13 May 2022 - - US-based biologic therapeutics developer Akston Biosciences Corp has dosed the first set of volunteers in an open-label study of AKS-452, its protein subunit COVID-19 vaccine, as a booster, the company said.

The Phase II booster study is designed to investigate the response of the immune system in up to 600 volunteers who have previously been vaccinated with EMA-registered vaccines from Pfizer, Moderna, Johnson and Johnson (Janssen) and AstraZeneca.

The study is being conducted at the University Medical Center Groningen, 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, is serving in the same capacity for the booster trial.

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 not have 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 up to 150 subjects, based on having previously received the Pfizer (NYSE: PFE), Moderna (NASDAQ: MRNA), Johnson and Johnson (NYSE: JNJ) or AstraZeneca (NYSE: AZN) vaccine. Each participant will receive one dose of the AKS-452 antigen (90 µg).

Antibody levels, virus neutralization activity, and T cell response will be measured over nine months from samples taken in 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.

The dosing of all volunteers is expected by mid-June. The trial is managed by TRACER Europe B.V., a CRO specializing in fast-track clinical trials and which conducted the Phase I and II trials for AKS-452.

A 1,600 subject Phase II/III clinical trial of AKS-452 as a two-dose primary vaccine is currently underway in India.

The University Medical Center Groningen 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.

Tracer Europe B.V. is a Clinical Research Organization specializing in fast-track solutions for testing innovative biologic medicines and is a founding member of the COVID-19 Rapid Cure Task Force.

Tracer and its partners provide its clients with the expertise, infrastructure, and capacity to rapidly generate accurate first-in-human clinical data. 

Akston Biosciences Corp. 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 and Co. (NYSE: MRK)), 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.