Indapta Therapeutics Receives U.S. FDA Fast Track Designation for Lead Clinical Drug Candidate IDP-023 for Non-Hodgkin’s Lymphoma and Myeloma
29 Feb 2024
Cell TherapyFast TrackImmunotherapyPhase 1Accelerated Approval
– Highly Differentiated Allogeneic Natural Killer Cell Therapy in Phase 1 Trial, with Initial Data Expected in Second Half of 2024 –
HOUSTON & SEATTLE--(BUSINESS WIRE)-- Indapta Therapeutics, Inc., a privately held biotechnology company developing next-generation differentiated cell therapies for the treatment of cancer and other immune-mediated diseases, today announced that the U.S. FDA has granted Fast Track designation for its lead clinical program, IDP-023, for the treatment of patients with non-Hodgkin’s lymphoma and multiple myeloma.
The FDA’s Fast Track process is designed to get drugs to patients more quickly by facilitating the development and expediting the review of drugs to treat serious conditions and fill an unmet medical need. Companies granted Fast Track designation may be eligible for more frequent interactions with the FDA, Accelerated Approval and Priority Review, and Rolling Review of a Biologic License Application (BLA).
“This designation highlights the promise of Indapta’s highly potent NK cell platform and will further accelerate clinical development of our lead drug candidate, IDP-023, for two of the largest unmet needs in B-cell driven blood cancers, non-Hodgkin’s lymphoma and multiple myeloma,” said Dr. Mark Frohlich, CEO of Indapta.
Patients being enrolled now in Indapta’s Phase 1 clinical trial are receiving up to three planned doses of IDP-023 with or without interleukin-2. Once safety of multiple doses in combination with interleukin-2 has been established, cohorts of patients with lymphoma and multiple myeloma will receive treatment with IDP-023 in combination with the monoclonal antibodies, rituximab and daratumumab, respectively.
Indapta’s Differentiated G-NK Cell Therapy
Indapta’s universal, allogeneic NK cell therapy platform consists of a potent subset of naturally occurring NK cells, known as “G minus” NK cells, or “g-NK” that have markedly greater killing capacity than conventional NK cells, without the need for genetically engineering the cells. G-NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors with increased numbers of g-NK cells, with low donor-to-donor variability.
Indapta’s g-NK are capable of releasing dramatically more immune activating cytokines and cancer-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. (Bigley et al., Blood Advances 2021, )
About Indapta Therapeutics
Indapta is a privately-held company focused on developing and bringing to market a diverse pipeline of cell therapies to treat the still unmet medical needs of patients with blood and solid-tumor cancers and other immune-mediated diseases. The company’s proprietary robust platform of naturally-occurring g-NK cells is specifically designed to create best-in-class, highly potent, more accessible, and scalable cell therapies. For more information, please visit .
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