Shilpa Biocare Pvt Ltd, a subsidiary of Shilpa Medicare Limited, has entered a strategic equity partnership with Barcelona-based Gate2Brain to advance G2B-002, a first-in-class therapy candidate for deadly pediatric brain cancers. Under the deal, Shilpa becomes a strategic shareholder and CMC, manufacturing, and regulatory partner for the program, which targets diffuse intrinsic pontine glioma (DIPG) and pediatric glioblastoma (pGBM), both of which hold Orphan Drug Designation from the US FDA and EMA. G2B-002 leverages Gate2Brain’s proprietary MiniAp4 peptide shuttle to deliver SN-38 across the blood-brain barrier and has demonstrated up to a 100-fold increase in brain drug transport in preclinical studies. First-in-human trials are anticipated by fiscal year 2028.
The collaboration positions G2B-002 in several high-growth oncology segments, including the glioblastoma market, projected to reach USD 6.48 billion by 2035 (CAGR 7.97%), the pediatric brain tumor market, forecast at USD 2.47 billion by 2031 (CAGR 6.9%), and a DIPG market estimated at USD 1.2 billion by 2035 (CAGR 7.1%). Gate2Brain’s MiniAp4 platform also offers expansion potential into other rare pediatric cancers and broader CNS indications. Shilpa said this marks its fourth strategic equity partnership and aligns with its strategy to back differentiated innovation while driving long-term value creation for shareholders and society.
“Gate2Brain's blood-brain-barrier technology is among the most differentiated CNS-delivery platforms we have evaluated,” said Vishnukant Bhutada, managing director, Shilpa Medicare Ltd. “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.” Gate2Brain CEO Meritxell Teixidó Turà said the alliance “gives G2B-002 a clear, de-risked path to the clinic and validates our peptide-shuttle platform with a top-tier oncology partner,” adding that aligning Shilpa’s manufacturing and regulatory capabilities with the company’s science is “the right structure to deliver this program — and the next ones — to patients.”
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