Corvus Pharmaceuticals Announces Partner Angel Pharmaceuticals Received IND Approval for a Phase 1b/2 Clinical Trial of Soquelitinib in China for the Treatment of Atopic Dermatitis
Trial will be conducted by Angel Pharma and will study 12-week dosing of soquelitinib in patients with moderate-to-severe atopic dermatitis
SOUTH SAN FRANCISCO, Calif., June 25, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that the IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to initiate a Phase 1b/2 clinical trial of soquelitinib for the treatment of patients with moderate-to-severe atopic dermatitis in China.
Corvus co-founded Angel Pharma to develop its pipeline in greater China. Angel Pharma licensed the rights from Corvus to develop, manufacture and commercialize soquelitinib in greater China and is responsible for all expenses related to its development in China.
“Atopic dermatitis affects patients worldwide, including a significant number in China where treatment with biologics and other systemic therapies is growing in use,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “Based on our clinical data to-date, we believe soquelitinib could be a compelling new treatment option for atopic dermatitis in China and globally, and we look forward to our partners at Angel Pharma exploring this potential. The Angel Phase 1b/2 trial will further expand the clinical experience with soquelitinib in atopic dermatitis, including a 12-week treatment period and a 400 mg once-daily dose. We anticipate they will begin enrolling patients in the third quarter 2025, with data from the Phase 1b portion available in 2026. In the U.S., we remain on track with the development of soquelitinib for atopic dermatitis with ongoing patient enrollment in our Phase 1 extension cohort and plans to initiate a Phase 2 trial by the end of year.”
Angel Pharma’s Phase 1b/2 clinical trial for soquelitinib in patients with atopic dermatitis will build on the data previously presented by Corvus from its ongoing Phase 1 trial by studying a longer treatment period and an additional dosing option. The Phase 1b trial will be randomized, double-blinded, placebo-controlled and enroll patients with moderate-to-severe atopic dermatitis as follows:
- Soquelitinib Cohort 1 (24 patients) – 8 patients receive placebo, 8 patients receive soquelitinib 100 mg twice per day and 8 patients receive soquelitinib 200 mg once per day
- Soquelitinib Cohort 2 (24 patients) – 8 patients receive placebo, 8 patients receive soquelitinib 200 mg twice per day and 8 patients receive soquelitinib 400 mg once per day
- The treatment period will be 12 weeks
The Phase 2 trial will also be a randomized, double-blinded, placebo-controlled study. It will enroll additional patients and focus on two doses that will be selected based on the safety and efficacy results from the Phase 1b trial.
The principal investigator of the Phase 1b/2 clinical trial is Yuling Shi, M.D, Ph.D. Dr. Shi is professor of dermatology, the Vice President of Shanghai Skin Disease Hospital at the Tongji University School of Medicine, and the founder and director of the Institute of Psoriasis at Tongji University School of Medicine, the first psoriasis institute in China. Dr. Shi has published more than 100 peer-reviewed articles, most focusing on psoriasis, skin autoimmunity, and inflammatory skin diseases.
About Angel Pharmaceuticals
Angel Pharmaceuticals is a privately held biopharmaceutical company developing a pipeline of immune modulators for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharmaceuticals was launched through strategic collaboration with U.S.-based Corvus Pharmaceuticals and investments from Zhejiang Puissance Capital, Hisun Pharmaceuticals, Tigermed and funds associated with Betta Pharmaceuticals. Corvus’ ownership interest in Angel is approximately 49.7% excluding 7% of Angel Pharmaceuticals’ equity reserved for issuance under the Angel Pharmaceuticals Employee Stock Ownership Plan. For more information, visit www.angelpharma.com.
About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com or follow the Company on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements related to the potential of the Company’s product candidates including soquelitinib, the Angel Pharma Phase 1b/2 clinical trial of soquelitinib for the treatment of patients with moderate-to-severe atopic dermatitis in China, including trial design, conduct, enrollment and timing of data, the potential of ITK in atopic dermatitis, and continued advancement of the Company’s clinical pipeline. 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 Quarterly Report on Form 10-Q for the first quarter ended March 31, 2025, filed with the Securities and Exchange Commission on May 8, 2025, 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 its product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; changes in relations between the United States and foreign countries, including China; the costs of clinical trials may exceed expectations; the Company’s ability to raise additional capital; and the Company has limited control over and may not realize the potential benefits of its collaboration with Angel Pharma. 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
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