Replimune Group, Inc. Announces First Patient Dosed with RP3 in a Phase 1 Clinical Trial in Patients with Advanced Solid Tumors
January 05, 2021 at 01:00 pm
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Replimune Group, Inc. announced it has dosed the first patient in a Phase 1, open-label, dose-escalation and expansion clinical trial of RP3 both alone and in combination with anti-PD-1 therapy. RP3, Replimune’s third product candidate to enter clinical development, encodes for CD40L and 4-1BBL in addition to the GALV-GP R(-) fusogenic protein encoded in RP1 and the anti-CTLA-4 molecule encoded in RP2. Expression of CD40L and 4-1BBL are intended to further stimulate an anti-tumor immune response through immune co-stimulatory pathway activation. Replimune’s product candidates are designed to comprehensively activate an anti-tumor immune response to a patient’s cancer through the delivery of potent immune activating signals into the tumor, such that each of the stages of immune activation are maximized. The signals provided are (i) potent antigen release and presentation, so-called immunologic “Signal 1”, provided by robust tumor destruction and immunogenic cell death through the use of the high potency oncolytic backbone expressing the GALV-GP R- fusogenic protein in all of our product candidates; (ii) the inhibition of signals which block full immune activation, provided by expression of anti-CTLA-4 in both RP2 and RP3; (iii) provision of potent immune co-stimulatory signals, so-called immunologic “Signal 2”, provided by expression of CD40L and 4-1BBL in RP3; and (iv) the production of inflammatory cytokines, so-called immunologic “Signal 3”, also intended to be stimulated by the expression of CD40L and 4-1BBL in RP3. RP3 therefore represents the culmination of this approach to date, and is intended to build on the compelling clinical data generated with RP1 and RP2, including in immune non-responsive tumor types. The Phase 1, dose-escalation clinical trial is currently enrolling patients with advanced solid tumors. The clinical trial is primarily designed to assess safety and tolerability of RP3 and to determine the recommended Phase 2 dose. Following dose selection, the second part of the clinical trial is intended to dose patients with RP3 in combination with anti-PD1 therapy to further assess for both safety and initial efficacy.
Replimune Group, Inc. a clinical-stage biotechnology company engaged in the development of a novel class of oncolytic immunotherapies. The Companyâs 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. RP1 (vusolimogene oderparepvec) is its lead product candidate and 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. It is also developing additional product candidates, RP2 and RP3, to enhance anti-tumor immune responses and are intended to address additional tumor types, including traditionally less immune responsive tumor types. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF.
REPLIMUNE GROUP, INC. 
