(“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
An estimated 100,000 in
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 theCancer 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 fromNational Cancer Institute , part of theNational Institutes of Health
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
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
The results of the Phase 2 study will be presented at two leading scientific conferences in Q2 24. Following a positive end of Phase 2 meeting with the FDA and, Emtora plans to initiate a Phase 3 multi-center, double-blind, placebo-controlled study in FAP. The Phase 3 study, which is expected to be registrational, plans to recruit approximately 140 patients across thirty or more sites, with a primary endpoint being time to a progression free survival event (the occurrence of which is related to the reduction in polyp burden studied in the earlier Phase 2 trial). The study is expected to recruit over 15 months and is supported by a further non-dilutive grant of
eRapa in Non-Muscle Invasive Bladder Cancer
Non-muscle Invasive Bladder Cancer (“NMIBC”) refers to tumors found in the tissue that lines the inner surface of the bladder. The most common treatment is transurethral resection of the bladder tumor followed by intravesical Bacillus Calmette-Guerin (“BCG”) with chemotherapy depending upon assessment of risk of recurrence. NMIBC is the fourth most common cancer in men with an incidence of 10.1 per 100,000 and 2.5 per 100,000 in women4.
Emtora’s ongoing multi-center, double-blind, placebo-controlled Phase 2 study in NMIBC is expected to enroll up to 166 patients with primary endpoints of safety/tolerability and relapse free survival after 12 months of treatment. The Phase 2 study, which is supported by a
Other Potential Indications for eRapa
A number of rare/orphan gastro-intestinal diseases (other than FAP) have been identified that share the strong scientific rationale (relating to mTOR inhibition) and support the potential utility of eRapa in FAP. Biodexa intends to evaluate such opportunities over the coming months, including by leveraging low-cost, investigator-sponsored trials to produce initial proof of concept data.
The License Transaction
The transaction terms include the issuance to Emtora of 378,163 of the Company’s American Depository Shares (representing 5% of the Company’s issued and outstanding ordinary shares on a fully-diluted basis (including in-the-money warrants)) at close. In addition, the Company may pay up to
The
To date, CPRIT has awarded $2.9 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has recruited 237 distinguished researchers, supported the establishment, expansion or relocation of 43 companies to Texas and generated over $5.7 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 7.4 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. On November 5, 2019, Texas voters overwhelmingly approved a constitutional amendment to provide an additional $3 billion to CPRIT for a total $6 billion investment in cancer research and prevention. Learn more at https://cprit.texas.gov/.
1. Tian et al., mTOR Signaling in Cancer and mTOR Inhibitors in Solid Tumor Targeting Therapy, Int J Mol Sci. 2019 Feb; 20(3): 755
2. www.rarediseases.org
3. www.orpha.net
4. Cassell et al., World J Oncol. 2019 Jun; 10(3): 123–131
For more information, please contact:
Tel: +44 (0)29 20480 180 www.biodexapharma.com |
Emtora Biosciences Tel: +1 210 381 2486 www.emtorabio.com |
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About Emtora
Emtora Biosciences is a clinical stage biopharmaceutical company headquartered in
Forward-Looking Statements
Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the
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
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