Fast delivery improves activity and durability, and a new generation of ready-to-use CAR-T therapy is granted orphan drug designation by the FDA

▎WuXi AppTec Content Team Editor Allogene Therapeutics is a clinical-stage biotechnology company developing allogeneic chimeric antigen receptor T-cell (AlloCAR T) products targeting cancer
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Recently, the company announced that the U.
S.
FDA has granted orphan drug designation (ODD) for the investigational CAR-T therapy ALLO-605 for the treatment of multiple myeloma
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ALLO-605, currently in Phase 1 clinical development, is part of Allogene's multi-pronged strategy to target B cell maturation antigen (BCMA)
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BCMA is a ubiquitously expressed antigen on multiple myeloma cells and a proven anticancer target
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It is worth mentioning that ALLO-605 is the first investigational therapy developed by the company's TurboCAR technology platform, which is expected to improve the function of T cells
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Allogene's TurboCAR platform specifically activates signaling of specific cytokines in CAR-T cells
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A variety of cytokines play an important role in stimulating T cell activity and maintaining T cell persistence, but systemic use of cytokines often brings toxic side effects
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By expressing recombinant proteins on the surface of CAR-T cells, the TurboCAR platform activates the cytokine signaling pathway only in CAR-T cells, thereby improving the function of CAR-T therapy without activating host immune cells, possibly avoiding systemic toxicity
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▲About ALLO-605 (Image source: Allogene’s official website) The preclinical results of ALLO-605 were announced at the American Society of Hematology (ASH) annual meeting in December 2020.
Preclinical studies show that TurboCAR technology may improve cell therapy colonization and durability sex, delayed T cell exhaustion
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Additionally, the U.
S.
FDA granted Fast Track designation to ALLO-605 in the second quarter of 2021 based on the product candidate's potential to address an unmet need in patients who have failed other standard multiple myeloma treatments
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Rafael Amado, MD, executive vice president of research and development and chief medical officer at Allogene, said: "Orphan drug designation marks an important step toward developing an anti-BCMA portfolio for patients with multiple myeloma and providing patients with an allogeneic CAR-T product.
Step
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" Reference: Allogene Therapeutics Receives FDA Orphan-Drug Designation for ALLO-605, its First TurboCAR T Cell Product Candidate, for the Treatment of Multiple Myeloma.
Retrieved April 27, 2022, from https://ir.
allogene.
com /news-releases/news-release-details/allogene-therapeutics-receives-fda-orphan-drug-designation-allo Disclaimer: The WuXi AppTec content team focuses on global biomedical health research progress
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.