Prommune has completed completion of its third proof of concept study in pigs for its lead products HeptaVac, a self-adjuvating peptide vaccine cocktail and HISP-P, an immunoactivator and molecular adjuvant both for use in pigs with Swine Influenza A Virus infections.
HeptaVac was designed to elicit cellular immunity and contains antigenic peptides from the H1N1 influenza virus proteins, two of which represent conserved sequences between the seasonal and pandemic strains. Each antigenic peptide was individually linked to Prommune’s molecular adjuvant HISP which activates the innate immune system and generates a Th1-biased immune response. HeptaVac was delivered intramuscularly and showed a dose response and a statistically significant reduction in the number of lung lesions in pigs infected with the H1N1 strain of the virus compared to the controls.
Another arm of the study compared the efficacy of HeptaVac to HISP-P delivered intranasally. This part of the study again showed the efficacy of HeptaVac but also showed that the immunoactivator HISP-P can reduce the viral load in lung lesions in a statistically significant manner in addition to an overall reduction in the number of lesions. Successful intranasal delivery, opens the door for potential use as mucosal vaccines and adjuvants.
Prommune has recently engaged a cGMP manufacturing partner and will be initiating filings to obtain the necessary licenses to market the two products in the US, in the coming weeks. It is also continuing its research and development activities on its pipeline of products for other production animal species and expects to apply for further licenses within the next 12-18 months.
Dr. Sam Al-Murrani, interim CEO said: “There is a considerable need for new therapeutics, prophylactics and adjuvants for veterinary and human medicine applications. Prommune’s lead biologics engage and activate the immune system in ways that are different from the ways through which the majority of “classical” vaccines and adjuvants currently work.”