Full Press Release Details
into Clinical Collaboration Agreement with Roche for the Development of RP3 In Colorectal Cancer and Hepatocellular Carcinoma
RP3 will be developed
in combination with atezolizumab and bevacizumab for the third-line treatment of colorectal cancer (CRC) and for the first- and second-line
treatment of hepatocellular carcinoma (HCC)
sharing for development in third-line CRC and second-line HCC
RP2/3 Phase 2 development plans to be provided by year end
Woburn, MA, December 7, 2022
- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class
of tumor-directed oncolytic immunotherapies, today announced that the company has entered into a Master Clinical Trial Collaboration
and Supply Agreement in relation to Replimune's RP2/3 program in colorectal cancer (CRC) and hepatocellular carcinoma (HCC). Specifically,
the companies will collaborate in third-line (3L) CRC and in first- and second-line (1L & 2L) HCC. Under the terms of the agreement,
the companies will share costs and Roche will supply its currently approved drugs, atezolizumab and bevacizumab for 2L HCC and 3L CRC
combined with RP3. Roche will also supply atezolizumab and bevacizumab for 1L HCC combined with RP3, and for 3L CRC combined with RP2.
Approximately 30 patients will be enrolled within each cohort. Replimune will have responsibility for operationalizing the clinical trial.
Atezolizumab in combination with bevacizumab
is FDA approved and the current standard of care for the 1L treatment of unresectable HCC, with current treatment options for the treatment
of 2L HCC being very limited. Combining RP3 with atezolizumab and bevacizumab has the potential to increase response rates and clinical
benefit for patients with 1L disease, and to provide a much needed option for patients with 2L disease. While, bevacizumab is FDA approved
to treat metastatic colorectal cancer, or mCRC, for first- or second-line treatment in combination with chemotherapy, late line CRC is
a significant unmet need.
"This collaboration announcement
is in keeping with our philosophy of partnering with industry leaders in oncology and in indications where our immunotherapies have the
potential to become a key cornerstone of treatment," said Pamela Esposito, Ph.D., Chief Business Officer of Replimune. "With
similar collaborations already in place for our lead candidate RP1 with Regeneron and Bristol-Myers Squibb, we believe this latest cost
and supply sharing collaboration with Roche, a leader in GI cancers, will help us efficiently advance RP2/3 for the development of CRC
Replimune remains on track to initiate
its Phase 2 development program with RP2/3 in the first half of 2023. As previously announced, this program is intended to include Phase
2 clinical trials in squamous cell carcinoma of the head and neck (SCCHN; locally advanced and recurrent/metastatic), hepatocellular
carcinoma (HCC; first line and second line) and colorectal cancer (CRC; third line), combined with current standard of care where appropriate.
RP2 and RP3 are enhanced potency oncolytic
versions of HSV that express a fusogenic glycoprotein which provides robust immunogenic cell death together with additional immune-activating
proteins. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule and GM-CSF and RP3 additionally expresses the anti-CTLA-4
antibody-like molecule and the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are intended to provide
targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with
the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.
Replimune Group, Inc., headquartered
in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel tumor-directed
oncolytic immunotherapies. Replimune's proprietary RPx platform is based on a potent HSV-1 backbone with payloads added to maximize
immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform has a unique dual local and systemic
mechanism of action (MOA) consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived
antigens and altering of the tumor microenvironment (TME) to ignite a strong and durable systemic response. This MOA is expected to be
synergistic with most established and experimental cancer treatment modalities, and, with an attractive safety profile the RPx platform
has the versatility to be developed alone or combined with a variety of other treatment options. 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 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, 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 Securities and Exchange Commission. 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.
Verge Scientific Communications