Indapta Therapeutics has announced plans to begin a Phase I trial of an allogeneic natural killer (NK) cell therapy, IDP-023, to treat multiple myeloma and lymphoma patients.
The company’s decision comes after the US Food and Drug Administration (FDA) cleared its investigational new drug (IND) application for IDP-023.
The first-in-human trial will assess three different dose levels of G-NK cells from the company alone and along with interleukin-2 and the monoclonal antibodies, daratumumab and rituximab, in relapsed/refractory multiple myeloma or lymphoma patients.
It is expected to commence in the second half of this year.
The University of Texas MD Anderson Cancer Center in the US will serve as the first clinical site and the trial will be led by Dr Krina Patel.
Indapta Therapeutics CEO Dr Mark Frohlich said: “This is a major milestone achievement for our team, who successfully demonstrated the reproducibility of our manufacturing process and designed a robust clinical trial.
“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 I trial.”
The company noted that the IND clearance triggers the second $30m tranche of its $60m Series A financing raised in January last year.
The funding was obtained from lead investors RA Capital, Vertex Ventures, Pontifax, and Leaps by Bayer.
Indapta’s G-NK cell therapy platform has been designed to improve the monoclonal antibody (mAb) therapy’s cancer killing power in several types of cancer.
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