Glenmark Pharmaceuticals has signed an exclusive licence agreement with Harbour BioMed for the development, manufacture and commercialisation of its immuno-oncology candidate GBR 1302 in Greater China to treat HER2-positive cancers.

Generated using Glenmark’s Bispecific Engagement of Antibodies based on the T cell receptor (BEAT) technology platform, GBR 1302 is a bispecific antibody designed to target HER2 and CD3 tumours.

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The drug candidate activates the patient’s immune system against tumour cells that over-express HER2.

GBR 1302 is being investigated in a clinical trial to establish the maximum tolerated dose (MTD) in an all-comers population of patients with different HER2-positive cancers in the US and Germany.

Glenmark chairman and managing director Glenn Saldanha said: “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.

“GBR 1302 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 programme, which brings extensive local experience, is very important to Glenmark.”

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Harbour BioMed founder and CEO Dr Jingsong Wang 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.

“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.”

“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.”

As part of the licensing agreement, Glenmark will be eligible for a payment of more than $120m, which includes an upfront payment, as well as potential pre-specified development, regulatory and commercialisation milestones.

In addition, the company will receive tiered royalties on net sales for any approved products covered under the deal.

Harbour BioMed is responsible for the clinical development and commercialisation of GBR 1302, and holds the option to manufacture the oncology candidate in Greater China.

The partners will jointly work to obtain clinical data for supporting the registration of the product for HER2-positive indications in their respective territories.