ABSK043 / Abbisko - LARVOL DELTA

ABBISKO THERAPEUTICS AND ALLIST ENTER INTO A COOPERATION AGREEMENT TO EXPLORE ABSK043 IN COMBINATION GLECIRASIB FOR THE TREATMENT OF NSCLC (HKEXnews) - "...Abbisko Therapeutics...announced that it has entered into a cooperation agreement with Shanghai Allist Pharmaceuticals...to explore the combination of Abbisko Therapeutics’ investigational oral PD-L1 inhibitor, ABSK043, with Allist’s KRAS-G12C inhibitor, glecirasib, for the treatment of non-small cell lung cancer patients with KRAS-G12C mutation."

Licensing / partnership • Non Small Cell Lung Cancer

A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib (clinicaltrials.gov) - P2 | N=54 | Recruiting | Sponsor: Abbisko Therapeutics Co, Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2025 ➔ Nov 2024 | Trial primary completion date: Jun 2027 ➔ Dec 2027

Combination therapy • Enrollment open • Metastases • Trial initiation date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Updated results of oral PD-L1 inhibitor ABSK043 in advanced solid tumor patients (pts) from a phase I study (ESMO Asia 2024) - P1 | "Conclusions ABSK043 demonstrated a favorable safety profile and impressive anti-tumor activity as a single agent, especially in EGFR-mutated lung cancers with high PD-L1 expression, where monotherapies of ICI antibodies were shown to be ineffective in the past. These findings support a continuing investigation of ABSK043, in EGFR-mutated lung cancers and various other solid tumors."

Clinical • IO biomarker • Metastases • P1 data • Breast Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Gastric Cancer • Lung Cancer • Melanoma • Microsatellite Instability • Oncology • Solid Tumor • Squamous Cell Carcinoma • Vaginal Cancer • KRAS • MSI

Phase II clinical trial of oral PD-L1 small molecule inhibitor ABSK043 combined with FGFR2/3 small molecule inhibitor ABSK061 for the treatment of solid tumors completed and the first gastric cancer patient was dosed [Google translation] (pharnexcloud.com) - "Heyu Pharmaceuticals...announced that it had completed the dosing of the first gastric cancer patient in an open-label multicenter Phase II clinical study evaluating the safety and efficacy of ABSK061 and ABSK043 with or without chemotherapy in patients with metastatic/unresectable solid tumors with FGFR2/3 alterations (Protocol number: ABSK061-201)....The dose escalation will evaluate the safety, tolerability, preliminary efficacy and PK characteristics of ABSK061+ABSK043 in patients with metastatic/unresectable advanced solid tumors with FGFR2/3 activation changes or overexpression, and recommend the dosage for the expansion phase."

Trial status • Gastric Cancer • Solid Tumor

A Phase 2 Clinical Study of ABSK061 and ABSK043 (clinicaltrials.gov) - P2 | N=202 | Recruiting | Sponsor: Abbisko Therapeutics Co, Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Esophageal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR2 • FGFR3 • HER-2

A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib (clinicaltrials.gov) - P2 | N=54 | Not yet recruiting | Sponsor: Abbisko Therapeutics Co, Ltd

Combination therapy • Metastases • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase 2 Clinical Study of ABSK061 and ABSK043 (clinicaltrials.gov) - P2 | N=202 | Not yet recruiting | Sponsor: Abbisko Therapeutics Co, Ltd

Metastases • New P2 trial • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR2 • FGFR3 • HER-2

First-in-human dose-escalating study of ABSK043, a novel and oral small-molecule inhibitor of PD-L1, in patients with advanced solid tumors (ESMO 2023) - P1 | "On-target PD effects were consistent with PD-L1 inhibition and data reported by anti-PD-(L)1 mAbs. Preliminary anti-tumor activity was observed, and further studies are warranted to explore the efficacy in a larger number of patients."

Clinical • Metastases • P1 data • Breast Cancer • Endometrial Cancer • Microsatellite Instability • Oncology • Solid Tumor • CXCL9 • IFNG • IL2 • MSI

Abbisko will debut two blockbuster clinical research results at the 2023 European Society for Medical Oncology (ESMO)1 (PRNewswire) - P1 | N=60 | NCT04964375 | Sponsor: Abbisko Therapeutics Co, Ltd | "Abbisko Therapeutics...announced that...the clinical results of first-in-human dose-escalating of PD-L1 inhibitor ABSK043 with advanced solid tumors will be presented at the 2023 European Society for Medical Oncology (ESMO) annual meeting....ABSK043 was well tolerated up to 1000 mg BID with no DLT reported and has a safety profile consistent with monoclonal antibody immune checkpoint inhibitors. On-target PD effects were consistent with PD-L1 inhibition and data reported by anti-PD-(L)1 mAbs. Preliminary anti-tumor activity was observed, and further investigation is warranted to explore the efficacy in a larger number of patients."

P1 data • Solid Tumor

Broad anti-tumor activity of a potent and selective small molecule antagonist of PD-L1 ABSK043 in combination with other agents in preclinical models (SITC 2022) - "Results ABSK043 demonstrated strong in vivo synergy with several therapeutic agents such as carboplatin, a key component of the widely used CRC standard-of care chemotherapy treatment regimen, as well as other target therapy or immune-oncology agents. Conclusions Taken together, these data for the first time demonstrated broad combination synergy of a small molecule PD-L1 antagonist with other agents and provided basis for potential clinical evaluation of these combination treatment for cancer patients."

Combination therapy • Preclinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • PD-L1

Heyu-B(02256): The first domestic patient dose of ABSK043, a small molecule PD-L1 inhibitor [Google Translation] (Zhitong Finance) - "Zhitong Finance APP News, Heyu-B (02256) announced that Shanghai Heyu Biomedical Technology Co., Ltd., a subsidiary of the company, completed the first domestic patient administration of the small molecule PD-L1 inhibitor ABSK043."

Trial status • Oncology

A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Abbisko Therapeutics Co, Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • MSI

A potent and selective small molecule antagonist of PD-L1 ABSK043 demonstrates significant anti-tumor efficacy in combination with other agents in preclinical models (AACR 2022) - "To explore potential synergy of ABSK043 with other therapeutic agents, in vivo combination experiments were conducted.In this work, we present in vivo combination results for ABSK043 with several therapeutic agents such as a VEGFR inhibitor axitinib, or carboplatin, a key component of the widely used CRC standard-of care chemotherapy treatment regimen, as well as other immune-oncology agents. These combinations demonstrated strong in vivo synergy in tumor mouse syngeneic models. Taken together, these data for the first time demonstrated combination synergy of a small molecule PD-L1 inhibitor with other agents and pave the road for potential clinical evaluation of combination treatment of ABSK043 with these agents in patients."

Combination therapy • Late-breaking abstract • Preclinical • Oncology • PD-L1

A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: Abbisko Therapeutics Co, Ltd

Clinical • New P1 trial • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • MSI