On January 11, 2024 Indapta Therapeutics, Inc., a privately held biotechnology company developing IDP-023, a natural killer (NK) cell therapy for the treatment of cancer, reported that the company has initiated treatment of the first patients in its Phase 1 trial in multiple myeloma and Non-Hodgkin’s lymphoma (Press release, Indapta Therapeutics, JAN 11, 2024, View Source [SID1234639209]). The patients were treated at the University of Texas MD Anderson Cancer Center and NEXT Oncology, Virginia.
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The first patient received a single dose of IDP-023. The second patient has received the first of three planned doses of IDP-023. Subsequent cohorts of patients will receive three 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.
"We are excited to transition to a clinical stage company," said Dr. Mark Frohlich, CEO of Indapta. "Based on the encouraging clinical activity of NK cells demonstrated by others and the superior activity of IDP-023 compared to conventional NK cells in preclinical models, we are looking forward to evaluating the safety and clinical activity of IDP-023 in this Phase 1 trial."
Indapta also announced that it has successfully manufactured sufficient IDP-023 to supply the Phase 1 clinical trial through the second half of 2024. "We are very pleased with the high yields we are achieving in our GMP production runs," added Frohlich. "The recent improvements in our manufacturing process together with additional planned process changes should position us well for a competitive cost of goods by the time of product launch."
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 markedly improve the cancer killing power of monoclonal antibody (mAb) therapy, 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. Indapta’s off-the-shelf g-NK cell therapy is further differentiated from other NK cell therapies in that it is a cryopreserved product with low 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 2020, View Source)