Replimune Shares Down 76% On FDA's CRL For RP1 In Combination With Nivolumab For Advanced Melanoma

Replimune Group

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(RTTNews) - Shares of Replimune Group Inc. (REPL) are down more than 76 percent in the pre-market activity on the Nasdaq after the clinical stage biotechnology company focused on oncolytic immunotherapies announced Tuesday that it has received a Complete Response Letter or CRL from the U.S. Food and Drug Administration.

The CRL is regarding the Biologics License Application or BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.

The company said it plans to request a Type A meeting and expects it will be granted within 30 days. Replimune plans to urgently interact with the FDA to find a path forward for the timely accelerated approval of RP1 without which the development of RP1 for advanced cancer patients with limited options will not be viable.

RP1, Replimunes lead product candidate, is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

The CRL indicates that the FDA is unable to approve the application in its present form, and that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.

Further, the agency said the trial cannot be adequately interpreted due to the heterogeneity of the patient population. The CRL also states that there are items related to the confirmatory trial study design which need to be addressed, including contribution of components. Importantly, no safety issues were raised.

Sushil Patel, Chief Executive Officer, Replimune, said, "We are surprised by this FDA decision and disappointed for advanced melanoma patients who have limited treatment options as highlighted by the granting of breakthrough status at the time we provided the IGNYTE primary data. The issues highlighted in the CRL were not raised by the agency during the mid- and late-cycle reviews. Additionally, we had also aligned on the design of the confirmatory study. We strongly believe that RP1 in combination with nivolumab can bring substantial benefit to advanced melanoma patients."

In the pre-market activity on the Nasdaq, the shares were trading at $2.94, down 76.15%.

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