Immunophotonics, Inc. has announced the completion of treatment of the last patient in its INJECTABL-1 multicenter Phase 1b/2a clinical trial of IP-001 for advanced solid tumors. The 41-patient trial evaluated three distinct cancer types—colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma—across multiple countries including France, Germany, Switzerland, the UK, and the US.
Novel Approach to Tumor Ablation
The INJECTABL-1 trial was designed to evaluate the systemic immune-mediated anti-cancer effects of IP-001 following tumor ablation. While tumor ablation is an approved and well-established procedure readily available at most hospitals and clinics that aims to destroy all cells in targeted tumor lesions, it fails to induce robust anti-tumor immunity in patients with advanced solid tumors.
IP-001 represents a novel immunotherapy administered by injection into the ablation zone. The therapy works by retaining tumor debris, including tumor antigens, and by activating the patient's own immune system to allow systemic tumor surveillance. This immune surveillance enables the patient's own defense mechanisms to recognize and destroy tumor cells that had escaped the destroyed metastatic lesion.
Mechanism of Action
IP-001 is a proprietary glycan polymer that generates tumor antigen depots and acts as a potent, multimodal immune stimulant intended to induce immunological responses to eradicate cancer. The therapy is designed to achieve four key objectives: prolong the availability of targeted tumor antigens, facilitate the recruitment and activation of innate immune cells such as antigen-presenting cells (APCs), increase the uptake of tumor antigens into the APCs, and lead to a downstream adaptive immune response against tumor cells.
The activation of a systemic, adaptive immune response allows immune effector cells to seek out and eliminate tumor cells throughout the body, addressing circulating tumor cells and micrometastases left behind after ablation.
Clinical Significance and Future Directions
Prof. Dr. Markus Jörger, Principal Investigator for the trial at the Cantonal Hospital St. Gallen Clinic for Medical Oncology and Hematology, stated: "We are proud to announce the completion of treatment of the last patient in our INJECTABL-1 Phase 1b/2a clinical trial. This significant milestone brings us closer to potentially providing a new treatment option for patients with advanced solid tumors."
Lu Alleruzzo, Immunophotonics co-founder and CEO, emphasized the company's commitment to leading the field of Interventional Immuno-Oncology through a therapeutic approach intended to reduce tumor recurrence after standard-of-care local ablation therapy, which remains a significant unmet medical need. "With the completion of our INJECTABL-1 trial, we will evaluate data to assess IP-001's ability to transform ablation into something more powerful as we continue to advance the clinical development of our proprietary novel asset. Early signals are positive, and the company has expanded clinical collaborations to further assess the efficacy of this novel therapy," Alleruzzo stated.
Company Background
Immunophotonics 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, is currently assessed in multiple clinical trials and has the potential to overcome the local defenses of the tumor microenvironment to enable a tumor-specific immune response in solid cancers. The company maintains world headquarters in St. Louis, Missouri, USA, and European headquarters in Bern, Switzerland.
