ABSK141 / Abbisko - LARVOL DELTA

Synergistic antitumor activity of the MTA-cooperative PRMT5 inhibitor ABSK131 in combination with multiple therapeutic agents in diverse cancer models (AACR 2026) - "In KRAS-mutant and MTAP-deleted models, ABSK131 led to robust tumor growth inhibition when combined with KRAS G12C inhibitor AMG510 or KRAS G12D inhibitor ABSK141. In EGFR-mutant and MTAP-deleted NSCLC, ABSK131 combined with osimertinib produced enhanced anti-proliferative and in vivo antitumor efficacy. ABSK131 synergizes with multiple therapeutic classes across MTAP-deleted models, providing compelling preclinical support for developing ABSK131-based combination strategies in genetically defined patient populations in clinic."

Combination therapy • IO biomarker • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • MAT2A • MTAP

A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 ) (clinicaltrials.gov) - P1/2 | N=401 | Recruiting | Sponsor: Abbisko Therapeutics Co, Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

…Abbisko Therapeutics …announced that the first patient has been successfully dosed in the Phase I/II clinical study of ABSK141, an oral, highly potent, and selective small-molecule KRAS G12D inhibitor, for the treatment of patients with advanced solid tumors harboring KRAS G12D mutations (HKEXnews)

Trial status • Solid Tumor

A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 ) (clinicaltrials.gov) - P1/2 | N=401 | Not yet recruiting | Sponsor: Abbisko Therapeutics Co, Ltd

First-in-human • New P1/2 trial • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

On 24 December 2025, Abbisko Therapeutics… announced that the China National Medical Products Administration ('NMPA') has cleared the Investigational New Drug ('IND') application for ABSK141... (HKEXnews) - "The cleared study is an open-label Phase I/II clinical trial designed to assess the safety, tolerability, efficacy and pharmacokinetics of ABSK141 in patients with advanced solid tumors harboring KRAS G12D mutations."

New P1/2 trial • Solid Tumor

Abbisko Cayman Says U.S. FDA Clears IND Application For ABSK141 (TradingView)

IND • Solid Tumor

Heyu Pharmaceuticals' Potential Best-In-Class PRMT5*MTA Inhibitor Debuts at the 36th ENA Conference [Google translation] (bydrug.pharmcube.com) - "On October 23, Heyu Pharmaceuticals issued an announcement stating that the company's two preclinical research results were released at the 36th International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR conference...ABSK131 presented by Heyu Pharmaceuticals is a highly selective brain-accessible MTA-synergistic PRMT5 inhibitor, and its excellent properties support its rapid preclinical development...In in vitro experiments, ABSK141 showed high binding ability and good biochemical activity for KRASG12D. It also showed strong inhibitory effects on KRAS downstream signaling pathways and efficient anti-proliferation ability in a series of KRASG12D tumor cell lines. In vivo efficacy experiments also showed the strong anti-tumor ability of ABSK141 in multiple different KRASG12D tumor models."

Preclinical • Oncology

Discovery and characterization of a high orally available small molecule inhibitor of KRASG12D (EORTC-NCI-AACR 2024) - "Preclinical DMPK analysis demonstrated excellent bioavailability across several animal species. Together, the superior preclinical profile of ABSK141 support its fast-track preclinical development."

Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS