Research & Development
Innovent to launch clinical trials of Anti-OX40 Monoclonal Antibody IBI101 upon US FDA approval
5 December 2018 -

Chinese biopharmaceutical company Innovent Biologics, Inc (Innovent) (HKEX:01801) revealed on Tuesday the receipt of the US Food & Drug Administration (FDA) approval to initiate the US phase I clinical trial of its Anti-OX40 Monoclonal Antibody IBI101 in patients with advanced solid tumors.

In addition, Innovent is the first Chinese biopharmaceutical company to receive clinical trial approval from US FDA for an anti-OX40 monoclonal antibody.It has received US FDA's IND approvals for IBI308 (Sintilimab, an anti-PD-1 antibody) in January 2018 and IBI188 (an anti-CD47 antibody) in September 2018 respectively.

Following the US FDA approval, the company will initiate the US phase I clinical trial of IBI101 based on results from the China phase I study in patients with advanced solid tumours. IBI101 is its third molecule approved for clinical trials by US FDA.

IBI101, a recombinant fully human anti-OX40 (tumour necrosis factor receptor superfamily member 4) monoclonal antibody, was developed by the company and has independent intellectual property rights. Pre-clinical data confirm that IBI101 can significantly enhance the activation of effector T cells and mediate the clearance of regulatory T cells, thus inhibiting the growth of tumour cells. Agonistic OX40 candidates will be used in combination with other immunomodulation agents, including anti-PD-1 monoclonal antibody (IBI308) and other drugs in its R&D pipeline, to meet more unmet medical needs of cancer patients.

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