On September 25, 2016 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported preclinical data as well as preliminary biomarker data from its ongoing Phase 1/1b study of CPI-444 as a single agent and in combination with Genentech’s TECENTRIQ (atezolizumab), a fully humanized monoclonal antibody targeting protein programmed cell death ligand 1 (PD-L1) (Filing, 8-K, Corvus Pharmaceuticals, SEP 26, 2016, View Source [SID:SID1234515364]). CPI-444 is a selective and potent inhibitor of the adenosine A2A receptor. The data were presented today in both oral and poster presentations by Stephen Willingham, Ph.D., Corvus senior scientist, at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science into Survival, which is taking place in New York at the Sheraton New York Times Square Hotel and the New York Hilton Midtown.

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"We are very encouraged by the early data showing that CPI-444 is well tolerated and by the biomarker data indicating that treatment with CPI-444 as a single agent is associated with activation of T-cells detected in the blood. We believe this is the first demonstration of immune modulation in cancer patients receiving an adenosine antagonist," said Richard A. Miller, M.D., an oncologist and co-founder, president and chief executive officer of Corvus. "Patient enrollment in our CPI-444 Phase 1/1b study is on schedule, and we anticipate completing the dose-selection portion of the study and reporting interim safety and efficacy data at a scientific conference later this year. That data will enable us to choose the best dose for testing in disease-specific expansion cohorts, which we expect to initiate before year end."

According to preclinical study results presented at the Conference:

· CPI-444 has been shown to be active, both as a single agent and in combination with anti-PD-1 and anti-PD-L1 antibodies, in stimulating various immune cells, generating anti-tumor immunity, suppressing tumor growth, delaying tumor progression and generating complete tumor rejection in multiple animal models of cancer.
· Results from mechanism of action studies indicate that CD8+ cytotoxic T-lymphocytes are necessary for CPI-444’s activity in animal models.
· Long-term immunity was demonstrated upon tumor re-challenge in animals previously treated with CPI-444.



Preliminary biomarker data from ongoing analyses of patients with various solid tumors treated to date in the ongoing Phase 1/1b study presented at the Conference demonstrated:

· In the first 11 patients analyzed, 40-100 percent blockade of peripheral blood lymphocyte A2A receptors was achieved in a dose-dependent manner with CPI-444 treatment.
· All three patients receiving CPI-444 100 mg twice daily for 28 days achieved 90-100 percent continuous, sustained blockade of peripheral blood lymphocyte A2A receptors.
· Pharmacodynamic markers on peripheral blood lymphocytes showed evidence of activation of T-cell mediated immunity in all three patients treated with CPI-444 100 mg twice daily for 28 days. In these patients, increases in cytotoxic T-lymphocytes that were both PD-1-positive and CD8-positive (double positive) were seen in the blood following 28 days of treatment compared to baseline pretreatment. Previous research from others has shown that PD-1, CD8 double positive T-cells are associated with anti-tumor immune responses.
· CPI-444 has been well tolerated to date, with no drug-related dose limiting toxicities or serious adverse events observed.
· The trial is currently enrolling patients at 25 sites in the United States, Canada and Australia with 39 patients enrolled to date.

About the Phase 1/1b Trial
The Phase 1/1b trial is designed to examine the activity of CPI-444 as a single agent and in combination with Genentech’s TECENTRIQ (atezolizumab), an anti-PD-L1 antibody. The first part of the study (dose-selection) includes four cohorts of 12 patients each — three cohorts treated with single agent CPI-444 (100 mg twice daily for 14 days; 100 mg twice daily for 28 days; 200 mg once daily for 14 days) and one cohort treated with the combination (CPI-444 50 mg or 100 mg twice daily for 14 days combined with TECENTRIQ). A treatment cycle is 28 days. Patients with non-small cell lung cancer, melanoma, renal cell cancer, triple-negative breast cancer, colorectal cancer, head and neck cancer, bladder cancer and prostate cancer who have failed all standard therapies are eligible. Based on safety and biomarker analyses, an optimum single agent and combination dose will be selected. The second part of the study will evaluate CPI-444 as a single agent in five disease-specific cohorts, and CPI-444 in combination with TECENTRIQ in five additional matched disease-specific cohorts. Corvus expects that each of these 10 cohorts will initially enroll 14 patients, but each cohort may be expanded based on efficacy.