ACM Biolabs has announced the initiation of a Phase 1 trial of its ACM-001 vaccine candidate against SARS-CoV-2. The SAD study will compare ACM-001 to an intramuscular vaccine as a booster in 80 healthy adults who have already received 3 doses of a COVID-19 vaccine.
According to ACM, the intranasal vaccine is based on the company’s artificial cell membrane (ACM) technology, which uses vesicles made from polymers for delivery of biologics and is stable at 4°C. ACM-001 is based on the beta variant of the SARS-CoV-2 virus and has demonstrated the ability to neutralize other variants, including delta and omicron, in preclinical studies, the company added.
ACM Biolabs CEO Madhavan Nallani said, “The start of this first-in-human trial is an important milestone for ACM Biolabs. Our next generation COVID-19 vaccine ACM-001, a nasal vaccine, can make a significant contribution to block infections and transmission. The current situation of high infection and reinfection rates despite repeated booster vaccinations reinforces the emerging consensus of the scientific community that there is a high need for an intranasal COVID vaccine. We are now very much looking forward to see our promising preclinical results translate in this important Phase 1 study within the next months.”
Chief Medical Officer Pierre Vandepapeliere added, “With our preclinical data we achieved not only mucosal immunity but also the same kind of systemic immunogenicity as the currently licensed vaccines. Knowing that the infection and transmission of covid virus pass through the upper respiratory tract, this study will allow confirmation in human that intranasal administration induces stronger and better immune responses at the portal of virus entry than classical intramuscular administration. Utilizing this disruptive vaccine platform, ACM Biolabs has the potential to become a real game-changer in the field of vaccines, thanks to its capacity to be administered intranasally, to carry various types of vaccine antigens like proteins or mRNA, and its thermostability.”
Read the ACM Biolabs press release.
