Biodexa Secures MTX240 Licensing for TKI-Resistant GIST with 2037 Patent Protection
Biodexa licensed exclusive worldwide (ex-Japan) rights to MTX240, a Phase 1-ready molecular glue targeting PDE3A-SLFN12-induced apoptosis in gastrointestinal stromal tumors, with Composition of Matter patents through 2037 and orphan exclusivity up to 10 years in EU. The company plans Phase 1b/2a dosing studies by year-end, focusing on TKI-resistant GIST.
1. Licensing Deal
Biodexa secured exclusive worldwide rights (excluding Japan) to MTX240 from Otsuka for an undisclosed upfront fee, low double-digit approval milestones, and mid-single-digit royalties. This expands Biodexa’s GI/oncology portfolio with a Phase 1-ready candidate targeting rare gastrointestinal tumors.
2. Mechanism and Preclinical Data
MTX240 is a molecular glue that binds PDE3A and SLFN12 in GIST cells, triggering apoptosis even in TKI-resistant tumors. Preclinical patient-derived xenograft models demonstrated dose-dependent tumor shrinkage in both non-resistant and resistant GIST models.
3. Development Plan
Biodexa aims to manufacture clinical supplies and initiate a Phase 1b/2a study by year-end, featuring dose escalation to determine the maximum tolerated dose and an extension cohort for TKI-resistant patients. The trial is designed to rapidly validate safety and preliminary efficacy in a high-need population.
4. Market Potential and Exclusivity
GIST represents a $1.3 billion market growing at 6.6% annually, with 4,000–6,000 U.S. cases diagnosed each year. MTX240 is eligible for seven years of market exclusivity in the US and ten years in the EU, under orphan drug status, and holds Composition of Matter patents through 2037.