ImmPACT Bio Announces Opening of California-Based GMP Facility
ImmPACT Bio Announces Opening of California-Based GMP Facility for Clinical Production of IMPT-314, a CD19/CD20 CAR T Therapy for B-Cell Malignancies and Autoimmune Diseases
ImmPACT Bio USA, Inc. (“ImmPACT Bio”), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, today announced the opening of the Company’s 21,500 square foot Good Manufacturing Practices (GMP) facility in Los Angeles, California. The integrated, state-of-the-art development and manufacturing facility will support clinical production of the Company’s lead candidate IMPT-314, a potential first-in-class CD19/CD20 bispecific CAR T therapy for B-cell mediated malignancies and autoimmune diseases. IMPT-341 was based on research and work conducted by Yvonne Chen, Ph.D., associate professor, and Sarah Larson, M.D., principal investigator, both of University of California, Los Angeles (UCLA). Drs. Chen and Larson initiated an ongoing investigator Phase 1 study at UCLA in patients with relapsed or refractory non-Hodgkin lymphoma. ImmPACT Bio licensed the logic-gate-based CAR T-cell platforms from UCLA Technology Development Group.
“We are pleased to celebrate the grand opening of ImmPACT Bio’s first U.S.-based GMP manufacturing facility, an instrumental milestone marking the clinical readiness of our lead program IMPT-314. The West Hills facility in Los Angeles will support our clinical manufacturing capacity, advance our clinical studies, and help position us for success when we approach commercial launch,” said Sumant Ramachandra, M.D., Ph.D., president and chief executive officer of ImmPACT Bio. “Importantly, it will help ImmPACT Bio deliver a differentiated CAR T therapy that offers the potential for unmatched safety and durability based on initial UCLA-led Phase 1 data. We look forward to dosing the first patient with IMPT-341 in our Phase 1/2 trial in aggressive B-cell malignancies in the second quarter of this year.”
Sylvain Roy, chief technology officer of ImmPACT Bio added, “The integrated and streamlined design of the West Hills facility offers efficient and flexible end-to-end manufacturing capabilities. By fostering cross-collaboration, the all-encompassing layout that includes research, development, quality labs plus manufacturing in one facility aims to help break barriers between teams and facilitate the rapid transfer of knowledge. We want to thank everyone at ImmPACT Bio and our partners for their support in bringing us one step closer to our goal of delivering potentially transformative therapies to patients with cancer and autoimmune diseases.”
The 21,500 square foot West Hills facility is a state-of-the-art, multi-use, single location facility integrating GMP manufacturing, quality control (QC) labs, process and analytical development labs, research labs, and office space. The GMP manufacturing space includes a 4,800 square foot clean room separated into two manufacturing suites, a 5,700 square foot QC lab, and a 3,000 square foot space for future cleanroom expansion. The Company’s two manufacturing suites are dedicated to autologous cell therapy drug manufacturing, using the most stringent aseptic processing controls and advanced manufacturing technologies.
ImmPACT Bio’s GMP manufacturing facility will initially focus on clinical manufacturing of IMPT-314, a bispecific autologous CAR T-cell therapy targeting prevalent B-cell antigens CD19 and CD20. ImmPACT Bio will evaluate IMPT-314 in a Phase 1/2 clinical trial for aggressive B-cell lymphoma, including diffuse large B-cell lymphoma. Dosing of the first patient is expected in Q2 2023 with initial Phase 1 safety and efficacy data expected in the second half of 2023. The open Investigational New Drug Application for IMPT-341 was based on research and work by Drs. Chen and Larson.
About ImmPACT Bio
About ImmPACT Bio
ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies for patients in need of safer and more efficacious treatment options. The Company’s logic-gate-based CAR T-cell platforms, licensed from University of California, Los Angeles (UCLA) Technology Development Group, address key biological challenges in treating cancer. ImmPACT Bio’s technologies are specifically designed to prevent antigen escape, and overcome the immunosuppressive tumor microenvironment. The Company’s technology is based on the work of pioneering scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from UCLA. In addition, another logic-gate-based CAR T-cell technology is based on the work of Gideon Gross, Ph.D., from the MIGAL-Galilee Research Institute, to address the prevention of ‘on-target, off-tumor’ toxicities. For more information, visit www.immpact-bio.com.
SOURCE: ImmPACT Bio