Glenmark Announces the Discovery and Initiation of IND-Enabling Studies of a Novel Bi-Specific Monoclonal Antibody Targeting CD38

Mumbai: GlenmarK Pharmaceuticals S.A. (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), has announced the discovery and initiation of IND-enabling studies for a novel clinical development candidate, GBR 1342. GBR 1342 is a CD38xCD3 bi-specific antibody based on Glenmark’s proprietary BEAT® platform. GBR 1342 is the second clinical development candidate (following GBR 1302 a HER2xCD3 bi-specific antibody) based on the BEAT® technology. It is also Glenmark’s second clinical candidate targeting oncology indications.

CD38 is one of the few known markers for plasma cells and is a well-established target for multiple myeloma, a cancer caused by malignant plasma cells. CD38 is potentially also a target for other hematopoietic malignancies

Commenting on this achievement, Dr. Michael Buschle, Chief Scientific Officer & President - Biologics, Glenmark Pharmaceuticals said: “GBR 1342 is the second bi-specific antibody emerging from our BEAT® platform. With the 1302 project we learned how to efficiently engineer and manufacture this novel type of antibody and we are now applying those lessons to several other targets”.

GBR 1342’s mode of action is similar to GBR 1302, Glenmark’s first CD3 redirecting antibody. GBR 1342 redirects cytotoxic T cells through its CD3 binding arm onto CD38-expressing cancer cells and induces the killing of these cancer cells by the T cells. Glenmark is committed to moving GBR 1342 rapidly into clinical trials.

BEAT® (Bi-specific Engagement by Antibodies based on the T cell receptor) is Glenmark’s technology for production of bi-specific antibodies. Engaging two targets with one bi-specific antibody is a novel concept to design new therapeutics. For the past 20 years, bi-specific antibodies have been a challenge to the industry since most bi-specific formats developed thus far have stability and/or manufacturing issues. With the invention of the BEAT® technology Glenmark’s scientists have now overcome these hurdles and are able to efficiently engineer and manufacture bi-specific antibodies.

Glenmark’s Novel Biologics Entity pipeline:

Glenmark has three monoclonal antibodies in the Novel Biologics Entity (NBE) pipeline undergoing active clinical development:

GBR 830, a best in class OX40 antagonist for autoimmune diseases which is currently in Phase II clinical development for atopic dermatitis.

GBR 900 targets the TrkA receptor for chronic pain and is currently in clinical Phase I. This project is developed under license from Lay Line Genomics S.p.A., an Italian based Company. Monoclonal antibodies specific for TrkA represent a first-in-class opportunity for the treatment of chronic pain, which has a high level of unmet need.

GBR 1302, the first clinical candidate based on Glenmark’s proprietary best in class BEAT® platform. GBR 1302 is Glenmark’s first clinical candidate targeting oncology indications. The BEAT® antibody technology platform facilitates the efficient development and manufacturing of antibodies with dual specificities called bi-specific antibodies.