Indapta Therapeutics Announces FDA Clearance of IND for Phase 1 Trial of IDP-023 for Progressive Multiple Sclerosis

Company’s g-NK Cell Therapy Has Multiple Potential Mechanisms That Could Impact Biology of Multiple Sclerosis

HOUSTON & SEATTLE--(BUSINESS WIRE)--Indapta Therapeutics, Inc., a privately held clinical stage biotechnology company developing next-generation differentiated cell therapies for the treatment of cancer and autoimmune diseases, today announced that the U.S. FDA has cleared the IND for the company’s Phase 1 clinical trial of its g-natural killer (g-NK) cell therapy, IDP-023, in progressive multiple sclerosis (MS).

Stanford University and the University of California, San Francisco (UCSF) will lead the clinical trial. People with progressive MS will receive IDP-023 in combination with the anti-CD20 monoclonal antibody, ocrelizumab. The study will interrogate the biologic effects of IDP-023 using a translational program developed in collaboration with Stanford and UCSF.

“I am excited to participate in this clinical trial because of the multiple potential mechanisms by which g-NK cells may impact the biology of MS,” said Dr. Lawrence Steinman, Professor of Medicine and Principal Investigator at Stanford. “In addition to being able to achieve B cell depletion by combining with a B cell directed monoclonal antibody, g-NK cells have the ability to kill HLA-E expressing autoreactive T and B cells. In addition, g-NK cells have potent anti-viral activity, and therefore may also address the Epstein Barr Virus reservoir that contributes to the disease pathogenesis.”

Indapta is currently conducting a Phase 1/2 trial of IDP-023 in patients with non-Hodgkin’s lymphoma and multiple myeloma.

“This IND is another in a series of milestone achievements from our team in recent months,” said Dr. Mark Frohlich, CEO of Indapta. “We look forward to the second half of the year during which we plan to initiate this trial and continue progress with our ongoing Phase 1/2 trial of IDP-023 in patients with hematologic cancers, where we have seen very encouraging responses to date.”

Indapta’s Proprietary 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” 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 low donor to donor variability. IDP-023 has several differentiated mechanisms of killing target cells without the need for genetic engineering, including highly robust antibody-dependent cell mediated cytotoxicity (ADCC), the targeting of HLA-E expressing cells via the NKG2C receptor, and the inherent anti-viral activity of g-NK cells.

Indapta’s g-NK can release dramatically more immune activating cytokines and cell-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, https://doi.org/10.1182/bloodadvances.2020002440). g-NK cells in combination with a B cell targeting antibody can also deplete normal B cells from healthy donors or patients with autoimmune disease.

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 as well as autoimmune 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 www.indapta.com.