PhageNova Bio’s next key steps for PNB-001 are completing GMP manufacturing of its hybrid bacteriophage adeno-associated virus vector, IND-enabling efforts, toxicology studies, and submitting an IND application to the FDA. Upon acceptance, PhageNova Bio will commence a first in-human, dose escalating, phase 1 clinical trial testing PNB-001 in patients with advanced cancer at select clinical research institutions.
The company has engaged leading clinical research support teams, including a clinical research organization to support its IND-filing efforts, a contract development and manufacturing organization, toxicology teams, and chemistry, manufacturing, and control experts. The company is working closely with these organizations with respect to all aspects of development, engagement with the FDA, and plans to reach the clinic.
The first in human study is designed to assess the safety of the vector in patients with advanced malignancies within the dosage range selected, demonstrate localization of the vector to the tumor microenvironment, and provide evidence of modulation of the tumor phenotype. These preliminary data will be the foundation for the design of a formal Phase I/II trial to define an appropriate dose for further clinical studies of efficacy. Biopsy material will be analyzed using multiple techniques in order to detect the presence of the gene product, and expected targeted cell killing activity.
In an effort to support the effort to vaccinate and protect against COVID-19, and to limit and potentially eliminate the spread of SARS-CoV-2 infection, PhageNova Bio has utilized its platform for vaccination efforts. Our scientific pursuits in this area have been focused on the fact that the phage genome can be engineered to serve many purposes. The specific focus has been on using lymph node-targeting phage particles designed to display SARS-CoV-2 Spike protein epitopes on the viral capsid surface, and utilize a validated ligand-directed phage-based gene delivery vector to achieve humoral and cell-mediated immunity by selective expression of the SARS-CoV-2 spike (S) protein in target tissues with antigen-presenting capabilities, such as the lung and the lymph nodes. The premise is that targeted delivery of SARS-CoV-2 spike protein antigens using our engineered phage, which is itself immunogenic (thus serving as an adjuvant), will induce robust and long-lasting responses. Mouse and rhesus macaques (monkey) testing is underway. In addition, we will leverage epitopes recognized by antibodies known to have neutralizing activity (including but not limited to, the ones elicited by existing vaccines, or recognized by antibody cocktails already in Phase III trials). Excitingly, the research effort brings to bear an epitope discovery arm, focused on patients who recovered from COVID-19. Taken together, these efforts enable a proof-of-concept vaccination strategy to advance rapidly, while strategically benefiting from the body of existing knowledge as we engineer and produce a vaccine against the SARS-CoV-2 virus.
