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Checkmate Pharmaceuticals Announces Initiation of Patient Dosing in Phase 2 Head and Neck Cancer Trial

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CAMBRIDGE, Mass., April 19, 2021 (GLOBE NEWSWIRE) -- Checkmate Pharmaceuticals Inc. (NASDAQ: CMPI) (“Checkmate”), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, today announced the initiation of dosing in a Phase 2 proof-of-concept trial in patients with head and neck squamous cell carcinoma (HNSCC). The trial will assess the efficacy and safety of vidutolimod (CMP-001) in combination with pembrolizumab for the treatment of patients with first-line relapsed or metastatic HNSCC. The results of this trial are expected in the 2nd half of 2022, with initial data in a subset of patients anticipated before the end of 2021.

“The initiation of patient dosing in this head and neck cancer trial is an important milestone for our indication-expansion strategy for vidutolimod,” said Barry Labinger, President and Chief Executive Officer of Checkmate. “Fewer than 20% of patients with relapsed or metastatic HNSCC respond to single-agent checkpoint blockade, which highlights the substantial need for a chemotherapy-free regimen with an improved rate and duration of response.”

Checkmate is also conducting two clinical trials of vidutolimod in combination with nivolumab in the lead indication of melanoma. The first is a Phase 2 trial assessing the efficacy and safety of vidutolimod in combination with nivolumab for the treatment of patients with anti-PD-1 refractory melanoma. The second is a Phase 2/3 trial comparing the efficacy and safety of vidutolimod in combination with nivolumab to nivolumab monotherapy in patients with first-line metastatic or unresectable melanoma. Checkmate previously announced initiation of patient dosing in the first-line melanoma trial in March 2021. Trial sites have been activated and patient screening is underway in the refractory melanoma study.

Additional information about Checkmate’s HNSCC trial, including participating investigative sites, can be found here: https://clinicaltrials.gov/ct2/show/NCT04633278.

Information about the Phase 2 anti-PD-1 refractory melanoma trial and the Phase 2/3 melanoma study can be found here: https://checkmatepharma.com/pipeline/clinical-trials/.

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 TLR9 agonist delivered as a biologic virus-like particle 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), our investor relations website (ir.checkmatepharma.com), and on social media (Twitter and LinkedIn), 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. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. 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 Statements

Various 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 product candidate, including its development and therapeutic potential and the advancement of our clinical and preclinical pipeline; expectations regarding the results and analysis of data; and expectations regarding the timing, initiation, implementation and success of its planned and ongoing clinical trials for CMP-001, and the benefits and related implications of current and future partnerships and/or collaborations. 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 our product candidate, 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 and plans, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and obtaining, maintaining and protecting our intellectual property. 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 Annual Report on Form 10-K for the year ending December 31, 2020, as filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act 1933, as amended, which is 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 Checkmate’s 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.

CONTACT: Investor Contact Rob Dolski Chief Financial Officer rdolski@checkmatepharma.com Media Contact Karen Sharma MacDougall 781-235-3060 ksharma@macbiocom.com