Indapta Therapeutics Announces U.S. FDA Clearance of IND for IDP-023, an Allogeneic Natural Killer (NK) Cell Therapy for Cancer

May 17, 2023 |

2 min read

Indapta Therapeutics, Inc. today announced 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.

– First-in-human trial of G-NK cells in combination with monoclonal antibodies for patients with relapsed/refractory multiple myeloma or lymphoma expected to commence in second half of 2023 –

-- Milestone triggers second $30 million tranche of $60M Series A financing --

HOUSTON & SEATTLE--(BUSINESS WIRE)-- 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, today announced 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. The University of Texas MD Anderson Cancer Center will serve as the initial clinical site, where Dr. Krina Patel will lead the study.

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.

About Indapta Therapeutics

Indapta Therapeutics, Inc. is a biotechnology company focused on developing and commercializing a proprietary allogeneic cell therapy to treat multiple types of hematologic cancers and solid tumors. The company has developed allogeneic FcεRIγ-deficient natural killer cells, known as G-NK cells, and is working to bring this off-the-shelf cell therapy to patients to address the limitations of currently available autologous T-cell therapies. For more information, please visit www.indapta.com.