Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) is a clinical-stage biopharmaceutical company focused on the development of precisely targeted oncology and immune-mediated therapies. The company's pipeline is anchored by three lead product candidates - soquelitinib, ciforadenant, and mupadolimab - which are in various stages of clinical development for the treatment of solid tumors, T-cell lymphomas, and autoimmune diseases.

Business Overview

Corvus was founded in 2014 and is headquartered in Burlingame, California. The company's strategy is to leverage its expertise in immunology and small molecule drug discovery to develop novel therapies that can modulate the immune system and disrupt the tumor microenvironment. Corvus' lead product candidate, soquelitinib, is a selective, covalent inhibitor of ITK (interleukin 2 inducible T cell kinase) that is being evaluated in clinical trials for the treatment of T-cell lymphomas and autoimmune diseases.

Soquelitinib is designed to inhibit the proliferation of certain malignant T cells and also affect the differentiation of normal T cells, which could enhance immunity to tumor cells. The company believes these properties have the potential to regulate the growth and activity of both abnormal malignant T cells and abnormal T cells involved in autoimmunity and allergy. Soquelitinib is currently being studied in a Phase 1/1b clinical trial in patients with various T-cell lymphomas, and the company plans to initiate a potentially registrational Phase 3 trial in relapsed peripheral T-cell lymphoma (PTCL) in the third quarter of 2024.

Corvus' second lead product candidate, ciforadenant, is an oral, small molecule antagonist of the A2A receptor for adenosine. Ciforadenant is designed to disable a tumor's ability to subvert attack by the immune system by blocking the binding of immunosuppressive adenosine in the tumor microenvironment to the A2A receptor. Corvus is collaborating with the Kidney Cancer Research Consortium to evaluate ciforadenant in an open-label Phase 1b/2 clinical trial as a first-line therapy for metastatic renal cell carcinoma (RCC) in combination with ipilimumab and nivolumab.

The company's third product candidate, mupadolimab, is a humanized monoclonal antibody that is designed to react with a specific site on CD73. Mupadolimab has demonstrated the ability to activate B cells and enhance immune responses in both preclinical and in vivo studies. While Corvus believes mupadolimab has the potential to be an important new therapeutic agent with a novel mechanism of action for the treatment of a broad range of cancers and infectious diseases, the company is currently prioritizing the development of its other two lead product candidates.

Financials

For the full year 2023, Corvus reported a net loss of $27.0 million and had no revenue. The company's annual operating cash flow was -$23.9 million, and its annual free cash flow was -$23.9 million. As of March 31, 2023, Corvus had cash, cash equivalents, and marketable securities totaling $22.1 million.

On May 6, 2023, the company closed a $30.6 million registered direct offering, which, combined with the company's existing cash resources, extends its cash runway into the fourth quarter of 2025. This financing included investments from a premier group of biotech investors as well as members of Corvus' leadership team.

Soquelitinib for Peripheral T-Cell Lymphoma (PTCL)

Corvus' lead program is the development of soquelitinib for the treatment of PTCL. The company is currently preparing for a potentially registrational Phase 3 clinical trial of soquelitinib in relapsed PTCL, which is expected to begin in the third quarter of 2024.

In the ongoing Phase 1/1b clinical trial of soquelitinib in T-cell lymphomas, the company has reported encouraging data. As of the most recent data cutoff on May 3, 2023, the objective response rate (ORR) for the 23 evaluable patients in the 200 mg twice-daily dose cohort was 39%, including 5 complete responses (CRs) and 4 partial responses (PRs). The median progression-free survival (PFS) for this group was 6.2 months, which compares favorably to the reported PFS of 1.6 and 3.5 months for the standard-of-care agents, belinostat and pralatrexate, respectively.

Soquelitinib for Atopic Dermatitis

In April 2023, Corvus initiated a randomized, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The trial is designed to enroll 64 patients who have failed at least one prior therapy and will evaluate four different 28-day dosing regimens of soquelitinib compared to placebo. The primary endpoint is safety and tolerability, with efficacy measured using the Eczema Area and Severity Index (EASI) score.

Corvus expects to report initial data from the first cohorts of this trial before the end of 2024, with study completion anticipated in early 2025. The company believes soquelitinib's novel mechanism of action, which involves the inhibition of Th2 and Th17 cells, may provide a differentiated approach to the treatment of atopic dermatitis and other autoimmune and inflammatory diseases.

Ciforadenant for Renal Cell Carcinoma (RCC)

Corvus is also advancing its A2A receptor antagonist, ciforadenant, in collaboration with the Kidney Cancer Research Consortium (KCRC). The company is evaluating ciforadenant in an open-label Phase 1b/2 clinical trial as a first-line therapy for metastatic RCC in combination with ipilimumab and nivolumab.

In an interim analysis, the trial has met the prespecified statistical threshold for efficacy, demonstrating a deep response rate (complete response plus partial response with >50% tumor volume reduction) of at least 50% above the 32% deep response rate seen in previous trials of the ipilimumab/nivolumab combination. As of May 2, 2023, the trial continues to enroll additional patients.

Corvus believes the synergistic activity observed between ciforadenant and immune checkpoint blockade in preclinical studies may represent a novel immunotherapy approach for the treatment of RCC and other solid tumors.

Corporate Partnerships and Business Development

In October 2020, Corvus formed a strategic partnership with Angel Pharmaceuticals, a China-based biopharmaceutical company, to develop and commercialize the company's three clinical-stage candidates - soquelitinib, ciforadenant, and mupadolimab - in Greater China. As part of the agreement, Angel Pharmaceuticals obtained global rights to Corvus' BTK inhibitor preclinical programs.

Corvus continues to explore additional partnership opportunities, both regionally and globally, to maximize the potential of its pipeline. The company's business development strategy is focused on finding partners with expertise in immune-mediated diseases, as well as seeking regional collaborations in oncology that would complement Corvus' internal capabilities.

Risks and Challenges

Corvus faces several risks and challenges common to clinical-stage biopharmaceutical companies, including the need to successfully complete ongoing and planned clinical trials, obtain regulatory approvals, and effectively commercialize its product candidates, if approved. The company also faces competition from other companies developing novel treatments and technology platforms in the areas of oncology and immunology.

Additionally, Corvus' operations in China through its partnership with Angel Pharmaceuticals may be subject to increased regulatory scrutiny and geopolitical risks, which could impact the development and commercialization of its product candidates in that region.

Outlook

With the recent $30.6 million financing, Corvus is well-positioned to advance its pipeline and achieve several key milestones in 2024 and 2025. The company plans to initiate a potentially registrational Phase 3 trial of soquelitinib in relapsed PTCL in the third quarter of 2024, report interim data from the soquelitinib Phase 1 atopic dermatitis trial before the end of 2024, and generate additional data from the ciforadenant Phase 1b/2 RCC trial later this year.

Conclusion

Corvus' diverse pipeline and its focus on precisely targeted oncology and immune-mediated therapies demonstrate the company's expertise in understanding and developing immunology-focused assets. The potential of the company's ITK inhibition platform across a range of oncology and autoimmune indications, combined with its strategic partnerships and ongoing business development efforts, position Corvus as a promising player in the rapidly evolving fields of cancer and immunology.