Shilpa Biologicals Pvt. Ltd. (SBPL), a wholly owned subsidiary of Shilpa Medicare Limited, has entered into a strategic co-development and commercialization partnership with mAbTree Biologics AG, based in Basel, Switzerland.

The collaboration focuses on developing, manufacturing, marketing, and selling a novel biological entity (NBE) for immuno-oncology applications.

Under the terms of the agreement, Shilpa Biologicals will support the entire development process, including first-in-human clinical trials, while also ensuring long-term commercial supply through its Good Manufacturing Practice (GMP) manufacturing capabilities. The partnership will also enable mAbTree Biologics to gain access to Indian and global markets through Shilpa’s extensive partner network, strengthening its market presence.

The partnership is centered around a new immune checkpoint protein that plays a crucial role in activating T cells and generating a strong immune response against tumors. This approach is similar to the PD-1/PD-L1 blockade, which has demonstrated remarkable clinical success.

The novel asset holds significant potential in treating various types of cancers, including lung cancer, head and neck squamous cell carcinoma, and hematologic malignancies. By converting cold tumors with poor immune cell infiltration into hot tumors with good immune infiltration, the therapy could also suppress tumor metastasis and make refractory tumors more susceptible to chemotherapy.

Madhav Bhutada, Director of Shilpa Biologicals, emphasized the importance of the collaboration, stating that both companies share a common vision of bringing innovative solutions to address unmet medical needs, particularly in oncology. He highlighted Shilpa’s long history of providing affordable and effective treatment options in the field.

Shilpa Biologicals will leverage its extensive research and development expertise, utilizing its state-of-the-art bio-manufacturing facility in Dharwad, Karnataka, to handle both manufacturing and clinical supply. The company’s large R&D teams will contribute at every stage, from cell line development to GMP drug product manufacturing.

Dr. Sridevi Khambhampaty, CEO of Shilpa Biologicals, described the therapy as a significant breakthrough in immuno-oncology, with the potential to provide treatment options for patients who do not currently benefit from existing immunotherapies. She expressed optimism that this novel approach could transform cancer treatment and improve patient outcomes worldwide.

Raj Andhuvan, CEO of mAbTree Biologics, expressed excitement about continuing the strategic partnership with Shilpa Biologicals. He underscored the importance of expanding access to advanced therapies, particularly in India and other regions where availability has been limited. He praised Shilpa’s scientific expertise and commitment, emphasizing the potential for rapid advancements in the development of novel biological entities.

Shilpa Biologicals will present its leadership team at BIO-Europe Spring in Milan from March 17-19 and at the Bioprocessing Summit Europe in Barcelona from March 18-20 to explore further collaboration opportunities and discuss the advancement of biologics.