Sunitinib Malate

April 2, 2026 Biodexa Announces Partnership with Syngene To Manufacture MTX240 GMP Clinical Trial Supplies Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) (“Biodexa” or “Company”), a clinical stage biopharmaceutical company developing a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers, is pleased to announce that it has partnered with Syngene International Ltd (BSE: 539268, NSE: SYNGENE) (“Syngene”) for the manufacture of both MTX240 active pharmaceutical ingredient and dosage form. Commenting, Dan Palmer, Vice President, Technology at Biodexa said “We are delighted to be partnering with Syngene for the second time. Syngene manufactured tolimidone dosage form for us on time and on budget and, given the license for MTX240 from Otsuka was only signed in early February, they have once again demonstrated their responsiveness and flexibility in designing a program to manufacture GMP product within only a few weeks” About MTX240, its Unique Mechanism of Action, Clinical Rationale and Next Steps Molecular glue technology represents a novel approach that induces targeted protein interactions, offering a distinct mechanism of action to conventional kinase inhibitors for rare oncology indications. Gastrointestinal Stromal Tumors (“GIST”) is mostly driven by activating mutations in the KIT and/or PDGFR receptor tyrosine kinase. While tyrosine kinase inhibitors (TKIs) such as imatinib, sunitinib, and regorafenib are reported to have significantly improved outcomes for GIST patients, resistance almost always develops through secondary KIT or PDGFR mutations or activation of alternative signalling pathways. This represents a substantial clinical challenge with limited therapeutic options for patients once they have cycled through the available TKIs. MTX240 acts as a molecular glue, bringing two intracellular proteins, PDE3a and SLFN12, specifically co-expressed by GIST cancer cells, into close proximity to form a stable complex. This interaction stabilizes SLFN12, enabling it to drive RNase-mediated apoptosis in GIST cells through a mechanism independent of KIT signalling. By triggering cell death through this alternative pathway, MTX240 is designed to overcome the resistance mechanisms that render TKI-resistant GISTs refractory to conventional kinase inhibitors. This novel mechanism may provide clinical benefit for a significant proportion of GIST patients, not only those who have developed resistance to TKIs. Biodexa is planning to IND and initiate a Phase 1b/2a study towards the end of the year. The study will likely be in two parts: a dose escalation part to establish a safe and tolerable dose followed by an expansion part designed to generate an efficacy signal in TKI-resistant GIST patients. For more information, please contact: Biodexa Pharmaceuticals PLC Dan Palmer, VP Technology Tel: +44 (0)29 20480 180 About Biodexa Pharmaceuticals PLC Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, MTX240 under development for Gastrointestinal Stromal Tumors (GIST) and tolimidone, under development for the treatment of type 1 diabetes. eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR ( m ammalian T arget O f R apamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis. MTX240 is a molecular glue, bringing two intracellular proteins, PDE3a and SLFN12, specifically co-expressed by GIST cancer cells, into close proximity to form a stable complex. This interaction stabilizes SLFN12, enabling it to drive RNase-mediated apoptosis in GIST cells through a mechanism independent of KIT signalling. Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycaemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit . Forward-Looking Statements Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. Reference should be made to those documents that Biodexa shall time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.

Cogent Biosciences (NASDAQ: COGT) has submitted a New Drug Application to the US FDA for bezuclastinib, a selective KIT tyrosine kinase inhibitor, seeking approval for use in combination with sunitinib in patients with gastrointestinal stromal tumors (GIST) who have received prior treatment with imatinib. The filing marks the first NDA submission for bezuclastinib in GIST and positions the drug as the first potential new FDA-approved therapy specifically for second-line post-imatinib GIST since sunitinib’s 2006 approval. The NDA was submitted under the US FDA’s Real-Time Oncology Review program, a pathway designed to allow rolling review of data prior to formal submission completion. Bezuclastinib also holds Breakthrough Therapy Designation for GIST, granted earlier in 2026, the company said. No PDUFA date has been disclosed. The filing seeks approval for bezuclastinib administered in combination with sunitinib, targeting patients who have progressed on or are resistant to imatinib — the established first-line standard of care for KIT-driven GIST. The submission is supported by data from the PEAK trial, a global, randomized Phase III study evaluating bezuclastinib plus sunitinib against sunitinib monotherapy in imatinib-pretreated GIST patients. Top-line results from PEAK were reported in November 2025. The combination arm met the primary endpoint of progression-free survival, reducing the risk of disease progression or death by 50% relative to sunitinib alone, with a hazard ratio of 0.50 (95% CI: 0.39–0.65). Median PFS, assessed by blinded independent central review, was 16.5 months in the bezuclastinib combination arm versus 9.2 months with sunitinib monotherapy. The objective response rate was 46% in the combination group compared with 26% for sunitinib. Overall survival data remain immature. The company said the combination was generally well tolerated, with no unique risks identified beyond the known safety profile of sunitinib. Full PEAK data are expected to be presented at a major medical meeting in the first half of 2026. The clinical rationale for bezuclastinib in this setting is grounded in the molecular biology of imatinib resistance. The majority of GIST are driven by activating mutations in the KIT receptor tyrosine kinase, most commonly in exons 9 and 11. Resistance to imatinib typically arises through secondary mutations in the KIT activation loop, particularly in exon 17 — a region that existing approved agents, including sunitinib, cover with limited efficacy. Bezuclastinib is designed to selectively inhibit KIT exon 17 mutations, including KIT D816V, addressing the dominant molecular mechanism underlying acquired imatinib resistance. Adding bezuclastinib to sunitinib is intended to provide complementary kinase coverage across both primary and secondary resistance mutations. The GIST treatment landscape has followed a sequential TKI paradigm since imatinib received FDA approval in 2002. Sunitinib was approved in the second-line setting in 2006, and regorafenib followed in the third line in 2013. More recently, avapritinib (Ayvakit) received approval in 2020 for patients with PDGFRA exon 18 mutations, including the D842V variant, while ripretinib (Qinlock) was approved the same year for patients who have received three or more prior kinase inhibitors. Despite this sequential framework, no new therapy has been approved specifically in the second-line post-imatinib setting since sunitinib. An attempt by ripretinib to displace sunitinib in second-line GIST — the INTRIGUE trial — did not demonstrate superiority, leaving sunitinib entrenched as the standard comparator. The PEAK data represent the first Phase III evidence of a combination strategy outperforming sunitinib monotherapy in this patient population. The 7.3-month improvement in median PFS and the near-doubling of the objective response rate are notable in a disease where responses to second-line therapy have historically been modest. The company reported that the estimated mean treatment duration for patients on the bezuclastinib combination arm is projected to exceed 19 months at the time of data cutoff, though overall survival data are not yet mature and will be required to fully characterise the clinical benefit. Cogent is also advancing bezuclastinib in additional settings. The company said it is on track to initiate a Phase II trial in Q2 2026 investigating bezuclastinib plus sunitinib in first-line GIST patients with KIT exon 9 mutations who are treatment-naive or have recently initiated imatinib. A separate NDA submission for bezuclastinib in advanced systemic mastocytosis — where the KIT D816V mutation is the primary disease driver — remains on track for the first half of 2026, the company said. Expanded access programs for both GIST and systemic mastocytosis are currently active in the United States. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website