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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.