Shilpa Biologicals, mAbTree Biologics ink pact for cancer drug

Karnataka: Shilpa Biologicals Pvt Ltd., a fully owned subsidiary of Shilpa Medicare Limited has signed an exclusive partnership with mAbTree Biologics AG to co-develop, commercialize novel biologic asset [a checkpoint inhibitor] for immuno oncological applications.

Under the terms of the strategic agreement, Shilpa Biologicals will support both development – including clinical studies – as well as long-term commercial supply with GMP manufacturing. Additionally, Shilpa Group will provide mAbTree access to India and several global markets through its extensive partner network.

This program aims to develop a fully human monoclonal antibody against a novel immune checkpoint protein that enables T cell activation and generation of strong immune responses against tumours akin to the well-established PD-1/PD-L1 blockade. While PD-1/PD-L1 blockade has demonstrated remarkable clinical successes, recent studies suggest the company's novel target has as a highly attractive therapeutic potential in various immuno-oncological states both as a monotherapy and combinatorial therapy. This approach has the potential to convert cold tumours (poor immune cell infiltration) hot (good immune infiltration), suppress tumour metastasis and make the refractory tumors susceptible to chemotherapy as well and is applicable in various cancers, including lung cancer, head and neck squamous cell carcinoma, and hematologic malignancies.

“We are delighted to enter this strategic collaboration with mAbTree Biologics as we share a common vision to bring innovative solutions to address unmet medical needs around the globe especially in the field of oncology where Shilpa has had a long history of providing affordable innovative solutions” said Madhav Bhutada, Director, Shilpa Biologicals.

Shilpa Biologicals will utilize its large R&D teams – providing full-service capabilities from cell line development to GMP drug product manufacturing – with manufacturing and clinical supply conducted at its state-of-the art bio manufacturing facility at Dharwad, Karnataka.

Commenting on the co-development deal and its potential impact on patients, Dr Sridevi Khambhampaty, CEO Shilpa Biologicals, “This novel therapy represents a new frontier in immuno-oncology, with the potential to expand treatment for patients who do not benefit from current immunotherapy options – so it’s potentially a massive breakthrough.”

“mAbTree is excited to continue our strategic partnership with Shilpa Biologicals and our aim is to enable greater access to medicines for more patients across the world, especially focusing on India and ROW markets where access has been limited”, added Mr Raj Andhuvan, CEO mAbTree. “But what really impresses us about Shilpa is their commitment and scientific expertise. We look forward to rapidly advancing therapeutic options in the NBE space and to addressing emerging health challenges.”