Recent Articles in Cell & Gene Therapy

Guangzhou Bio-gene Technologies has started a China Phase I trial for an autologous CAR-T cell therapy that targets CLL-1, a member of the C-type lectin-like receptor family, in patients with relapsed/refractory acute myeloid leukemia (AML). BG1805 has already been studied in Investigator Initiated Studies, where it showed efficacy in both adults and children with blood malignancies and solid tumors. The BG1805 trial is the first of Bio-Gene’s CAR-T candidates to start formal clinical studies, although several have been tested in Investigator Initiated Trials. More details....
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Shenzhen EurekaBio closed a $40 Series B+ funding to support the commercialization of its EuLV™ Lentiviral Vector Production System, a technology that the company believes could transform large-scale production of lentiviral vectors. The system is based on stable cell lines and a serum-free suspension system. Eureka believes its novel technology will have a major impact in how cell and gene therapies are developed. The B+ round was led by Yeuxiu Industrial Fund, with participation from China funds and follow-on investments from US funds. More detail....

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Legend Biotech reported Europe’s CHMP recommended approval of its lead CAR-T drug, Carvykti®, for a new indication: second-line therapy for adult patients with relapsed and refractory multiple myeloma. Carvykti® (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy. It is currently indicated to treat adult M/M patients as a fifth-line therapy. The filing was conducted by a subsidiary of Janssen, Legend’s partner on the drug. Legend was spun out of Nanjing’s GenScript, though it now lists Somerset, NJ as its global headquarters while continuing to operate in Nanjing as well. More details...

Stock Symbol: (NSDQ: LEGN)

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Wuhan iRegene Therapeutics has dosed the first patient in a China Phase I/II clinical trial of a novel therapy for Parkinson’s Disease. NouvNeu001 is a chemically induced human dopaminergic neuron precursor derived from iPSC stem cells. Upon transplantation, the cells establish connections with the body's existing neurons with the goal of augmenting cellular secretion functions, The trial will test the efficacy of a stereotactic bilateral intracerebral injection of NouvNeu001 in patients with moderate to advanced Parkinson's disease. iRegene says NouvNeu001 is the world's first iPSC-based, chemically induced universal cell therapy product. More details....

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Gracell Biotech, a Suzhou-San Diego CAR-T company, was cleared to begin a US Phase 1 clinical trial of its FasTCAR next-day manufacturing candidate GC012F in the US as an early-line treatment of multiple myeloma (ELMM). It is the third U.S. IND clearance for GC012F, which is an autologous CAR-T candidate with a dual-targeting B cell maturation antigen (BCMA) and CD19. GC012F is currently being tested in multiple hematological cancer trials as well as autoimmune diseases. Gracell said it has demonstrated a consistently strong efficacy and safety profile. In December, Gracell announced it would be acquired by AstraZeneca for $1.2 billion. More details....

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