Press Release
Replimune Highlights Company Progress and Expected 2019 Milestones Ahead of Presentation at the 37th Annual JPMorgan Healthcare Conference
“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
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 testingRP1 in a two-part Phase 1/2 clinical trial in collaboration withBristol Myers Squibb . In part one of the Phase 1/2 clinical trial,Replimune is assessing the safety and tolerability ofRP1 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 trialReplimune intends to study the safety and efficacy ofRP1 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 withRP1 , under the Company’s collaboration with Regeneron. Cemiplimab is Regeneron’s anti-PD1 drug which was approved by theU.S. Food and Drug Administration (FDA ) for the treatment of locally recurrent and metastatic CSCC in 2018.
Recent
- 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, inthe United States (U.S.) andUnited Kingdom (UK ).- Data from the full Phase 1 part of the Phase 1/2 study (
RP1 alone andRP1 combined with nivolumab) is expected to be presented at a medical conference in the second half of 2019.
- Data from the full Phase 1 part of the Phase 1/2 study (
- 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 (
Replimune’s pipeline product candidates are further armed versions of
RP2 is a version ofRP1 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 ofRP2 alone and in combination with anti-PD1 therapy in the first half of 2019.
- The Company remains on track to initiate the clinical development of
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 selectedRP3 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 ofRP3 alone and in combination with anti-PD1 therapy in the first half of 2020.
- The Company remains on track to initiate the clinical development of
Cash Position: Based on its current operating plan,
JPMorgan Conference Presentation and Webcast
As previously announced,
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.
About
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.
Replimune Contact
617.233.6988
pamela@replimune.com
Investor Inquiries
Westwicke Partners
339.970.2843
chris.brinzey@westwicke.com
Media Inquiries
917.548.1582
agoldenberg@vergescientific.com
Source: Replimune Group Inc