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
Corvus Pharmaceuticals (NASDAQ: CRVS) announced that its Chinese partner Angel Pharmaceuticals received IND approval from China's NMPA to begin a Phase 1b/2 clinical trial of soquelitinib for treating moderate-to-severe atopic dermatitis.
The trial will evaluate 12-week dosing across multiple cohorts, with Phase 1b enrolling 48 patients across two cohorts testing different dosing regimens. Patient enrollment is expected to begin in Q3 2025, with Phase 1b data anticipated in 2026. The study will be led by Dr. Yuling Shi, a prominent dermatology expert from Shanghai Skin Disease Hospital.
Corvus, which co-founded Angel Pharma to develop its pipeline in greater China, has licensed the rights for soquelitinib development, manufacturing, and commercialization in the region to Angel Pharma.
Corvus Pharmaceuticals (NASDAQ: CRVS) ha annunciato che il suo partner cinese Angel Pharmaceuticals ha ottenuto l'approvazione IND dalla NMPA cinese per avviare una fase 1b/2 di sperimentazione clinica di soquelitinib per il trattamento della dermatite atopica da moderata a grave.
Lo studio valuterà una somministrazione di 12 settimane in più coorti, con la fase 1b che arruolerà 48 pazienti suddivisi in due coorti per testare diversi regimi posologici. L'arruolamento dei pazienti è previsto per il terzo trimestre 2025, mentre i dati della fase 1b sono attesi nel 2026. Lo studio sarà guidato dal dott. Yuling Shi, rinomato esperto di dermatologia dell'Ospedale per le Malattie della Pelle di Shanghai.
Corvus, che ha co-fondato Angel Pharma per sviluppare il proprio portafoglio in Cina continentale, ha concesso in licenza ad Angel Pharma i diritti di sviluppo, produzione e commercializzazione di soquelitinib nella regione.
Corvus Pharmaceuticals (NASDAQ: CRVS) anunció que su socio chino Angel Pharmaceuticals recibió la aprobación IND de la NMPA de China para iniciar un ensayo clínico de fase 1b/2 de soquelitinib para el tratamiento de la dermatitis atópica moderada a grave.
El ensayo evaluará una dosificación de 12 semanas en múltiples cohortes, con la fase 1b inscribiendo a 48 pacientes en dos cohortes que probarán diferentes regímenes de dosificación. Se espera que la inscripción de pacientes comience en el tercer trimestre de 2025, y los datos de la fase 1b se anticipan para 2026. El estudio estará dirigido por el Dr. Yuling Shi, un destacado experto en dermatología del Hospital de Enfermedades de la Piel de Shanghai.
Corvus, que cofundó Angel Pharma para desarrollar su cartera en la China continental, ha otorgado a Angel Pharma la licencia para el desarrollo, fabricación y comercialización de soquelitinib en la región.
Corvus Pharmaceuticals (NASDAQ: CRVS)는 중국 파트너인 Angel Pharmaceuticals가 중국 NMPA로부터 중등도에서 중증 아토피 피부염 치료를 위한 soquelitinib의 1b/2상 임상시험 IND 승인을 받았다고 발표했습니다.
이번 임상시험은 여러 코호트에서 12주 투여를 평가할 예정이며, 1b상에서는 서로 다른 투여 요법을 시험하는 두 개 코호트에 48명의 환자를 등록할 계획입니다. 환자 등록은 2025년 3분기에 시작될 예정이며, 1b상 데이터는 2026년에 예상됩니다. 이 연구는 상하이 피부병원 피부과 전문가인 시 율링 박사가 주도합니다.
Corvus는 중국 내 파이프라인 개발을 위해 Angel Pharma를 공동 설립했으며, soquelitinib의 개발, 제조 및 상업화 권리를 Angel Pharma에 라이선스했습니다.
Corvus Pharmaceuticals (NASDAQ : CRVS) a annoncé que son partenaire chinois Angel Pharmaceuticals a obtenu l'approbation IND de la NMPA chinoise pour débuter un essai clinique de phase 1b/2 du soquelitinib pour le traitement de la dermatite atopique modérée à sévère.
L'essai évaluera un traitement de 12 semaines sur plusieurs cohortes, avec la phase 1b incluant 48 patients répartis en deux cohortes testant différents schémas posologiques. Le recrutement des patients devrait commencer au 3e trimestre 2025, avec des données de phase 1b attendues en 2026. L'étude sera dirigée par le Dr Yuling Shi, un expert renommé en dermatologie de l'Hôpital des Maladies de la Peau de Shanghai.
Corvus, qui a cofondé Angel Pharma pour développer son portefeuille en Chine continentale, a concédé à Angel Pharma les droits de développement, de fabrication et de commercialisation du soquelitinib dans la région.
Corvus Pharmaceuticals (NASDAQ: CRVS) gab bekannt, dass sein chinesischer Partner Angel Pharmaceuticals die IND-Zulassung der chinesischen NMPA erhalten hat, um eine Phase 1b/2 klinische Studie mit Soquelitinib zur Behandlung von mittelschwerer bis schwerer atopischer Dermatitis zu starten.
Die Studie wird eine 12-wöchige Dosierung über mehrere Kohorten hinweg bewerten, wobei in Phase 1b 48 Patienten in zwei Kohorten mit unterschiedlichen Dosierungsregimen eingeschlossen werden. Die Patientenaufnahme soll im 3. Quartal 2025 beginnen, und die Daten der Phase 1b werden für 2026 erwartet. Die Studie wird von Dr. Yuling Shi, einem renommierten Dermatologie-Experten des Shanghai Skin Disease Hospital, geleitet.
Corvus, das Angel Pharma mitbegründet hat, um seine Pipeline in Festlandchina zu entwickeln, hat Angel Pharma die Rechte für Entwicklung, Herstellung und Vermarktung von Soquelitinib in der Region lizenziert.
- IND approval received from Chinese regulators for Phase 1b/2 trial
- Expanded clinical testing with longer 12-week treatment period
- Multiple dosing options being evaluated to optimize treatment
- Development costs in China covered by Angel Pharmaceuticals
- None.
Insights
China IND approval for Corvus' soquelitinib expands development potential for atopic dermatitis treatment while preserving financial resources.
This IND approval from Chinese regulators represents a significant development milestone for Corvus Pharmaceuticals' soquelitinib program. The upcoming Phase 1b/2 trial in China brings multiple strategic advantages to Corvus. First, it provides additional clinical validation pathways without Corvus bearing the development costs, as Angel Pharmaceuticals is responsible for all expenses related to the Chinese development program. This capital-efficient approach allows Corvus to potentially expand its market reach while preserving financial resources.
The trial design offers valuable scientific benefits by testing both longer treatment durations (12 weeks) and various dosing regimens including 100mg twice daily, 200mg once/twice daily, and 400mg once daily. These expanded parameters will generate complementary data to Corvus' ongoing U.S. development program, potentially accelerating the overall clinical development timeline.
The Chinese market represents a significant opportunity for atopic dermatitis treatments. The planned study under respected dermatologist Dr. Yuling Shi adds credibility to the program. Importantly, this development occurs while Corvus continues its parallel U.S. development program with its Phase 1 extension cohort and planned Phase 2 initiation by year-end.
While promising, investors should note this remains an early/mid-stage program with Phase 1b data not expected until 2026. The partnership structure means Corvus' financial benefit from Chinese commercialization would come through its ownership stake in Angel Pharma rather than direct product revenues.
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
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
FAQ
What is the significance of Angel Pharmaceuticals' IND approval for soquelitinib in China?
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