China‑based Alphamab Oncology (HKG: 9966) today announced that the first patient received a dose of its self‑developed bispecific antibody‑drug conjugate (ADC) JSKN022 in a Phase I clinical study (Study No.: JSKN022‑101) at Sun Yat‑sen University Cancer Center. This milestone marks the fourth ADC from Alphamab to enter the clinical‑trial stage and the world’s first PD‑L1/αvβ6 bispecific ADC to move into human testing.
Product Overview
- Mechanism of Action – JSKN022 simultaneously targets PD‑L1 and integrin αvβ6 on tumor cells. The ADC is internalized via target‑mediated endocytosis; a protease‑cleavable linker releases a topoisomerase‑I inhibitor, inducing apoptosis.
- Dual Immuno‑Oncology & ADC Technology – Built on Alphamab’s proprietary Envafolimab platform, the bispecific format combines immune checkpoint blockade with targeted cytotoxic delivery.
- Advanced Chemistry – Site‑specific glycan conjugation and an Alphatecan linker‑payload deliver high stability and homogeneity, enhancing therapeutic index.
Clinical Trial Highlights
- Study Design – Phase I, open‑label, dose‑escalation at Sun Yat‑sen University Cancer Center.
- Population – Patients with advanced malignant solid tumors expressing either PD‑L1 or integrin αvβ6.
- Objectives – Establish safety, tolerability, pharmacokinetics, and preliminary anti‑tumor activity.
- First‑Dose Milestone – First patient dosed 24 Oct 2025; dose‑expansion cohorts to begin Q1‑2026.
Strategic Significance
- First‑in‑Class – Positions Alphamab as a pioneer in bispecific ADCs, expanding the therapeutic landscape for solid tumors.
- Bystander Effect & Immune Modulation – The design allows killing of antigen‑negative cells while engaging the immune system via TGF‑β blockade, potentially overcoming resistance mechanisms.
- Pipeline Synergy – Complements Alphamab’s existing ADC portfolio, strengthening its position in the rapidly growing oncology‑ADC market.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech
