Interim data from Phase 1/1b clinical trial of CPI-818, including new evidence supporting the recently implemented minimum absolute lymphocyte count (ALC) predictive biomarker

Data presented at the 10^th Whistler Global Summit on Hematologic Malignancies

BURLINGAME, Calif., April 03, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced interim data demonstrating the potential of CPI-818, the Company’s ITK inhibitor, for the treatment of T cell lymphoma (TCL) at the 10^th Whistler Global Summit on Hematologic Malignancies, which took place March 29 to April 2, 2023 in Whistler British Columbia, Canada. The CPI-818 data was presented by John Reneau, MD, PhD, from The Ohio State University Comprehensive Cancer Center. Dr. Reneau is a hematologist who specializes in treating patients with lymphoma and an investigator for the Phase 1/1b clinical trial of CPI-818 for TCL.

“T cell lymphoma is a challenging disease to treat and there is significant need for new approaches given the limited efficacy of current therapeutic options,” said Dr. Reneau. “CPI-818 has a novel mechanism of action that includes the stimulation of normal T cells to infiltrate and destroy tumors. Our recent work indicates that the peripheral blood absolute lymphocyte count is a biomarker that may predict patients most likely to benefit from CPI-818. This positions our trial to build on the results CPI-818 has already demonstrated - monotherapy activity in advanced, relapsed patients, with potential for higher response rates driven by this new biomarker.”

CPI-818 Phase 1/1b T Cell Lymphoma Data
CPI-818 is currently being studied in a Phase 1/1b clinical trial as a single agent therapy in patients with relapsed TCL. As of February 23, 2023, 20 patients were enrolled in the 200 mg cohort (optimal dose), including 13 evaluable for tumor response. There have been 1 complete response (CR) of 24 months duration, 1 equivocal CR awaiting confirmatory PET scan of 13+ months duration (a previous partial response (PR)), 1 nodal CR of 21 months duration and 1 PR of 7 months duration. Ten patients continue on therapy, including seven who have not yet been evaluated for tumor response.

Corvus has identified minimum absolute lymphocyte count (ALC) above 900 per cubic milliliter of blood as a biomarker associated with response to CPI-818. Interim data from the 200 mg cohort in the Phase 1/1b clinical trial indicate that this minimum ALC level is required for tumor response and disease control. As of February 23, 2023, four of eight patients with ALC above 900 had objective responses (those four patients are described above), all eight had disease control (stable disease, PR, CR) and the median progression free survival (PFS) was 28.1 months. No objective responses were seen in five patients (0 of 5) with ALC below 900 and the PFS was 2.1 months.

New interim data, as of February 23, 2023, presented by Dr. Reneau evaluated the effect of ALC on PFS of patients based on their last prior chemotherapy treatment before receiving CPI-818. There was no significant difference in the PFS achieved in patients with ALC less than 900 per cubic milliliter (PFS = 3.2 months) compared to patients with ALC greater than or equal to 900 per cubic milliliter (PFS = 3.4 months), which suggests the ALC biomarker is not predictive for standard therapies. This result is consistent with CPI-818’s proposed mechanism of action, which involves the enhancement of normal lymphocyte function, and indicates that the improved results seen with CPI-818 in patients with ALC above 900 is not due to more favorable patient characteristics.

The swimmer and waterfall tumor plots for these patients, along with the data summarizing the ALC biomarker data, are included in Dr. Reneau’s presentation slides, which are available on the Publications and Presentations page of the Corvus website.

“The data from our Phase 1/1b trial of CPI-818 for T cell lymphoma continues to be strong, with durable and deep tumor responses observed to date,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “We are encouraged that enrollment has accelerated and that we have implemented a biomarker that we believe will enable us to enroll patients most likely to benefit from CPI-818, which is of particular importance as we plan for a registration Phase 3 randomized clinical trial. I want to thank Dr. Reneau and all our investigators for their participation in the trial and for the work they do in support of patients.”

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus’ lead product candidate is CPI-818, an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies and is in a multicenter Phase 1/1b clinical trial in patients with several types of T cell lymphomas. The Company’s second clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor that is in an open-label Phase 1b/2 clinical trial. Its third clinical program, mupadolimab (CPI-006), is a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical and clinical studies. For more information, visit www.corvuspharma.com.

About CPI-818
CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T cell kinase) in preclinical studies. It was designed to block malignant T cell growth and to modulate immune responses. ITK, an enzyme, is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Recent clinical data in T cell lymphomas suggests that CPI-818 has the potential to control differentiation of T helper cells and enhance immune responses to tumors. Interference with ITK signaling also can modulate immune responses to various antigens. Optimal doses of CPI-818 have been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of Th2 related cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The immunologic effects of CPI-818 lead to what is known as Th1 skewing and is made possible by the high selectivity of CPI-818 for ITK. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with T cell lymphomas, solid tumors, and in patients with autoimmune and allergic diseases. The Company is conducting a Phase 1/1b trial in patients with refractory T cell lymphomas that was designed to select the optimal dose of CPI-818 and evaluate its safety, PK, target occupancy, immunologic effects, biomarkers and efficacy. Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, and identified a dose that maximally affects T helper cell differentiation.

Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of CPI-818, ciforadenant and mupadolimab; the Company’s ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company Phase 1/1b clinical trial of CPI-818 and the Company’s planned Phase 3 registration clinical trial with CPI-818 for T cell lymphoma; the design of clinical trials, including the target number of patients to be enrolled and whether identifying certain biomarkers will help accelerate enrollment; and the timing of the availability and announcement of clinical data and certain other product development milestones. 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 Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 28, 2023, 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 CPI-818, ciforadenant and mupadolimab; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; and the Company’s ability to raise additional capital. 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.
+1-650-900-4522
llea@corvuspharma.com

MEDIA CONTACT:
Sheryl Seapy
Real Chemistry
+1-949-903-4750
sseapy@realchemistry.com

Source: Corvus Pharmaceuticals, Inc.