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Allink Biotherapeutics to Present First Clinical Data for ALK201 ( FGFR2b-Targeting ADC) in Advanced Solid Tumors at ASCO 2026
Release Time：2026-05-30 21:55:42 Article Source：安领科生物
· International Phase I/II trial of novel FGFR2b-targeted ADC, ALK201, selected for poster presentation at ASCO 2026
· ALK201 is a potential first- and best-in-class FGFR2b-targeted ADC with promising clinical efficacy and safety across multiple tumor types
· US FDA Orphan Drug Designation (ODD) granted for ALK201 in gastric cancer
Shanghai, China – May 30th, 2026 – Allink Biotherapeutics, Inc. (AllinkBio), a clinical-stage biotechnology company focusing on developing advanced antibody-drug conjugates (ADCs) and multi-specific antibody therapeutics for oncology and immunology, today announced that the first clinical data of ALK201 will be presented in a poster session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. ALK201, an ADC targeting the fibroblast growth factor receptor-2b (FGFR2b), is in an ongoing, multicenter, open-label phase I/II clinical study (NCT06656390) conducted across the US, China, and Australia. The latest dose-escalation results show that ALK201 monotherapy has a favorable safety profile and promising anti-cancer activity in pretreated advanced solid tumors.
As of the April 1, 2026 data cutoff, a total of 54 patients were enrolled for Part A dose-escalation. Of these 54 patients, almost all (48 patients, 88.9%) had metastatic cancer, and nearly half (25 patients, 46.3%) had 3 or more lines of prior therapy. The patients were distributed across 7 dose groups ranging from 1.5 mg/kg to 12.0 mg/kg without dose-limiting toxicities observed.
Efficacy results demonstrate the objective response rate (ORR) was 21.6% with a disease control rate (DCR) of 89.2% in 37 efficacy-evaluable patients ≥7.2 mg/kg cohorts. Notably, the higher confirmed ORR (cORR) of 27.3% with DCR of 100% was observed in 11 squamous non-small cell lung cancer (sqNSCLC) patients with FGFR2b IHC 2+/3+ (≥5% of tumor cells). 21 patients, including the 11 with sqNSCLC, remained on treatment and follow-up, with the longest duration spanning more than 40 weeks.
Treatment-related adverse events (AEs) were carefully examined to determine ALK201’s safety profile. The most commonly observed TRAEs across all dose levels included nausea (55.6%) , anemia (46.3%) , decreased neutrophil count (42.6%) , decreased white blood cell count (38.9%) , decreased platelet count (27.8%) , and decreased appetite (25.9%) . Adverse events of special interest (AESI) all fell under ocular toxicities, mainly Grade 1 dry eye. No participants reported AESIs of Grade 3 or higher.
“The encouraging first-in-human data for ALK201 presented at ASCO provide compelling clinical validation of FGFR2b as a promising target in precision oncology, particularly for patients with advanced cancer who face a global lack of effective treatment options,” said Dr. Hui Feng, Chief Executive Officer of Allink Biotherapeutics. “Historically, targeting the FGFR pathway has been hindered by a narrow therapeutic window and off-target toxicities. By leveraging our proprietary hydrophilic linker-payload platform, ALK201 has demonstrated not only robust, biomarker-correlated anti-tumor activity in heavily pre-treated patients, but also a differentiated safety profile that avoids the severe ocular toxicities observed with earlier-generation therapies. These results strongly validate our underlying ADC design philosophy and establish a clear, accelerated clinical development pathway as we look to advance ALK201 into broader dose-expansion cohorts and front-line combination strategies.”
About ALK201
AllinkBio’s ALK201 is an investigational antibody-drug conjugate (ADC) targeting FGFR2b. FGFR2b is a receptor tyrosine kinase predominantly expressed on the surface of epithelial cells that supports cellular function. In malignancies, particularly gastric cancer, FGFR2b overexpression is strongly correlated with a poor prognosis.
ALK201 is composed of a recombinant humanized anti-FGFR2b monoclonal antibody linked to the DNA topoisomerase I inhibitor exatecan via a proprietary, cleavable linker. ALK201 exerts its antitumor efficacy through target-selective intracellular delivery of the potent cytotoxic payload to achieve specific tumor eradication, complemented by strong bystander killing effect, ligand blockade, and antibody-dependent cellular cytotoxicity (ADCC).
In both preclinical and clinical settings, ALK201 has showcased encouraging anti-tumor activity and a favorable safety window, supporting its clinical advancement. Based on its compelling clinical potential, ALK201's therapeutic reach extends beyond gastric cancer to a broad spectrum of malignancies. ALK201 is currently being studied in patients with advanced FGFR2b-expressing solid tumors (NCT06656390).
About AllinkBio
Founded in 2023, AllinkBio is a clinical-stage biotechnology company dedicated to the discovery and development of differentiated ADCs and multi-specific antibodies for oncology and immunology. Leveraging a synergy of innovative platform capabilities and exceptional R&D efficiency, the company has rapidly advanced two ADC candidates, ALK201 and ALK202, into global Phase I/II clinical trials. AllinkBio is committed to advancing ADC and multi-specific antibody innovation to transform lives for patients in need worldwide.
· ALK201 is a potential first- and best-in-class FGFR2b-targeted ADC with promising clinical efficacy and safety across multiple tumor types
· US FDA Orphan Drug Designation (ODD) granted for ALK201 in gastric cancer
Shanghai, China – May 30th, 2026 – Allink Biotherapeutics, Inc. (AllinkBio), a clinical-stage biotechnology company focusing on developing advanced antibody-drug conjugates (ADCs) and multi-specific antibody therapeutics for oncology and immunology, today announced that the first clinical data of ALK201 will be presented in a poster session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. ALK201, an ADC targeting the fibroblast growth factor receptor-2b (FGFR2b), is in an ongoing, multicenter, open-label phase I/II clinical study (NCT06656390) conducted across the US, China, and Australia. The latest dose-escalation results show that ALK201 monotherapy has a favorable safety profile and promising anti-cancer activity in pretreated advanced solid tumors.
As of the April 1, 2026 data cutoff, a total of 54 patients were enrolled for Part A dose-escalation. Of these 54 patients, almost all (48 patients, 88.9%) had metastatic cancer, and nearly half (25 patients, 46.3%) had 3 or more lines of prior therapy. The patients were distributed across 7 dose groups ranging from 1.5 mg/kg to 12.0 mg/kg without dose-limiting toxicities observed.
Efficacy results demonstrate the objective response rate (ORR) was 21.6% with a disease control rate (DCR) of 89.2% in 37 efficacy-evaluable patients ≥7.2 mg/kg cohorts. Notably, the higher confirmed ORR (cORR) of 27.3% with DCR of 100% was observed in 11 squamous non-small cell lung cancer (sqNSCLC) patients with FGFR2b IHC 2+/3+ (≥5% of tumor cells). 21 patients, including the 11 with sqNSCLC, remained on treatment and follow-up, with the longest duration spanning more than 40 weeks.
Treatment-related adverse events (AEs) were carefully examined to determine ALK201’s safety profile. The most commonly observed TRAEs across all dose levels included nausea (55.6%) , anemia (46.3%) , decreased neutrophil count (42.6%) , decreased white blood cell count (38.9%) , decreased platelet count (27.8%) , and decreased appetite (25.9%) . Adverse events of special interest (AESI) all fell under ocular toxicities, mainly Grade 1 dry eye. No participants reported AESIs of Grade 3 or higher.
“The encouraging first-in-human data for ALK201 presented at ASCO provide compelling clinical validation of FGFR2b as a promising target in precision oncology, particularly for patients with advanced cancer who face a global lack of effective treatment options,” said Dr. Hui Feng, Chief Executive Officer of Allink Biotherapeutics. “Historically, targeting the FGFR pathway has been hindered by a narrow therapeutic window and off-target toxicities. By leveraging our proprietary hydrophilic linker-payload platform, ALK201 has demonstrated not only robust, biomarker-correlated anti-tumor activity in heavily pre-treated patients, but also a differentiated safety profile that avoids the severe ocular toxicities observed with earlier-generation therapies. These results strongly validate our underlying ADC design philosophy and establish a clear, accelerated clinical development pathway as we look to advance ALK201 into broader dose-expansion cohorts and front-line combination strategies.”
About ALK201
AllinkBio’s ALK201 is an investigational antibody-drug conjugate (ADC) targeting FGFR2b. FGFR2b is a receptor tyrosine kinase predominantly expressed on the surface of epithelial cells that supports cellular function. In malignancies, particularly gastric cancer, FGFR2b overexpression is strongly correlated with a poor prognosis.
ALK201 is composed of a recombinant humanized anti-FGFR2b monoclonal antibody linked to the DNA topoisomerase I inhibitor exatecan via a proprietary, cleavable linker. ALK201 exerts its antitumor efficacy through target-selective intracellular delivery of the potent cytotoxic payload to achieve specific tumor eradication, complemented by strong bystander killing effect, ligand blockade, and antibody-dependent cellular cytotoxicity (ADCC).
In both preclinical and clinical settings, ALK201 has showcased encouraging anti-tumor activity and a favorable safety window, supporting its clinical advancement. Based on its compelling clinical potential, ALK201's therapeutic reach extends beyond gastric cancer to a broad spectrum of malignancies. ALK201 is currently being studied in patients with advanced FGFR2b-expressing solid tumors (NCT06656390).
About AllinkBio
Founded in 2023, AllinkBio is a clinical-stage biotechnology company dedicated to the discovery and development of differentiated ADCs and multi-specific antibodies for oncology and immunology. Leveraging a synergy of innovative platform capabilities and exceptional R&D efficiency, the company has rapidly advanced two ADC candidates, ALK201 and ALK202, into global Phase I/II clinical trials. AllinkBio is committed to advancing ADC and multi-specific antibody innovation to transform lives for patients in need worldwide.
