Shilpa Biologicals and mAbTree Biologics to Collaborate on Novel Immuno-Oncology Asset

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Editor's note: this story was originally published on BioPharm International.com.

India-based Shilpa Biologicals, a fully owned subsidiary of Shilpa Medicare Limited, announced on March 17, 2025 that it has entered into a strategic partnership with Switzerland-based mAbTree Biologics. The companies will co-develop and commercialize mAbTree’s novel biologic asset—a checkpoint inhibitor for immuno-oncological applications.

Under the agreement, Shilpa Biologicals will support development—including clinical studies—and long-term commercial supply with good manufacturing practice (GMP) manufacturing. Meanwhile, Shilpa Group will provide mAbTree access to India and several global markets through its partner network (1).

The partners aim to develop a fully human monoclonal antibody (mAb) against a novel immune checkpoint protein. This protein enables T-cell activation and the generation of strong immune responses against tumors, similar to the more well-established blocking action of programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1).While blocking PD-1/PD-L1 has demonstrated significant clinical successes, recent studies suggest that Shilpa Biologicals’ and mAbTree’s novel target carries a highly attractive therapeutic potential in various immuno-oncological states as both a monotherapy and combinatorial therapy. Their approach has the potential to convert cold tumors (those with poor immune cell infiltration) to hot (having good immune infiltration). Their approach can also suppress tumor metastasis and make refractory tumors susceptible to chemotherapy. This target is applicable in various cancers, including lung cancer, head and neck squamous cell carcinoma, and hematologic malignancies, according to a company press release (1).

“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, in the press release (1).

Shilpa Biologics’ large R&D teams will provide full-service capabilities, from cell line development to GMP drug product manufacturing. Manufacturing activities and the provision of clinical supply will be conducted at the company’s biomanufacturing facility at Dharwad, Karnataka, in India.

“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 [rest of world] markets where access has been limited,” said Raj Andhuvan, CEO, mAbTree in the release. “But what really impresses us about Shilpa is their commitment and scientific expertise. We look forward to rapidly advancing therapeutic options in the NBE [new biological entity] space and to addressing emerging health challenges.”

mAbTree’s pipeline (including this asset under the partnership with Shilpa Biologicals) includes two oncology assets that have completed preclinical studies and two assets currently in the R&D phase, one multiple sclerosis and the other in psoriasis. The rest of the company’s pipeline includes two undisclosed candidates in the investigational new drug application-enabling phase, one in the in-vivo proof-of-concept phase, and two in the lead optimization phase (2).

Shilpa Biologicals’ pipeline primarily includes biosimilars in various stages of development. It has an adalimumab biosimilar that has complete Phase III trials, an aflibercept biosimilar entering Phase III trials, and a FC fusion protein biosimilar and another mAb biosimilar in preclinical studies. The company also has a new biological entity, recombinant human albumin, that has started Phase III trials (3).

References

1. Shilpa Biologicals. Shilpa Biologicals Pvt Ltd Signs Strategic Development Partnership with mAbTree Biologics AG for a Novel Immuno-Oncology Asset. Press Release. March 17, 2025.
2. mAbTree Biologics. Pipeline. mabtree.com/pipeline (accessed March 17, 2025).
3. Shilpa Biologicals. Product Portfolio. shilpabio.com/product-pipeline (accessed March 17, 2025).