Full Press Release Details
Provides 2020 Year End Review and Overview of Expected 2021 Milestones
Data in new indications expected in 2021 in anti-PD1 failed NSCLC, anti-PD1 failed CSCC and CSCC solid organ transplant recipient
patients; further updates expected to be provided across all studies
RP2; New data to be reported in 2021
in combination with Opdivo in Phase 1 all comers study
RP3; First patient dosed; single agent
data expected to be reported in 2021
Commercial-scale facility operational;
GMP manufacturing underway
Woburn, MA, January 11, 2021 - Replimune Group
Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform,
provides corporate update, highlighting the progress of its key programs.
"Replimune made great progress in 2020 providing positive
data read outs in multiple tumor types which support our registration-directed programs with RP1, as well as with RP2, demonstrating
the potential of our platform to redefine the cancer treatment paradigm by providing what we believe to be the most practical and
effective way to ignite a systemic immune response to a patient's cancer. During the year we also completed the construction
of and technology transfer to our state of the art commercial scale manufacturing facility" said Philip Astley-Sparke, Chief
Executive Officer of Replimune. "We start this year with the recent news that dosing of patients has commenced with our third
product candidate, RP3, which like RP2 is intended to treat tumor types which are not traditionally thought of as immune-responsive',
and look forward to releasing further data on all of our programs during the course of 2021. We continue to enroll into our two
registration-directed clinical trials in cutaneous squamous cell carcinoma (CSCC), the "CERPASS" study, and anti-PD1
failed melanoma, the "IGNYTE" study, and commercial planning activities are underway. We also expect to start dosing
RP1 combined with Opdivo in anti-PD1 failed non-small cell lung cancer (NSCLC) patients and anti-PD1 failed CSCC patients this
quarter. I am proud of the entire Replimune team for our accomplishments to date, as we continue to execute upon our mission to
make oncolytic immuno-gene therapy a foundational cornerstone of cancer treatment."
Program Highlights and Upcoming Milestones
J.P. Morgan Conference Presentation and Webcast.
As previously announced, the Company will be virtually presenting
at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12th at 5:20 p.m. ET. A simultaneous webcast
of the presentation 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. Replimune'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 across
a broad range of cancers. 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 cash runway, the
advancement of our clinical trials, our plans to initiate new clinical trials, 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 COVID-19 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 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.
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