Drugs / AKS-452
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | COVID-19 | — | “The positive results from that study have been submitted as part of an Emergency Use Application in India.” akstonbio.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT04681092 | Apr 2021 → Mar 2022 | COVID-19 | University Medical Center Groningen | Completed | Met primary |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2024-02-26 | Akston Biosciences Corporation | Results Akston Biosciences’ AKS-452 Vaccine Study Published in Nature, Showcasing Ambifect<sup>®</sup> Platform’s Versatility akstonbio.com ↗
Akston Biosciences , dedicated to accelerating the next revolution in Animal Health, announced the publication in Nature Vaccines of phase II study results for AKS-452, based on Akston’s Ambifect ® Fc-fusion protein platform . |
| 2022-11-01 | Akston Biosciences Corporation | Results Akston Biosciences Announces Positive Interim Phase II Results from COVID “Universal” Booster Vaccine Trial akstonbio.com ↗
An interim analysis of the data found that 93% of subjects previously vaccinated with Pfizer, Moderna, Johnson & Johnson (Janssen), and AstraZeneca vaccines showed an increase in neutralizing antibody titers after receiving a single dose of AKS-452. |
| 2022-06-24 | Halcygen Pharmaceuticals Limited | Results Biolexis and Akston Biosciences Announce Encouraging Top-Line Results from Phase II/III Trial of their Thermostable 2nd Gen COVID-19 Vaccine strides.com ↗
Interim analysis shows a 91% seroconversion rate. |
| 2022-06-24 | Akston Biosciences Corporation | Results Biolexis and Akston Biosciences Announce Encouraging Top-Line Results from Phase II/III Trial of their Thermostable 2nd Gen COVID-19 Vaccine akstonbio.com ↗
Results of 100 subjects bridging study and 1,500 subjects placebo-controlled trial of Akston’s AKS-452 announced. |
| 2022-04-12 | Akston Biosciences Corporation | Results Akston Biosciences CEO to Present at the World Vaccine Congress akstonbio.com ↗
During the discussion, Dr. Zion will discuss recent clinical results including: 96% (1-dose) and 100% (2-dose) seroconversion |
| 2022-03-31 | Akston Biosciences Corporation | Regulatory Akston Biosciences Receives Regulatory Approval for Phase II Clinical Trial for Shelf-Stable COVID-19 Vaccine Booster akstonbio.com ↗ |
| 2022-02-08 | Akston Biosciences Corporation | Results Akston Biosciences Announces Publication in Vaccine of Positive Data for a Room Temperature Protein Subunit COVID-19 Vaccine akstonbio.com ↗
The adjuvanted vaccine was generally well-tolerated and produced a 100% seroconversion rate in the 90 µg single-dose regimen, as well as in the 45 µg and 90 µg two-dose regimens. |
| 2021-12-21 | Akston Biosciences Corporation | Results Akston Biosciences Announces Positive Top-Line Data from Phase II Study of COVID-19 Vaccine in the Netherlands akstonbio.com ↗
The interim analysis showed a robust overall 98% seroconversion response after either two 45μg doses (100%), or a single 90μg dose (96%) in healthy adults at 56 days. |
| 2021-07-08 | Akston Biosciences Corporation | Results Akston Biosciences Announces Positive Phase I Data for Second-Generation COVID-19 Vaccine Candidate akstonbio.com ↗ |
All press releases naming this drug 11 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AKS-452 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04681092 ↗ |
| Modality | Vaccine | “a recombinant subunit vaccine, AKS-452, is being developed comprising an Fc fusion protein of the SARS-CoV-2 viral spike protein receptor binding domain (SP/RBD) antigen and...” PMID 35115195 ↗ Jan 2022 |
| Route | Subcutaneous | “Subcutaneous injection of pre-defined dose (22,5 ug, 125 uL) single-dose” NCT04681092 ↗ |