FDA grants orphan drug designation to OmnImmune cell therapy for acute myeloid leukemia
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The FDA granted orphan drug designation to TCB-002 for treatment of adults with relapsed or refractory acute myeloid leukemia.
TCB-002 (OmnImmune, TC BioPharm) is an allogeneic, nongene-edited gamma-delta T-cell therapy.
The treatment is derived from gamma-delta T lymphocytes from healthy HLA-matched or blood-related donors. The lymphocytes are expanded and activated ex vivo and then frozen for use as a subsequent infusion.
The FDA based the orphan drug designation on results of an ongoing phase 1B/2A trial of TCB-002 for adults with relapsed or refractory AML.
The single-center dose-escalation study is underway in the Czech Republic. Researchers reported positive efficacy results from the first seven patients treated with the investigational therapy, including a 50% complete response rate in the study’s higher-dose cohort.
Early safety results showed no cases of graft-versus-host disease, immune effector cell-associated neurotoxicity syndrome or cytokine release syndrome, according to a press release from the manufacturer.
TC BioPharm intends to begin enrollment for a pivotal phase 2B/phase 3 trial of TCB-002 during the first quarter of this year. The study will initially include patients in the U.K. but has planned expansion into the U.S. later in 2022, according to the manufacturer.
“This is another milestone achieved by TC BioPharm, further strengthening our leadership position in gamma-delta therapies for oncology,” Bryan Kobel, CEO of TC BioPharm, said in the press release. “We look forward to the advancement of OmnImmune in the [phase 2B/phase 3 trial] and to helping patients with AML in the near future.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
References:
TC BioPharm announces FDA orphan drug status granted for OmnImmune. https://ir.tcbiopharm.com/news/press-releases/detail/21/tc-biopharm-announces-fda-orphan-drug-status-granted-for. Published March 17, 2022. Accessed March 17, 2022.
TC BioPharm announces positive phase 1b/2a data in late-stage acute myeloid leukemia patients treated with allogeneic gamma delta T cells. https://ir.tcbiopharm.com/news/press-releases/detail/19/tc-biopharm-announces-positive-phase-1b2a-data-in. Published March 8, 2022. Accessed March 17, 2022.
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