ACM Biolabs, a biotechnology company with operations in Singapore, Switzerland and Australia, focusing on the development of next generation vaccines for infectious diseases, personalized immunotherapy for cancer patients using its proprietary delivery platform (non-lipid, non-viral), today announced that the first subject has been dosed in the first–in–human Phase 1 trial of its clinical candidate vaccine, ACM-001, a 2nd generation adjuvanted SARS-CoV-2 spike protein (beta variant) vaccine with broad protection against variants of concerns, including delta and omicron demonstrated in a variety of preclinical studies (Clinicaltrials.gov identifier NCT05385991).
About the study: The vaccine is evaluated as a booster in a phase 1, dose escalation study comparing intramuscular versus intranasal administration of various doses of antigen and adjuvant in healthy adult volunteers who have previously received 3 doses of approved Covid vaccines.
“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,” said Dr. Madhavan Nallani, Chief Executive Officer of ACM Biolabs. “We are now very much looking forward to see our promising preclinical results translate in this important Phase 1 study within the next months.”
The spike-protein component of ACM-001 is modeled after the immune-evasive beta variant. In animal studies the clinical vaccine candidate was safe and generated a protective immune response against the beta-variant and ancestral form of SARS-2. Additionally, it also elicited broadly neutralizing antibodies against other variants, including delta and omicron. Furthermore, the plug-and-play platform would allow for quick adaption for current and future mutations of the SARS-2 virus.
ACM-001 is utilizing ACM Biolabs’ innovative delivery technology, allowing administration not only via the conventional intramuscular route but also the intranasal route. The nose is the entry point for SARS-CoV-2 and the site where the virus initiates replication. Vaccine application to the mucosal surface lining the nasal cavity is deemed highly relevant and disrupts infection and potentially transmission of COVID-19. This effect could also be applicable to other respiratory infectious diseases. ACM Biolabs has published its comprehensive investigation of the significant benefits of intranasal ACM-001 (Lam JH et al., Biorxiv 2022.02.12.480188). Animals that were immunized with ACM-001 and were infected with live virus, had significantly less viral burden in their noses than their unvaccinated counterparts. Moreover, animals that had received ACM-001 through the nose, needed significantly lesser time to clear infection.
ACM Biolabs’ researchers described the exact way of how the vaccine component is delivered inside the body. The formulation facilitates uptake of the vaccine by specialized cells of the body’s own immune system (Lam JH et al., ACS Nano 2021, 15, 10, 15754–15770). These cells are highly efficient activators of T-cells, antibody-producing B-cells as well as the immune system’s memory.
“With our preclinical data we achieved not only mucosal immunity but also the same kind of systemic immunogenicity as the currently licensed vaccines”, said Pierre Vandepapeliere, M.D., PhD, Chief Medical Officer of ACM Biolabs. “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.”
ACM-001 vaccine is developed based on the company’s proprietary ACM (artificial cell membrane) polymer-based technology. This next generation delivery platform offers flexibility with multiple payloads (proteins to RNA) and can be stored in a refrigerator in contrast to the current LNP-based delivery. ACM is working on a wide range of products beyond infectious disease vaccines including personalized immunotherapy for cancer patients.