Deal to acquire infectious disease vaccine candidates
Poolbeg has signed an option agreement with University College Dublin for MelioVac, a late preclinical-stage infectious disease vaccine for Burkholderia pseudomallei, the bacterium that causes the tropical disease melioidosis. The option provides a period of time for Poolbeg to complete its due diligence before signing a formal licensing agreement. The company is also evaluating candidates for five other early-stage infectious disease products from the same team at University College Dublin (UCD).
Option over UCD infectious disease research
The option deal, if exercised, would represent the first expansion of Poolbeg's research & development (R&D) pipeline since the company was formed, via a spin-out from Open Orphan, earlier this year. It also highlights Poolbeg's ambitions to build a broad-based biotech with an infectious disease focus.
An option would typically have a small consideration and envisage a licensing deal for the intellectual property (IP) that would include a modest upfront payment, milestone payments and royalties on eventual sales.
The option agreement with UCD covers MelioVac, a potential vaccine based on antigens that are expressed on the membrane of pathogenic Burkholderia strains. These bacteria cause melioidosis (or Whitmore's disease), a condition that has a rising incidence with no approved vaccine. Treatment is currently with a long course of antibiotics, although it is proving to be highly resistant.
Poolbeg is also evaluating five other potential vaccine candidates identified at UCD. These are for Klebsiella pneumoniae, Escherichia coli (O157), Burkholderia cepacia complex, Pseudomonas aeruginosa and Acinetobacter baumannii. None of these infections can currently be prevented by vaccination, although there is one product in clinical development for Klebsiella (Limmatech Biologics/GSK). Valneva conducted clinical studies unsuccessfully on a pseudomonas vaccine in 2012-2016.
POLB 001 plans take shape
Meanwhile, Poolbeg's development plans for lead product POLB 001 are beginning to take shape, with the aim of starting a Phase Ib study mid next year. Last month, Poolbeg signed engagements with the Centre for Human Drug Research (CHDR), a specialist Leiden, Netherlands-based contract research organisation (CRO), and with Seda Pharmaceutical Development Services, a Manchester area-based consulting group, to conduct the first study of POLB 001 and provide drug formulation services respectively.
The planned study will provide the first human data on the potential activity of POLB 001, a p38 MAP kinase inhibitor, in a human model that mimics the over-stimulation of the immune system that can occur in severe influenza. The study will be conducted in healthy volunteers, without the virus being present. We would expect the Phase Ib study to be conducted quickly, potentially allowing Poolbeg to consider further studies including possibly in flu-infected patients in late 2022/early 23 (it could for example target the flu season in the Southern Hemisphere). Poolbeg has, however, given indications it may choose to license out POLB 001 ahead of Phase II efficacy studies.
First expansion of R&D pipeline post IPO