ASC61 / Ascletis - LARVOL DELTA

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Gannex Pharma Co., Ltd. | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Gannex Pharma Co., Ltd. | Trial completion date: Mar 2023 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • PD-L1

Ascletis Announces IND Approval of Oral PD-L1 Small Molecule Inhibitor ASC61 for Treatment of Advanced Solid Tumors by China NMPA (PRNewswire) - "Ascletis Pharma...announces today the approval of the Investigational New Drug (IND) application by China National Medical Products Administration (NMPA) for the in-house developed oral PD-L1 small molecule inhibitor, ASC61, for the treatment of advanced solid tumors. While the ASC61 Phase I dose escalation study is ongoing in the U.S., IND approval in China will accelerate the global development of ASC61."

Trial status • Oncology • Solid Tumor

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Gannex Pharma Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • PD-L1

Ascletis Announces First Patient Dosed in the U.S. Phase I Clinical Trial of Oral PD-L1 Small Molecule Inhibitor Prodrug ASC61 for Treatment of Advanced Solid Tumors (PRNewswire) - "Ascletis Pharma Inc...announces the completion of first patient dosing in the U.S. Phase I clinical trial of ASC61, an oral PD-L1 small molecule inhibitor prodrug, for treatment of advanced solid tumors...This U.S. Phase I trial is a dose-escalation study to evaluate the safety and tolerability of ASC61 as well as to define the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ASC61 in patients with advanced solid tumors who have disease progression during or following standard therapy....In a head-to-head comparison study using the human PD-L1 expressing cells and fresh peripheral blood mononuclear cells (PBMCs) co-culture assay, ASC61-A treatment induced secretion of IFNγ in a concentration dependent manner, with an EC50 of 2.86 nM. Maximal levels of IFNγ induced by ASC61-A were similar to that induced by Keytruda."

Preclinical • Trial status • Oncology • Solid Tumor

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Gannex Pharma Co., Ltd. | Initiation date: Mar 2022 ➔ Jul 2022

Trial initiation date • Oncology • Solid Tumor • PD-L1

In vivo efficacy evaluation of ASC61, an oral PD-L1 inhibitor, in two tumor mouse models (AACR 2022) - "Results of this study show that ASC61 is well tolerated in both mouse models, and ASC61 has comparable antitumor efficacies as the FDA-approved PD-L1 antibody, Atezolizumab. ASC61 is an oral PD-L1 inhibitor, and thus will have better patient compliance than injective PD-1/PD-L1 antibody. ASC61 first in human clinical trial will begin soon."

Preclinical • Oncology

Ascletis Announces the Latest Results of the Preclinical Studies of Two Novel Anti-Cancer Drug Candidates, ASC61 and ASC60, to be presented at AACR Annual Meeting 2022 (PRNewswire) - "Ascletis Pharma Inc...announces that the latest preclinical research results of the company's two novel anti-cancer drug candidates, ASC61, an oral PD-L1 inhibitor and ASC60, an oral fatty acid synthase (FASN) inhibitor have been selected for presentations at the American Association for Cancer Research (AACR) Annual Meeting 2022 (the '2022 AACR Annual Meeting'), and the abstracts have already been published on AACR's official website."

Preclinical • Oncology • Solid Tumor

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Gannex Pharma Co., Ltd.

New P1 trial • Oncology • Solid Tumor • PD-L1

"#Ascletis Announces U.S. #IND Approval of Oral #PDL1 #SmallMoleculeInhibitor #ASC61 for Treatment of Advanced #SolidTumors https://t.co/ZRHbF3qm8S" (@1stOncology)

Oncology • Solid Tumor • PD-L1

Ascletis Announces U.S. IND Approval of Oral PD-L1 Small Molecule Inhibitor ASC61 for Treatment of Advanced Solid Tumors (PRNewswire) - "Ascletis Pharma...announces today the approval of the Investigational New Drug (IND) application by U.S. Food and Drug Administration (FDA) for in-house developed oral PD-L1 small molecule inhibitor, ASC61, for the treatment of advanced solid tumors....The ASC61 Phase I trial in the U.S. is a dose escalation study in patients with advanced solid tumors. The objectives of such study are to find a recommended Phase II dose (RP2D) and obtain preliminary efficacy in patients with advanced solid tumors. The first U.S. patient is expected to be dosed in the first half of 2022."

IND • New P1 trial • Oncology • Solid Tumor

Ascletis Announces U.S. IND Filing for In-House Developed Oral PD-L1 Small Molecule Inhibitor ASC61 for Treatment of Advanced Solid Tumors (PRNewswire) - "Ascletis Pharma...announces today the filing of the U.S. Investigational New Drug (IND) application for in-house developed oral PD-L1 small molecule inhibitor, ASC61, for the treatment of advanced solid tumors....ASC61 is a potent and highly selective oral PD-L1 small-molecule inhibitor and blocks PD-1/PD-L1 interaction through inducing PD-L1 dimerization and internalization. ASC61 shows significant antitumor efficacy as a single agent in various animal models."

IND • Oncology • Solid Tumor