ABSK012 / Abbisko - LARVOL DELTA

Abbisko Therapeutics Obtained Approval from U.S. FDA to Conduct First-in-Human (FIH) Clinical Study of ANext-Generation FGFR4 Mutant Inhibitor ABSK012 (Abbisko Therap Press Release) - "Abbisko Therapeutics Co., Ltd...today announced that ABSK012...has obtained investigational new drug (IND) approval of thefirst-in-human (FIH) phase I clinical study from the U.S. FDA....The approved study is 'A Phase 1, Open-Label Study of ABSK012 to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced Solid Tumors'. The study population are patients with advanced solid tumors harboring specific molecular alterations, hepatocellular carcinoma (HCC) patients with FGF19 overexpression, and rhabdomyosarcoma (RMS) patients with FGFR4 mutations etc."

IND • New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Discovery & characterization of a next-generation FGFR4 inhibitor overcoming resistant mutations (AACR 2023) - "Efficacy studies were conducted in HCC xenograft models and mutant FGFR4-dependent xenograft models including a RMS PDX model harboring FGFR4 V550L mutation. ABSK012 demonstrated strong potency over multiple FGFR4 mutants that are insensitive to a first generation FGFR4 inhibitor BLU-554. ABSK012, presented here by Abbisko Therapeutics, is a highly potent, selective, and next-generation small molecule FGFR4 inhibitor overcoming FGFR4 mutations resistant to first-generation inhibitors. Its superior preclinical profile supports its fast-track development into clinic."

Late-breaking abstract • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor • AVEN • FGF19 • FGFR4

Abbisko presents the research results of 5 programs at the 2023 AACR Annual Meeting (PRNewswire) - "Abbisko...announced the results of five latest preclinical studies at the 2023 American Association for Cancer Research (AACR) annual meeting....Abstract Number: LB328:...ABSK012, presented here by Abbisko Therapeutics, is a highly potent, selective, and next-generation small molecule FGFR4 inhibitor overcoming FGFR4 mutations resistant to first-generation inhibitors. Its superior preclinical profile supports its fast-track development into clinic."

Preclinical • Oncology • Solid Tumor • FGFR4

Abbisko Cayman Unit Gets Orphan Drug Designation to Soft Tissue Sarcoma Drug (Market Screener) - "Abbisko Therapeutics, a unit of Abbisko Cayman...obtained an orphan drug designation from the US Food and Drug Administration for FGFR4 mutant inhibitor ABSK012 as a treatment for soft tissue sarcoma."

Orphan drug • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor