Poolbeg expands R&D portfolio
Poolbeg Pharma has in-licensed a late preclinical-stage, potentially broad-spectrum treatment for respiratory virus infections, representing the second expansion of its R&D pipeline in as many months. The new agent is a nasally-administered RNA-based approach with prophylactic and therapeutic applications in influenza, respiratory syncytial virus (RSV) and SARS-CoV-2. It joins in the Poolbeg R&D pipeline POLB 001, the lead clinical-stage small molecule immunotherapeutic for severe influenza, and MelioVac, a vaccine for Burkholderia pseudomallei infection (melioidosis), which was optioned only last month.
Broad-spectrum treatment for respiratory virus infections
This latest deal represents the second in-licensing from an academic source and comes only six months after the company was founded. The deal highlights Poolbeg’s ambitious plans to build a broadly based biotech in the until-recently rather overlooked area of anti-infectives, as well as suggesting there are plenty of infectious disease assets unexploited within academia available to be licensed. Moreover, it is noteworthy that Poolbeg has been able to obtain rights to these products against the background of anti-infectives coming back into focus with the biotech/pharma industry post-Covid.
The therapy has been licensed from the University of Warwick and is based on the work of professors Andrew Easton and Nigel Dimmock, both noted virologists (indeed they are two of the three editors of the seminal textbook, Introduction to Modern Virology). Although not specifically disclosed by Poolbeg, their involvement suggests the licensed IP is from the field of defective interfering RNA (iRNA), which interferes with the replication of pathogenic viral RNA within the cell (this being the research interest area of the two academics).
iRNAs are non-pathogenic (they have large genomic deletions) and are packaged into virions (viral particles) in the same way as infectious viruses and retain the appropriate molecular signals to infect the cells in the respiratory tract. The idea underpinning this technology is thus that iRNAs could be administered to stimulate innate immunity (to prevent viral infection), while in cells that have already been infected, they would block viral replication via genomic interference.
This asset has seen significant prior investment including in vivo studies, but we would expect it to require several years to get to the point where formal clinical studies could start. Financial terms of the transaction with the University were not disclosed, although we would expect the upfront sum involved to be relatively modest given its stage of development and the company's capital-light model.
Separately, Poolbeg is completing its due diligence on MelioVac, before executing the option to license from University College Dublin (UCD). The vaccine addresses melioidosis, a severe infection common in many tropical and subtropical regions. Poolbeg is also reviewing five other earlier-stage vaccine candidates from UCD. In addition, Poolbeg signed a binding term sheet in December to license microencapsulation/ nanoencapsulation technology from AnaBio Technologies, an Irish biotech company, for use in oral vaccines, presumably including MelioVac.
Second in-licensing deal from academia
In November, Poolbeg reported that it had engaged a CRO, as well as drug formulation and manufacturing partners for POLB 001 and was looking to finalise the design of a phase Ib LPS (lipopolysaccaride) human challenge study by the end of Q1 this year. The study will provide 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.
Poolbeg is well capitalised having raised £25mln in July 2021. The company has not confirmed a date for its first financial results, but these would normally be expected to be reported in March/April.
Progressing POLB 001 to the clinic