Glenmark Pharmaceuticals and Harbour BioMed 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.
"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.
"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," Dr. Jingsong Wang, founder and CEO of Harbour BioMed said.
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.