Replimune Enrolls First Patient in Phase 1 Clinical Trial of RP2 for Advanced Cancer

Replimune Group Inc., a biotechnology company specializing in oncolytic immuno-gene therapies, has initiated a Phase 1 clinical trial for its second product candidate, RP2. This innovative therapy is designed to express an anti-CTLA-4 antibody-like molecule, alongside GALV-GP-R- and GM-CSF, aiming to block the inhibition of immune responses caused by CTLA-4. The trial will explore RP2's efficacy both as a standalone treatment and in combination with Opdivo (nivolumab), provided by Bristol-Myers Squibb Company (BMS), in patients with advanced solid tumors.

Robert Coffin, Ph.D., co-founder, President, and CEO of Replimune, expressed enthusiasm about advancing RP2 into clinical studies. He highlighted the potential of combining anti-CTLA-4 expression with oncolytic tumor destruction and antigen release to enhance the efficacy of CTLA-4 inhibition while minimizing systemic toxicity.

The Phase 1 clinical trial is a collaborative effort with BMS, which has granted Replimune a nonexclusive, non-transferable, royalty-free license to use Opdivo in combination with RP2. The study's primary objectives include evaluating the safety, tolerability, and determining the optimal dose of RP2 alone and in combination with anti-PD1 therapy.

RP2, based on a proprietary new strain of herpes simplex virus, represents a significant advancement in Replimune's Immulytic platform. Preclinical studies have demonstrated RP2's enhanced efficacy, both independently and in conjunction with anti-PD1 therapy, in treating injected and uninjected tumors.

Replimune, headquartered in Woburn, MA, was established in 2015 with the mission to develop next-generation oncolytic immune-gene therapies for cancer treatment. The company's Immulytic platform is designed to maximize systemic immune activation against tumor neoantigens, leveraging viral-mediated immunogenic tumor cell killing and the delivery of immune-activating proteins to the tumor and draining lymph nodes. This approach is anticipated to be highly synergistic with immune checkpoint blockade and other cancer treatment modalities.