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Biodexa Announces Partnership with Syngene To Manufacture MTX240 GMP Clinical Trial Supplies
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 file an 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
www.biodexapharma.com
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 (mammalian Target Of Rapamycin) 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 www.biodexapharma.com.
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 file from 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.
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$BDRX 🗞️
US Market News
4月前
Biodexa Licenses Phase 1 Ready Drug Candidate from Otsuka for Rare Stomach CancerFebruary 19, 2026 7:30 AM
ACCESS NewswireMTX240's mechanistic novelty may give it a long-awaited edge in treatments for gastrointestinal stromal tumors (GIST)Meg Flippin, Benzinga Staff WriterCARDIFF, UK / ACCESS Newswire / February 19, 2026 / Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), a clinical-stage biopharmaceutical company developing a pipeline of innovative products for the treatment of rare diseases with an increasing focus on products to treat or prevent gastrointestinal cancers, has added a new Phase 1 ready candidate to its portfolio, this time to target gastrointestinal stromal tumors, or GIST. Several drugs are available to treat GIST, but all ultimately fail when the tumor develops resistance. When that occurs, median overall survival drops to less than a year. The value and hope of a better drug is at least partially evidenced by the eye-popping $1 billion GSK paid last year for a Phase 1 candidate, even though it shares the same mechanism of action as the currently approved drugs.MTX240's unique molecular glue mechanism of action separates it from the current standard of care, notes Stephen Stamp, CEO of Biodexa. "It has the potential to benefit a broader spectrum of GIST patients, including those with TKI-resistant disease, and it strategically aligns with our emerging GI/oncology pipeline which includes our ongoing phase 3 development of eRapa in Familial Adenomatous Polyposis."What is GIST?GIST is a hard-to-treat tumor that grows mainly in the stomach wall and is caused by mutations in the so-called Interstitial Cells of Cajal (ICCs) which facilitate gut motility. Mutations in the key tyrosine kinase proteins KIT or PDGFR perturb intra-cellular signaling pathways in ICCs, causing rapid cell proliferation and tumorgenesis. Patients typically undergo resection but, once the GIST becomes unmanageable or the tumors are unresectable, targeted treatments called tyrosine kinase inhibitors (TKIs) are the current standard of care.Current standard of careCurrently, there are four approved TKI treatments for GIST, generally prescribed in the following order as GIST mutations occur and patients acquire resistance to each of them - (1) imatinib (Gleevec) from Novartis AG (NVS); (2) sunitinib (Sutent) from Pfizer Inc. (PFE); (3) regorafenib (Stivarga) from Bayer AG. (BAYN); and (4) ripretinib (Qinlock) from Deciphera Pharmaceuticals Inc (DCPH).Once patients have cycled through the available TKIs, having acquired resistance to all of them, median time to tumor progression is 1.2 months and median overall survival is 9.8 months.As a result of these shortcomings, drug developers, including Biodexa, are jockeying for position in what is currently a $1.3 billion market[1], with projected growth of around 6.6% annually through 2032. It makes sense that drug developers are eyeing this market. In the U.S. alone, between 4,000 and 6,000 people are diagnosed with GIST each year[2]. Globally, the number of new GIST patient annually is estimated at between 80,000 to 120,000.Biodexa's novel drug candidate - MTX240Enter MTX240, Biodexa's latest developmental treatment, which it recently licensed from Otsuka Pharmaceutical Co., Ltd. MTX240 is a novel molecular glue that works by forcing PDE3A and SLFN12, two proteins expressed in GIST cells to bind together, in turn triggering the tumor cells to self-destruct in a process called apoptosis. Importantly, healthy ICCs do not significantly express either of these proteins and are not therefore affected by MTX240.Unlike the TKIs that frequently fail once the tumor cells mutate, and render the drug ineffective, MTX240's unique mechanism of action is designed to work whether or not the GIST has acquired secondary mutations.Early success and promiseIn preclinical PDX models, which use human tumor tissues to mirror real-world genetic complexity, MTX240 demonstrated dose-dependent efficacy in shrinking GIST in both non-resistant (left hand chart) and TKI-resistant tumors (middle and right hand chart) as illustrated below [3]: Note: MTX240 was coded OPB-171775 by Otsuka in the charts.If the preclinical results are replicated in clinical trials and MTX240 proves to be lethal to GIST without inducing resistance, it has the potential for co-administration with TKIs and ultimately, to replace the entire class.MTX240 is eligible for FDA and EU Orphan Drug designation, which means the company is eligible for seven and 10 years of market exclusivity upon approval in the US and EU, respectively. In addition, MTX240 has issued Composition of Matter patents extending through 2037.Next stepsNext step is to manufacture clinical trial supplies of MTX240 and then initiate a Phase 1b/2a study by year-end. The study is expected to be in two parts: a standard dose escalation part to determine a maximum tolerated dose, followed by an extension part. The extension part is likely to enrol patients with TKI-resistant GIST. By focusing on this high-need population, Biodexa is aiming to rapidly validate MTX240's potential as a way to treat patients who don't respond to the current standards of care.Deal validationBiodexa in-licensed exclusive worldwide rights to MTX240 with the exception of Japan rights, which were retained by Otsuka for an undisclosed upfront fee. The deal includes one modest development milestone, low double digit approval milestones and mid single-digit tiered royalties.Biodexa's entrance into the GIST market with MTX240 puts it in a space that's garnering interest from Big Pharma as well as Wall Street. Take GSK Plc. (GSK) as one example. In January 2025 GSK paid $1 billion cash upfront to buy IDRx, Inc., a single product company developing IDRX-42, another TKI for GIST that was in Phase 1 at the time [4]. Meanwhile, Cogent Biosciences Inc. (COGT), which is developing bezuclastinib (another TKI) for co-administration with sunitinib, saw its market cap surge approximately $2Bn following the release of Phase 3 trial data [5], which demonstrated bezuclastinib plus sunitinib compared with sunitinib alone extended median progression free survival from 9.2 months to 16.5 months in imatinib-resistant patients, underscoring the importance of this sector [6].With Biodexa showing promising initial results with MTX240, this is a treatment investors may want to pay attention to. To learn more about Biodexa and MTX240, click here.References:DataBridge Market Research. (2023). Gastrointestinal stromal tumor market size, trends and forecasts (2024-2032). Retrieved from https://www.databridgemarketresearch.com/reports/global-gastrointestinal-stromal-tumor-marketZhu, H., et al. (2023). Update of epidemiology, survival and initial treatment in gastrointestinal stromal tumor: A population-based analysis. BMJ Open, 13(7), e072945. https://doi.org/10.1136/bmjopen-2023-072945Takaki, E. O., et al. (2024). A PDE3A-SLFN12 molecular glue exhibits significant antitumor activity in TKI-resistant gastrointestinal stromal tumors. Clinical Cancer Research. https://doi.org/10.1158/1078-0432.CCR-24-0096GSK. (2025, January 13). GSK enters agreement to acquire IDRx, Inc. https://www.gsk.com/en-gb/media/press-releases/gsk-enters-agreement-to-acquire-idrx-incTalk Bio. (2025, November 11). Cogent Biosciences soars on positive Phase 3 PEAK results in gastrointestinal stromal tumors (GIST). Cogent Biosciences Stock Soars 346% in a Year, but One Fund Just Sold Off $4.5 MillionCogent Biosciences, Inc. (2025, November 10). Cogent Biosciences reports positive results from bezuclastinib PEAK Phase 3 trial in gastrointestinal stromal tumors (GIST). https://investors.cogentbio.com/news-releases/news-release-details/cogent-biosciences-reports-positive-results-bezuclastinib-peakFeatured image from Shutterstock.This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Please see 17(b) disclosure here for more information.Click here for more information on Biodexa Pharmaceuticals.Contact:
Stephen Stamp, CEO, CFO
ir@biodexapharma.comImportant notice, please read: Certain statements in this article 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 article 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 file from 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 article. 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.SOURCE: Biodexa Pharmaceuticals PLCView the original press release on ACCESS NewswireOriginal: Biodexa Licenses Phase 1 Ready Drug Candidate from Otsuka for Rare Stomach Cancer
georgie18
5月前
BDRX...$2.21...🥳...Strong Volume for BDRX...
georgie18
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Re: georgie18 post# 295
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BDRX...$2.26...🥳...Added here...
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Re: georgie18 post# 402508
Wednesday, January 07, 2026 1:02:39 PM
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BDRX...$2.35...🥳...Adding...$3.28 Offering winding down...imo...we shall see...
georgie18
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Re: georgie18 post# 293
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BDRX...$2.52...🥳...Trying to Reverse here...
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Re: georgie18 post# 402240
Friday, January 02, 2026 12:41:01 PM
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BDRX...$2.40...🥳...Hod...
georgie18
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Re: georgie18 post# 291
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georgie18
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BDRX...Loading the $3.15 dip...🥳
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Re: georgie18 post# 402009
Monday, December 22, 2025 9:36:27 PM
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BDRX...$3.32...🥳... Bullish 3 Gap Downs... https://schrts.co/XPBwysxz ...Zero Borrow shares available...Just had $3.28 offering...
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