New Delhi: Glenmark Pharmaceuticals and biopharmaceutical firm Harbour BioMed have entered into an exclusive licence agreement to develop, manufacture and commercialise Glenmark’s GBR 1302, for the treatment of certain kinds of cancers for the Greater China territory.

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 commercialisation milestones, as well as tiered royalties on net sales for any approved products from Harbour BioMed.

Glenmark in a regulatory filing said the agreement is potentially worth more than $120 million (approx Rs 822.60 crore) in addition to royalties for Glenmark. Harbour BioMed will lead the clinical development and commercialisation of GBR 1302, with the option to manufacture GBR 1302 for the Greater China market.

“We are very pleased to begin this strategic relationship with Harbour BioMed for the development and commercialisation of our bispecific antibody, GBR 1302 in Greater China, where the predominance of certain HER2 positive cancers presents a significant clinical need,” Glenmark’s Chairman and Managing Director Glenn Saldanha said.

Dr Jingsong Wang, founder and CEO of Harbour BioMed said, “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.”

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.
Glenmark’s 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 US and Germany.