Swiss firm mAbTree Biologics AG has signed an exclusive co-development and commercialisation partnership with Shilpa Biologicals (a fully owned subsidiary of Raichur-based Shilpa Medicare) for its 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 programme 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 our 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.
Shilpa Biologics will utilise 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 said, “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.”
“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 Raj Andhuvan, CEO, mAbTree.
Image caption- Dr Sridevi Khambhampaty, CEO of Shilpa Biologicals, and Raj Andhuvan, CEO of mAbTree
