Elucidation of CD68 as a Downstream Target of Adenosine Refines Adenosine Gene Signature into a Practical Pathology Test Provides Opportunity to Further Enrich Patient Selection for Responders
Data Includes Additional Patients with Advanced Refractory Renal Cell Cancer, Supporting Earlier Results Published in Cancer Discovery in JanuaryData Presented at the ASCO20 Virtual Scientific ProgramBURLINGAME, Calif., May 29, 2020 (GLOBE NEWSWIRE) — Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies and the utilization of novel biomarkers to enhance patient selection, announced updated results from its Phase 1b/2 clinical trial of ciforadenant, its adenosine A2A receptor antagonist, in patients with advanced refractory renal cell carcinoma (RCC). The new data supports and refines the utility of the Adenosine Gene Signature (AdenoSig), which was discovered by Corvus, as a predictive biomarker to identify RCC patients most likely to respond to treatment with ciforadenant. The discovery of the AdenoSig was described in a research article published in Cancer Discovery in January 2020. In the publication, for 30 patients with available tumor biopsies, AdenoSig positive patients had a 17% objective response rate (ORR) by RECIST criteria compared to 0% in AdenoSig negative patients. In the new data, which covers over 50 patients, the ORR remained 17% for the Adenosine Gene Signature and improved to 27% with the refined version of the test, which is based the measurement of CD68 positive myeloid cells, the downstream target of adenosine.“We are pleased that the utility of the Adenosine Gene Signature as a biomarker for ciforadenant treatment has been supported in a larger number of patients,” said Richard A. Miller, M.D., president and chief executive officer of Corvus. “Through our recent work, we refined the signature to a single, practical IHC test that can be performed in a routine pathology lab based on the enumeration of CD68 positive myeloid cells.  The underlying research that elucidated this refinement also contributed to a better understanding of the role of adenosine and its action in tumors. I am proud of the scientific achievements of our team, which has brought us closer to providing a potential novel, targeted treatment option for RCC patients.”The updated data covers 51 RCC patients that were treated with ciforadenant monotherapy or in combination with Genentech’s Tecentriq^® (atezolizumab), an anti-PD-L1 antibody, and whose tumors were biopsied to test with the AdenoSig.  The data were made available today in an on-demand, electronic poster format for registered participants of the ASCO20 Virtual Scientific Program, which is taking place from May 29-31, 2020. The key updates from the presentation include:31 patients (30 evaluable) were positive for the AdenoSig and 20 patients were negative. Patients had a median of three prior therapies, including 86% that failed a prior anti PD-(L)1 therapy.In the AdenoSig positive group, there were five partial responses (PR, RECIST) for an ORR of 17% and six additional patients that had tumor regression not meeting the criteria for a PR.In the AdenoSig negative group, there were no PRs and no patients with tumor regression.In the AdenoSig positive group, the progression free survival (PFS) curve plateaued at 23% at 40 weeks, compared to declining to 0% in the AdenoSig negative group.In addition, the enrollment of new patients in the study was intended to support the study and refinement of the AdenoSig. As part of this work, Corvus investigators demonstrated that CD68 positive (CD68+) myeloid cells, which are known to be myeloid derived suppressor cells, are the downstream target of adenosine present in the tumor microenvironment. Immunohistochemistry (IHC) testing showed that an increase of CD68+ myeloid cells in a tumor further enriched the AdenoSig identification of responders to treatment with ciforadenant. This work indicates that the single CD68+ IHC test could potentially be utilized to enrich patient selection for responding patients and as a substitute for the AdenoSig biomarker previously utilized by Corvus.  The key data related to CD68 presented in the poster include:CD68 analysis was available for 53 patients, including 15 CD68 positive (CD68+) and 38 CD68 negative (CD68-) patients.All but one patient in the study with a PR were in the CD68+ group.The ORR in the CD68+ group was 26.7% (4 of 15), compared to an ORR of 2.6% (1 of 38) in the CD68- group.Treatment with ciforadenant was associated with a reduction of infiltrating CD68+ cells in pre-treatment compared to on-treatment tumor biopsies (paired to individual patients), supporting the biologic effects of ciforadenant and the potential predictive utility of CD68 to identify RCC patients most likely to respond to treatment with ciforadenant.About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies and the utilization of novel biomarkers to enhance patient selection. Corvus’ lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against CD73 that exhibits immunomodulatory activity and activation of immune cells. These product candidates are being studied in ongoing Phase 1b/2 and Phase 1/1b clinical trials in patients with a wide range of advanced solid tumors. Ciforadenant is being evaluated in a successive expansion cohort Phase 1b/2 trial examining its activity both as a single agent and in combination with an anti-PD-L1 antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant and pembrolizumab. The Company’s third clinical program, CPI-818, an oral, small molecule drug that has been shown to selectively inhibit ITK, is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. For more information, visit www.corvuspharma.com.About Ciforadenant
Ciforadenant (CPI-444) is a small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic.Adenosine Gene Signature and CD68+ Myeloid Cells
The adenosine gene signature is a biomarker that reflects adenosine induced immunosuppression in the tumor.  These genes express chemokines that recruit myeloid cells including immunosuppressive tumor associated CD68+ myeloid cells, which are thought to mediate resistance to anti-PD-(L)1 treatment. To date, in our clinical trial of renal cell cancer, this biomarker has been associated with a higher rate of response to ciforadenant. CD68+ cells can be enumerated using standard immunohistochemical techniques that are routinely available in pathology laboratories. Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of ciforadenant, the Company’s ability to identify and utilize the adenosine gene signature or the CD68+ gene for purposes of its clinical trials, including the Company’s Phase 1b/2 clinical trial of ciforadenant . All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the Securities and Exchange Commission on April 30, 2020, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of ciforadenant; the Company’s ability to utilize biomarker data; the results of preclinical studies may not be predictive of future results; and the effects of COVID-19 on the Company’s clinical programs and business operations. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.INVESTOR CONTACT:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
650-900-4522
[email protected] MEDIA CONTACT:
Sheryl Seapy
W2O pure
+1 213-262-9390
[email protected]

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