Indapta Therapeutics and Lonza Announce Strategic Partnership to Advance a Next-generation, Off-the-shelf, Allogeneic Immuno-oncology Therapy
• Indapta developing first-in-class, proprietary cancer therapy based on a specific, potent variety of Natural Killer immune cells for use in combination with multiple monoclonal antibodies
• Lonza to provide process development, clinical manufacturing and regulatory support for IND filing
Guy DiPierro, founder and chief executive officer of Indapta Therapeutics:
“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. 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.”
Ronald Martell, co-founder and executive chairman, Indapta Therapeutics
“Lonza, with its demonstrated expertise in cell therapy manufacturing, is the ideal strategic partner to help us advance our clinical program and scale the production of our G-NK cell therapy. We are currently completing Investigational New Drug-enabling studies and plan to submit an IND application in late 2020 and initiate a first-in-human Phase 1/2 study in early 2021.”
Scott Waldman, Chief Strategy Officer, Lonza
“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.
Alberto Santagostino, SVP, Head of Cell & Gene Technologies, Lonza.
“With our long-standing experience in cell therapy manufacturing, we are committed to providing Indapta with the expertise, resources and services it needs for cGMP manufacturing to advance its promising program into the clinic and beyond.”
San Francisco (CA), USA and Basel, Switzerland, 10 January 2020 – Indapta Therapeutics, Inc., a biotechnology company focused on developing and commercializing a proprietary, first-in-class, off-the-shelf, non-engineered, allogeneic G-NK (FcRγ-deficient Natural Killer) cell therapy to treat multiple cancers, and Lonza today announced a strategic partnership.
Under the terms of the agreement, Lonza will manufacture Indapta's off-the-shelf, 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), USA.