UK-based biopharma company Biodexa has entered into an exclusive licencing agreement with Emtora Biosciences for the rare precancerous condition-treating drug eRapa.
As per the agreement, Biodexa will hold exclusive rights to develop and commercialise eRapa globally, along with a $17m grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to help advance the candidate into a Phase III trial for familial adenomatous polyposis (FAP).
Following the 26 April announcement, Biodexa’s stock increased by 128.8%, raising the stock price from $0.73 at closing on 25 April, to $1.67 on 26 April when the markets opened.
The asset is being evaluated in an ongoing Phase II study (NCT04230499), supported by a $3m grant from the CPRIT. In the trial, thirty patients with FAP who are undergoing endoscopic surveillance will be given eRapa at one of three escalating doses for a year. The primary endpoints of the study are safety and tolerability, with data expected to be presented in Q2 2024.
Following a positive end of Phase II meeting with the US Food and Drug Administration (FDA), Emtora had announced plans to initiate a Phase III trial for FAP. The worldwide rights come with a $17m grant awarded by CPRIT to support the Phase III trial.
FAP is a rare, genetic condition characterised by the development of polyps in the colon and rectum. These polyps are precancerous and can lead to colorectal cancer if not treated. There is currently no approved treatment for the condition, with many patients requiring surgical removal of the colon and/or rectum.
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By GlobalData
Developed at the University of Texas, eRapa is an oral tablet formulation of the generic drug rapamycin. Rapamycin first gained FDA approval in 1999 for treating organ rejection in renal transplantation, and was marketed by Pfizer as Rapamune. As of 31 December 2023, Rapamune has been discontinued.
A different formulation of rapamycin or sirolimus is also marketed as Fyarro by Aadi Bioscience. Fyarro consists of sirolimus albumin-bound particles, and is administered as an intravenous (IV) infusion twice a month. The drug won US Food and Drug Administration (FDA) approval in 2021 for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumours. According to GlobalData consensus forecasts, Fyarro will generate $404m by 2030.
GlobalData is the parent company of Pharmaceutical Technology.
In the announcement accompanying the deal, Biodexa’s CEO Stephen Stamp said: “Acquiring a Phase III 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.”
The asset is also being evaluated in an ongoing Phase II trial (NCT04375813) in non-muscle invasive bladder cancer (NMIBC). The study which is supported with $3m in funding from the National Cancer Institute has primary endpoints of safety, tolerability, and relapse free survival after 12 months.
