developments

The report answers questions such as:

1. What is the market size and forecast of the Global Stem Cell Therapy Market?

2. What are the inhibiting factors and impact of COVID-19 shaping the Global Stem Cell Therapy Market during the forecast period?

3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Stem Cell Therapy Market?

4. What is the competitive strategic window for opportunities in the Global Stem Cell Therapy Market?

5. What are the technology trends and regulatory frameworks in the Global Stem Cell Therapy Market?

6. What is the market share of the leading vendors in the Global Stem Cell Therapy Market?

7. What modes and strategic moves are considered suitable for entering the Global Stem Cell Therapy Market?

Market Dynamics

Drivers

Restraints

Opportunities

Challenges

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/e3hv5y

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Insights on the Stem Cell Therapy Global Market to 2027 - Ongoing Advancements in Regenerative Medicine Presents Opportunities -...

Organogenesis (NASDAQ:ORGO Get Rating) was downgraded by Zacks Investment Research from a hold rating to a sell rating in a research report issued to clients and investors on Saturday, Zacks.com reports.

According to Zacks, Organogenesis is a leading regenerative medicine company focused on the development, manufacture and commercialization of solutions for the Advanced Wound Care and Surgical & Sports Medicine markets.

Shares of ORGO stock opened at $6.17 on Friday. The stock has a market cap of $796.39 million, a P/E ratio of 9.79 and a beta of 1.72. Organogenesis has a one year low of $5.30 and a one year high of $19.75. The stock has a fifty day moving average price of $7.26 and a 200 day moving average price of $8.40. The company has a debt-to-equity ratio of 0.29, a current ratio of 2.77 and a quick ratio of 2.46.

In other Organogenesis news, VP Antonio S. Montecalvo sold 97,436 shares of Organogenesis stock in a transaction on Thursday, March 10th. The stock was sold at an average price of $8.39, for a total transaction of $817,488.04. The sale was disclosed in a legal filing with the Securities & Exchange Commission, which is available through this hyperlink. 34.20% of the stock is currently owned by company insiders.

Several hedge funds and other institutional investors have recently modified their holdings of ORGO. Morgan Stanley increased its stake in shares of Organogenesis by 2,249.9% in the second quarter. Morgan Stanley now owns 1,849,596 shares of the companys stock valued at $30,741,000 after buying an additional 1,770,888 shares in the last quarter. BlackRock Inc. increased its stake in shares of Organogenesis by 17.1% in the first quarter. BlackRock Inc. now owns 9,652,188 shares of the companys stock valued at $73,551,000 after buying an additional 1,412,356 shares in the last quarter. Soleus Capital Management L.P. increased its stake in shares of Organogenesis by 212.4% in the fourth quarter. Soleus Capital Management L.P. now owns 1,999,087 shares of the companys stock valued at $18,472,000 after buying an additional 1,359,200 shares in the last quarter. State Street Corp increased its stake in shares of Organogenesis by 33.0% in the fourth quarter. State Street Corp now owns 5,400,860 shares of the companys stock valued at $49,904,000 after buying an additional 1,341,450 shares in the last quarter. Finally, Macquarie Group Ltd. acquired a new stake in shares of Organogenesis in the third quarter valued at $17,647,000. 38.41% of the stock is owned by institutional investors.

Organogenesis Company Profile (Get Rating)

Organogenesis Holdings Inc, a regenerative medicine company develops, manufactures, and commercializes solutions for the advanced wound care, and surgical and sports medicine markets in the United States. The company's advanced wound care products include Affinity, an amniotic membrane wound covering in which viable cells growth factors/cytokines, and ECM proteins in the native tissue are preserved; Apligraf, a bioengineered living cell therapy that produce spectrum of cytokines and growth factors; Dermagraft, a bioengineered product that produces human collagen, ECM, proteins, and cytokines; NuShield, a wound covering tissue includes both amnion and chorion membranes for spongy/intermediate layer intact; PuraPly , a antimicrobial barrier that enables conformability and fluid drainage; and Novachor, an amniotic membrane wound covering in which viable cells, growth factors/cytokines, and ECM proteins are preserved.

Further Reading

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Organogenesis (NASDAQ:ORGO) Rating Lowered to Sell at Zacks Investment Research - Defense World

The new report by Expert Market Research titled, GlobalRegenerative Medicine MarketReport and Forecast 2021-2026, gives an in-depth analysis of the global regenerative medicine market, assessing the market based on its segments like technology, applications, and major regions . The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analyzing the market based on the SWOT and Porters Five Forces models.

Request a free sample copy in PDF or view the report [emailprotected]https://www.expertmarketresearch.com/reports/regenerative-medicine-market/requestsample

The key highlights of the report include:

Market Overview (2016-2026)

The emergence ofstem celltechnology, the untapped potential of nanotechnology, the rise in prevalence ofchronicdiseases and trauma emergencies, advancements in monitoring devices andsurgicaltechnologies, the rise in incidence of degenerative diseases, and the scarcity of organs for transplantation are all factors driving the growth of this market. Over the forecast period, the market is expected to be driven by rise in modern technology. The market expansion is predicted to be supplemented by a greater focus on stem cells and an increase in R&D activity in emerging markets. The emerging countries are concentrating on technical improvements, which is predicted to promote worldwide market growth. However, the markets expansion is expected to be hampered by government regulations, operational inefficiency, and the high cost of regenerative medicine treatment.

Industry Definition and Major Segments

Regenerative medicine is a branch of tissue engineering and molecular biology concerned with the replacement and regeneration of human cells, tissues, and organs in order to restore normal function. Bone graft alternatives, osteoarticular diseases, dermatological, cardiovascular, central nervous system, and other conditions are all treated with regenerative medicine.

Explore the full report with the table of [emailprotected]https://www.expertmarketresearch.com/reports/regenerative-medicine-market

By technology, the market is divided into:

Based on applications, the industry can be divided into:

By region, the industry is categorised into:

Latest News on Global Regenerative Medicine [emailprotected]https://www.expertmarketresearch.com/pressrelease/regenerative-medicine-market

Market Trends

The high number of clinical trials, growing economic impact on regenerative medicine, emerging applications of gene therapy in regenerative medicine, increasing government and private sector funding to support the development of regenerative medicine, and technological advances in stem cell, tissue engineering, and nanotechnology are driving the global regenerative medicine market. The regenerative medicine market is also being fueled by an increase in strategic partnerships, which aid in the commercialisation of regenerative medicine. Another factor driving up demand for regenerative treatments is the rising prevalence of chronic diseases and hereditary disorders, along with degenerative diseases and bone and joint problems. The high cost of therapy and the regulatory difficulties relating to stem cells, tissues engineering, and regenerative medicine, could stymie the industrys expansion.

The global market was dominated by North America. This is due to the presence of a large number of key players in the United States. The high number of clinical trials in this region is due to the availability of advanced technology and the existence of research institutes working in the development of innovative treatments. Due to the increase of infrastructure and facilities to expedite stem cell research in the regions growing economies, Asia Pacific is expected to have the highest CAGR during the projected period. The Chinese government has approved many research projects involving human embryonic stem cells, encouraging scientists to investigate the cells clinical potential. These factors are expected to boost the market during the foreast period as well.

Key Market Players

The major players in the market are Novartis AG, Vericel, Integra Lifesciences, Mimedx Group, Stryker, Wright Medical, Spark Therapeutics, Osiris Therapeutics, Kite Pharma (Subsidiary of Gilead Sciences), and Organogenesis, among others. The report covers the market shares, capacities, expansions, investments and mergers and acquisitions, among other latest developments of these market players.

About Us:

Expert Market Research is a leading business intelligence firm, providing custom and syndicated market reports along with consultancy services for our clients. We serve a wide client base ranging from Fortune 1000 companies to small and medium enterprises. Our reports cover over 100 industries across established and emerging markets researched by our skilled analysts who track the latest economic, demographic, trade and market data globally.

At Expert Market Research, we tailor our approach according to our clients needs and preferences, providing them with valuable, actionable and up-to-date insights into the market, thus, helping them realize their optimum growth potential. We offer market intelligence across a range of industry verticals which include Pharmaceuticals, Food and Beverage, Technology, Retail, Chemical and Materials, Energy and Mining, Packaging and Agriculture.

Media Contact

Company Name: EMR Inc.Contact Person: Steven Luke, Corporate Sales Specialist U.S.A.Email:[emailprotected]Toll Free Number: +1-415-325-5166 | +44-702-402-5790Address: 30 North Gould Street, Sheridan, WY 82801, USACity: SheridanState: WyomingCountry: United StatesWebsite:https://www.expertmarketresearch.com

Also, CheckProcurement Intelligencewhich provides you with Infallible research solutions.

*We at Expert Market Research always thrive to give you the latest information. The numbers in the article are only indicative and may be different from the actual report.

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Global Regenerative Medicine Market To Be Driven By Increasing Clinical Trials During The Forecast Period Of 2021-2026 ManufactureLink -...

MENLO PARK, Calif.--(BUSINESS WIRE)--Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, today announced that new clinical data on its lead investigational high-precision cell therapy, Orca-T, will be shared in an oral presentation at the hybrid European Hematology Association (EHA) Congress from June 9-17, 2022, in Vienna, Austria.

Oral Session: Clinical Studies in Transplantation

Title: Orca-T, an Engineered Allograft, Results in High GVHD-Free and Relapse-Free Survival Following Myeloablative Conditioning for Hematological MalignanciesAbstract Number: S237Date and Time: Sunday, June 12, at 11:3012:45 CEST / 5:30AM6:45AM EDTLocation: Hall Stolz 1-2

The presentation will highlight results from the single-center Phase 2 and multi-center Phase 1b trials of Orca-T in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS). Data included in the abstract will be updated at the time of presentation.

The oral session will take place in Vienna and will be livestreamed on the EHA Congress platform.

About Orca-T

Orca-T is an investigational, high-precision allogeneic cell therapy derived from the stem and immune cells from either related or unrelated HLA-matched donors. Orca-T is intended to safely replace a patients compromised blood and immune system with that from a healthy donor. Orca-T is currently being evaluated in a Phase 3 clinical trial for the treatment of multiple hematologic malignancies and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

About Orca Bio

Orca Bio is a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders. Our investigational therapies are intended to deliver better survival rates with dramatically less risk of graft versus host disease and other debilitating transplant-related toxicities. At Orca Bio, we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their quality of life. For more information, visit http://www.orcabio.com and follow Orca Bio on Twitter: @OrcaBio.

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Orca Bio to Present New Clinical Data on Orca-T at the European Hematology Association 2022 Congress - Business Wire