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Lonza to provide process development, clinical manufacturing and regulatory support for IND filing.
January 13, 2020
By: Tim Wright
Editor-in-Chief, Contract Pharma
Indapta Therapeutics, a biotechnology company focused on developing and commercializing a first-in-class, off-the-shelf, non-engineered, allogeneic G-NK (FcRγ-deficient Natural Killer) cell therapy to treat multiple cancers, and Lonza have entered a strategic partnership. Under the terms of the agreement, Lonza will manufacture Indapta’s allogeneic G-NK cell therapy under current good manufacturing practices (cGMP) for use in clinical studies. Indapta will leverage Lonza’s process development capabilities and expertise to ensure a robust, reproducible and scalable cGMP process. Process development and manufacturing will take place in Lonza’s state-of-the-art cell and gene therapy manufacturing facility in Houston, TX. “We believe our first-in-class, off-the-shelf, allogeneic G-NK cell therapy will drive the next critical phase in the evolution of cancer therapies following CAR T-cell therapies,” said Guy DiPierro, founder and chief executive officer, Indapta Therapeutics. “Current autologous CAR T-cell therapies have proven efficacy in various hematologic cancers but have been beset with serious clinical and manufacturing challenges. By providing an off-the-shelf solution with our G-NK cell therapy, we can eliminate the need for a patient-specific therapy. Additionally, because our investigational cell therapies are not engineered, they are likely to be more effective, less costly and have a simpler regulatory pathway.” Scott Waldman, chief strategy officer, Lonza, said, “Indapta’s world-class team of NK cell scientists and clinicians and cell therapy experts has created an innovative off-the-shelf immuno-oncology therapy based on a subset of cancer-killing NK cells that could make a truly meaningful impact in the treatment of hematologic malignancies and solid tumors.”
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