Replimune Provides 2019 Year End Corporate Update and Reviews Expected 2020 Milestones
“Replimune had a very productive 2019 where a key highlight included the presentation of initial clinical data with
- The registration-directed Phase 2 clinical trial of
RP1in combination with Libtayo in CSCC is underway. This multi-center, randomized, controlled clinical trial is intended to enroll approximately 240 patients with CSCC. The clinical trial’s primary objective is to compare the response rate following treatment with RP1in combination with Libtayo to the response rate achieved with Libtayo alone. Libtayo is an FDA-approved anti-PD-1 therapy developed by Regeneron and Sanofifor the treatment of patients with metastatic or locally-advanced CSCC who are not candidates for curative surgery or radiation. This clinical trial is being conducted under the Company’s collaboration agreement with Regeneron, whereby the Company and Regeneron split development and supply costs equally. Recruitment for this clinical trial is expected to take approximately 18 to 24 months and enroll patients in the United States, Australia, Canada, United Kingdomand European Union.
- Recruitment is currently ongoing in the Phase 2 part of the Phase 1/2 clinical trial of
RP1in combination with Opdivo. The Phase 2 part of the clinical trial is currently enrolling 30-patient cohorts with melanoma, non-melanoma skin cancers, metastatic bladder cancer, and MSI-H tumors. Data from completely enrolled or ongoing skin cancer cohorts is expected to be presented during the second half of 2020 with further data from all four cohorts expected to be available by year-end.
- On track to initiate a new registration-directed 125-patient cohort in the Phase 2 clinical trial of
RP1in combination with Opdivo in anti-PD-1 refractory melanoma patients in the first quarter of 2020, based on the initial clinical efficacy data with RP1in melanoma. The additional cohort will be enrolled under an expansion of the clinical trial collaboration and Opdivo supply agreement with BMS.
- On track to initiate a clinical trial of
RP1as monotherapy in solid organ transplant recipients with CSCC in the first half of 2020. The U.S. Food and Drug Administration( FDA) has accepted the protocol for this clinical trial under its previously-accepted Investigational New Drug application for RP1. The clinical trial is intended to enroll approximately 30 patients and assess the safety and efficacy of RP1in liver and kidney transplant recipients with recurrent CSCC and is expected to provide initial data by the end of 2020.
- The Phase 1 clinical trial of
RP2alone and in combination with Opdivo is underway. The clinical trial is designed to assess the safety and tolerability, and to determine the optimal dose, of RP2alone and in combination with Opdivo and is being conducted under a clinical trial collaboration and agreement with BMS for the supply of Opdivo. Initial data from this all-comers trial is expected by the end of 2020.
- The Phase 1 clinical trial of
RP3alone and in combination with an anti-PD-1 therapy is expected to initiate in 2020.
- Manufacturing: Completed the build-out of Replimune’s state of the art manufacturing facility to support late-stage development and commercialization. The 63,000-square-foot facility in
Framingham, MAis intended to provide multi-product manufacturing capabilities for Replimune’s Immulytic product candidates. The Company believes that the capacity of this facility is sufficient to support full commercialization of its product candidates. An occupancy certificate for the facility has been obtained and the first technology transfer manufacturing run has been successfully completed. Full GMP manufacturing is expected to commence in the first half of 2020.
- Cash Position: Based on its current operating plan,
Replimuneexpects that its cash, cash equivalents and short-term investments, of approximately $183 millionas of December 31, 2019, will be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2022.
J.P. Morgan Conference Presentation and Webcast.
As previously announced, the Company will be presenting at the 38th Annual
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 cash runway, our advancement of our clinical trials, results of our clinical trials, our goals to develop and commercialize our product candidates, our plans to operate our own in-house manufacturing facility, our expectations with respect to our own in-house manufacturing capabilities, our proposed investor presentations, 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 as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the
Source: Replimune Group Inc