Singapore and Basel, Switzerland, March 4, 2022
ACM Biolabs, a Singaporean-Swiss biotechnology company focusing on the development of prophylactic and therapeutic vaccines for infectious diseases and therapeutic vaccines for personalized cancer treatment, today announced that its first clinical candidate vaccine, ACM-001, a 2nd generation COVID vaccine, demonstrated broad protection against variants of concerns, including delta and omicron in a variety of preclinical studies. ACM-001 can be given intramuscularly as well as intranasally.
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) without requiring ultra-low temperatures for mRNA compared to the current lipids-based platforms. ACM is working on a wide range of products that includes vaccine for immunological therapy for cancer.
After completion of the preclinical safety testing, the lead program, ACM-001, an adjuvanted SARS-CoV-2 spike protein (beta variant) vaccine, is ready to be tested in humans. The plug-and-play platform allows for quick adaption of the COVID vaccine for future variants as well as combinations as multi-valent vaccines. In addition to being needle and pain-free, an intranasal vaccine is expected to achieve maximum protection already in the upper airways where respiratory viruses first enter the body.
While the currently approved vaccines resulted in attenuation or prevention of disease, they do not provide mucosal immunity and therefore do not prevent replication of virus in the nasal cavity and hence do not stop transmission of SARS-CoV-2. ACM Biolabs has now published its comprehensive investigation of the significant benefits of intranasal ACM-001 (https://acmbiolabs.com/?p=634). While cross-neutralization against variants of concern, including delta and omicron was seen after intramuscular and intranasal delivery, the virus load in the nasal cavity was 100-fold lower already at day 2 when compared with intramuscular administration suggesting a slowing down in virus spread. The reported preclinical studies have provided critical proof of concept and enabled the design of the Phase 1 clinical trial. Following the regulatory approval, which is expected in the next few weeks, healthy adults who had already received two doses of a COVID vaccine will be included in the study.
“Currently, most of COVID-19 vaccines in use or development are administered via an intramuscular injection, which produces a rather poor mucosal immune response,” said Professor Onur Boyman, Director of the Clinic for Immunology at the University of Zurich. “Intranasal vaccination is thus an ideal approach to fight respiratory viruses. ACM-001 has now produced very promising preclinical data showing that intranasal vaccination greatly improves mucosal immune responses, which inhibit infection at the site of virus entry.”
“We are very pleased about the intriguing properties of our ACM platform which hold great potential for the development of urgently needed next-generation Covid-19 vaccines,” said Dr. Madhavan Nallani, Chief Executive Officer of ACM Biolabs. “Now that we successfully completed all regulatory requirements including a comprehensive safety evaluation of our ACM platform and that the clinical trial material for ACM-001 is available we are excited to start the Phase 1 study of ACM-001 within the next weeks.”
For further information please contact:
Dr. Alexander Breidenbach
Chief Development Officer
+41 61 975 85 88
Dr. Stephan Feldhaus
Feldhaus & Partner
+41 79 865 92 56
About ACM Biolabs
ACM Biolabs is developing prophylactic and therapeutic vaccines for infectious diseases and therapeutic vaccines for personalized cancer treatment based on its proprietary ACM (Artificial Cell Membranes) polymer-based delivery platform technology. The companies lead program, ACM-001, is an adjuvanted SARS-CoV-2 spike protein (beta variant) vaccine ready to move into Phase 1.
Founded in Singapore in 2013, ACM Biolabs has established laboratories for research and early manufacturing activities. In 2020 ACM Biosciences, a subsidiary of ACM Biolabs, was established in Basel, Switzerland, to internationalize its development activities. ACM Biosciences leads all clinical and regulatory activities of its pipeline programs. It also coordinates business development discussions with potential partners.
For further information, please visit: www.acmbiolabs.com.
This press release contains forward-looking statements which 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.