Articles tagged with: Autologous Cellular Therapies
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Stockholm, Sweden (Press Release) – XNK Therapeutics AB ("XNK") today announced it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its leading investigational drug candidate in the treatment of multiple myeloma (MM).
Receiving ODD status from the FDA for the treatment of multiple myeloma is a critical next step for the development of XNK's leading investigational drug candidate. XNK has already received ODD status in the EU.
"Obtaining an ODD by the FDA is a significant milestone for XNK and our goal of taking the present …
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Boston, MA (Press Release) – OncoPep, Inc. today announced a licensing agreement with MANA Therapeutics for use of its EDIFY™ platform for the development of an autologous multi-tumor antigen adoptive T cell therapy for the treatment of multiple myeloma and solid tumors, as an additional T cell focused immunotherapeutic for its product pipeline.
“The addition of a multi-antigen adoptive T cell therapy to our pipeline expands the breadth of our immuno-oncology programs in multiple myeloma in addition to solid tumors, and provides patients with another potential treatment option for a disease for which …
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With the start of its second clinical trial, NexImmune expands development of its unique non-genetically engineered T cell immunotherapies across a range of hematologic malignancies
Gaithersburg, MD (Press Release) – NexImmune, a clinical-stage biotechnology company developing a portfolio of unique non-genetically-engineered T cell immunotherapies, announced today that it has dosed the first patient in its Phase 1/2 clinical trial for NEXI-002. NEXI-002 is a patient-derived cellular product that contains populations of naturally-occurring CD8+ T cells directed against several multiple myeloma (MM)-specific antigen targets. It is the second clinical product NexImmune has generated with its AIM nanoparticle technology.
“While the primary objective in this trial with NEXI-002 is to demonstrate safety and tolerability, we also hope to see initial …
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- FDA set a target action date of March 27, 2021
- Ide-cel is the first CAR T cell therapy accepted for regulatory review for multiple myeloma
Princeton, NJ and Cambridge, MA (Press Release) – Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review their Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and …
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First investigational product being recommended for Breakthrough Therapy Designation in China
Somerset, NJ (Press Release) – Legend Biotech Corporation (NASDAQ:LEGN) announced today that the China Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) has recommended Breakthrough Therapy Designation (BTD) for ciltacabtagene autoleucel (cilta-cel; LCAR-B38M CAR-T cells), an investigational B-cell maturation antigen (BCMA) targeted chimeric antigen receptor (CAR) T-cell therapy being studied for the treatment of adults with relapsed or refractory multiple myeloma (RRMM).
The BTD for cilta-cel (LCAR-B38M CAR-T cells) is based on the ongoing Phase 2 CARTIFAN-1 study being conducted in China (MMY2002, NCT03758417, CTR20181007), the ongoing Phase 1b/2 CARTITUDE-1 study …
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- BLA submission based on results from pivotal Phase 2 KarMMa study evaluating ide-cel in heavily pre-treated patient population
- Companies are committed to working with the FDA to rapidly advance ide-cel through the regulatory review process
Princeton, NJ and Cambridge, MA – Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma. This submission provides further details on the Chemistry, Manufacturing and Controls (CMC) module to address the outstanding …
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Applications based on positive results from pivotal KarMMa study in relapsed and refractory multiple myeloma and QUAZAR®-AML-001 study in acute myeloid leukemia
Princeton, NJ (Press Release) – Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Applications (MAA) for both idecabtagene vicleucel (ide-cel, bb2121) and CC-486. Validation of each application confirms the respective submissions are complete and begins the EMA’s centralized review process.
The MAA for ide-cel, the company’s investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy co-developed with bluebird bio, Inc., is for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory …