Press Release
Replimune Provides Updated Data from RP2 at the 2021 Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting
Initiated Phase 1 expansion of
Updated
The updated interim data shows:
- In the nine-patient monotherapy cohort with
RP2 , two of the initial three patients who achieved response remain in response, these being a patient with esophageal cancer (partial response; previously anti-PDL1 failed) at 22 months from entering the trial and a patient with mucoepidermoid carcinoma (complete response) at 19 months from entering the trial. As previously reported, the third responding patient with uveal melanoma with a partial response (Yervoy/Opdivo failed) progressed at 15 months from entering the trial. - Updated data from the 30-patient cohort of
RP2 in combination with Opdivo shows durable responses ongoing at out to >425 days. - To date, seven of the 30 patient (23.3%) cohort of
RP2 in combination with Opdivo have achieved partial responses, with additional patients still on study with the opportunity to achieve a response. Six of the seven responses are ongoing with depth of response having been maintained or deepened over time. - The responding patients are four of nine patients with cutaneous melanoma (all anti-PD1 or anti-PD1 and anti-CTLA-4 failed), two of eight patients with uveal melanoma (anti-PD1 or anti-PD1 and anti-CTLA-4 failed) and one of three patients with squamous cell carcinoma of the head and neck (anti-PD1 failed).
- Biomarker data continues to demonstrate substantial increases CD8 T cells and PD-L1 expression, with T cell receptor sequencing and Nanostring expression analysis further indicating potent and broad activation of an anti-tumor immune response.
- No correlation has been observed between the degree of anti-tumor response and the baseline levels of PD-L1 expression, in line with the intended mechanism of action for
RP2 of turning immunologically ‘cold’ tumors ‘hot’. - Overall the data, including the durability of the responses, continues to support that oncolytic immunotherapy-mediated expression of anti-CTLA-4 from
RP2 provides potent & systemic anti-tumor effects, without substantial additional toxicity as compared to the oncolytic backbone (RP1 ), including without evidence of the side effects associated with systemic ipilimumab. - Based on the observation of durable clinical responses in patients with liver metastases following treatment with both
RP1 andRP2 , the Company has amended the clinical trial protocol to enrol an additional 24 patients with liver metastases from lung cancer, gastrointestinal cancers, breast cancer and uveal melanoma.
Abstract Title: ARTACUS: An open-label, multicenter, phase 1b/2 study of
Abstract Number: 550
Session Date and Time:
Location: Hall E
Abstract Title: CERPASS: A randomized, controlled, open-label, phase 2 study of cemiplimab ±
Abstract Number: 547
Session Date and Time:
Location: Hall E
Abstract Title: IGNYTE: An open-label, multicenter, phase 1/2 (Ph 1/2) clinical trial of
Abstract Number: 506
Session Date and Time:
Location: Hall E
The full posters will be posted to the presentations section of the
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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 the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, the potential impact of the global coronavirus pandemic and the global economy on our operations and milestones, 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 operating our 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, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues, 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
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