On January 3, 2019 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported status updates highlighting progress with the Company’s key programs (Press release, Replimune, JAN 3, 2019, View Source [SID1234532398]).
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"Replimune had a very productive 2018 with our successful initial public offering in July providing us with the funds to continue to advance our new generation of potentially best in class oncolytic immuno-gene therapies into and through clinical trials," said Robert Coffin, Ph.D., co-founder, President and CEO of Replimune. "We have made tremendous progress with all aspects of our business and are pleased that all programs continue to progress on track. We now look forward to 2019 when we expect to initiate enrollment of the Phase 2 portion of the Phase 1/2 clinical trial of RP1 in combination with nivolumab in four solid tumor types, initiate enrollment of our potentially pivotal randomized controlled Phase 2 clinical trial of RP1 in combination with cemiplimab in cutaneous squamous cell carcinoma (CSCC), and initiate clinical development of our RP2 product candidate expressing anti-CTLA-4."
Program Updates
RP1:RP1 is Replimune’s first product candidate to enter the clinic and is based on a proprietary new strain of herpes simplex virus armed with a gene encoding a potent fusogenic protein (GALV-GP-R-), intended to enhance tumor killing potency, immunogenic cell death and the activation of systemic anti-tumor immune responses, and with a gene encoding the cytokine GM-CSF. Replimune is currently testing RP1 in a two-part Phase 1/2 clinical trial in collaboration with Bristol Myers Squibb. In part one of the Phase 1/2 clinical trial, Replimune is assessing the safety and tolerability of RP1 administered alone in patients with advanced solid tumors followed by dosing in combination with nivolumab anti-PD1 therapy. In part two of the Phase 1/2 clinical trial Replimune intends to study the safety and efficacy of RP1 in combination with nivolumab in four cohorts of patients with different solid tumor types. Replimune also intends to initiate a registration-directed randomized controlled Phase 2 clinical trial of approximately 240 patients with CSCC comparing treatment with cemiplimab alone to treatment in combination with RP1, under the Company’s collaboration with Regeneron. Cemiplimab is Regeneron’s anti-PD1 drug which was approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally recurrent and metastatic CSCC in 2018.
Recent RP1-specific program progress is summarized below:
Completed enrollment of RP1 alone in the Phase 1 portion of the Phase 1/2 study.
Opened enrollment of the second part of the Phase 1 portion of the study, in which RP1 is being combined with nivolumab, in the United States (U.S.) and United Kingdom (UK).
Data from the full Phase 1 part of the Phase 1/2 study (RP1 alone and RP1 combined with nivolumab) is expected to be presented at a medical conference in the second half of 2019.
On track to initiate the Phase 2 portion of the study in the first half of 2019 in four cohorts of approximately 30 patients each with melanoma, bladder cancer, microsatellite instability high cancers, and non-melanoma skin cancers.
On track to initiate the registration-directed randomized, controlled Phase 2 clinical trial of RP1 in combination with cemiplimab in CSCC in the first half of 2019.
Pipeline product candidates (RP2 & RP3)
Replimune’s pipeline product candidates are further armed versions of RP1 which focus on the delivery of immune activating genes to tumors which target clinically validated pathways that act as the immune response is initiated. In particular, these are pathways where Replimune believes systemic engagement may be sub-optimal.
RP2 is a version of RP1 that, in addition to expressing GALV-GP-R and GM-CSF, also expresses a genetically encoded anti-CTLA-4 antibody intended to block the inhibition of the initiation of immune response caused by CTLA-4. RP2 is intended to be used primarily in combination with anti-PD-1 or anti-PD-L1 therapy.
The Company remains on track to initiate the clinical development of RP2 in a Phase 1 clinical trial of RP2 alone and in combination with anti-PD1 therapy in the first half of 2019.
RP3 is a further armed oncolytic immuno-gene therapy which expresses two immune co-stimulatory activating ligands. Following the assessment of a number of co-stimulatory pathways, which like anti-CTLA-4 are expected to be primarily active at the site and time of anti-tumor immune response initiation, the selected RP3 product candidate to be moved forward to clinical development has now been finalized and will express CD40L and 4-1BBL, together with anti-CTLA-4 and GALV-GP-R-. CD40L activates CD40, resulting in the broad activation of both innate and adaptive immunity, and 4-1BBL activates 4-1BB (CD137) to promote the expansion of cellular and memory immune responses.
The Company remains on track to initiate the clinical development of RP3 in a Phase 1 clinical trial of RP3 alone and in combination with anti-PD1 therapy in the first half of 2020.
Cash Position: Based on its current operating plan, Replimune expects that its current cash, cash equivalents and short-term investments will enable it to fund its operating expenses and capital expenditure requirements into the second half of 2021.
JPMorgan Conference Presentation and Webcast
As previously announced, Replimune will be presenting at the 37th Annual JPMorgan Healthcare Conference on January 9 at 8:00am PT.
A simultaneous webcast will be available in the Investors section of Replimune’s website at www.replimune.com. A replay will be available for 30 days following the conference.