ALK-202 / Allink Biotherapeutics - LARVOL DELTA

First-in-Human Phase I Study of ALK202, a Novel EGFR/c-MET Bispecific Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors (IASLC-WCLC 2026) - P1 | "Exposure of total antibody, ALK202, and payload increased proportionally with dose, and no accumulation was observed upon repeated dosing. Conclusions : ALK202 demonstrated a manageable safety profile and promising antitumor activity at doses of 5.6 and 6.4 mg/kg Q3W and 3.2 mg/kg D1/D8 Q3W, particularly in patients with EGFR-mutant NSCLC, warranting further investigation at these effective dose levels."

ADC • Bispecific • Clinical • First-in-human • Metastases • P1 data • Anorexia • Constipation • Gastroenterology • Gastrointestinal Disorder • Leukopenia • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pruritus • Solid Tumor • EGFR • MET

Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Drugs in NSCLC Participants. (clinicaltrials.gov) - P2 | N=252 | Not yet recruiting | Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.

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

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

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=234 | Recruiting | Sponsor: Shanghai Allink Biotherapeutics Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

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 ALK202 in Participants with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=234 | Not yet recruiting | Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor

Anlinke: ALK202 starts 234 cases of Phase I clinical trial [Google translation] (bydrug.pharmcube.com) - "The Phase I clinical trial plans to enroll 234 patients with advanced solid tumors and is expected to be initially completed by the end of 2027. According to clinical registration information, ALK202 is an EGFR/cMET targeted drug. Judging from the R&D code and the competitive landscape, ALK202 is likely to be an EGFR/cMET dual-antibody ADC drug."

Trial primary completion date • Oncology • Solid Tumor