US FDA grants orphan drug status to TC BioPharms OmnImmune to treat acute myeloid leukaemia

TC Biopharm (Holdings) PLC, a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, announces orphan drug status has been granted for lead product OmnImmune for use in acute myeloid leukaemia (AML). After reviewing the phase 1b/2a trial results in relapse/refractory AML patients the FDA approved the Company's application for Orphan Drug Status. "This is another milestone achieved by TC BioPharm, further strengthening our leadership position in Gamma Delta therapies for oncology," stated CEO Bryan Kobel. "The granting of orphan drug status provides us a seven-year window post approval of exclusive marketing rights for allogeneic gamma delta use in AML, another added layer of protection around our lead product in a commercial setting beyond our existing strong IP. We look forward to the advancement of OmnImmune in the phase 2b/3 trial and to helping patients with AML in the near future." Orphan drug status is a designation granted by the Federal Drug Administration for therapies targeting rare diseases. The status allows for a seven-year exclusive marketing window post approval of the drug, certain lowered application fees and tax incentives, broadly. OmnImmunean allogeneic unmodified cell therapy consisting of activated and expanded gamma delta T cells. The trial, for treatment of patients suffering from relapse/refractory acute myeloid leukaemia, OmnImmune comprises GDT cells sourced from healthy donors, expanded and activated in large numbers before being purified and formulated for infusion into patients. OmnImmune is a frozen and thawed product, now "banked" from donor derived cells. Phase 2/3 trials will begin enrollment in the first quarter of 2022 in the UK with expansion into the US in 2022. TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer and viral infections with human efficacy data in acute myeloid leukaemia.

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