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PublicationsCIRSE InsiderImmunophotonics, CIRSE, and Next Research announce innovative phase 2/3 clinical trial: INJECTABL-3

Immunophotonics, CIRSE, and Next Research announce innovative phase 2/3 clinical trial: INJECTABL-3

September 14, 2024

Tumor ablation is a routine treatment happening in many hospitals around the world. Presently, the approach is successful in eliminating the targeted tumors. By partnering on a clinical trial with Immunophotonics, Inc. on their lead clinical asset IP-001, CIRSE is hoping to help address the major unmet medical issues of tumor recurrence following tumor ablation by driving a systemic tumor specific immune response and potentially eliminating circulating tumor cells in patients.

The trial, entitled INJECTABL-3, is designed in collaboration with a Steering Committee nominated by CIRSE and managed by CIRSE’s contract research organization, Next Research. This trial will be a phase 2/3 clinical trial conducted in two phases and is expected to enroll an estimated 300–500 patients in a randomized, controlled study in the United States and Europe. This pivotal trial will evaluate the safety and efficacy of IP-001 in combination with ablation treatments in key indications where tumor ablation is the current standard of care.

Prof. Philippe L. Pereira commented, “The collaboration between Immunophotonics, CIRSE, and Next Research highlights the importance of multidisciplinary partnerships in advancing major medical breakthroughs for patients in need. As the global pioneer of a concept called Interventional Immuno-Oncology, Immunophotonics’ approach is not only practical for clinicians and patients, but early data indicates it has tremendous promise.”

Prof. Uwe Martens, Medical Oncologist at SLK-Clinics Heilbronn GmbH stated, “We are looking forward to playing a part in the INJECTABL-3 trial and seeing the potential for IP-001 to become a game-changing treatment option for patients that receive tumor ablation. Early data demonstrates tolerability of the investigational product along with promise in terms of IP-001’s ability to drive abscopal effects. This type of immune-mediated response could be quite beneficial for patients, and therefore it will be important to conduct this clinical trial.”

CIRSE and Next Research representatives met with Immunophotoics during CIRSE 2024 for meetings and recordings.

About IP-001

IP-001 is a proprietary glycan polymer that acts both as an antigen depot and a potent, multimodal immune stimulant capable of inducing immunological responses against cancer.  It is designed to (1) prolong the availability of the target antigens, whether 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 downstream adaptive immune response against the antigenic targets.  This systemic, adaptive immune response then seeks out and eliminates its target throughout the body.