ST. LOUIS, MISSOURI, USA, May 16, 2023 -- Immunophotonics, Inc., a clinical-stage biotech company focused on the discovery and development of novel innate immune stimulating drugs with antigen depot properties, has announced the U.S. Food and Drug Administration (FDA) completed its safety review of the company’s Investigational New Drug (IND) application and concluded that Immunophotonics may proceed with the clinical investigation of intratumoral injection of IP-001 following thermal ablation in patients with advanced solid tumors at sites within the U.S. The U.S. study is part of an international, multi-center Phase 1b/2a Trial of IP-001 in colorectal cancer, non-small cell lung cancer, and soft-tissue sarcoma patients.
Dr. Robert C.G. Martin II, M.D., Ph.D., FACS, Professor of Surgery at the University of Louisville, member of the Scientific Advisory Board of Immunophotonics, and lead investigator of the U.S. clinical trial expressed his excitement, observing, “I am very excited to be a part of this groundbreaking new strategy to drive a systemic immune response against cancer following a local tumor ablation. This clinical program is intended to demonstrate the benefits of in situ antigen capture and immune stimulation by IP-001 which presents a new approach to reduce local and systemic recurrence rates following routine destruction techniques.”
Diane M. Beatty, Ph.D., VP of Regulatory & Clinical Affairs at Immunophotonics, who has 25 years of experience in the formulation and execution of scientific and regulatory strategies for drug, biologic, and device development programs, pronounced, “This is an exciting time for Immunophotonics to have an open U.S. IND. Receiving the green light from FDA that our ‘Study May Proceed’ is the culmination of hard work and dedication of the entire Immunophotonics team. This marks an important step for us as we prepare for a new clinical trial program in the United States, and I am thrilled to be a part of the team that is moving this program forward.” Echoing that sentiment, Immunophotonics CEO Lu Alleruzzo thanked the company’s team for their amazing and tireless work to achieve this major milestone.
More information about INJECTABLE-1 clinical trial and enrollment can be found at Clinicaltrials.gov
IP-001 is a proprietary glycan polymer that acts both as an antigen depot and a potent immune stimulant capable of inducing immunological responses against cancer. It is designed to (1) prolong the availability of the target antigens (whether it is sourced through formulation or tumoricidal therapies), (2) facilitate the recruitment and activation of innate immune cells such as antigen-presenting cells (APCs), (3) increase the uptake of the tumor antigens into the APCs, and (4) lead to a potent downstream adaptive immune response against the antigenic targets. This ignited adaptive immune response then seeks out and eliminates its target throughout the body.
Immunophotonics, Inc. is a privately owned clinical-stage biotech company pioneering the field of Interventional Immuno-Oncology™. IP-001, the first asset from the company’s intellectual property platform, has the potential to overcome the local defenses of the tumor microenvironment to enable a tumor-specific anticancer immune response in multiple solid tumor indications. The company is in early Phase 2 development and is based in St. Louis, Missouri, USA.
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This press release may contain forward-looking statements. Such statements involve inherent risks and uncertainties, and numerous factors could cause actual results to differ materially from those made or implied herein. All information provided in this press release is as of the date of this press release, and Immunophotonics, Inc. undertakes no duty to update such information, except as required under applicable law.