ACM Biolabs shines at NTUitive’s Technology Roadshow 2023

“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

• 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, 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 further information please contact:

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

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.

Abstract

Current parenteral coronavirus disease 2019 (Covid-19) vaccines inadequately protect against infection of the upper respiratory tract. Additionally, antibodies generated by wild type (WT) spike-based vaccines poorly neutralize severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants. To address the need for a second-generation vaccine, we have initiated a preclinical program to produce and evaluate a potential candidate. Our vaccine consists of recombinant Beta spike protein coadministered with synthetic CpG adjuvant. Both components are encapsulated within artificial cell membrane (ACM) polymersomes, synthetic nanovesicles efficiently internalized by antigen presenting cells, including dendritic cells, enabling targeted delivery of cargo for enhanced immune responses. ACM vaccine is immunogenic in C57BL/6 mice and Golden Syrian hamsters, evoking high serum IgG and neutralizing responses. Compared to an ACM-WT spike vaccine that generates predominantly WT-neutralizing antibodies, the ACM-Beta spike vaccine induces antibodies that neutralize WT and Beta viruses equally. Intramuscular (IM)-immunized hamsters are strongly protected from weight loss and other clinical symptoms after the Beta challenge but show delayed viral clearance in the upper airway. With intranasal (IN) immunization, however, neutralizing antibodies are generated in the upper airway concomitant with rapid and potent reduction of viral load. Moreover, antibodies are cross-neutralizing and show good activity against Omicron. Safety is evaluated in New Zealand white rabbits in a repeated dose toxicological study under Good Laboratory Practice (GLP) conditions. Three doses, IM or IN, at two-week intervals do not induce an adverse effect or systemic toxicity. Cumulatively, these results support the application for a Phase 1 clinical trial of ACM-polymersome-based Covid-19 vaccine (ClinicalTrials.gov identifier: NCT05385991).

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 2^nd 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: 

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 16-18^th. 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

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiological agent of coronavirus disease 2019 (Covid-19), an ongoing global public health emergency. Despite the availability of safe and efficacious vaccines, achieving herd immunity remains a challenge due in part to rapid viral evolution. Multiple variants of concern (VOCs) have emerged, the latest being the heavily mutated Omicron, which exhibits the highest resistance to neutralizing antibodies from past vaccination or infection. Currently approved vaccines generate robust systemic immunity, yet poor immunity at the respiratory tract. We have demonstrated that a polymersome-based protein subunit vaccine with wild type (WT) spike protein and CpG adjuvant induces robust systemic immunity (humoral and T cell responses) in mice. Both antigen and adjuvant are encapsulated in artificial cell membrane (ACM) polymersomes – synthetic, nanoscale vesicles that substantially enhance the immune response through efficient delivery to dendritic cells. In the present study, we have formulated a vaccine candidate with the spike protein from Beta variant and assessed its immunogenicity in golden Syrian hamsters. Two doses of ACM-Beta spike vaccine administered via intramuscular (IM) injection evoke modest serum neutralizing titers that are equally efficacious towards WT and Beta viruses. In contrast, the ACM-WT spike vaccine induces a predominantly WT-specific serum neutralizing response with pronounced reduction in potency towards the Beta variant. Remarkably, immunogenicity of the ACM-Beta spike vaccine is greatly enhanced through intranasal (IN) administration. Following IN challenge with the Beta variant, IM-immunized hamsters are fully protected from disease but not infection, displaying similar peak viral RNA loads in oral swabs as non-vaccinated controls. In contrast, hamsters IN vaccinated with ACM-Beta spike vaccine are protected from disease and infection, exhibiting a ∼100-fold drop in total and subgenomic RNA load as early as day 2 post challenge. We further demonstrate that nasal washes from IN-but not IM-immunized animals possess virus neutralizing activity that is broadly efficacious towards Delta and Omicron variants. Altogether, our results show IN administration of ACM-Beta spike vaccine to evoke systemic and mucosal antibodies that cross-neutralize multiple SARS-CoV-2 VOCs. Our work supports IN administration of ACM-Beta spike vaccine for a next-generation vaccination strategy that not only protects against disease but also an infection of the respiratory tract, thus potentially preventing asymptomatic transmission.

Competing Interest Statement

J.H.L., D.S., T.W.C., S.L.C., S.V., G.S., T.Y.A., S.W. and M.N. are employees of ACM Biolabs Pte Ltd, Singapore. P.V is acting Chief Medical Officer of ACM Biosciences AG, Basel, Singapore.

 Singapur und Basel, Schweiz, 4. März, 2022 

 ACM Biolabs, ein schweizerisch-singapurisches Biotechnologieunternehmen, das sich auf die Entwicklung von prophylaktischen und therapeutischen Impfstoffen gegen Infektionskrankheiten und von therapeutischen Impfstoffen für die personalisierte Krebsbehandlung spezialisiert hat, gab heute bekannt, dass sein klinischer Impfstoffkandidat, ACM-001, ein COVID-Impfstoff der zweiten Generation, in einer Reihe von präklinischen Studien einen breiten Schutz gegen verschiedene SARS-CoV-2 Virusvarianten, einschliesslich Delta und Omicron, gezeigt hat. Im Gegensatz zu den gegenwärtig zugelassenen Impfstoffen gegen SARS-CoV-2 kann ACM-001 sowohl intramuskulär als auch intranasal verabreicht werden. 

ACM-001 basiert auf der patentgeschützten ACM-Technologie (ACM steht für «Artificial Cell Membrane»). Diese revolutionäre Plattform ermöglicht das Verpacken und den Transport von komplexen Molekülen wie beispielsweise Proteine oder mRNA in Zielzellen. Wegen ihrer einzigartigen Flexibilität gehört sie zur nächsten Generation von Enkapsulierungstechnologien. Im Vergleich zu den derzeit verwendeten mRNA Impfstoffen mit Liponanopartikeln (LNP) sind auch keine Gefriertemperaturen für die Lagerung erforderlich. ACM arbeitet an einer breiten Palette von Produkten, darunter auch Impfstoffe für die personalisierte Krebsimmuntherapie. 

Nachdem ACM-001, ein SARS-CoV-2-Spike-Protein-Impfstoff (Beta-Variante) kombiniert mit einem Adjuvans, erfolgreich alle präklinischen Sicherheitstests erfüllt hat, kann diese Vakzine der zweiten Generation in Kürze die klinische Entwicklung starten. Die Plug-and-Play-Plattform ermöglicht eine schnelle Anpassung dieses COVID-Impfstoffs an künftige Varianten. 

Ein intranasaler Impfstoff ist nicht nur nadel- und schmerzfrei, sondern kann bereits dort einen maximalen Schutz bieten, wo Atemwegsviren wie SARS-CoV-2 zuerst in den Körper gelangen. Die derzeit zugelassenen Impfstoffe führen in der Regel zu einer Abschwächung oder Verhinderung der Erkrankung, bieten jedoch keine Schleimhautimmunität und verhindern daher nicht die Replikation des Virus in der Nasenhöhle und somit auch nicht die Übertragung von SARS-CoV-2. ACM Biolabs hat nun eine umfassende Untersuchung der signifikanten Vorteile seines auch intranasal zu verabreichenden Impfstoffkandidaten ACM-001 veröffentlicht (https://acmbiolabs.com/?p=634). 

Während sowohl nach intramuskulärer als auch nach intranasaler Verabreichung eine Kreuzneutralisierung gegen die verschiedenen Virusvarianten, einschliesslich Delta und Omicron, festgestellt wurde, konnte die Viruslast in der Nasenhöhle durch die intranasale Verabreichung bereits am zweiten Tag um das Hundertfache verringert werden, was auf eine Verlangsamung der Virusvermehrung durch die Immunantwort schliessen lässt. Diese präklinischen Studien haben entscheidend dazu beigetragen, die klinische Phase-1-Studie zu planen. Nach behördlicher Genehmigung der Studie, die bereits in den nächsten Wochen erwartet wird, werden gesunde Erwachsene, die eine COVID-Grundimmunisierung erhalten haben, mit ACM-001 immunisiert. 

“Derzeit werden die meisten der verwendeten oder in Entwicklung befindlichen COVID-19-Impfstoffe durch eine intramuskuläre Injektion verabreicht, die eine eher schwache Immunantwort auf den Schleimhäuten hervorruft”, sagte Professor Onur Boyman, Direktor der Klinik für Immunologie der Universität Zürich. “Die intranasale Impfung ist daher ein idealer Ansatz zur Bekämpfung von Atemwegsviren. ACM-001 hat nun sehr vielversprechende präklinische Daten geliefert, die zeigen, dass die intranasale Impfung die Immunreaktion der Schleimhäute stark verbessert, was die Infektion an der Eintrittsstelle des Virus hemmt.” 

“Wir freuen uns sehr über die erneute Bestätigung der vielfältigen Eigenschaften unserer ACM-Plattform, die grosses Potenzial für die Entwicklung der dringend benötigten COVID-19-Impfstoffe der nächsten Generation haben”, sagte Dr. Madhavan Nallani, Chief Executive Officer von ACM Biolabs. “Da wir jetzt alle behördlichen Anforderungen, einschließlich einer umfassenden Sicherheitsbewertung unseres Impfstoffes, erfolgreich abgeschlossen haben und das klinische Testmaterial für ACM-001 zur Verfügung steht, können wir schon in den nächsten Wochen mit der

Für weitere Informationen wenden Sie sich bitte an: Phase-1-Studie beginnen.” 

Über ACM Biolabs 

ACM Biolabs entwickelt prophylaktische und therapeutische Impfstoffe gegen Infektionskrankheiten sowie therapeutische Impfstoffe für die personalisierte Krebsbehandlung auf der Grundlage der firmeneigenen polymerbasierten ACM-Plattformtechnologie (ACM – Artificial Cell Membranes). Das führende Programm des Unternehmens, ACM-001, ist ein adjuvantierter SARS-CoV-2-Spike-Protein-Impfstoff (Beta-Variante). Eine erste Phase 1 Studie steht kurz vor dem Start. 

ACM Biolabs wurde 2013 in Singapur gegründet und unterhält dort Labore für Forschung und frühe Produktionsaktivitäten. Im Jahr 2020 wurde ACM Biosciences als Tochtergesellschaft von ACM Biolabs in Basel, Schweiz, gegründet, um vor allem die Entwicklungsaktivitäten zu internationalisieren. ACM Biosciences leitet alle klinischen und regulatorischen Aktivitäten der ACM-Programme und koordiniert auch die Geschäftsentwicklungsgespräche mit potenziellen Partnern. 

Für weitere Informationen: www.acmbiolabs.com. 

Disclaimer 

Diese Pressemitteilung enthält in die Zukunft gerichtete Aussagen, die auf derzeitigen Annahmen und Prognosen der Unternehmensleitung von ACM Biolabs und ACM Biosciences beruhen. Bekannte und unbekannte Risiken, Ungewissheiten und andere Faktoren können dazu führen, dass die tatsächliche Entwicklung wesentlich von den hier gemachten zukunftsgerichteten Aussagen abweicht. Die Leserinnen und Leser werden davor gewarnt, sich in unangemessener Weise auf zukunftsgerichtete Aussagen zu verlassen, da diese nur das Datum dieser Mitteilung widerspiegeln. ACM Biolabs und ACM Biosciences lehnen jede Verpflichtung ab, zukunftsgerichtete Aussagen zu aktualisieren und zu überarbeiten, sei es aufgrund neuer Informationen, zukünftiger Ereignisse oder aus anderen Gründen. 

View this Press Release in German

 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: 

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.