ACM Biolabs Announces Positive Topline Results from a Phase I Trial of SARS-CoV-2 Booster Vaccine ACM-001

2023-09-05

疫苗临床1期临床结果信使RNA

Provides clinical validation for ACM Biolab's Tunable Platform ("ATP™"), ACM Biolab's proprietary polymer-based delivery platform

ACM-001 was well tolerated at the recommended dose levels with no serious adverse events and encouraging early immunogenicity data

ACM is in partnering discussions to provide new drug delivery solutions that address the most significant challenges faced using lipid nanoparticle-based (LNP) delivery systems

SINGAPORE and BASEL, Switzerland and SYDNEY, Sept. 5, 2023 /PRNewswire/ -- ACM Biolabs, a biotechnology company using its next-generation polymer-based delivery platform to develop new nano formulations for use in multiple therapeutic fields, today announced positive topline results from a Phase I trial of ACM-001, the Company's first clinical-stage development program.

ACM-001 is an adjuvanted booster vaccine for SARS-CoV-2, the virus responsible for COVID-19. It comprises a spike-protein component from the immune-evasive beta SARS-CoV-2 variant and an immunostimulant, CpG 7909, formulated using the Company's polymer-based delivery technology, ACM Biolabs' Tunable Platform (ATP™).

The trial, which was conducted in thirty-six subjects at six sites in Australia, showed that the vaccine candidate was safe and well-tolerated at the recommended dose level for both standard intramuscular injection as well as mucosal delivery. Promising early immunogenicity data indicate that the intramuscular vaccine initiated a broadly active antibody response targeting previous variants as well as currently circulating omicron strains.

Vaccine developers face many, widely known challenges using

lipid nanoparticles (LNPs). These include ultra-low cold storage (-60°C to -90°C) throughout the supply chain and an inflexible processing time. ATP™ has the potential to overcome many of these challenges and ACM Biolabs also benefits from a clear and robust IP position underpinning its technology.

Further data to be presented at a key industry medical conference over the coming months and published in a peer-reviewed scientific journal.

Madhavan Nallani,

Ph.D.,

Chief Executive Officer of ACM Biolabs, commented: "This is excellent news for ACM Biolabs as it substantially de-risks our core technology and enables us to progress all our formulations in discovery and development. We have received a lot of interest in our technology from partners who we believe will find the data valuable as we advance projects with them."

Pierre Vandepapelière, M.D., Ph.D., Chief Medical Officer of ACM Biolabs, added: "These positive Phase I results provide clinical validation for ATP™, our flexible proprietary delivery platform. It means we can move forward with confidence and explore the full potential of the technology in multiple therapeutic areas including vaccines. What excites us the most is the broader neutralization upon vaccine administration suggests the high quality of antibodies generated by targeting immune cells. On behalf of ACM, I would like to thank all study participants and staff members at the clinical sites."

About ACM Biolabs

ACM Biolabs is a biotechnology company that is using its proprietary polymer-based nanoparticle delivery platform to develop new formulations for use in multiple therapeutic fields.

ACM Biolabs' Tunable Platform (ATP™) is a polymer/lipid hybrid, non-viral delivery platform that offers the flexibility to deliver multiple payloads including oligonucleotides, small molecules, proteins, and mRNA. ATP™ is thermostable, allowing mRNA storage at 4°C in contrast to the current lipid nanoparticle-based delivery systems that require ultra-low cold storage. ACM Biolabs has programs targeting multiple organs, tissues, and immune cells.

The Company has a growing pipeline of discovery and development-stage product formulations targeting numerous therapeutic areas including infectious diseases, oncology, and ophthalmology. ACM's first clinical-stage development program ACM-001, is an adjuvanted SARS-CoV-2 spike protein (beta variant) vaccine and the company is seeking a partner to develop an mRNA vaccine. The Company has several oncology products including a program for solid tumors targeting a Toll-like receptor (TLR) and a lung cancer program. In ophthalmology, ACM Biolabs is exploring a specialized formulation suitable for topical application to the retina.

ACM Biolabs was founded in 2013 in Singapore. It has subsidiaries in Basel, Switzerland, and Sydney, Australia. The Phase I trial of ACM-001 was undertaken by ACM Biolabs' wholly-owned Australian subsidiary, ACM Biolabs Pty Ltd.

For further information, please visit: https://acmbiolabs.com/

Disclaimer

This press release contains forward-looking statements that are based on current assumptions and forecasts of the ACM Biolabs and ACM Biosciences management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. ACM Biolabs and ACM Biosciences disclaim any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise

SOURCE ACM Biolabs