On August 8, 2023 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and provided financial results for the second quarter ended June 30, 2023 (Press release, Corvus Pharmaceuticals, AUG 8, 2023, View Source [SID1234633962]).

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"During the second quarter, we continued to strengthen the scientific and clinical foundation for the potential use of soquelitinib for a variety of cancers and have several important near-term milestones for our clinical programs," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We believe that soquelitinib, our selective ITK inhibitor, may offer a new approach to cancer immunotherapy based on its unique mechanism of action, which is to increase infiltration of cytotoxic T cells into tumors, increase the cytolytic capacity of T cells and reduce T cell exhaustion. This mechanism is distinct and independent from current immuno-oncology therapies based on checkpoint inhibition. We remain on track to meet with the FDA this quarter to discuss a potential registrational Phase 3 clinical trial with soquelitinib in relapsed T cell lymphomas (TCL). We also are planning to initiate clinical studies with soquelitinib in solid tumors. Lastly, enrollment is ongoing in clinical trials evaluating our partner led programs, ciforadenant and mupadolimab, with the potential for initial ciforadenant data from the Phase 1b/2 trial in front line therapy for patients with metastatic renal cell cancer to be released by year end."

Business Update and Strategy

Prioritized Program: Soquelitinib (formerly CPI-818, Corvus’ selective ITK inhibitor)

Soquelitinib for T Cell Lymphoma

Corvus continues to enroll patients with relapsed TCL in a Phase 1/1b clinical trial evaluating single agent therapy with soquelitinib, including utilizing its recently incorporated biomarker based on absolute lymphocyte count (ALC). The latest data from the trial was reported at the International Conference on Malignant Lymphoma, which took place June 13-17, 2023 in Lugano, Switzerland. As of the May 18, 2023 cut-off date, a total of 30 patients were enrolled at the optimum 200 mg two-times a day dose, including 20 evaluable for tumor response. There were 3 complete responses (CR) and 3 partial responses (PR) with one of these PRs demonstrating continued regression of the tumor. One of the patients with a CR and two with PRs remained on therapy. A total of ten patients remained on therapy, including six who have not had their initial tumor response evaluation. For patients with ALC above 900 per cubic milliliter of blood, objective responses (CR plus PR) were seen in 6 of 14 patients with disease control (CR, PR and stable disease) in 12 of 14 patients. No objective responses were seen in six patients (0 for 6) with ALC below 900.
Based on the current enrollment rate of the Phase 1/1b clinical trial, Corvus believes that the number of patients treated in this clinical trial would provide adequate safety and preliminary efficacy data to inform the design of a potential registrational Phase 3 randomized clinical trial. As recommended by the FDA, Corvus plans to meet with the FDA to discuss such a clinical trial; it is anticipated that this meeting will take place during the third quarter of this year.
Soquelitinib Preclinical Data in Hematologic and Solid Tumors

On July 6, 2023, Corvus announced the publication of preclinical data on soquelitinib as a preprint at bioRxiv, which highlighted the selective inhibition of ITK to potentially enhance anti-tumor immune response to hematologic and solid tumors and provide a novel approach to cancer immunotherapy. Important findings from the preclinical studies include the demonstration of soquelitinib’s ability to induce skewing and enrichment of T-helper type 1 (Th1) cells and increase infiltration of cancer killing T cells into tumors with greater potency and less resistance due to exhaustion. Data also showed that soquelitinib monotherapy led to in vivo anti-tumor activity in several mouse tumor models, including colon, renal, melanoma, B cell and T cell tumors.
Partner Led Programs: Ciforadenant (adenosine 2a receptor inhibitor) and Mupadolimab (anti-CD73)

The Kidney Cancer Research Consortium (KCRC) is enrolling a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The Phase 1b portion of this trial has been completed and patients are now being enrolled in the Phase 2 portion. The clinical trial is expected to enroll up to 60 patients and initial data is anticipated before the end of 2023.

Support for the mechanism of action and anti-tumor activity of ciforadenant was recently presented at the Japanese Cancer Association and American Association for Cancer Research (AACR) (Free AACR Whitepaper) (JCA-AACR) Precision Cancer Medicine International Conference, which took place June 28-30, 2023 in Kyoto, Japan. The presentation highlighted preclinical data suggesting a synergy between ciforadenant and immune checkpoint blockade (ICB), leading to a proinflammatory response.
Angel Pharmaceuticals, Corvus’ partner in China, is enrolling patients in a Phase 1/1b clinical trial of mupadolimab in patients with non-small cell lung cancer (NSCLC) and head and neck squamous cell cancers. In this clinical trial, patients will receive mupadolimab monotherapy or in combination with pembrolizumab.
Financial Results
As of June 30, 2023, Corvus had cash, cash equivalents and marketable securities of $37.0 million as compared to $42.3 million as of December 31, 2022. During the quarter ending June 30, 2023, the Company sold 2,329,851 shares of its common stock through its at-the-market (ATM) program, generating net proceeds to the Company of $7.5 million. Corvus expects full year 2023 net cash used in operating activities to be between approximately $20 million and $22 million, resulting in a projected cash balance of between $28 million and $30 million as of December 31, 2023. Based on its current plans, Corvus expects its cash to fund operations into the second half of 2024.

Research and development expenses for the three months ended June 30, 2023 totaled $4.0 million compared to $4.9 million for the same period in 2022. The decrease of $0.9 million was primarily due to lower clinical trial and manufacturing costs associated with the development of mupadolimab.

The net loss for the three months ended June 30, 2023 was $6.5 million compared to a net loss of $8.4 million for the same period in 2022. Total stock compensation expense for the three months ended June 30, 2023 was $0.5 million compared to $0.7 million for the same period in 2022 and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $1.3 million for the three months ended June 30, 2023 compared to $1.6 million in the same period in 2022.

Conference Call Details
Corvus will host a conference call and webcast today, Tuesday, August 8, 2023, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2023 financial results. The conference call can be accessed by dialing 1-855-327-6837 (toll-free domestic) or 1-631-891-4304 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.