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CARVYKTI™ (ciltacabtagene autoleucel), BCMA-Directed CAR-T Therapy, Receives U.S. FDA Approval for the Treatment of Adult Patients With Relapsed or Refractory Multiple Myeloma
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CARVYKTI™ marks the first product approved by a health authority for Legend Biotech
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Approval is primarily based on the pivotal phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate (ORR) of 98 percent in patients with refractory or relapsed multiple myeloma after four or more prior lines of therapy including proteasome inhibitor, immunomodulatory agent and anti-CD38 monoclonal antibody1
Onk Therapeutics Secures $21.5M Series A for Cord Blood and iPSC-derived NK Cell therapies
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$21.5M Series A financing round to advance pipeline of next-gen engineered off-the-shelf NK cell therapies
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Funding round led by current investors Acorn Bioventures and ALSHC; joined by new investor Cormorant Asset Management
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Financing will drive multiple pre-clinical programs through IND-enabling studies and the continued progression of a GMP manufacturing capability
CAR-T Cell Therapeutics: A Multi-Billion Dollar Market
CAR-T is a promising type of immunotherapy where doctors collect immune cells, modify them in a laboratory, and provide them the capacity to recognize and kill cancer cells. When infused into a patient, the cells get multiplied and stay in the body as “living drugs.”
Since the approval of the first CAR-T cell therapeutic in 2017, widespread research, proliferating clinical trials, aggressive M&A activity, and lucrative IPOs have created a robust CAR-T cell market. [Read more…]
The State of CAR-T Cell Therapies in 2021
Scientific progress within the field of cancer immunotherapy has led to five CAR-T cell therapy approvals: Kymriah (tisagenlecleucel), Yescarta (axicabtagene ciloleucel), Tecartus (brexucabtagene autoleucel), Breyanzi (lisocabtagene maraleucel), and Abecma (idecabtagene vicleucel). Additionally, JW Therapeutics has announced NMPA approval of Relmacabtagene Autoleucel Injection in China. This is the first CAR-T product independently developed in China and approved as a Category 1 biologics product, as well as the sixth approved CAR-T product globally. [Read more…]
JW Therapeutics Achieves Approval of Sixth CAR-T Product Globally by NMPA in China
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The first CAR-T product independently developed in China and approved as a Category 1 biologics product, and the sixth approved CAR-T product globally
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Currently the only approved CAR-T product that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designation
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May provide a best-in-class CAR-T therapy in China given its demonstration of high rates of durable disease response and low rates of CAR-T associated toxicities
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