On May 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 quarter ended March 31, 2023 (Press release, Corvus Pharmaceuticals, MAY 8, 2023, View Source [SID1234631134]).
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"We continue to focus on advancing CPI-818, our ITK inhibitor, towards a potential registrational Phase 3 randomized trial for T cell lymphoma later this year," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We are generating encouraging clinical data from our ongoing Phase 1/1b trial with meaningful objective responses seen in patients with multiply recurrent T cell lymphomas. The data generated so far, continues to support the use of our recently identified biomarker to enrich for patients most likely to respond to treatment with CPI-818. In addition, we recently presented data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting that highlights CPI-818’s therapeutic potential in solid tumors via a novel immunotherapy mechanism of action. This adds to the broad preclinical and clinical data supporting the potential of ITK inhibition with CPI-818 as a platform opportunity across oncology and immune diseases. For our partner led programs, enrollment is ongoing in clinical trials evaluating ciforadenant and mupadolimab, with the potential for initial ciforadenant data from the Phase 1b/2 trial in patients with metastatic renal cell cancer expected to be released before the end of 2023."
Business Update and Strategy
Prioritized Program: CPI-818 (Corvus’ selective ITK inhibitor)
CPI-818 for T Cell Lymphoma
Corvus continues to enroll patients with relapsed T cell lymphomas (TCL) in a Phase 1/1b trial evaluating single agent therapy with CPI-818. When last reported as of February 23, 2023, 20 patients were enrolled at the optimum 200 mg BID dose, including 13 evaluable for tumor response and seven patients that had not yet been evaluated for tumor response. This data was presented at the 10th Whistler Global Summit on Hematologic Malignancies, which took place March 29 to April 2, 2023 in Whistler British Columbia, Canada. At that meeting Corvus also reported on the use of a recently incorporated biomarker based on peripheral blood absolute lymphocyte count (ALC), which identified patients most likely to respond to therapy with CPI-818. Data presented also showed that this biomarker did not select for more favorable patients based on response to their last treatment regimen prior to receiving CPI-818.
Updated data as of May 1, 2023: A total of 28 patients were enrolled in the Phase 1/1b trial at the optimum 200 mg BID dose, including 19 evaluable for tumor response. There have been 2 complete responses (CR), 1 nodal CR and 3 partial responses (PR). Two of the patients with PRs remain on therapy. A total of nine patients remain on therapy, including five 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 six of 13 patients with disease control (CR, PR and stable disease) in 11 of 13 patients. No objective responses were seen in six patients (0 for 6) with ALC below 900. The median progression free survival is 19.9 months versus 2.1 months for patients with ALC above 900 and ALC below 900, respectively. Eligible patients for the clinical trial are now required to have ALC above 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.
CPI-818 Preclinical Data in Solid Tumors
On April 17, 2023, Corvus presented data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating CPI-818’s potential to treat a variety of solid and hematological cancers based on a novel immunotherapy mechanism of action. The data demonstrated that CPI-818 monotherapy (7 days oral administration) provided statistically significant inhibition of growth in established tumors in the following cancer models: CT26 colon cancer, RENCA kidney cancer, B16 melanoma, EL4 TCL and A20 B cell lymphoma. Corvus believes the data supports a novel mechanism of action: CPI-818 modulates T cell differentiation and enhances the immune system via Th1 skewing, increased T cell cytolytic capacity and reduction of T cell exhaustion.
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 clinical trial is expected to enroll up to 60 patients and initial data is anticipated before the end of 2023.
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 March 31, 2023, Corvus had cash, cash equivalents and marketable securities totaling $34.5 million. This compared to cash, cash equivalents and marketable securities of $42.3 million as of December 31, 2022. Corvus expects full year 2023 net cash used in operating activities to be between approximately $19 million and $22 million, resulting in a projected cash balance of between $20 million and $23 million as of December 31, 2023. Based on its current plans, Corvus expects its cash to fund operations into 2024.
Research and development expenses for the three months ended March 31, 2023 totaled $4.6 million compared to $5.1 million for the same period in 2022. The decrease of $0.5 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 March 31, 2023 was $7.9 million compared to a net loss of $8.3 million for the same period in 2022. Total stock compensation expense for the three months ended March 31, 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 $1.7 million for the three months ended March 31, 2023 compared to $1.0 million in the same period in 2022.