Chinese biopharmaceutical firm Innovent Biologics has started treating patients in a Phase I clinical trial of its monoclonal antibody candidate IBI101.
IBI101 is a recombinant fully human anti-tumour necrosis factor receptor superfamily member 4 (anti-OX40) monoclonal antibody, which is indicated for the treatment of advanced solid tumours.
Pre-clinical testing showed that the therapeutic could boost effector T cells activation and mediate clearance of regulatory T cells, helping to inhibit the growth of tumours.
An investigational new drug (IND) application for the product was approved by the US Food and Drug Administration (FDA) in December last year.
During the Phase I trial, the safety, tolerance and primary efficacy of IBI101 will be assessed when given as a single agent or in combination with Tyvyt (sintilimab).
Sintilimab is an anti-programmed cell death protein 1 (PD-1) antibody jointly developed by Innovent and Eli Lilly.
The trail will enrol approximately 80 advanced solid tumour patients who did not experience adequate response to standard treatments.
Phase Ia of the trial saw eight dose levels of IBI101 evaluated, while the Ib portion will study four dose levels of the product in combination with sintilimab.
Innovent Biologics founder, CEO and chairman Michael Yu said: “We are dedicated to exploring the most advanced research areas in cancer immunotherapy and providing innovative medicines that improve lives around the world.
“The initiation of Phase I study of IBI101 and dosing of first patient have again demonstrated our efforts and commitment. We truly anticipate further breakthroughs so that more patients will potentially benefit in the future.”
The trial’s primary outcome measure is the incidence of adverse events, while its secondary measures include overall response rate, time to and duration of response, and progression-free survival.
It is expected to be completed by January 2022.