RP1: U.S. Enrollment Opened for Phase 1/2 Clinical Trial in Combination with Nivolumab in Patients with Solid Tumors
RP1: Randomized Controlled Phase 2 Clinical Trial Alone and in Combination with Cemiplimab On Track to Initiate H1 2019
RP2: Phase 1 Clinical Trial Alone and in Combination with Anti-PD1 Therapy On Track to Initiate H1 2019
RP3: Clinical Candidate Expressing Immune Co-Stimulatory Pathway Activating Ligands Selected
WOBURN, Mass., Jan. 03, 2019 (GLOBE NEWSWIRE) -- Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic™ platform, today announced status updates highlighting progress with the Company’s key programs.
“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.”
Recent RP1-specific program progress is summarized below:
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.
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.
Replimune Group Inc., headquartered in Woburn, MA, was founded in 2015 to develop the next generation of “oncolytic immune-gene therapies” for the treatment of cancer. Replimune is developing novel, proprietary therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response to the tumor antigens released. The Company’s Immulytic™ platform is designed to maximize systemic immune activation, in particular to tumor neoantigens, through robust viral-mediated immunogenic tumor cell killing and the delivery of optimal combinations of immune-activating proteins to the tumor and draining lymph nodes. The approach is expected to be highly synergistic with immune checkpoint blockade and other approaches to cancer treatment. Replimune intends to progress these therapies rapidly through clinical development in combination with other immuno-oncology products with complementary mechanisms of action. For more information, please visit www.replimune.com.
Forward Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about our use of cash, our advancement of our clinical trials, our goals to develop and commercialize our product candidates, our plans to establish our own in-house manufacturing capabilities, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of establishing, equipping, and operating our planned in-house manufacturing facility, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, and other risks set forth under the heading “Risk Factors” of our Quarterly Report on Form 10-Q for the second quarter ended September 30, 2018. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Pamela Esposito, Ph.D.
Replimune Group Inc.
Verge Scientific Communications