Shilpa Medicare, Gate2Brain Partner to Advance First-in-Class Brain Cancer Therapy

Editor’s Take: A proprietary peptide shuttle to deliver therapeutics across the blood-brain barrier holds first-in-human potential.

Shilpa Biocare, a subsidiary of Shilpa Medicare, has a strategic equity partnership with Gate2Brain, developing central nervous system (CNS) therapeutics. By engaging with this biotechnology company, Shilpa becomes a strategic shareholder in Gate2Brain’s lead program, G2B-002. Shilpa will also be Gate2Brain’s chemistry, manufacturing, and controls (CMC), manufacturing, and regulatory partner for the candidate.

According to Shilpa, this is the company’s fourth strategic equity partnership.

Gate2Brain’s Proprietary Program

Namely, G2B-002 targets the deadly pediatric brain cancers DIPG and pGBM. The program has Orphan Drug Designations from both the U.S. FDA and the European Medicines Agency. It uses Gate2Brain’s proprietary peptide shuttle, called MiniAp4, to deliver the drug SN-38 across the blood-brain barrier.

In anticipating first-in-human trials for fiscal year 2028, Gate2Brain says G2B-002 has shown approximately 100-fold greater brain drug transport preclinically.

“Gate2Brain’s blood-brain-barrier technology is among the most differentiated CNS-delivery platforms we have evaluated,” Vishnukant Bhutada, Shilpa Medicare Managing Director, said. “Becoming a strategic shareholder allows Shilpa to participate in long-term value creation while contributing the manufacturing and regulatory depth required

Following first-in-human studies, Bhutada added, G2B-002 might be applied to other molecules and therapy categories. Gate2Brain CEO Meritxell Teixidó Turà agreed.

“This partnership gives G2B-002 a clear, de-risked path to the clinic and validates our peptide-shuttle platform,” Turà said. “Aligning Shilpa’s manufacturing and regulatory capabilities with our science is the right structure to deliver this program … to patients.”

Shilpa Exploring High-Growth Markets

In a press release, Shilpa noted that G2B-002 is targeting high-growth oncology markets. Example: The glioblastoma market is projected at US$6.48 billion by 2035, with a compound annual growth rate (CAGR) of 7.97%. Pediatric brain tumors are projected at $2.47 billion by 2031 (CAGR 6.9%); DIPG, at $1.2 billion by 2035 (CAGR 7.1%).