Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI)
(“Checkmate”), a clinical stage biotechnology company focused
on developing its proprietary technology to harness the power of
the immune system to combat cancer, today announced the
University of Iowa Holden Comprehensive Cancer Center’s
presentation of preliminary data from an investigator-sponsored
phase 1/2 trial evaluating vidutolimod, a first-in-class,
immunostimulatory, noninfectious virus-like particle (VLP)
containing a CpG-A Toll-like receptor 9 (TLR9) agonist. The early
phase trial is investigating intratumoral vidutolimod therapy in
combination with intravenous pembrolizumab in patients with
relapsed lymphoma. The objective of this study is to determine the
dose of vidutolimod that, in combination with pembrolizumab, has
optimal clinical efficacy and acceptable toxicity in patients with
relapsed lymphoma who have failed at least one line of therapy. In
addition to the funding provided by Checkmate, the ongoing study is
supported by NCI grant P50 CA97274 to the University of Iowa/Mayo
Clinic (UI/MC) Lymphoma SPORE (specialized program of research
excellence).
Preliminary results from an early-phase trial
of in situ immunization of
lymphoma with a virus-like particle containing a TLR9 agonist
combined with anti–PD-1 therapy (Abstract #: 2639:
NCT03983668)
During the 2022 ASCO Developmental Therapeutics—Immunotherapy
Poster Session on Sunday, June 5 at 9:00am ET, Umar Farooq, M.D.,
Clinical Associate Professor of Internal Medicine at University of
Iowa Hospitals & Clinics, principal investigator, and study
sponsor, will present preliminary safety, response and
translational laboratory data from 7 enrolled patients with
relapsed lymphoma.Key highlights from the presentation include:
- Preliminary results
suggest that in situ immunization with vidutolimod plus systemic
pembrolizumab had clinical activity in a variety of lymphomas in 5
of 7 patients studied
- No significant
adverse effects (AEs) were reported after the 4-hour observation
period other than mild headache or fatigue lasting only through day
1
- Consistent with
preclinical data, generation of anti-Qβ antibodies after the
initial subcutaneous (SC) vidutolimod dose correlated with response
to study treatment; further evaluation in additional patients is
needed to confirm these initial observations
- Additional
evaluation of complex interactions between cells in the tumor
microenvironment in response to vidutolimod will be needed to
understand these findings
Study enrollment is ongoing and given the common use of B cell
depleting therapies for the treatment of certain lymphomas, the
study was modified to require generation of anti-Qβ antibodies
after the initial SC dose of vidutolimod before patients receive IT
therapy.
“Our understanding of the immune and therapeutic responses to
intratumoral vidutolimod with checkpoint inhibitors continues to
grow stronger based on these data,” said Art Krieg, M.D., Founder
and Chief Scientific Officer of Checkmate. “These initial
observations provide valuable insights into the mechanism of action
of vidutolimod and reinforce earlier preclinical data from the Iowa
team that suggest the activity of vidutolimod requires the
generation of anti-Qβ antibodies. We look forward to the continued
investigation of vidutolimod in combination with immune checkpoint
inhibitors to improve available treatment options for people with
lymphoma and other difficult to treat cancers.”
About Checkmate Pharmaceuticals Checkmate
Pharmaceuticals is a clinical stage biotechnology company focused
on developing its proprietary technology to harness the power of
the immune system to combat cancer. Checkmate Pharmaceuticals’
product candidate, vidutolimod (CMP-001), is an advanced generation
Toll-like receptor 9 (TLR9) agonist, delivered as a biologic
virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key
component, designed to trigger the body’s innate immune system to
attack tumors in combination with other therapies. Information
regarding Checkmate Pharmaceuticals is available at
www.checkmatepharma.com.
Availability of Other Information About Checkmate
Pharmaceuticals
Investors and others should note that we communicate with our
investors and the public using our website
(www.checkmatepharma.com) and our investor relations website
(ir.checkmatepharma.com), including but not limited to: investor
presentations and investor fact sheets, U.S. Securities and
Exchange Commission filings, press releases, public conference
calls and webcasts. The information that Checkmate Pharmaceuticals
posts on these channels and websites could be deemed to be material
information. As a result, we encourage investors, the media, and
others interested in us to review the information that is posted on
these channels, including the investor relations website, on a
regular basis. The contents of our website or these channels, or
any other website that may be accessed from our website or these
channels, shall not be deemed incorporated by reference in any
filing under the Securities Act of 1933.
Forward-Looking StatementsVarious statements in
this release are “forward-looking statements” within the meaning of
the Private Securities Litigation Reform Act of 1995, as amended,
including words such as, but not limited to, “anticipate,”
“believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,”
“intend,” “may,” “might,” “objective,” “plan,” “predict,”
“project,” “target,” “likely,” “should,” “will,” and “would,” or
the negative of these terms and similar expressions or words,
identify forward-looking statements. Forward-looking statements are
based upon current expectations that involve risks, changes in
circumstances, assumptions, and uncertainties. These statements
include those regarding our ability to consummate the proposed
merger with Regeneron, the timing of the closing of such merger,
including the satisfaction to conditions to closing of the proposed
merger within the expected timeframe or at all, the expected
benefits of the proposed merger, vidutolimod (CMP-001), including
its development, efficacy and therapeutic potential and the
advancement of our clinical and preclinical pipeline, and the
timing of our ongoing clinical trials, including the potential
benefit of acceleration in development following the consummation
of the proposed merger. Forward-looking statements should not be
read as a guarantee of future performance or results and may not be
accurate indications of when such performance or results will be
achieved. These forward-looking statements are subject to risks and
uncertainties, including those related to the development of
vidutolimod, including any delays in our ongoing or planned
preclinical or clinical trials, the results from clinical trials,
including the fact that positive results from a trial may not
necessarily be predictive of the results of future or ongoing
clinical trials, the impact of the ongoing COVID-19 pandemic on our
business, operations, clinical supply , clinical enrollment and
plans, the risks inherent in the drug development process,
including related to regulatory approval, the risks regarding the
accuracy of our estimates of expenses and timing of development,
our capital requirements, and obtaining, maintaining and protecting
our intellectual property, risks associated with our ability to
consummate the proposed merger and the timing of the closing of the
proposed merger, including the risks that a condition to closing
would not be satisfied within the expected timeframe or at all or
that the closing of the proposed merger will not occur, the outcome
of any legal proceedings that may be instituted against the parties
and others related to the definitive agreement entered into with
Regeneron, the occurrence of any event, change or other
circumstance or condition that could give rise to the termination
of the merger agreement, unanticipated difficulties or expenditures
relating to the proposed merger, the response of business partners
and competitors to the announcement of the proposed merger, and/or
potential difficulties in employee retention as a result of the
announcement and pendency of the proposed merger, and the response
of our stockholders to the merger agreement, and ongoing actions
taken and any future actions that may be taken by activist
stockholders. These and additional risks are discussed in the
sections titled “Risk Factors” and “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” in our
Quarterly Report on Form 10-Q for the three months ended March 31,
2022 and Annual Report on Form 10-K for the year ending December
31, 2021, filed with the Securities and Exchange Commission, which
are available on the Securities and Exchange Commission’s website
at www.sec.gov, and as well as discussions of potential risks,
uncertainties and other important factors in our subsequent filings
with the Securities and Exchange Commission. All information in
this press release is as of the date of the release, and Checkmate
undertakes no duty to update this information unless required by
law.
Investor Contact
Rob Dolski
Chief Financial Officer
rdolski@checkmatepharma.com
Media Contact
Karen Sharma
MacDougall Advisors
781-235-3060
ksharma@macdougall.bio
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