Alphamab Oncology Announces the First Patient Dosed in a Phase I Clinical Study of PD-L1/αvβ6 Bispecfic ADC JSKN022

SUZHOU, China, Oct. 24, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that the first patient has been successfully dosed at Sun Yat-sen University Cancer Center in the phase I clinical study (Study ID: JSKN022-101) of JSKN022, an independently developed innovative bispecific antibody-drug conjugate (ADC) targeting PD-L1 and integrin αvβ6, for the treatment of advanced malignant solid tumors. JSKN022 is the Company's fourth ADC candidate entering clinical development, as well as the world's first PD-L1/αvβ6 bispecific ADC to advance into clinical trials.

JSKN022 innovatively combines immuno-oncology (IO) mechanisms with ADC approaches, utilizing Alphamab Oncology's proprietary glycan-specific conjugation platform and linker-payload (Alphatecan) to significantly improve stability and homogeneity. The molecule is designed to bind to PD-L1 and/or integrin αvβ6 on the surface of tumor cells. After binding to either target, JSKN022 enters the lysosome through target-mediated endocytosis. The linker is hydrolyzed by proteolytic enzymes, releasing cytotoxic topoisomerase I inhibitor, which then induces apoptosis of PD-L1 and/or integrin αvβ6 positive tumor cells. In addition, the inhibitor can block TGFβ signaling to modulate immune function, and kill antigen-negative cells through the bystander effect, thereby achieving multiple anti-tumor activity. Preclinical data presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting, demonstrated that JSKN022 effectively inhibited the proliferation of cancer cells and demonstrated greater tumor suppression than single-target ADCs.

JSKN022-101 is an open-label, multi-center, phase I clinical trial of JSKN022, including dose-escalating and dose-optimization phases. This study aims to evaluate the safety, tolerability, pharmacokinetics (PK)/pharmacodynamics (PD), and antitumor activity of JSKN022 in patients with advanced malignant solid tumors, and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).

At present, no ADC targeting integrin αvβ6 or PD-L1 has been approved for marketing worldwide, with all related investigational candidates remaining in clinical development stages. JSKN022 will potentially bring in novelty in the therapeutic approach for cancers that are refractory or resistant to PD-1/PD-L1 inhibitors.

About JSKN022

JSKN022 is a first-in-class ADC targeting both PD-L1 and integrin αvβ6. Based on independently developed Envafolimab, Alphamab integrates immuno-oncology (IO) mechanisms with ADC approaches. This novel drug molecule utilizes proprietary glycan-specific conjugation technology and linker-payload (Alphatecan) to enhance both stability and homogeneity. The molecule is designed to bind to PD-L1 and/or integrin αvβ6 on the surface of tumor cells. After binding to either target, JSKN022 enters the lysosome through target-mediated endocytosis. The linker is hydrolyzed by proteolytic enzymes, releasing cytotoxic topoisomerase I inhibitor, which then induces apoptosis of PD-L1 and/or integrin αvβ6 positive tumor cells. In addition, the inhibitor can block TGFβ signaling to modulate immune function, and kill antigen-negative cells through the bystander effect, thereby achieving multiple anti-tumor activity. JSKN022 is expected to provide a novel therapeutic option for cancers that are refractory or resistant to PD-1/PD-L1 inhibitors. The Phase I clinical study of JSKN022 in patients with advanced malignant solid tumors has been conducted in China.

About Alphamab Oncology

Alphamab Oncology is an innovative biopharmaceutical company focused on oncology. On December 12, 2019, the Company was successfully listed on the Main Board of the Hong Kong Stock Exchange (Stock Code: 9966.HK).

Leveraging proprietary platforms-including single-domain antibodies, bispecific antibodies, glycan-specific conjugation, linker-payloads, dual-payload ADCs, and high-concentration subcutaneous formulations-the Company has built a differentiated and globally competitive pipeline, covering cutting-edge candidates in ADCs, bispecific antibodies, and single-domain antibodies.

One product has received market approval: Envafolimab (KN035, brand name: 恩维达®), the world's first subcutaneously injected PD-(L)1 inhibitor, offering greater convenience and accessibility in cancer treatment. The NMPA has accepted the new drug application for KN026 (Anbenitamab Injection), a HER2 bispecific antibody, for second-line or later HER2-positive gastric cancer. Four bispecific ADC candidates have entered clinical stages, and next-generation ADC pipelines, such as dual-payload ADCs, are advancing rapidly. The Company has established strategic partnerships with organizations including CSPC, ArriVent, and Glenmark, covering both product development and technology platforms.

Our overarching mission is to make cancer manageable and curable by addressing unmet clinical needs in oncology. Alphamab Oncology is continuously dedicated to the development of effective, safe, and globally competitive anti-tumor drugs, delivering China-innovated cancer therapies to benefit patients worldwide.