Replimune Announces FDA Acceptance of Investigational New Drug Application for its Lead Oncolytic Immunotherapy Candidate, RP...
September 06 2018 - 4:01PM
Replimune Group Inc. (NASDAQ: REPL), a biotechnology company
developing oncolytic immunotherapies derived from its Immulytic™
platform, today announced the U.S. Food and Drug Administration
(FDA) has accepted the Company’s investigational new drug (IND)
application for its lead product candidate, RP1, for patients with
solid tumors. The Company intends to open its ongoing Phase 1/2
clinical trial in the U.S. and begin enrolling patients in the
fourth quarter of 2018. The clinical trial is currently ongoing in
the U.K., as previously announced.
In part one of the Phase 1/2 clinical trial, Replimune is
assessing the safety and tolerability of RP1 administered alone in
patients with advanced solid tumors. Following this dose escalation
phase, further patients will receive RP1 in combination with
nivolumab anti-PD1 therapy. In part two of the Phase 1/2 clinical
trial, expected to initiate in the first half of 2019, Replimune
intends to study the safety and efficacy of RP1 in combination with
nivolumab in approximately 120 patients with metastatic melanoma,
metastatic bladder cancer, microsatelite instability high cancers,
and non-melanoma skin cancers. For each of the tumor types other
than melanoma, patients will be naïve to immune checkpoint
blockade, whereas in melanoma, patients both previously treated and
previously untreated with immune checkpoint blockade will be
enrolled. This clinical trial is a collaboration with Bristol Myers
Squibb, which is providing nivolumab for use in the study.
RP1 is Replimune’s first Immulytic™ product candidate to enter
the clinic and is based on a proprietary new strain of herpes
simplex virus engineered to maximize tumor killing potency. This is
intended to result in highly immunogenic cell death and robust
activation of a systemic anti-tumor immune response.
About Oncolytic ImmunotherapyOncolytic
immunotherapy is an emerging class of cancer therapy which exploits
the ability of viruses to selectively replicate in and kill tumors,
while at the same time inducing a potent, patient-specific,
anti-tumor immune response. Oncolytic viruses have the ability
to induce a robust immune response against a patient’s particular
complement of tumor antigens, including neo-antigens, in situ in
the patient in an off-the-shelf format. While clinically active
alone, oncolytic immunotherapy may have synergy with certain other
treatments and, in particular, with immune checkpoint blockade
therapies.
About Replimune Replimune Group, Inc,
headquartered in Woburn, MA, was founded in 2015 to develop the
next generation of ‘oncolytic immunotherapies’ 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. The Company’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.
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 the timing and progress of
our clinical development of our RP1 product candidate 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 obtain necessary funding, 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 first quarter
ended June 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 ContactPamela Esposito,
Ph.D.Replimune Group Inc.pamela@replimune.com
Investor Inquiries Chris BrinzeyWestwicke
Partners339.970.2843chris.brinzey@westwicke.com
Media InquiriesArleen Goldenberg Verge
Scientific
Communications917.548.1582agoldenberg@vergescientific.com
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