UVax 2129
Alternative Names: 1c-SApNP vaccine - Ufovax; Coronavirus vaccine - Ufovax; UVax-2129Latest Information Update: 04 Dec 2020
At a glance
- Originator The Scripps Research Institute
- Developer The Scripps Research Institute; Uvax Bio
- Class Viral vaccines
- Mechanism of Action Immunostimulants
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Preclinical COVID 2019 infections
Most Recent Events
- 11 Nov 2021 Scripps Research has patents pending for the 1C-SApNP platform technology and individual vaccines in USA (UVax Bio website, November 2021)
- 03 Nov 2021 Immunogenicity data from preclinical studies in COVID-2019 infections (Prevention) released by UVax Bio
- 03 Nov 2021 Preliminary immunogenicity data from research studies in COVID-2019 infections (Prevention) released by UVax Bio
Development Overview
Introduction
UVax 2129, a COVID-2019 vaccine, is being developed by UVax Bio (also known as Ufovax, a spin-off company from Scripps Research), for prevention against the coronavirus SARS-CoV-2 infection. The candidate is developed using the patented one component self-assembling protein nanoparticle (1c-SApNP) vaccine platform technology. The vaccine prototype features SARS-CoV-2 protein spikes protruding from a protein nanoparticle scaffold. The nanoparticle vaccine would induce the immune system to rapidly generate antibodies to neutralise or deactivate the coronavirus, offering a recipient protection against the virus. The nanoparticle vaccine consists of self-assembling virus-like particles made from identical proteins. These proteins are synthesised through the insertion of a single plasmid encoding the relevant gene into a CHO or C1 (DYAI) host cell, followed by one-step expression and two subsequent purifications. Early research is underway in the US.
UFOTON platform technology involves creating virus-like particles (VLPs) that present highly stable uncleaved prefusion-optimised proteins, which mimic the native-like, closed state of a viral envelope spike before cell entry occurs, to elicit robust neutralising antibody responses in the host.
UVax Bio was previously known as Ufovax.
Company Agreements
Before March 2020, Ufovax acquired exclusive rights to develop and commercialise Scripps Research nanoparticle vaccine technology for certain vaccine targets. In July 2020, the Ufovax in-licensed exclusive rights to develop and commercialise vaccines using the Scripps Research Institute's patented technology for novel scaffolded HIV-1 vaccine immunogens. [1] [2]
Key Development Milestones
In November 2021, UVax Bio released early research data and preclinical data for UVax 2129 [3] .
In September 2020, early results from preclinical studies were released by Ufovax [4] .
Ufovax developed and purified the first COVID-19 candidate in February 2020. The company developed five final candidates and initiated preclinical mouse immunogenicity study in late May 2020. The company intends to conduct GLP-toxicology studies, and file an IND application to initiate first-in-human studies of coronavirus vaccine [5] .
Financing information
Prior to November 2021, the research studies for UVax 2129 were funded by the National Institutes of Health, in addition to the company's funding [3] .
Patent Information
As at November 2021, Scripps Research has five pending patents covering the 1C-SApNP platform technology and individual vaccines by Scripps Research (UVax Bio website, November 2021).
As at December 2020, provisional patents have been filed for UVax 2129 by UVax Bio (UVax Bio website, November 2021) [6] .
In November 2020, the U.S. Patent & Trademark Office (USPTO) approved the patent, entitled "Stabilized Coronavirus Spike (S) Protein Immunogens and Related Vaccines", covering the design of an optimised antigen for SARS-CoV-2. The patent was filled by The Scripps Research Institute, in June 2020 [6] .
As of March 2020, Ufovax has patent protection for its one component self-assembling protein nanoparticle (1c-SApNP) vaccine platform technology in the US [1] .
Drug Properties & Chemical Synopsis
- Route of administration Parenteral
- Formulation unspecified
- Class Viral vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B (Viral Vaccines)
-
EPhMRA code
J7E (Viral Vaccines)
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| UVax 2129 | seryl-tRNA synthetase | Arm Group Description |
| T-Cell differentiation antigen CD8 | Detailed Description |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | Prevention | Preclinical | USA | Parenteral / unspecified | The Scripps Research Institute, Uvax Bio | 31 May 2020 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| The Scripps Research Institute | Originator | USA |
| The Scripps Research Institute | Owner | USA |
| Uvax Bio | Licensee | World |
| National Institutes of Health (USA) | Funder | USA |
Scientific Summary
Immunogenicity
In preclinical studies, COVID-2019 vaccine demonstrated consistent 8- to 10-fold increases in neutralizing antibody (NAb) titers in mice as compared with S2GΔHR2 spike alone (not carried on a nanoparticle) as well as the S2P spike alone. The construct was also found to induce cellular (T-cell) immunity [4]
Preclinical studies with UVax 2129 in murine model showed that the vaccine elicited a potent neutralising response against the original Wuhan strain of COVID-19, and all the other major variants of concern including the delta variant with the same potency. Uvax 2129 showed longer and stronger engagement with the immune cells that allowed long-term immunity [3] .
Early research studies with UVax 2129 showed that the vaccine generated a potent neutralising antibody response to alpha, beta, gamma, and delta variants of SARS-CoV-2. Compared with the soluble spike, Uvax 2129 showed sixfold longer retention, fourfold greater presentation on follicular dendritic cell dendrites, and fivefold stronger germinal center reactions in lymph node follicles. The study suggested that UVax 2129 engaged the immune system much more robustly than other vaccine strategies [3]
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 30 Jun 2022 | Trial Update | Uvax Bio plans a phase I trial for COVID-2019 infections (Prevention) in USA for the first half of 2022 [3] | 11 Nov 2021 |
| 31 Mar 2021 | Trial Update | Ufovax plans IND-enabling studies for COVID-2019 infections in early 2021 [6] | 04 Dec 2020 |
| 31 Dec 2020 | Regulatory Status | Ufovax announces intention to submit IND to regulatory body for COVID-2019 infections (Prevention) in fourth quarter of 2020 [5] | 07 Sep 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 11 Nov 2021 | Patent Information | Scripps Research has patents pending for the 1C-SApNP platform technology and individual vaccines in USA (UVax Bio website, November 2021) Updated 04 Dec 2020 |
| 03 Nov 2021 | Scientific Update | Immunogenicity data from preclinical studies in COVID-2019 infections (Prevention) released by UVax Bio [3] Updated 11 Nov 2021 |
| 03 Nov 2021 | Scientific Update | Preliminary immunogenicity data from research studies in COVID-2019 infections (Prevention) released by UVax Bio [3] Updated 11 Nov 2021 |
| 03 Nov 2021 | Trial Update | Uvax Bio plans a phase I trial for COVID-2019 infections (Prevention) in USA for the first half of 2022 [3] Updated 11 Nov 2021 |
| 03 Jun 2021 | Biomarker Update | Biomarkers information updated Updated 13 Nov 2021 |
| 01 Dec 2020 | Patent Information | UVax Bio files for provisional patents for UVax 2129 in USA (UVax Bio website, November 2021) [6] Updated 04 Dec 2020 |
| 01 Dec 2020 | Trial Update | Ufovax plans IND-enabling studies for COVID-2019 infections in early 2021 [6] Updated 04 Dec 2020 |
| 17 Sep 2020 | Scientific Update | Immunogenicity data from preclinical studies in COVID-2019 infections released by Ufovax [4] Updated 21 Sep 2020 |
| 25 Aug 2020 | Regulatory Status | Ufovax announces intention to submit IND to regulatory body for COVID-2019 infections (Prevention) [5] Updated 11 Nov 2021 |
| 25 Aug 2020 | Regulatory Status | Ufovax announces intention to submit IND to regulatory body for COVID-2019 infections (Prevention) in fourth quarter of 2020 [5] Updated 07 Sep 2020 |
| 31 May 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral) [5] Updated 07 Sep 2020 |
| 24 Mar 2020 | Patent Information | Ufovax has patent protection for one component self-assembling protein nanoparticle (1c-SApNP) vaccine platform technology in USA [1] Updated 26 Mar 2020 |
| 24 Mar 2020 | Phase Change | Early research in COVID-2019 infections in USA (Parenteral) [1] Updated 26 Mar 2020 |
| 24 Mar 2020 | Trial Update | Ufovax plans preclinical and clinical trials for COVID-2019 infections [1] Updated 26 Mar 2020 |
| 23 Mar 2020 | Licensing Status | Ufovax in-licenses nanoparticle vaccine technology from The Scripps Research Institute before March 2020 [1] Updated 27 Mar 2020 |
References
-
Ufovax successfully extended its Nanoparticle vaccine technology to SARS-CoV-2.
Media Release -
U.S. Patent & Trademark Office has allowed Scripps Research patent application Novel Scaffolded HIV-1 Vaccine Immunogens.
Media Release -
Uvax-2129, a Recombinant Protein Nanoparticle Vaccine, Uvax Bios Answer to COVID-19, Shows Great Promise Against Variants of Concern.
Media Release -
Ufovax Announces Its Self-Assembling NanoParticles as the Next-Generation Vaccine Solution for COVID-19.
Media Release -
Scripps Research Spin-Off Ushers a New Era in Vaccinology With Platform Technology.
Media Release -
Ufovax Extends Its Intellectual Property Portfolio to Include a Patent Covering the Design of an Optimized Antigen For COVID-19.
Media Release
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