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ACM Biolabs Launches Phase 1 Trial for Innovative Intranasal COVID-19 Vaccine ACM-001

ACM Biolabs Launches Phase 1 Trial for Innovative Intranasal COVID-19 Vaccine ACM-001

First Human Dosing Marks a Significant Step Towards Next-Generation Vaccine Development

SINGAPORE, BASEL, Switzerland, and SYDNEY, July 29, 2022 — ACM Biolabs, a biotechnology firm with operations in Singapore, Switzerland, and Australia, has announced that it has successfully dosed its first subject in the first-in-human Phase 1 trial for its clinical candidate vaccine, ACM-001. This 2nd generation adjuvanted SARS-CoV-2 spike protein vaccine targets the beta variant and aims to provide broad protection against various COVID-19 variants, including delta and omicron, as demonstrated in numerous preclinical studies (Clinicaltrials.gov identifier NCT05385991).

The trial evaluates ACM-001 as a booster vaccine in a Phase 1, dose escalation study. It compares intramuscular and intranasal administration of varying doses of the antigen and adjuvant in healthy adult volunteers who have already received three doses of authorized COVID-19 vaccines.

Dr. Madhavan Nallani, CEO of ACM Biolabs, stated:
“The initiation of this first-in-human trial represents a crucial milestone for ACM Biolabs. Our next-generation COVID-19 vaccine, ACM-001, administered nasally, has the potential to significantly reduce infections and transmission rates. The current high infection and reinfection rates, despite numerous booster vaccinations, highlight the pressing need for an intranasal COVID vaccine.”

The spike protein in ACM-001 is modeled after the immune-evasive beta variant. Preclinical animal studies indicate that the vaccine candidate is safe and produces a protective immune response against the beta variant as well as the ancestral form of SARS-CoV-2. Additionally, it generates broadly neutralizing antibodies against delta and omicron variants. The plug-and-play platform allows rapid adaptation to emerging mutations of the virus.

ACM-001 employs ACM Biolabs’ proprietary delivery technology, facilitating administration via both conventional intramuscular and intranasal routes. Targeting the nasal cavity is particularly relevant, as this is the primary entry point for SARS-CoV-2, where initial viral replication occurs. Administering the vaccine to the mucosal surfaces can potentially disrupt both infection and transmission of COVID-19, with possible applications for other respiratory infectious diseases.

ACM Biolabs has documented the significant advantages of its intranasal ACM-001 vaccine (Lam JH et al., Biorxiv 2022.02.12.480188). Immunized animals exhibited significantly reduced viral loads in their nasal cavities compared to unvaccinated subjects and required less time to clear the infection.

Pierre Vandepapeliere, M.D., PhD, Chief Medical Officer of ACM Biolabs, remarked:
“Our preclinical findings demonstrate that we achieve not only mucosal immunity but also systemic immunogenicity similar to currently licensed vaccines. Given that the virus infects and transmits via the upper respiratory tract, this study will confirm whether intranasal administration induces stronger immune responses at the site of entry compared to traditional intramuscular injections.”

ACM-001 is based on the company’s proprietary ACM (artificial cell membrane) polymer-based technology, which offers flexibility for multiple types of vaccine antigens, including proteins and RNA. This delivery platform can be stored in a refrigerator, contrasting with current lipid nanoparticle (LNP)-based systems. ACM Biolabs is also pursuing a diverse portfolio of products beyond vaccines for infectious diseases, focusing on personalized immunotherapy for cancer patients.

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