Zinger Key Point:
MTX240's mechanistic novelty may give it a long-awaited edge in treatments for gastrointestinal stromal tumors (GIST)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.
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?
Current Standard Of Care
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.
Biodexa's Novel Drug Candidate – 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 Promise
In 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 U.S. and EU, respectively. In addition, MTX240 has issued Composition of Matter patents extending through 2037.
Next Steps
Deal Validation
Biodexa 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.
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:
Featured image courtesy of Biodexa.
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Contact:
Stephen Stamp, CEO, CFO
[email protected]
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