AKS-452 / Akston - LARVOL DELTA

Immunogenicity phase II study evaluating booster capacity of nonadjuvanted AKS-452 SARS-Cov-2 RBD Fc vaccine. (PubMed, NPJ Vaccines) - P2 | "Nucleocapsid protein (Np) titers suggested infection occurred in 66% (46 of 70) of subjects, in which only 20 reported mild symptomatic COVID-19. These favorable safety and immunogenicity profiles support booster evaluation in a planned phase III universal booster study of this room-temperature stable vaccine that can be rapidly and inexpensively manufactured to serve vaccination at a global scale without the need of a complex distribution or cold chain."

Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A randomized phase I/II safety and immunogenicity study of the Montanide-adjuvanted SARS-CoV-2 spike protein-RBD-Fc vaccine, AKS-452. (PubMed, Vaccine) - P1/2 | "These favorable safety and immunogenicity profiles of the candidate vaccine as demonstrated in this phase II study are consistent with those of the phase I study (ClinicalTrials.gov: NCT04681092) and suggest that a total of 90 µg received in 2 doses may offer a greater duration of cross-reactive neutralizing titers than when given in a single dose."

Journal • P1/2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study (clinicaltrials.gov) - P1/2 | N=112 | Completed | Sponsor: University Medical Center Groningen | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Anti-COVID19 VaccinaTion AKS-452 BOOSTER (ACT-BOOSTER Study) (clinicaltrials.gov) - P2 | N=600 | Recruiting | Sponsor: University Medical Center Groningen | Not yet recruiting ➔ Recruiting | Trial completion date: Jul 2022 ➔ Feb 2023 | Initiation date: Dec 2021 ➔ Apr 2022

Enrollment open • Trial completion date • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Phase I interim results of a phase I/II study of the IgG-Fc fusion COVID-19 subunit vaccine, AKS-452. (PubMed, Vaccine) - P1/2 | "All IgG titers were Th1-isotype skewed and efficiently bound mutant SP/RBD from several SARS-CoV-2 variants with strong neutralization potencies of live virus infection of cells (including alpha and delta variants). The favorable safety and immunogenicity profiles of this phase I study (ClinicalTrials.gov: NCT04681092) support phase II initiation of this room-temperature stable vaccine that can be rapidly and inexpensively manufactured to serve vaccination at a global scale without the need of a complex distribution or cold chain."

Journal • P1/2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study (clinicaltrials.gov) - P1/2; N=112; Active, not recruiting; Sponsor: University Medical Center Groningen; Recruiting ➔ Active, not recruiting; Trial completion date: Oct 2021 ➔ May 2022; Trial primary completion date: Sep 2021 ➔ Feb 2022

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Anti-COVID19 VaccinaTion AKS-452 BOOSTER (ACT-BOOSTER Study) (clinicaltrials.gov) - P2; N=600; Not yet recruiting; Sponsor: University Medical Center Groningen

New P2 trial • Infectious Disease • Novel Coronavirus Disease

Development of an IgG-Fc fusion COVID-19 subunit vaccine, AKS-452. (PubMed, Vaccine) - "Furthermore, ISA 720-adjuvanted AKS-452 was immunogenic in rabbits and non-human primates (NHPs) and protected from infection and clinical symptoms with live SARS-CoV-2 virus in NHPs (USA-WA1/2020 viral strain) and the K18 human ACE2-trangenic (K18-huACE2-Tg) mouse (South African B.1.351 viral variant). These preclinical studies support the initiation of Phase I clinical studies with adjuvanted AKS-452 with the expectation that this room-temperature stable, Fc-fusion subunit vaccine can be rapidly and inexpensively manufactured to provide billions of doses per year especially in regions where the cold-chain is difficult to maintain."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Anti-COVID19 AKS-452 - ACT Study (clinicaltrials.gov) - P1/2; N=112; Recruiting; Sponsor: University Medical Center Groningen; Enrolling by invitation ➔ Recruiting

Enrollment status • Infectious Disease • Novel Coronavirus Disease

Anti-COVID19 AKS-452 - ACT Study (clinicaltrials.gov) - P1/2; N=130; Enrolling by invitation; Sponsor: University Medical Center Groningen; Recruiting ➔ Enrolling by invitation

Enrollment status • Infectious Disease • Novel Coronavirus Disease

Anti-COVID19 AKS-452 - ACT Study (clinicaltrials.gov) - P1/2; N=130; Recruiting; Sponsor: University Medical Center Groningen; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease

Vaccination phase I/II study against COVID-19 Vaccinatie fase I/II studie tegen COVID-19 (clinicaltrialsregister.eu) - P1/2; N=176; Ongoing; Sponsor: UMCG

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

Akston Biosciences and LakePharma Announce Strategic Partnership to Manufacture Second-Generation COVID-19 Vaccine (PRNewswire) - "Akston Biosciences...and LakePharma...announced today that they have established a strategic partnership. LakePharma will manufacture commercial quantities of Akston's adjuvated COVID-19 vaccine candidate (AKS-452), which is scheduled to begin Phase 1/2 clinical testing later this month....'Partnering with LakePharma gives us great confidence that we can ramp up quickly to deliver large quantities of AKS-452 on a commercial basis.'"

Commercial • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Anti-COVID19 AKS-452 - ACT Study (clinicaltrials.gov) - P1/2; N=130; Not yet recruiting; Sponsor: University Medical Center Groningen

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease