Biodexa Pharmaceuticals PLC Partners With Syngene International Ltd To Manufacture MTX240 API And Finished Dosage Form

Biodexa Pharmaceuticals PLC, a clinical-stage biopharmaceutical company developing innovative treatments aimed at preventing or treating gastrointestinal cancers, announced that it has entered into a partnership with Syngene International Ltd for the manufacture of both the MTX240 active pharmaceutical ingredient (API) and its finished dosage form.

Dan Palmer, Vice President of Technology at the company, said that the team is pleased to collaborate with Syngene again. He noted that Syngene previously manufactured the tolimidone dosage form successfully, meeting timelines and budget expectations. He added that since the license for MTX240 from Otsuka was finalized only in early February, Syngene has again demonstrated strong responsiveness by developing a plan to deliver GMP-grade product within just a few weeks.

MTX240 is based on molecular glue technology, an emerging therapeutic approach that induces interactions between specific proteins. This method provides a distinct mechanism of action compared with traditional kinase inhibitors and is especially relevant for treating rare oncology conditions.

Gastrointestinal stromal tumors (GIST) are usually driven by activating mutations in KIT or PDGFR receptor tyrosine kinases. Although tyrosine kinase inhibitors (TKIs) such as imatinib, sunitinib, and regorafenib have substantially improved outcomes for many patients, resistance almost always develops. This often occurs through secondary mutations in KIT or PDGFR or activation of alternative signaling pathways, leaving patients with limited treatment options after exhausting available TKIs.

MTX240 is designed to address this challenge by acting as a molecular glue that brings together two intracellular proteins—PDE3a and SLFN12—which are specifically co-expressed in GIST cancer cells. By facilitating their interaction, the compound stabilizes SLFN12, enabling it to drive RNase-mediated apoptosis through a pathway independent of KIT signaling. This alternative mechanism of inducing cell death could allow MTX240 to overcome the resistance mechanisms that make TKI-resistant GIST unresponsive to current treatments. Because this approach does not rely on blocking KIT, it may offer potential benefit not only for patients who have developed resistance but also for a broader group of GIST patients.

Biodexa plans to file an Investigational New Drug (IND) application and begin a Phase 1b/2a clinical study toward the end of the year. The study is expected to include a dose-escalation phase to determine a safe and tolerable dose, followed by an expansion phase aimed at generating preliminary efficacy data in patients with TKI-resistant GIST.