Innovent Biologics has dosed the first subject in an investigator-initiated-trial of its chimeric antigen receptor T (CAR-T) cell product called IBI345, to treat advanced Claudin18.2-positive solid tumours. 

IBI345 is an immunoglobulin G (IgG)-based universal ‘modular’ Claudin 18.2-targeting CAR-T. Presently, subject enrolment in the trial is underway. 

Innovent developed IBI345 leveraging the technology of Roche. It is a well-differentiated CAR-T cell product possessing a novel mechanism of action. 

As against standard CAR-T cells that directly detect and destroy tumour cells, IBI345 has two components: anti-Claudin18.2 antibodies as well as ‘modular’ CAR-T cells.

The anti-Claudin18.2 antibody detects antigen of the tumour to regulate and intensify the antigen signal. This approach aids ‘modular’ CAR-T cells to penetrate the tumour to commence CAR-T cells’ cytotoxic and antitumor activity. 

Analysing the safety, tolerability, pharmacokinetics and initial efficacy of IBI345 in Claudin18.2-positive solid tumour patients will be the primary goal of the trial.

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Furthermore, the clinical dosage and regimen will be assessed to obtain clinical data that will aid in submitting investigational new drug application (IND).

Innovent Biologics vice-president and R&D Cell Therapy head Dr Xu Wei said: “IBI345 is a highly differentiated CAR-T cell product with a new mechanism of action developed by Innovent based on Roche’s proprietary technology. 

“As a universal ‘modular’ CAR-T cell therapy product, equipped with a precisely targeted antibody switch, it regulates the expansion of CAR-T cells to control side effects, potentially providing an opportunity to switch to another antibody that targets different antigens to prevent recurrence and treat different tumours.” 

The latest development comes after the company reported that two Phase III trials, CREDIT-1 and CREDIT-4, assessing its antibody IBI306 to treat hypercholesterolemia met the primary endpoint. 

Innovent anticipates seeking a new drug application (NDA) for IBI306 in China for the treatment of people with primary hypercholesterolemia and combined hyperlipidemia.

Cell & Gene Therapy Coverage on Clinical Trials Arena supported by Cytiva.

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