ZVX 60
Alternative Names: Coronavirus vaccine - Scorpius Holdings/University of Miami; COVID-19 vaccine - Scorpius Holdings; ZVX-60Latest Information Update: 09 Feb 2024
At a glance
- Originator Heat Biologics; University of Miami
- Developer Scorpius Holdings
- Class COVID-19 vaccines; 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
- Discontinued COVID 2019 infections
Most Recent Events
- 06 Feb 2024 NightHawk Biosciences is now called Scorpius Holdings
- 29 Apr 2023 Discontinued - Preclinical for COVID-2019 infections (Prevention) in USA (Parenteral) prior to April 2023 (NightHawk Biosciences pipeline, April 2023)
- 29 Apr 2023 Discontinued - Preclinical for COVID-2019 infections in USA (Parenteral) prior to April 2023 (NightHawk Biosciences pipeline, April 2023)
Development Overview
Introduction
ZVX 60 a cell based coronavirus vaccine was being developed by NightHawk Biosciences (now Scorpius Holdings) in collaboration with University of Miami for the treatment and prevention of COVID-2019 infections using its gp96 vaccine platform. The vaccine, in evaluations, was found to express the Spike or S protein, gp96 and OX40L, a T cell co-stimulator. OX40L co-stimulation expands CD4+ helper T cells that promote B-cell differentiation and IgG/IgA antibody class switching. gp96 is a key protein that serves as a natural molecular warning system. gp96 platform leverages gp96’s role as a natural molecular warning system through allogeneic cell vaccines. The vaccine was designed to clear virus infected cells by promoting long-term cellular immunity, essential for preventing the spread of re-infection in susceptible individuals such as the elderly and other high-risk patients with relevant comorbidities. The vaccine was being developed for use as either a standalone vaccine, or in combination with other vaccines to enhance prophylactic protection. Preclinical development was underway in the US. However, as of April 2023, the candidate was no longer listed on the company pipeline, therefore, it appears that development has been discontinued.
Heat shock protein gp96 is a ubiquitous protein found in all human cells and also known as the immune system's swiss army knife due to its function as a potent immune adjuvant playing the role of molecular warning system to induce immunity against necrotic cells. Heat's proprietary gp96 vaccine platform reprograms live cells to continually secrete antigens of interest bound to the gp96, thus activating a robust T-cell response against those antigens. Heat's gp96 vaccine platform activates CD8 T cells, antigen presenting cells and natural killer cells, and induces mucosal immunity that can provide protection against COVID-19 infections.
Heat Biologics and University of Miami are also developing ZVX 55 [see Adis Insight Drug profile800059945] for COVID-2019 infections and a gp96 based vaccine research programme [see Adis Insight Drug profile800048160].
In May 2022, Heat Biologics changed its name to NightHawk Biosciences [1] .
In February 2024, Nighthawk Biosciences changed its name to Scorpius Holdings [2] .
Company Agreements
Heat Biologics (now Scorpius Holdings), in January 2021, transferred its gp96-based COVID-19 vaccine cell line (ZVX-60) to Waisman Biomanufacturing, for initiation of the manufacturing process of the vaccine, intended to be used alone or with other vaccines, for the prohylaxis of COVID-2019 infections. In May 2020, Heat Biologics and Waisman Biomanufacturing entered into a manufacturing agreement to manufacture COVID-19 vaccine. According to the agreement, Waisman will support the manufacturing of COVID-19 vaccine for expected phase I clinical trials. [3] [4] [1] [2]
In January 2023, notice of termination was provided by NightHawk Biosciences to the University of Miami for the termination of all agreements including agreements associated with the gp96 and TNFRSF25 platforms. In March 2020, Heat Biologics (now NightHawk Biosciences) entered into a strategic collaboration with the University of Miami Miller School of Medicine to support the development of a vaccine program leveraging Heat's proprietary gp96 platform designed to target the SARS-CoV-2 coronavirus that causes COVID-19. Under the terms of the research collaboration, University of Miami will develop and test one or more vaccine constructs utilizing Heat's gp-96 vaccine backbone to express antigens associated with COVID-19. [5] [1] [6] [2]
Key Development Milestones
In January 2023, notice of termination was provided by NightHawk Biosciences to the University of Miami for the termination of all agreements including agreements associated with the gp96 and TNFRSF25 platforms. [6] .
In January 2021, additional data from preclinical trial was released by Heat Biologics. In August 2020, results from preclinical studies were released by Heat Biologics [7] [8] [9] .
Preclinical studies have shown that ZVX 60 was able to increase the generation of effector and central memory cells over that of ZVX 55 (i.e., showing the contribution of OX40L addition), and was able to generate anti-Spike IgG and IgM antibodies, greater than ZVX 55 [10] .
As of June 2020, Heat Biologics achieved stable co-expression of gp96/nCoV-S protein in clinically validated human cell line, enabling selection of COVID-19 vaccine. Company completed design and development of ZVX 60 in July, and expect that p96/nCoV-2 expressing cell line will be available for clinical-grade manufacturing with Waisman Biomanufacturing, in early August [11] .
As of March 2020, preclinical development of ZVX 60 is underway in the US [12] .
Patent Information
Heat Biologics announced that it has filed a provisional patent for use of its technology platform for treating or preventing infection with the SARS-CoV-2 virus that causes coronavirus disease 2019 (COVID-19) [12] .
Drug Properties & Chemical Synopsis
- Route of administration Parenteral
- Formulation unspecified
- Class COVID-19 vaccines, Viral vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B-X03 (Covid-19 vaccines)
-
EPhMRA code
J7 (Vaccines)
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | Prevention | Discontinued (Preclinical) | USA | Parenteral / unspecified | Scorpius Holdings | 29 Apr 2023 |
| COVID 2019 infections | - | - | Discontinued (Preclinical) | USA | Parenteral / unspecified | Scorpius Holdings | 29 Apr 2023 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Heat Biologics | Originator | USA |
| University of Miami | Originator | USA |
| Scorpius Holdings | Owner | USA |
Scientific Summary
Pharmacodynamics
Summary
In preclinical animal models, coronavirus vaccine demonstrated in vivo confirmation of vaccine immunogenicity , including expansion of human-HLA-restricted T-cells against immuno-dominant epitopes of SARS-CoV-2 Spike protein. Expansion of antibody-supporting CD4+, and virus killing CD8+ T-cells in the lungs of the animals was also observed. The coronavirus vaccine exhibited a robust and effective immune response to support anti-viral immunity. Additionally, anti-viral killer CD8+ T-cells were also stimulated in human HLA-A2-positive transgenic mice. Vaccination with the coronavirus vaccine resulted in measured cytokines being produced by anti-viral CD4+ T-cells, indicating the generation of an optimal immune response. The vaccine induced the secretion of cytokines (IFN-gamma, IL-2, TNF-alpha) from CD8+ and CD4+ T cells in both the spleen and lungs. Also, induced high frequencies of S-protein specific (against S1 and S2 epitopes) CD8+ T cells in the respiratory airways, the predominant site of viral infections. coronavirus vaccine upregulated the CD69 and CXCR6 markers on CD8+ T-cells in the spleen, lung and BALF. Highest increase was observed in the BALF. In comparison with ZVX 55, coronavirus vaccine showed increased generation of effector and central memory cells (i.e., showing the contribution of OX40L addition). Also, the vaccine was able to generate anti-Spike IgG and IgM antibodies, greater than ZVX-55 [10] [8] [9] .
Immunogenicity
Summary
In preclinical studies, after 30 days of single vaccination, polyfunctional, anti-viral cytokine releasing, spike protein specific CD8+ and CD4+ T-cell memory responses were reported in the lungs and spleen of immunised animals. In addition, after 60 days of vaccination, memory CD8+ T-cell responses were also observed [7] .
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 06 Feb 2024 | Company Involvement | NightHawk Biosciences is now called Scorpius Holdings [2] Updated 09 Feb 2024 |
| 29 Apr 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for COVID-2019 infections (Prevention) in USA (Parenteral) prior to April 2023 [6] (NightHawk Biosciences pipeline, April 2023) Updated 05 May 2023 |
| 29 Apr 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for COVID-2019 infections in USA (Parenteral) prior to April 2023 [6] (NightHawk Biosciences pipeline, April 2023) Updated 05 May 2023 |
| 27 Jan 2023 | Licensing Status | NightHawk Biosciences terminates its agreement with University of Miami for gp96 and TNFRSF25 platforms [6] Updated 05 May 2023 |
| 03 May 2022 | Company Involvement | Heat Biologics is now called NightHawk Biosciences Updated 09 May 2022 |
| 27 Jan 2021 | Scientific Update | Additional immunogenicity data from preclinical studies in COVID-2019 infections released by Heat Biologics [7] Updated 01 Feb 2021 |
| 07 Oct 2020 | Trial Update | Heat Biologics plans a phase I trial for COVID-2019 infections (Prevention) Updated 14 Oct 2020 |
| 26 Aug 2020 | Scientific Update | Additional pharmacodynamics data from preclinical studies in COVID-2019 infections released by Heat Biologics [8] Updated 28 Aug 2020 |
| 29 Jul 2020 | Scientific Update | Pharmacodynamics data from preclinical studies in COVID-2019 infections released by Heat Biologics [9] Updated 04 Aug 2020 |
| 04 Jun 2020 | Trial Update | Heat Biologics plans a clinical trial for COVID-2019 infections [11] Updated 11 Jun 2020 |
| 05 Mar 2020 | Licensing Status | Heat Biologics enters into a research collaboration with University of Miami for the development of coronavirus vaccine [5] Updated 11 Mar 2020 |
| 03 Mar 2020 | Patent Information | Heat Biologics files a provisional patent application for use of its technology platform for treating or preventing infection with the SARS-CoV-2 virus that causes coronavirus disease 2019 (COVID-19) [12] Updated 04 May 2020 |
| 03 Mar 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral) [12] Updated 12 Mar 2020 |
| 03 Mar 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in USA (Parenteral) [12] Updated 11 Mar 2020 |
References
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Heat Biologics Completes Name Change to NightHawk Biosciences; Trading to Commence Under NHWK Effective at the Market Open Today.
Media Release -
NightHawk Biosciences Completes Name Change to Scorpius Holdings; Trading to Commence Under ##8220##SCPX##8221## Effective at the Market Open Today.
Media Release -
Heat Biologics Announces Collaboration with Waisman Biomanufacturing to Manufacture COVID-19 Vaccine.
Media Release -
Heat Biologics Commences Manufacturing Process for ZVX-60.
Media Release -
Heat Biologics Announces Research Collaboration with University of Miami to Develop Vaccine Designed to Protect Against COVID-19 Coronavirus.
Media Release -
NightHawkBiosciences Form 10K Annual report. Internet-Doc 2023;.
Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/1476963/000155837023005289/nhwk-20221231x10k.htm -
Heat Biologics Announces Publication of Additional Preclinical COVID-19 Vaccine Results.
Media Release -
Heat Biologics Announces Publication of Preclinical COVID-19 Vaccine Results.
Media Release -
Heat Biologics COVID-19 Vaccine Demonstrates Immunogenicity Proof-of-Concept in Pre-Clinical Studies.
Media Release -
https://www.sec.gov/Archives/edgar/data/1476963/000155837021003460/htbx-20201231x10k.htm. Internet-Doc 2021;.
Available from: URL: https://www.sec.gov/Archives/edgar/data/1476963/000155837021003460/htbx-20201231x10k.htm -
Heat Biologics Provides Update on COVID-19 Vaccine Efforts.
Media Release -
Heat Biologics Launches Program to Develop Vaccine Designed to Protect Against COVID-19 Coronavirus.
Media Release
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