On November 21, 2024 Allink Biotherapeutics, a clinical-stage biotechnology company pioneering next-generation bispecific antibody and ADC therapeutics, reported two significant milestones in the development of its lead program ALK201 (Press release, Shanghai Allink Biotherapeutics, NOV 21, 2024, View Source [SID1234648782]). The U.S. Food and Drug Administration (FDA) just cleared the company’s Investigational New Drug (IND) application, and first patient has been successfully dosed in Australia.
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Aberrations in FGF/FGFR2 signaling pathways are extensively documented in multiple malignancies, including gastroesophageal adenocarcinoma and breast cancer, correlating with poor clinical outcomes. ALK201 is an innovative ADC candidate targeting FGFR2b a critical oncogenic driver that has demonstrated clinical validation in various solid tumors . Leveraging the company’s proprietary hydrophilic linker and rationally selected payload, extensive preclinical studies of ALK201 have demonstrated robust anti-tumor activity and a promising therapeutic window, supporting its development as a potentially transformative ADC for FGFR2b-associated malignancies.
"The FDA’s IND clearance and first patient dosing in Australia represent significant milestones of ALK201, our first ADC program, advances into clinical development," said Hui Feng, Ph.D., Chief Executive Officer of AllinkBio. "The rapid advancement from first preclinical candidate to clinical stage exemplifies our R&D team’s operational efficiency. Encouraged by robust preclinical data demonstrating the anti-tumor efficacy in FGFR2b-expressing solid tumors. We are strategically advancing our clinical development to swiftly bring this potential therapeutic option to address unmet medical needs worldwide."
The Phase 1 multicenter clinical trial was designed to investigate ALK201, evaluating its safety, tolerability, pharmacokinetic profile, and preliminary antitumor activity in patients with advanced solid tumors. The study consists of two sequential segments: a dose-escalation phase to determine the maximum tolerated dose (MTD), followed by a clinical expansion phase in which biomarker-guided patient populations will be further investigated.
AllinkBio team’s strategic vision and outstanding R&D execution capability have enabled the company growing from a preclinical to clinical stage biotech in about one year. The company’s deep expertise in molecule discovery and drug design, combined with a sophisticated biomarker-driven approach, has empowered swift development of a number of promising therapeutic candidates. AllinkBio is highly committed to bringing innovative precision therapeutics to patients in need.
About ALK201
ALK201 is a novel FGFR2b targeted ADC, in development as a potential treatment for multiple solid tumors. FGFR2b is a promising target with its mutations and overexpression comprehensively implicated in oncogenesis across diverse solid tumor landscapes. ALK201 is currently being evaluated in a Phase 1 study.