Shilpa Biocare Pvt. Ltd., a wholly owned subsidiary of Shilpa Medicare, has entered into a strategic equity partnership with Spain-based biotechnology company Gate2Brain, strengthening its presence in innovative oncology and central nervous system (CNS) therapies.

As part of the agreement, Shilpa will become a strategic shareholder in Gate2Brain and serve as the company's dedicated manufacturing, chemistry, manufacturing and controls (CMC), and regulatory partner for G2B-002, Gate2Brain's lead drug candidate for brain cancer treatment.

G2B-002 has already received Orphan Drug Designation (ODD) from both the US FDA and the European Medicines Agency (EMA), highlighting its potential in treating rare and aggressive brain tumors such as diffuse intrinsic pontine glioma (DIPG) and pediatric glioblastoma (pGBM). The therapy uses Gate2Brain's proprietary MiniAp4 peptide-shuttle technology to transport the anti-cancer drug SN-38 across the blood-brain barrier, a major challenge in treating CNS diseases.

Preclinical studies have shown promising results, with the technology demonstrating significantly enhanced drug delivery to the brain compared to conventional approaches. The platform also has potential applications in other rare pediatric cancers, including Ewing sarcoma, rhabdomyosarcoma, and neuroblastoma.

Clinical manufacturing batches are expected to be ready next year, while first-in-human clinical trials are anticipated to begin by FY28.

The partnership marks Shilpa Medicare's fourth strategic equity investment in an innovative healthcare company and aligns with its strategy of building a portfolio of high-potential therapeutic assets. The company believes the collaboration offers long-term growth opportunities while addressing significant unmet medical needs in oncology and CNS disorders.