Indian pharmaceutical firm Glenmark Pharmaceuticals has obtained clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to commence a Phase I clinical trial of GBR 1342 to treat patients with multiple myeloma.

Based on the firm’s bispecific engagement by antibodies based on the T-cell receptor (BEAT) technology platform, GBR 1342 is a humanised monoclonal antibody (bsAb) currently being developed to trigger and redirect immune cells towards tumours.

The two-part Phase I trial will recruit patients who have received prior therapies.

The dose escalation part of the trial will establish the drug's safety profile and maximum tolerable dose, while the expansion cohort will further determine its safety profile and preliminary efficacy when administered at the maximum tolerable dose.

"While there is still significant development ahead, these steps signify that Glenmark's investment in discovery and development of biologics is rapidly progressing."

Glenmark Pharmaceuticals president and chief scientific officer Kurt Stoeckli said: "This is an exciting time for Glenmark as our flagship biotechnology platform and antibody science are beginning to become a reality for patients, now that we have a second oncology candidate entering clinical trials.

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.

See Also:

"While there is still significant development ahead, these steps signify that Glenmark's investment in discovery and development of biologics is rapidly progressing."

The firm intends to further investigate GBR 1342 as a treatment option for other malignancies.

Glenmark also developed HER2xCD3 bsAb GBR 1302 and EGFRxCD3 bsAb GBR 1372 based on BEAT technology.

GBR 1302 is currently being evaluated for the treatment of HER2+ cancers, and GBR 1372 showed activity against EGFR expressing cells observed in the case of resistant and refractory tumours.