On May 17, 2023 Indapta Therapeutics, Inc., a privately held biotechnology company developing a natural killer (NK) cell therapy platform for the treatment of blood and solid tumor cancers, reported that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on an Investigational New Drug (IND) application to commence its first-in-human phase 1 trial in patients with multiple myeloma and lymphoma anticipated to begin in the second half of 2023 (Press release, Indapta Therapeutics, MAY 17, 2023, View Source [SID1234631830]). The University of Texas MD Anderson Cancer Center will serve as the initial clinical site, where Dr. Krina Patel will lead the study.
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This milestone triggers the second $30 million tranche of its $60M Series A financing raised in January 2022 from its lead investors, Leaps by Bayer, Vertex Ventures, RA Capital, and Pontifax.
"This is a major milestone achievement for our team who successfully demonstrated the reproducibility of our manufacturing process and designed a robust clinical trial," said Dr. Mark Frohlich, CEO of Indapta. "G-NK cells have demonstrated highly potent antibody dependent cytotoxicity in combination with monoclonal antibodies in preclinical models and we are excited to evaluate the safety and clinical activity of G-NK cells in this Phase 1 trial."
The study will explore three different dose levels of Indapta’s G-NK cells alone and in combination with interleukin-2 and the monoclonal antibodies, rituximab and daratumumab.
Indapta’s Differentiated G-NK Cell Therapy
Indapta’s universal, allogeneic G-NK cell therapy platform is designed to substantially improve the cancer killing power of monoclonal antibody (mAb) therapy in multiple types of cancers. G-NK cells are a specific and potent subset of NK cells with specialized antitumor activity resulting from epigenetic changes. Indapta’s off-the-shelf G-NK cell therapy is further differentiated from other NK cell therapies in that it is a cell-banked product with low variability.
Indapta produces a G-NK cell therapy with its proprietary manufacturing process that has demonstrated more potent and persistent antitumor activity in preclinical studies compared to conventional NK cells, without the need for genetic engineering. Indapta’s G-NK cells recognize cancer cells coated with monoclonal antibodies and are capable of releasing dramatically more cancer-killing compounds than conventional NK cells, leading to potentially increased efficacy.