Biodexa Enters Into Exclusive License to eRapa™, a Phase 3 Ready Asset for the Treatment of Familial Adenomatous Polyposis (FAP)
April 26, 2024
Biodexa Pharmaceuticals PLC
(“Biodexa” or the “Company”)
Biodexa Enters Into Exclusive License to eRapa™, a Phase 3 Ready Asset for the
Treatment of Familial Adenomatous Polyposis (FAP)
Worldwide rights come with $17 million in non-dilutive grant funding for Pivotal Phase 3 trial in FAP
An estimated 100,000 in U.S. and Europe are afflicted with FAP, precancerous polyps that typically lead to surgical removal of the colon and/or rectum
In FAP, eRapa holds the potential of delaying or preventing surgical intervention
Multiple opportunities seen in other indications, including bladder and prostate cancers
FAP is a substantially genetic orphan disease for which there are no approved therapeutic options; the current standard of care is surveillance and surgery
Phase 3 FAP program is supported by a $17 million grant awarded from the Cancer Prevention and Research Institute of Texas (“CPRIT”) in a competitive process
Phase 2 results in FAP to be presented at two leading scientific conferences in Q2 ‘24
Ongoing Phase 2 study in Non-muscle Invasive Bladder Cancer expected to read-out in Q2 ‘25
Phase 2 study in NMI Bladder Cancer supported by $3 million grant from National Cancer Institute, part of the National Institutes of Health
Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced it entered into a definitive agreement with Rapamycin Holdings Inc. (d/b/a Emtora Biosciences) (“Emtora”) for the rights to eRapa under an exclusive, worldwide license (with the ability to grant sublicenses) to develop, manufacture, commercialize and otherwise advance the clinical potential of eRapa.
Stephen Stamp, CEO and CFO of Biodexa said, “Acquiring a Phase 3 ready asset, particularly one supported by $17 million of non-dilutive grant funding, significantly advances Biodexa’s oncology pipeline and adds numerous valuation catalysts for our stakeholders. We are delighted to be working with the Emtora team which has excelled in bringing eRapa close to the end of Phase 2 in Non-muscle Invasive Bladder Cancer and to the beginning of a Phase 3 trial in FAP, a devastating disease for which there is currently no approved pharmacological agent for altering its progression. Left untreated, it almost always leads to incredibly invasive surgery and a major deterioration in the quality of life.”
Stephen Dufilho, Executive Chairman of Emtora added, “The transaction with Biodexa is the culmination of a decade-long effort to advance our potentially game-changing eRapa to a registrational Phase 3 trial - and ultimately to patients in need. Our story began in San Antonio – where eRapa was originally invented at the University of Texas and funded in part by grants from the Cancer Prevention Research Institute of Texas. We thank the scientists, clinicians, investors and biotech executives that supported our efforts to reach this important milestone. We look forward to working with the Biodexa team as we embark upon this next chapter.”
About eRapa
eRapa is a proprietary oral tablet 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 tumorgenesis1. Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune®(Pfizer). Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. eRapa is protected by a number of issued patents which extend through 2035, with other pending applications potentially providing further protection beyond 2035.
eRapa in FAP
FAP is characterized as a proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US2 and one in 11,300 to 37,600 in Europe3. eRapa has received Orphan Designation in the US with plans to seek such designation in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP.
Emtora is currently completing an open-label, multi-center Phase 2 study in 30 patients with confirmed FAP with the primary endpoints of safety and tolerability, and percentage change in polyp burden after six months of treatment with eRapa. The Phase 2 study was partially funded by a $3.0 million grant from CPRIT.
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