Replimune Rises on Positive Melanoma Study Data

Shares in biotechnology company Replimune Group (Nasdaq: REPL), climbed nearly 15% on Monday morning after the company reported positive topline results from the primary analysis of its IGNYTE clinical trial evaluating RP1 plus nivolumab in anti-PD1 failed melanoma. The results showed that one-third of patients receiving RP1 plus nivolumab responded to treatment, with all responses lasting greater than 6 months from baseline. The results improved upon the investigator-assessed data presented at ASCO 2024, last week.

“The overall strength of the IGNYTE data and safety profile further highlights the potential of RP1 in a difficult treatment setting with limited options for patients,” said Sushil Patel, Ph.D., CEO of Replimune. “Based on these compelling results and recent FDA interactions, we are increasingly confident in our path forward. We have shared the results with the agency and plan to request a pre-BLA meeting, in advance of our intended BLA submission. With these data in hand, we are preparing for a commercial launch next year.”

RP1 is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

An estimated 1.5 million Americans are living with melanoma, the most deadly form of skin cancer. Approximately 97,000 people received a new diagnosis in 2023, according to the American Cancer Society.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

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Replimune Rises on Positive Melanoma Study Data

Catie Corcoran

Biotech Editor