Akston Biosciences Receives Regulatory Approval for Phase II Clinical Trial for Shelf-Stable COVID-19 Vaccine Booster

• 600 volunteers will participate in an AKS-452 booster study in the Netherlands to investigate boosting the immune response of those previously vaccinated with EMA-registered vaccines
• Vaccine is shelf stable for at least six months at room temperature: 25° Celsius (77° Fahrenheit) and maintains potency for one month at 37° Celsius (99° Fahrenheit)
• Currently undergoing Phase II/III clinical trial in India for Emergency Use Authorization (EUA) as a primary vaccine

Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today it received regulatory approval in the Netherlands to conduct an open-label study of AKS-452, its protein subunit COVID-19 vaccine, as a booster. The study is designed to investigate the response of the immune system to an AKS-452 booster shot in 600 volunteers who have previously been vaccinated with EMA-registered vaccines from Pfizer, Moderna, Johnson & Johnson (Janssen) and AstraZeneca.

The trial is managed by TRACER Europe B.V., a CRO specializing in fast-track clinical trials and which oversaw the Phase I and II trials for AKS-452. The study will be conducted at the University Medical Center Groningen (UMCG), one of the largest hospitals in the Netherlands. Schelto Kruijff, M.D. Ph.D., the principal investigator at the UMCG for the AKS-452 Phase I and Phase II primary vaccine trials, will serve in the same capacity for the booster trial.

“The interim analysis of the Phase II open-label study of AKS-452 as a primary vaccine showed a robust overall 98% seroconversion response after either two 45 μg doses (100%), or a single 90 μg dose (96%) in healthy adults at 56 days. The vaccine induced a Th1/Th2 mixed immune response against the Receptor Binding Domain (RBD) of the coronavirus spike protein,” Dr. Kruijff said. “Given the apparent waning of immune response, a promising vaccine candidate like AKS-452 could be an effective booster.”

The participants, healthy adults between the ages of 18 and 85, will have had their last COVID-19 vaccine shot at least three months earlier and will have not yet received a COVID-19 booster shot. To determine the efficacy of the AKS-452 as a booster, the study will divide participants into four groups, each of 150 subjects, based on having received previously the Pfizer, Moderna, Johnson & Johnson or AstraZeneca vaccine. Each participant will receive one dose of the AKS-452 booster (90 µg), and will have antibody levels, virus neutralization activity, and T cell response measured at several follow-on appointments to determine the effect over time. The primary efficacy endpoint will be the antibody titer level four weeks after receiving the booster. Participants will have their last follow-up appointment nine months after boosting.

“The clinical study results so far show that AKS-452, developed with our proprietary Fc-fusion protein platform, is well tolerated and effective as a primary vaccine,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences. “Many people now have underlying immunity from vaccination or infection, but it is clear that immunity wanes over time and the world will need an ongoing supply of boosters. AKS-452 is very cost-effective to manufacture at scale, and it does not have the cold-chain constraints of many other vaccines, so it can be a practical way to provide protection while reducing the development and spread of new variants, by reaching difficult-to-reach populations.”

Using the serum from subjects vaccinated with AKS-452, Akston has shown the ability to successfully neutralize the omicron variant of the SARS-CoV-2 virus. The company is also testing follow-on candidates that could reduce likelihood of future variants escaping.

A 1,600 subject Phase II/III clinical trial of AKS-452 as a two-dose primary vaccine is currently underway in India. Primary endpoint data is expected in May 2022 to support a potential EUA in H1 2022.

Akston has partnered with the Strides Group to manufacture and commercialize AKS-452, branded as AmbiVax-C^TM, in India and over 130 countries in Asia, Latin America, and Africa. These include most of the world’s low-and-middle-income countries (LMICs), where Strides has a deep market presence and established relationships.

About AKS-452

AKS-452 is a protein sub-unit vaccine, a type of vaccine used safely and widely for decades. AKS-452 does not contain mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus.

It is designed as a flexible and economical vaccine for those most at risk in low- and middle-income countries, particularly those that lack cold-chain infrastructure needed for mRNA and DNA vaccines. AKS-452 uses standard antibody manufacturing techniques and equipment, so that a single 2000L production train could produce over one billion doses per year, making it less inexpensive to make than many other COVID-19 vaccines.

Based on Akston’s proprietary Fc-fusion protein platform, AKS-452 is a SARS-CoV-2 vaccine designed to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel coronavirus spike protein. Being the primary locus for infection, the RBD is highly conserved among mutated forms of the virus, and clinical testing has demonstrated robust antibody neutralization of SARS-CoV-2 variants.

About University Medical Center Groningen

The University Medical Center Groningen (UMCG) is one of the largest hospitals in the Netherlands. The more than 12,000 employees work together on care, research, training and education with the common goal: building the future of health. Through innovative and sound research UMCG aims to understand mechanisms of disease; to push borders for diagnostics and treatment; and to help build a network for sustainable health. All of its research focuses on Healthy Ageing. Talent development and state-of-the-art infrastructure are of paramount importance to UMCG.

About TRACER

TRACER Europe B.V. (“TRACER”) is a Clinical Research Organization (CRO) specializing in fast-track solutions for testing innovative biologic medicines and is a founding member of the COVID-19 Rapid Cure Task Force (RCTF). TRACER and its partners provide its clients with the expertise, infrastructure, and capacity to rapidly generate accurate first-in-human clinical data. www.tracercro.com.

About Akston Biosciences

Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.), Akston has partnered with Dechra Pharmaceuticals PLC to commercialize once-a-week canine and feline insulin therapies. It operates a GMP biologics manufacturing facility and research laboratory at its Beverly, Mass. location. www.akstonbio.com.

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