On November 12, 2021 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, reported third quarter 2021 financial results and provided a business update (Press release, Checkmate Pharmaceuticals, NOV 12, 2021, View Source [SID1234595388]).
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"We are excited about the future of vidutolimod as a potential novel treatment for multiple tumor types, including melanoma and head and neck cancer. We continue to advance our clinical trials towards potential data readouts in 2022," said Alan Fuhrman, interim President and Chief Executive Officer of Checkmate.
Recent Business Updates
During The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting, Dr. John Kirkwood from the University of Pittsburgh Medical Center presented a poster on the final clinical data from the Phase 1b study of vidutolimod in combination with pembrolizumab or as a monotherapy in patients with anti-PD-1 refractory melanoma.
Vidutolimod in combination with pembrolizumab led to an ORR of 23.5% by RECIST v1.1, a complete response rate of 7.1%, and a median duration of response of 25.2 months.
Vidutolimod monotherapy resulted in a 20.0% ORR by RECIST v1.1 and a median duration of response of 5.6 months.
The most frequent treatment-related adverse events were consistent with flu-like symptoms and injection site reactions and were most commonly Grade 1 or 2.
We appointed Alan Fuhrman, an experienced biotech executive and Checkmate board member, as interim President and CEO.
Ongoing patient recruitment activities and enrollment across our clinical trials evaluating vidutolimod, including:
A Phase 2 trial of vidutolimod in combination with nivolumab in anti-PD-1 refractory advanced melanoma, supported by a clinical collaboration with Bristol Myers Squibb.
A randomized Phase 2/3 trial of vidutolimod in combination with nivolumab vs. nivolumab monotherapy in first-line metastatic or unresectable melanoma, also supported by the clinical collaboration with Bristol Myers Squibb.
A Phase 2 trial of vidutolimod in combination with pembrolizumab in recurrent or metastatic squamous cell head and neck cancer.
Start-up activities underway for the planned expansion of the development program for vidutolimod in combination with cemiplimab in cutaneous squamous cell carcinoma and Merkel cell carcinoma, supported by a clinical collaboration with Regeneron.
Third Quarter 2021 Financial Results
Research and development expenses (R&D): R&D expenses for the three months ending September 30, 2021, were $11.4 million, compared to $6.7 million for the same period in the prior year. This increase reflects higher third-party CRO and manufacturing costs directly related to the vidutolimod clinical trials, in addition to higher personnel and operating expense for the planning and execution of the clinical trials.
General and administration expenses (G&A): G&A expenses for the three months ending September 30, 2021, were $3.6 million, compared to $3.2 million for the same period in the prior year. This increase was primarily attributable to increases in personnel and operating expense incurred in connection with Checkmate operating as a publicly traded company.
Cash, cash equivalents and investments: Cash, cash equivalents and available-for-sale investments were $80.8 million as of September 30, 2021.