Shilpa Medicare Subsidiary Invests €7 Million in Gate2Brain to Advance First-in-Class Pediatric Brain Cancer Therapy
核心洞察
Shilpa Biocare acquires a 30.4% equity stake in Gate2Brain (搜索) through a €7 million investment comprising cash, equity for services, and project development funding.
Gate2Brain (搜索)'s lead candidate G2B-002 uses a proprietary MiniAp4 peptide shuttle (搜索) to deliver SN-38 across the blood-brain barrier, showing up to 100-fold higher brain drug transport preclinically.
G2B-002 has received Orphan Drug Designation from both the FDA and EMA for DIPG and pediatric glioblastoma (搜索), with first-in-human trials anticipated by FY28.
Shilpa Biocare Pvt Ltd (搜索), a subsidiary of Shilpa Medicare Limited, has entered into a strategic equity partnership with Barcelona-based biotechnology company Gate2Brain (搜索), S.L., committing €7 million to advance a first-in-class peptide-shuttle therapy targeting deadly pediatric brain cancers. Under the agreement, Shilpa Biocare will acquire a 30.4% equity stake in Gate2Brain through an overall contribution comprising €0.5 million as cash infusion, €5.5 million in equity for services, and €1 million toward project development.
The collaboration centers on G2B-002, Gate2Brain (搜索)'s lead oncology program, which has secured Orphan Drug Designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for diffuse intrinsic pontine glioma (搜索) (DIPG) and pediatric glioblastoma (搜索) (pGBM) — two aggressive childhood brain cancers with severely limited treatment options.
A Differentiated CNS-Delivery Platform
G2B-002 leverages Gate2Brain (搜索)'s proprietary MiniAp4 peptide shuttle (搜索) platform to transport SN-38, a potent anticancer agent, across the blood-brain barrier (BBB) directly to brain tumors. According to the company, preclinical studies demonstrated up to 100-fold higher brain drug transport compared to conventional approaches in animal models. The platform has also shown preclinical activity in other rare pediatric cancers, including Ewing sarcoma (搜索), rhabdomyosarcoma (搜索), and neuroblastoma (搜索), suggesting broader therapeutic potential beyond brain tumors.
Vishnukant Bhutada, Managing Director of Shilpa Medicare Ltd, commented: "Gate2Brain (搜索)'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."
Path to the Clinic
As part of the collaboration, Shilpa will serve as the integrated chemistry, manufacturing and controls (CMC), manufacturing, and regulatory partner for G2B-002. Clinical batches of the candidate are expected to be produced next year, with first-in-human clinical trials anticipated to commence by FY28.
Meritxell Teixidó Turà, CEO of Gate2Brain (搜索), stated: "This partnership gives G2B-002 a clear, de-risked path to the clinic and validates our peptide-shuttle platform with a top-tier oncology partner. Aligning Shilpa's manufacturing and regulatory capabilities with our science is the right structure to deliver this program — and the next ones — to patients."
Market Context and Strategic Significance
The glioblastoma market is projected to reach USD 6.48 billion by 2035, growing at a compound annual growth rate (CAGR) of 7.97%, while the pediatric brain tumor market is expected to reach USD 2.47 billion by 2031 (CAGR: 6.9%). The DIPG-specific market is projected at USD 1.2 billion by 2035 (CAGR: 7.1%).
This transaction marks Shilpa's fourth strategic equity partnership focused on differentiated innovation and high-potential therapeutic assets, reinforcing the company's commitment to long-term value creation in specialized oncology indications with significant unmet medical need.