“ACM Biolabs is just one of 70 deep-tech firms spun off from Nanyang Technological University (NTU) research since 2015, enterprises that are now collectively valued at around $820 million and armed with the potential to transform a host of sectors including healthcare, robotics and artificial intelligence.” – straitstimes.com
Singapore, Basel and Sydney, 5 September 2023 – 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 resultsprovide 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.
For Investors
Dr. Madhavan Nallani
Mr. David Lawrence
+65 6265 5646
bd@acmbiolabs.com
For Media:
Consilium Strategic Communications
Ashley Tapp, Andrew Stern
+44 20 3709 5700
ACMBiolabs@consilium-comms.com
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Newspost | 14.04.2023
We are delighted to announce the appointment of David Lawrence as Non-Executive Director effective immediately. David has over 30 years’ experience of leadership roles in life sciences, ranging from large biopharma companies such as GSK to start-ups and earlier stage companies, including Synpromics Ltd. He brings with him extensive industry experience including strategy, business development and M&A, and currently sits on the Boards of Enterobiotix Limited. He is also currently CFO of Sensorion, a gene therapy company listed on Euronext Growth in Paris and is a Director at EnteroBiotix Ltd. He has also advised several life sciences Venture Capital firms between 2006 and 2017.
We look forward to working closely with David as we progress with our partnering and accelerate the growth of ACM Biolabs.
Singapore, Basel, Sydney, July 29, 2022
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 by ACM Biolabs (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.”ur 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 Biolabs is working on a wide range of products beyond infectious disease vaccines including personalized immunotherapy for cancer patients.
For further information please contact:
For Investors:
Dr. Alexander Breidenbach
Chief Development Officer
ACM Biosciences
+41 61 975 85 88
office@acmbiosciences.com
For media:
Dr. Stephan Feldhaus
Feldhaus & Partner
+41 79 865 92 56
feldhaus@feldhaus-partner.ch
About ACM Biolabs
ACM Biolabs is developing next generation vaccines for infectious diseases, immuno-modulator therapies, and personalized cancer vaccines using its proprietary ACM (Artificial Cell Membranes) polymer-based delivery platform (non-lipid, non-viral). The company’s lead program, ACM-001, is an adjuvanted SARS-CoV-2 spike protein (beta variant) vaccine currently in 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. In 2022 ACM Biolabs Pty Ltd was established in Australia to operationalize clinical development. 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
Disclaimer
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.
ACM Biolabs at BioEquity Europe, Milano, May 16 -18, 2022
We are excited to inform you that Alexander Breidenbach, Chief Development Officer/Chief Business Officer ACM Biosciences, will take the opportunity to represent ACM Biolabs at BioEquity Europe, Europe’s premier international showcase for raising biotechs, taking place in Milan, Italy, May 16-18th. Dr Breidenbach will provide an overview of the company and present ACM’s versatile platform to deliver disease prevention and therapeutics and will be available to for in-person meetings with investors who are registered to attend the conference.
#acmbiosciences #acmbiolabs #polymersomes #vaccine
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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:
For Investors:
Dr. Alexander Breidenbach
Chief Development Officer
ACM Biosciences
+41 61 975 85 88
office@acmbiosciences.com
For Media:
Dr. Stephan Feldhaus
Feldhaus & Partner
+41 79 865 92 56
feldhaus@feldhaus-partner.ch
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.
Disclaimer
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.
Date: 2022-01-10 start / 2022-01-13 end
Basel, 27 May 2021 – ACM Biosciences AG, a Swiss biotechnology company focusing on the development of their proprietary polymersome-based vaccines, today announced that Innosuisse, the Swiss Innovation Agency, has awarded a grant for the development of a novel delivery system for mRNA COVD-19 vaccines. Dr. Steve Pascolo, global expert in mRNA vaccines and group leader at the University Hospital Zurich, and ACM Biosciences will join forces to develop a stable and novel carrier for mRNA with improved properties regarding storage at refrigerator temperature, logistics, and flexibility.
mRNA-based vaccines are one of the most important scientific breakthroughs arising from the COVID-19 pandemic. However, these vaccines are burdened with drawbacks that limit their widespread use. Specifically, they are unstable, requiring complex cooling solutions for transport and storage, and the manufacturing of the final product is complex and costly. With this project, ACM Biosciences aims to maximize the potential of mRNA vaccines by developing a novel vaccine carrier system to improve their efficacy, stability, and cost effectiveness. The proprietary Artificial Cell Membranes (ACMs) from ACM Biosciences are based on an innovative nanotechnology platform using non-immunogenic polymersomes as its stable carrier. In parallel to this project, the company is developing a sub-unit protein based COVID-19 vaccine candidate in clinical trials and is conducting an mRNA proof of concept stability and immunogenicity study.
Dr. Steve Pascolo, Principal Investigator at the University Hospital Zurich and co-founder of CureVac, a leading mRNA company, commented:
“A polymersome carrier would have a simpler structure than a lipid nanoparticle carrier, which is the current standard for mRNA vaccines. This could yield clear benefits such as higher stability with easier storage and handling, cheaper production and making global supply possible even in areas with poor infrastructure.”
“We are delighted to collaborate with Dr. Steve Pascolo with the support from Innosuisse to validate the polymersomes for mRNA delivery,” added Dr. Peter Moran, CEO of ACM Biosciences. “Through this public-private partnership, ACM Biosciences will push this platform as a stable mRNA vaccine closer to clinics. We are excited with this opportunity to strengthen our pipeline of polymersome-based vaccines as a highly effective and stable carrier.
About ACM
Biosciences ACM Biosciences was incorporated in Basel, Switzerland, in 2020 as the human infectious disease vaccine company of ACM Biolabs, which is based in Singapore, a leader in protein vaccines and novel nanoparticle delivery techniques in the oncology and veterinary fields. ACM Biosciences is dedicated to the development of infectious disease vaccines using the proprietary ACM polymersome platform technology. These artificial cell membranes (ACM) are nanoscale vesicles that are conceptually very similar to liposomes and have shown to have numerous advantages for both veterinary and human vaccines, including viral, bacterial, and oncological diseases. ACM Biosciences is now accelerating a COVID-19 vaccine into clinical trials. For further information, please visit: www.acmbiosciences.com
Basel, 7 April 2021 – ACM Biosciences AG, a Swiss biotechnology company focusing on the development of polymersome-based vaccines, today announced the closing of a first financing round to advance its human vaccines platform and a second-generation Covid-19 vaccine. ACM Biosciences secured the exclusive worldwide license to the proprietary polymersome platform for the development of human infectious disease vaccines from ACM Biolabs Pte Ltd in Singapore, which is a leader in protein vaccines and novel nanoparticle delivery techniques in the oncology and veterinary fields.
Dr Peter Moran, CEO of ACM Biosciences, commented:
“With the great results we have seen so far from our technology in animal health, this financing is a key step in our strategy and will provide the necessary financial resources to progress both the COVID-19 vaccine candidate into clinical trials and the mRNA proof of concept stability and immunogenicity study.”
The proprietary Artificial Cell Membranes (ACMs) are based on an innovative nanotechnology platform using non-immunogenic polymersomes as its carrier. Through past developments by ACM Biolabs in Singapore, the ACM polymersome platform has been shown to produce a safe and efficacious veterinary vaccine against porcine epidemic diarrhea, a highly contagious and deadly coronavirus in pigs, for which there is no effective commercial vaccine. By working closely together, the Singapore and Swiss entities have developed a protein-based COVID-19 vaccine which shows an excellent immune response in preclinical trials. With the necessary financial resources secured, ACM Biosciences will now accelerate its development of the COVID-19 vaccine candidate and proceed with the running mRNA vaccine proof of concept stability and immunogenicity studies.
Prof Dr Daniel Paris, Medical Director and Head of the Department of Medicine at Swiss Tropical and Public Health Institute commented:
“ACM Biosciences’ technology has the potential to bring a step-change in manufacturability, and durability of vaccines, something Press Release ACM Biosciences AG, Steinenberg 1, 4051 Basel; www.acmbiosciences.com Page 2 of 2 which is urgently needed for a long-term solution to COVID-19, but also for other vaccine preventable diseases. Their preclinical efficacy data are really exciting, and their vaccine candidate should be taken into clinical trials as quickly as possible.”
ACM Biosciences technology allows great variability because its polymersome platform is highly customizable and can be made compatible with different vaccine formats, including mRNA and protein antigens. A formulation with polymersomes also enables a vaccine to be delivered intranasally, which is not only a convenient route of administration but can reduce transmissibility by activating mucosal immunity. Furthermore, polymersomes do not suffer from vector neutralizing antibodies, are very stable for easy storage and shipping and do not need a complex cold chain. And they can be manufactured cost-effective and with scale. As such, the platform allows quick adjustability to new strains and is well suited for repetitive use and applications.
Prof Dr Onur Boyman, Professor and Chair of the Department of Immunology at the University of Zurich added:
“ACM Biosciences’ next-generation vaccines can readily be adapted to emerging mutant viruses, which is crucial to control infection with SARS-CoV-2 and with other viral diseases.”
About ACM Biosciences
ACM Biosciences was incorporated in Basel, Switzerland, in 2020 as the human infectious disease vaccine company of ACM Biolabs, which is based in Singapore, a leader in protein vaccines and novel nanoparticle delivery techniques in the oncology and veterinary fields. ACM Biosciences is dedicated to the development of infectious disease vaccines using the proprietary ACM polymersome platform technology. These artificial cell membranes (ACM) are nanoscale vesicles that are conceptually very similar to liposomes and have shown to have numerous advantages for both veterinary and human vaccines, including viral, bacterial, and oncological diseases. ACM Biosciences is now accelerating a COVID-19 vaccine into clinical trials. For further information, please visit: www.acmbiosciences.com