ABSK112 / Abbisko - LARVOL DELTA

Preclinical evaluation of ABSK112, a selective and CNS-penetrant compound with strong HER2 inhibitory activity for treating HER2-driven solid tumors (AACR 2025) - P1 | "Despite advancements in treatment options, such as the expanded use of tucatinib and HER2-targeting antibody-drug conjugates (ADCs), there remains a significant unmet need for therapies that are both more effective and better tolerated. These findings establish ABSK112 as a potent, selective and CNS-penetrant HER2 inhibitor, warranting further clinical evaluation of it as a monotherapy or in combination with HER2-targeted ADCs for the treatment of HER2+ cancers with brain metastases."

First-in-human • Late-breaking abstract • Preclinical • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Preclinical Evaluation of ABSK112, a Selective and CNS-penetrant Compound with Strong HER2 Inhibitory Activity for Treating HER2-Driven Solid Tumors (PRNewswire) - "Abbisko Therapeutics...announced that it has presented...late-breaking pre-clinical research posters at the 2025 AACR conference....Poster Number: LB240:...Our findings establish ABSK112 as a potent, selective and CNS-penetrant HER2 inhibitor, warranting further clinical evaluation of it as a monotherapy or in combination with HER2-targeted ADCs for the treatment of HER2+ cancers with brain metastases."

Late-breaking abstract • Preclinical • Oncology • Solid Tumor

A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=164 | Recruiting | Sponsor: Abbisko Therapeutics Co, Ltd

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Heyu-B (02256): The clinical trial application of ABSK112, a new generation of EGFR Exon20ins inhibitor, was approved by FDA [Google translation] (Zhitong Finance) - "Zhitong Finance APP News, Heyu-B (02256) issued an announcement. The company's subsidiary Shanghai Heyu Biomedical Technology Co., Ltd. announced that its self-developed new generation of EGFR Exon20ins inhibitor ABSK112 clinical trials have been approved by the US Food and Drug Administration (FDA) clinical research permit, and the first international human phase I clinical trial for non-small cell lung cancer (NSCLC) will be launched soon."

IND • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Discovery and characterization of ABSK112, a next-generation and potential best-in-class EGFR Exon20 mutant inhibitor with superior selectivity and brain penetration ability (AACR 2023) - "Kinome selectivity, safety profiles, PK and ADME profiles were also characterized. ABSK112 showed potent inhibition of proliferation in multiple EGFR Exon20 mutation cell lines and superior wild-type EGFR selectivity compare to other inhibitors including mobocertinib (TAK788). ABSK112 is a novel and next-generation EGFR Exon20 mutation inhibitor with improved selectivity over wild-type EGFR and strong brain penetrating ability. It has demonstrated superior in vivo efficacy in several xenograft models with various EGFR Exon20 mutations, and excellent drug-like properties supporting its further development into clinical studies."

EGFR exon 20 • Late-breaking abstract • Lung Cancer • Oncology • Solid Tumor • EGFR

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: LB327:...ABSK112 is a leading next-generation EGFR Exon20ins inhibitor with improved selectivity over wild-type EGFR and strong brain penetrating ability. It shows superior in vivo efficacy in various EGFR Exon20ins xenograft models, and broader spectrum of mutation coverage than clinical stage competitors."

EGFR exon 20 • Preclinical • Oncology • Solid Tumor • EGFR