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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
Treefrog Therapeutics appoints Scientific Advisory Board to guide the development of proprietary iPS platform & cell therapy pipeline
Bordeaux, France / March 1st, 2022 – TreeFrog Therapeutics, a French-based biotech aimed at making safer, more efficient and more affordable off-the-shelf cell therapies based on induced pluripotent stem cells (iPSCs), today announces the formation of its Scientific Advisory Board (SAB). Bringing together world-class experts in biophysics, pluripotent stem cell biology and gene editing, the newly created SAB will guide the development of proprietary C-StemTM technology platform and in-house cell therapy programs. [Read more…]
FDA Grants Orphan Drug Designation to Celularity’s CYNK-101, an NK Cell Therapy for GI Cancers
CYNK-101 is an investigational genetically modified NK cell therapy designed to synergize with antibody therapeutics for difficult to treat cancers of high unmet medical need
Phase 1/2a clinical trial will evaluate the safety and preliminary efficacy of CYNK-101 in combination with standard chemotherapy, trastuzumab, and pembrolizumab
5th designation received by Celularity within 12 months from the US FDA
EdiGene and Neukio to Develop iPSC-Derived NK Cell Therapies
Feb. 9, 2022, BEIJING & SHANGHAI & CAMBRIDGE, Mass. – EdiGene, Inc., a global biotechnology company focused on translating gene-editing technologies into transformative therapies for patients with serious genetic diseases and cancer, and Neukio Biotherapeutics, a biotechnology company focused on the development and commercialization of allogenic iPSC-CAR-NK cell therapies, today announced an R&D collaboration to develop next-generation immune cell therapies. [Read more…]
Exopharm Signs Master Collaborative Agreement to Manufacture Exosomes for Astellas
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Astellas Institute for Regenerative Medicine (AIRM) is a subsidiary of Astellas Pharma Inc., a top 20 global pharmaceutical company
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Initial services will seek to validate Exopharm’s LEAP, LOAD and EVPS technology platforms to manufacture exosomes for Astellas, firstly at Exopharm’s facilities in Melbourne followed by the Astellas facilities in Massachusetts USA
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Future potential collaboration is anticipated following validation
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This is Exopharm’s first collaboration services agreement with a major pharmaceutical company
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