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Harbour BioMed and Glenmark Pharmaceuticals Sign Agreement for Greater China to Develop GBR 1302, a First-in-Class Bispecific Antibody for Treatment of HER2-Positive Cancers

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  • Exclusive license agreement potentially worth more than $120
    million in addition to royalties
  • GBR 1302 is a clinical stage, HER2xCD3 bispecific antibody
    generated from Glenmark's proprietary BEAT™ (Bispecific Engagement of
    Antibodies based on the T cell receptor) technology platform

Harbour BioMed and Glenmark Pharmaceuticals S.A., announced today that
they have entered into an exclusive license agreement for the Greater
China territory to develop, manufacture and commercialize GBR 1302,
Glenmark's bispecific antibody targeting HER2 and CD3 for the
treatment of HER2-positive cancers.

This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20180806005701/en/

Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed
said: "We are looking forward to collaborating with Glenmark
Pharmaceuticals to develop and commercialize this promising, novel
bispecific antibody in Greater China to meet the significant unmet
medical needs of Chinese cancer patients. This collaboration is aligned
with our strategy to leverage our clinical development expertise by
in-licensing highly innovative clinical stage assets. GBR 1302 is
complementary to the internal portfolio we are building through our
industry leading transgenic mouse platforms for generating innovative
antibody-based therapeutics."

"We are very pleased to begin this strategic relationship with Harbour
BioMed for the development and commercialization of our bispecific
antibody, GBR 1302 in Greater China, where the predominance of certain
HER-2 positive cancers presents a significant clinical need," said Glenn
Saldanha
, Chairman and Managing Director of Glenmark. "GBR1302 is
representative of Glenmark's commitment to the discovery and development
of innovative therapeutics for unmet medical need, and the opportunity
to work collaboratively with Harbour BioMed on this program, which
brings extensive local experience, is very important to Glenmark."

Under the terms of the agreement, Glenmark will receive an upfront
payment and is eligible to receive payments for achieving pre-specified
development, regulatory and commercialization milestones, as well as
tiered royalties on net sales for any approved products from Harbour
BioMed. The agreement is potentially worth more than $120 million in
addition to royalties for Glenmark. Harbour BioMed will lead the
clinical development and commercialization of GBR 1302, with the option
to manufacture GBR 1302 for the Greater China market. The companies will
collaborate on the generation of clinical data to support the
registration of GBR 1302 in HER2-positive indications in their
respective territories.

GBR 1302, Glenmark's lead immuno-oncology candidate, works by
stimulating the patient's immune system against HER2 overexpressing
tumor cells. GBR 1302 is currently in a first-in-human study to
determine maximum tolerated dose (MTD) in an all-comers population of
patients with a variety of HER2-positive cancers. Enrollment for the GBR
1302 clinical study is currently ongoing in the U.S. and Germany.

Kurt Stoeckli, President and Chief Scientific Officer for
Glenmark added, "Harbour BioMed represents a company that is dedicated
to the same principles as Glenmark in pursuing highly effective,
precision-medicine based immunotherapeutics for the benefit of cancer
patients and we look forward to working closely with them to advance
meaningful treatment options."

About Glenmark's Oncology Pipeline and Proprietary BEAT® Technology
Glenmark's
pipeline currently includes three immuno-oncology candidates being
studied in a wide range of tumor types. These include three bispecific
monoclonal antibodies (bsAbs). GBR 1302, a HER2xCD3 bsAb, targets HER2
expressing tumors, including those not responsive to standard of care;
GBR 1342, a CD38XCD3 bsAb targeting CD38 positive tumors including
hematologic malignancies and solid tumors; and GBR 1372, an EGFRxCD3
bsAb targeting EGFR positive tumors including those resistant to
standard of care.

BEAT® (Bispecific Engagement by Antibodies
based on the T cell receptor) is Glenmark's proprietary
technology for the production of bsAbs. With BEAT® technology,
Glenmark's scientists have been able to overcome past production
obstacles encountered with bsAbs, and can efficiently manufacture these
molecules at clinical and commercial scale. Preclinically, BEAT® bsAbs
demonstrate the potential for more potent activity compared to existing
therapeutic antibodies. Additionally, structural similarity to
naturally-occurring antibodies may result in a normalized IgG half-life
and less immunogenicity. GBR 1302, GBR 1342 and GBR 1372 are based on
BEAT® technology.

About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd.
(GPL) is a global innovative pharmaceutical company with operations in
more than 50 countries. Glenmark has a diverse pipeline with several
compounds in various stages of clinical development, primarily focused
in the areas of oncology, respiratory disease and dermatology. Glenmark
has improved the lives of millions of patients by offering safe,
affordable medications for nearly 40 years. For more information, visit glenmarkpharma.com.

About Harbour BioMed
Harbour BioMed is a global
biopharmaceutical company discovering and developing innovative
therapeutics for oncology and immunological diseases. The company's
discovery and development programs are built around its two patented
transgenic mouse platforms for therapeutic antibody discovery. The
company is building its proprietary pipeline through its innovative
internal discovery programs, and through in-licensing clinical stage
assets that strategically fit its internal portfolio. Harbour BioMed
also licenses the platforms to companies and academic institutions
through its Harbour Antibodies subsidiary. For more information, visit www.harbourbiomed.com.

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