ALK-201 / Allink Biotherapeutics - LARVOL DELTA

Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK201 for Injection in Combination With Ivonescimab Injection in sqNSCLC Participants. (clinicaltrials.gov) - P2 | N=156 | Not yet recruiting | Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.

New P2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

First-in-human study of ALK201, a FGFR2b-targeting antibody-drug conjugate (ADC) for patients (pts) with advanced solid tumors. (ASCO 2026) - P1/2 | "ALK201 demonstrated a favorable safety profile in pts with pretreated advanced solid tumors. Promising anti-cancer activity was observed at doses of 7.2 mg/kg and above, warranting further investigation in those effective dose levels."

ADC • Clinical • First-in-human • Metastases • P1 data • Oncology • Solid Tumor

ALK201, a first-in-class FGFR2b-targeting antibody-drug conjugate for patients with FGFR2b+ gastric cancer and other solid tumors (AACR 2025) - P1/2 | "ALK201 blocked FGF7/10-FGFR2b interaction and inhibited downstream phospho-ERK activation, comparable to Bemarituzumab. In summary, preclinical results indicated that ALK201 is an effective candidate for the treatment of solid tumors expressing FGFR2b with a tolerable safety profile. The phase I/II clinical study including dose escalation and dose expansion to evaluate the safety, tolerability, PK and anti-tumor activity of ALK201 in adult participates with advanced solid tumor is ongoing (NCT06656390)."

ADC • Clinical • Late-breaking abstract • Gastric Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • FGF7 • FGFR2

Allink Biotherapeutics Completes $47M Extension Rounds of Series A to Accelerate Clinical Programs and Novel Platforms Development (PRNewswire) - "The Series A extension rounds will help advance global clinical development for the company's two leading programs with distinct competitive advantages. ALK201, a potential first- and best-in-class FGFR2b-targeted ADC, has demonstrated encouraging efficacy signals across multiple tumor types with a favorable safety profile, supporting its development as a backbone therapy for FGFR2b-overexpressing solid tumors. In parallel, early clinical data for ALK202 have provided preliminary support of the EGFR/cMET bispecific ADC's potential as a cornerstone therapy in non-small cell lung cancer."

Financing • Non Small Cell Lung Cancer

Allink Biotherapeutics Raises $42M Series A Financing to Accelerate Global Development of Bispecific Antibody and ADC Pipeline (PRNewswire) - "The Series A financing proceeds will be deployed to advance: Global clinical development of lead candidates ALK201 and ALK202 through Phase 1 studies in Australia, the United States and China; Enrichment of current portfolio by developing multiple highly competitive new assets in oncology and immunology; Further development of the company's proprietary bispecific antibody and ADC technology platform; Global footprint expansion to achieve world prominence."

Financing • Solid Tumor

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=202 | Recruiting | Sponsor: Shanghai Allink Biotherapeutics Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor