China’s National Medical Products Administration (NMPA) has granted approval for Ascletis Pharma’s Investigational New Drug (IND) application for its therapy ASC61 to treat advanced solid tumours.
ASC61 is an in-house developed oral PD-L1 small molecule inhibitor prodrug.
It showed significant antitumor efficacy in several animal models such as humanised mouse model as a single agent.
In preclinical studies, the small molecule inhibitor demonstrated good pharmacokinetic and safety profiles in animal models.
It is currently being assessed in the Phase I dose escalation study in the US.
The company stated that the IND approval in China would expedite ASC61’s global development.
ASC61 has higher patient compliance with safe and easy administration and ease of all oral combination therapies compared to PD-1/PD-L1 antibody injections.
Ascletis founder, chairman and CEO Dr Jinzi Wu said: “Immunogenicity and the poor permeability into tumour tissues are the major limitations of therapeutic antibodies, which can cause a low response rate of PD-1/PD-L1 antibodies.
“As a highly differentiated small molecule PD-L1 inhibitor, ASC61 showed a promising safety profile in the dose escalation study in patients with advanced solid tumours in the US so far.
“With two IND approvals in the US and China, we expect to accelerate the global development of ASC61 and provide more options for patients with advanced solid tumours.”
Recently, the company submitted an IND application to the US Food and Drug Administration (FDA) for its oral inhibitor drug candidate, ASC11, to treat Covid-19.
The IND application was filed after the pre-IND consultation with the regulatory agency.
