MUMBAI, August 20, 2014 /PRNewswire/ --
Glenmark Pharmaceuticals S.A. (GPSA), a wholly owned subsidiary
of Glenmark Pharmaceuticals Limited India (GPL), announces the
discovery and initiation of IND enabling studies of a novel
clinical development candidate, GBR 1302, a HER2xCD3 bispecific
antibody. GBR 1302 was discovered and developed by the Glenmark
Biologics Research Centre located in La Chaux-de-Fonds,
Switzerland. GBR 1302 is based on
Glenmark's innovative BEAT antibody technology platform which
facilitates the efficient development and manufacture of antibodies
with dual specificities, so-called bispecific antibodies. GBR 1302
is the first clinical development candidate based on the BEAT
technology. Glenmark expects to obtain approval for the initiation
of clinical studies during this financial year.
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HER2, also known as HER2/neu, or receptor tyrosine-protein
kinase erbB-2, is the target of the antibody cancer drugs
trastuzumab, pertuzumab and trastuzumab emtansine and is involved
in breast cancer and ovarian cancer.
GBR 1302's mode of action is different from current HER2
targeting antibodies. It redirects cytotoxic T cells through its
CD3 binding arm onto HER2 expressing cancer cells and induces the
killing of the cancer cells. The killing of cancer cells by GBR
1302 is more rapid, more complete and not subject to the same
resistance escape mechanisms as competing therapies.
BEAT (Bispecific Engagement by Antibodies
based on the T cell receptor) is a proprietary best-in-class
platform of Glenmark. Engaging two targets with one bispecific
antibody is an attractive concept to design new therapeutics. For
the past 20 years, bispecific antibodies have been a challenge to
the industry since all bispecific formats developed so far have had
stability and/or manufacturing issues. With the invention of the
BEAT technology Glenmark's scientists have now overcome these
bottlenecks and GBR 1302 is the first drug candidate based on this
antibody engineering breakthrough technology.
Commenting on this milestone, Dr.
Michael Buschle, Chief Scientific
Officer & President - Biologics, Glenmark Pharmaceuticals
mentioned, "GBR 1302 is significant for Glenmark on multiple
levels: It is our first bispecific antibody, it is our first
antibody based on our proprietary BEAT antibody engineering
platform and it represents the entry of Glenmark into the Oncology
innovator space, which has a huge commercial
potential."
Glenmark's Novel Biologics Entity Pipeline
With the addition of GBR 1302 to the pipeline, Glenmark now has
four monoclonal antibodies in the Novel Biologics Entity (NBE)
pipeline with three of them undergoing active clinical development.
First, GBR 500, a monoclonal antibody represents a first-in-class
opportunity indicated for the treatment of Multiple Sclerosis (MS)
and other autoimmune diseases. GBR 500 has been licensed to Sanofi
and is in Phase II trials in the US. The second monoclonal
antibody, 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 needs. The third antibody is GBR 830, a best in
class OX40 antagonist for autoimmune diseases which recently
entered Phase I clinical development.
About Glenmark
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven,
global, integrated pharmaceutical company headquartered at
Mumbai, India. It is ranked among
the top 80 pharma and biotech companies of the world in terms
of revenues (SCRIP 100 Rankings published in the year 2014).
Glenmark is a leading player in the discovery of new molecules both
NCEs (new chemical entity) and NBEs (new biological entity).
Glenmark has several molecules in various stages of clinical
development and is primarily focused in the areas of inflammation
[asthma/COPD, rheumatoid arthritis etc.] and pain [neuropathic pain
and inflammatory pain].
The company has a significant presence in branded generics
markets across emerging economies including India. GPL along with its subsidiary has 14
manufacturing facilities in four countries and has six R&D
centers. Its subsidiary, Glenmark Generics Limited services the
requirements of US and Western
Europe generics markets. The API business sells its products
in over 80 countries, including the US, various countries in the
EU, South America and India.
For more information visit www.glenmarkpharma.com
For licensing opportunities, please
contact:
Jeff Lange
Glenmark, NJ, US
Tel: +1-201-684-8000/8003
E-mail: jeffl@glenmarkpharma.com
Media Contact: Corporate Communications,
corpcomm@glenmarkpharma.com, +91-2240189999, Corporate
Communications, Glenmark Pharmaceuticals Ltd.