- Shilpa Biocare Pvt Ltd has entered a strategic equity partnership with Gate2Brain, becoming a shareholder and CMC, manufacturing, and regulatory partner for the CNS oncology candidate G2B-002.
- The companies aim to advance G2B-002, a therapy targeting pediatric brain cancers DIPG and pGBM, with first-in-human studies anticipated by FY28.
Shilpa Biocare Pvt Ltd, a subsidiary of Shilpa Medicare Limited, has entered a strategic equity partnership with Gate2Brain, S.L., a biotechnology company focused on central nervous system (CNS) therapeutics. Under the agreement, Shilpa will become a strategic shareholder in Gate2Brain and serve as the chemistry, manufacturing and controls (CMC), manufacturing, and regulatory partner for G2B-002, Gate2Brain’s lead development program for pediatric brain cancers diffuse intrinsic pontine glioma (DIPG) and pediatric glioblastoma (pGBM).
G2B-002 is designed to use Gate2Brain’s proprietary MiniAp4 peptide shuttle technology to transport SN-38 across the blood-brain barrier. According to the companies, the platform has demonstrated up to 100-fold greater brain drug transport in preclinical studies. The program has received Orphan Drug Designation from both the U.S. Food and Drug Administration and the European Medicines Agency, with first-in-human trials anticipated by FY28.
The companies said G2B-002 addresses oncology markets that include glioblastoma, pediatric brain tumors, and DIPG. Gate2Brain also plans to apply its MiniAp4 platform to additional rare pediatric cancers and broader CNS indications. The partnership represents Shilpa’s fourth strategic equity investment focused on innovative therapeutic technologies.
“Gate2Brain’s blood-brain-barrier technology is among the most differentiated CNS-delivery platforms we have evaluated. Becoming a strategic shareholder allows Shilpa to participate in long-term value creation while contributing the manufacturing and regulatory depth required to bring G2B-002 to first-in-human studies and extend its application to other molecules and therapy categories.”
Vishnukant Bhutada, Managing Director of Shilpa Medicare Ltd
The collaboration combines Gate2Brain’s CNS drug delivery platform with Shilpa’s manufacturing, regulatory, and development capabilities. The arrangement is intended to support the advancement of G2B-002 toward clinical development while exploring broader applications of the technology across additional therapeutic programs.
