ABNCoV2 cVLP based COVID-2019 vaccine - AdaptVac
Alternative Names: ABNCoV2; ABNCoV2 Vaccine; ABNCoV2-cVLP based COVID-19 vaccine; Coronavirus vaccine - AdaptVac; COVID-19 cVLP vaccine - AdaptVac; COVID-19 vaccine - AdaptVac; cVLP-RBD; RBDn-CLPLatest Information Update: 23 Jan 2023
At a glance
- Originator AdaptVac
- Developer AdaptVac; Bavarian Nordic
- Class COVID-19 vaccines; Subunit vaccines; Synthetic vaccines; Viral vaccines; Virus-like particle vaccines
- Mechanism of Action Immunostimulants
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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
- Phase II COVID 2019 infections
Most Recent Events
- 23 Jan 2023 Bavarian Nordic completes phase-II trial in COVID-2019 infections (Prevention) in Germany (IM) (NCT05077267) (EudraCT2021-001393-31) (AdaptVac pipeline; January 2023)
- 19 Oct 2022 AdaptVac complete enrolment in its phase II trial in Covid-2019 infections in Germany
- 17 Oct 2022 Updated immunogenicity data from a phase II trial in Covid-2019 infections released by Bavarian Nordic
Development Overview
Introduction
ABNCoV2 capsid virus like particle (cVLP) based SARS-CoV-2 subunit vaccine is being developed by AdaptVac (joint-venture between ExpreS2ion Biotechnologies and NextGen Vaccines, a spin-out of the University of Copenhagen) for prevention against COVID-2019 infections caused by the SARS-CoV-2 virus. The company is using its universal viral Capsid-Like Particle (CLP) technology to develop the COVID 19 candidate. The protein based CLP approach, activates the immune system in a potentially synergistic manner. Clinical development is underway in Netherlands, and Germany.
AdaptVac's viral capsid-like particle technology enables quick adaptation of the vaccine to viral mutations. The company utilises the split-protein conjugation system to generate stable isopeptide bound antigen-virus -like particle (VLP) complexes by simply mixing of the antigen and VLP components.
In July 2020, Bavarian Nordic in-licensed the vaccine candidate from AdaptVac. As of April 2021, Bavarian Nordic is seeking funding for the development of the vaccine.
AdaptVac is a joint venture between ExpreS2 ion Biotechnologies and NextGen Vaccines, combining ExpreS2 ion’s platform with novel proprietary and ground-breaking viral capsid-like particle (CLP) technology developed at the University of Copenhagen.
Company Agreements
In July 2020, Bavarian Nordic and AdaptVac entered into the final license agreement to license AdaptVac’s proprietary capsid virus like particle (cVLP) technology for coronaviruses, including the COVID-19 indication. Under the terms of the agreement, Bavarian Nordic will get global commercialization rights to the COVID-19 vaccine. Bavarian Nordic will make an upfront payment of EUR 4 million to AdaptVac, in addition to potential future development and sales milestones and tiered royalties. In May 2020, Bavarian Nordic entered into an exclusive agreement with AdaptVac to license AdaptVac’s proprietary capsid virus like particle (VLP) based SARS-CoV-2 subunit vaccine. Both the parties seek to enter into the final license agreement within the next two months. Upon execution of a final license agreement, Bavarian Nordic will make an initial upfront payment to Adaptvac in addition to future development and sales milestones and royalties. [1] [2]
In April 2020, AdaptVac and AGC Biologics entered into the manufacturing agreement for manufacture and scale-up of the COVID-19 (SARS-CoV-2) coronavirus vaccine. This agreement leverages AGC Biologics global manufacture expertise to accelerate the development and GMP manufacture of the SARS-CoV-2 capsid-Virus Like Particle (cVLP) vaccine.
[3]
Key Development Milestones
As of January 2023, Bavarian Nordic completed phase-II trial in COVID-2019 infections (AdaptVac pipeline; January 2023). The company intends to investigate the ability of ABNCoV2 to boost existing immunity for the prevention against the current SARS-CoV-2 variants (NCT05077267; EudraCT2021-001393-31). The trial initiated in August 2021 and enrolled 210 patients in Germany into two groups: one group of 150 seropositive (prior disease or fully vaccinated) subjects will receive one 100 µg dose of ABNCoV2. Enrollment into this group will be stratified by seropositivity, i.e., previous COVID-19 disease or type of previous vaccination received, with at least 40 subjects enrolled in each stratification group. A second group of up to 60 seronegative subjects will receive two 100 µg doses of ABNCoV2, 28 days apart [4] [5] [6] [7] . In December 2021, the company released immunogenicity and adverse events data from the trial [8] . In February 2022, additional results from the trial were released by the company [9] . In May 2022, Updated immunogenicity data from the trial were released by Bavarian Nordic [10] . In October 2022, the company released updated immunogenicity data from the trial [11]
In February 2022, Bavarian Nordic in collaboration with Radboud University completed a first-in-human phase I/II COUGH-1 trial which was designed to evaluate safety and tolerability of ABNCoV2 cVLP based COVID-2019 vaccine for the prevention of COVID-2019 infections (NCT04839146; NL76192.000.20, NL9334). The open label, dose-escalation trial was initiated in March 2021 and enrolled 45 volunteers in the Netherlands [12] . In the same month, AdaptVac announced that the central committee on research involving human subjects (CCMO) in the Netherlands approved the clinical trial application (CTA) for ABNCoV2 cVLP based COVID-2019 vaccine to initiate phase I/II trial [13] . Earlier, in January 2021, ExpreS2ion Biotech submitted clinical trial application (CTA) to the Central Committee on Research Involving Human Subjects (CCMO) in the Netherlands for initiation of phase I/II study. This application was submitted based on the positive results from preclinical trials [see below] [14] [15] [16] . In August 2021, Bavarian Nordic released data from the trial [6] . In August 2021, AdaptVac released immunogenicity and safety data from the trial [17] .
In April 2021, Bavarian Nordic announced preclinical data confirming the promising results of ABNCoV2 that suggested broad protection against variants of the SARS-CoV2 virus [18] [19] .
In January 2021, the University of Copenhagen, ExpreS2ion Biotech, its joint venture partner AdaptVac and the PREVENT-nCoV consortium, released preclinical results of the ABNCoV2 cVLP based COVID-2019 vaccine [14] [20] . In March 2021, Bavarian Nordic released follow-up data from preclinical trial in the prevention of COVID-2019 infections [15] . In March 2021, Bavarian Nordic released additional data from the preclinical study [7] .
In November 2020 AdaptVac completed the GMP manufacturing of the vaccine [14] .
)
In June 2020, AdaptVac released preclinical data of COVID-2019 cVLP vaccine [21]
Financing information
In September 2021, Bavarian Nordic announced that the funding agreement entered with the Danish Ministry of Health to further advance the development of ABNCoV2, has been approved by the finance committee of the Danish Parliament, thereby finally executing the agreement. Earlier in August 2021, Bavarian Nordic had announced that the company entered a funding agreement with the Danish Ministry of Health and will receive an upfront payment of USD$12 million (DKK 80 million), in addition to payments of up to USD$11 million (DKK 720 million) for the development of ABNCoV2 cVLP and for completion of the ongoing phase II trial, phase III development milestones and milestones related to upscaling of manufacturing for commercial production of the vaccine [22] [23]
In March 2021, Bavarian Nordic announced that it has successfully completed a directed issue and private placement of 5,150,000 new shares at an offer price of DKK 223 per share, raising gross proceeds to Bavarian Nordic of DKK 1,148.45 million. In the same month, March 2021, Bavarian Nordic announced to raise new capital through an offering of new shares. The company intends to use the net proceeds of this offering for the funding of a phase II clinical study and scale-up of manufacturing to accommodate potential future clinical development to support licensure of ABNCoV2 cVLP based COVID-2019 vaccine, to continue strengthening of manufacturing and company’s capital base and cash preparedness (general corporate purposes) [24] [25] .
In March 2020, AdaptVac received an Horizon 2020 EU grant of €2.7 million as part of the PREVENT-nCoV consortium. The company intends to use the funds for development of the coronavirus vaccine as well as to support production of the needed clinical supply of viral capsid-like particles for clinical projects, including AV 001 [see Adis Insight Drug Profile800052950] [26] [27] .
Patent Information
In January 2020, AdaptVac was granted a US patent number 10 526 376 B2 “Virus-like particle with efficient epitope display" covering its viral capsid-like particle (CLP) technology platform, and any vaccine produced using it (including the Her2 immunotherapy, AV 001 [see Adis Insight Drug Profile 800052950]. The new patent expands AdaptVac’s protection, thereby covering the entire pipeline of vaccines and immunotherapies including the heart disease therapy, targeting cholesterol reduction, as well as a long list of viral, bacterial, and additional chronic disease vaccines. The patent is valid until 2036 [28] .
The University Of Copenhagen has pending patent applications CA 3 010 975 A1, EP 3 244 915 A1, EA 201 791 598 A8, WO 2016 112 921 A1 and AU 2016 207 099 A1, DE 16 703 049 T1 entitled "Virus like particle with efficient epitope display", covering its virus-like particle (VLP) based vaccine. The patent relates to a technology and method for making a virus-like particle based vaccine with efficient epitope display and capable of inducing a strong and long-term protective immune response. The patent is related to the use of VLP-based vaccine for the prophylaxis and/or treatment of a diseases including, but not limited to, cancer, cardiovascular, infectious, chronic, neurological, asthma, allergy, immune-inflammatory diseases or disorders [29] .
Drug Properties & Chemical Synopsis
- Route of administration IM
- Formulation Injection
- Class COVID-19 vaccines, Subunit vaccines, Synthetic vaccines, Viral vaccines, Virus-like particle vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B-X (Other viral vaccines)
-
EPhMRA code
J7E9 (All other viral vaccines)
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | Prevention | Phase II | Germany | IM / Injection | Bavarian Nordic | 23 Aug 2021 |
| COVID 2019 infections | - | Prevention | Phase I/II | Netherlands | IM / Injection | AdaptVac | 12 Mar 2021 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| AdaptVac | Originator | Denmark |
| AdaptVac | Owner | Denmark |
| Bavarian Nordic | Licensee | Denmark |
| University of Copenhagen | Technology Provider | Denmark |
| ExpreS2ion Biotechnologies | Technology Provider | Denmark |
| European Commission | Funder | Belgium |
| Leiden University Medical Center | Collaborator | Netherlands |
| University of Tubingen | Collaborator | Germany |
| Wageningen University | Collaborator | Netherlands |
Scientific Summary
Adverse Events
In phase I/II COUGH-I trial, vaccine was well tolerated across all dose groups with no observed difference in the adverse event profile after first and second vaccination. No serious adverse events were reported and the safety profile was comparable to other vaccines based on recombinant protein-technology. It was well tolerated even at doses beyond those that induce maximal immune responses. The was released for 45 volunteers [6] [17] [16] .
In a phase II trial, vaccination with ABNCoV2 in COVID-2019 infections, was safe and well-tolerated with no serious adverse events reported. The most frequent observations were local injection site reactions that resolved shorty after vaccination [4] [8]
Pharmacodynamics
Summary
In preclinical study, coronavirus vaccine induced high levels of virus neutralising antibodies in an animal model. The vaccine elicited antibodies in mice which effectively prevented live SARS-CoV-2 virus from infecting and killing human cells in an in vitro assay [21]
Preclinical results of the ABNCoV2 cVLP based COVID-2019 vaccine demonstrated a more than 100-fold higher level of neutralising antibodies, when compared with published preclinical animal data from approved COVID-2019 vaccines. The receptor-binding domain (RBD)-capsid-like particle (CLP) vaccines induced higher levels of serum anti-spike antibodies than the soluble RBD vaccines. Single injection of RBD-CLP vaccine in mice produced virus neutralisation antibody titers, which were comparable to those found in patients that had recovered from COVID-2019. Following booster vaccinations, the virus neutralisation titers exceeded those measured after natural infection, at serum dilutions above 1:10 000 [14] [20] .
In the follow up study, different dosing regimens of the vaccine with and without adjuvant showed that, single administration of low and high dose with adjuvant, but also the high dose without adjuvant induced SARS-CoV-2 neutralizing antibodies at comparable levels to those measured in convalescent human samples, while a second administration of non-adjuvanted ABNCoV2 led to >50-fold higher titters. Additionally, following a challenge with SARS-CoV-2, virus load was significantly reduced in all vaccinated groups, compared to non-vaccinated controls, and no virus could be detected at any timepoint in the majority of the subjects vaccinated with two high doses of ABNCoV2 [15] . Additionally published results demonstrated that, the vaccine showed similarly high levels of neutralizing antibodies against the SARS-CoV2 variants B.1.1.7 (UK) and B.1.351 (South African) [7] .
Immunogenicity
In phase I/II COUGH trial, in all dose groups, antibody titters were significantly higher after the boost vaccination and were up to 12-fold higher than those measured in convalescent human samples and significantly higher than those reported for current approved mRNA COVID-19 vaccines (up to 4.1 fold convalescent sera). High neutralisation titters were demonstrated against all SARS-CoV-2 variants of concern, including the dominant Delta variant and the escape Beta variant. High titred antibody responses were achieved even at the lowest dose ranges which was further improved in participants receiving 25 ug or higher doses of ABNCoV2 with or without adjuvant. The data was released for 45 volunteers [6] [17] [16] .
Updated results from a phase II trial six months post vaccination showed that neutralization titers were six times higher than pre-boost titers against Wuhan and nearly 10 times higher than the pre-boost titers for Omicron BA.1. This represented less than a 50% decline in the peak neutralizing titers after six months and compared to the data published for mRNA vaccines, antibody decay appears less sharp, indicating a potentially longer duration of protection across variants of concern [11] . Earlier results from a phase II trial in previously vaccinated subjects with approved mRNA or adenoviral vaccines, demonstrated that vaccination with ABNCoV2 induced a significant boost to the neutralising antibodies against the omicron variant in the majority of subjects (87%) with a fold increase in the same range as previously reported for the original Wuhan SARS-CoV2 variant. While the neutralizing antibody titers against Omicron were the lowest when compared to all other variants previously reported (Wuhan, Alpha, Beta and Delta) they were boosted to levels associated with a high level of protection across both dose groups, 50µg and 100µg [10] . Neutralizing antibodies reached levels reported to be associated with a high level of protection (>90%) [31] . Earlier data in a group of 66 seropositive subjects who received one lower dose (50 μg) of ABNCoV2 confirmed similar high neutralizing antibody levels against the same SARS-CoV-2 variants of concern as observed with the higher dose. In a group of 28 seronegative subjects, who had not been previously vaccinated or infected with SARS-CoV-2 received 2 doses of the 100 μg formulation of ABNCoV2 4 weeks apart. These data confirmed the high neutralizing levels reported from the phase I trial (COUGH-1 study), 2 weeks post second dose, with neutralizing antibody levels against the Wuhan variant elevated to levels reported to be highly efficacious (>90%) against SARS-CoV-2 [9] . In previous results from a phase II trial, vaccination with ABNCoV2 in COVID-2019 infections, a 2-34-fold increase in the levels of neutralizing antibodies against the Wuhan SARS-CoV2 variant was observed one week post-vaccination and peaked at two weeks with a 2-40-fold increase depending on the initial antibody levels. However, all participants were boosted whether there was a low or high initial neutralizing antibody level to absolute antibody levels reported to be associated with a very high efficacy (>90%) against SARS-CoV2. The same trend in terms of the fold-increases post the booster with ABNCoV2 was also observed for all other SARS-CoV2 variants tested, namely alpha, beta and delta [4] [8]
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Aug 2022 | Trial Update | Bavarian Nordic plans a phase III trial in COVID-2019 infections (Prevention) in August 2022 [30] | 26 Aug 2022 |
| 30 Dec 2021 | Regulatory Status | Bavarian Nordic intends to gain regulatory approval for COVID-2019 infections, before the end of 2021 (9301370) | 27 Aug 2020 |
| 31 Aug 2021 | Trial Update | Bavarian Nordic plans a phase II trial for COVID-2019 (Prevention) infections in Germany in Later in August 2021 [6] | 24 Aug 2021 |
| 12 Mar 2021 | Trial Update | AdaptVaC plans a phase I/IIa trial for COVID-2019 infections (Prevention) in Netherlands (Parenteral) in the March 2021 (700319708) [25] | 18 Mar 2021 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 23 Jan 2023 | Trial Update | Bavarian Nordic completes phase-II trial in COVID-2019 infections (Prevention) in Germany (IM) (NCT05077267) (EudraCT2021-001393-31) (AdaptVac pipeline; January 2023) Updated 23 Jan 2023 |
| 19 Oct 2022 | Trial Update | AdaptVac complete enrolment in its phase II trial in Covid-2019 infections in Germany [11] Updated 19 Oct 2022 |
| 17 Oct 2022 | Scientific Update | Updated immunogenicity data from a phase II trial in Covid-2019 infections released by Bavarian Nordic [11] Updated 19 Oct 2022 |
| 24 Aug 2022 | Trial Update | Bavarian Nordic plans a phase III trial in COVID-2019 infections (Prevention) in August 2022 [30] Updated 26 Aug 2022 |
| 05 May 2022 | Scientific Update | Updated immunogenicity data from a phase II trial in Covid-2019 infections released by Bavarian Nordic [10] Updated 11 May 2022 |
| 28 Feb 2022 | Scientific Update | Updated immunogenicity data from a phase II trial in Covid-2019 infections released by Bavarian Nordic [9] Updated 01 Mar 2022 |
| 25 Feb 2022 | Trial Update | Bavarian Nordic and Radboud University Medical Center completes a phase I/II trial in COVID-2019 infections (Prevention) in Netherlands (Parenteral) [12] Updated 23 Mar 2022 |
| 05 Dec 2021 | Scientific Update | Immunogenicity and safety data from a phase II trial in COVID-2019 infections released by Bavarian Nordic [8] Updated 08 Dec 2021 |
| 23 Aug 2021 | Financial Update | Bavarian Nordic receives funding from the Danish Ministry of Health for the development of ABNCoV2 cVLP based COVID-2019 vaccine [23] Updated 25 Aug 2021 |
| 23 Aug 2021 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections (Prevention) in Germany (IM) [5] Updated 24 Aug 2021 |
| 09 Aug 2021 | Trial Update | Bavarian Nordic plans a phase II trial for COVID-2019 (Prevention) infections in Germany in Later in August 2021 [6] Updated 24 Aug 2021 |
| 09 Aug 2021 | Scientific Update | Immunogenicity and adverse events data from phase I/II trial in COVID-2019 infections released by AdaptVac [17] Updated 12 Aug 2021 |
| 09 Aug 2021 | Scientific Update | Immunogenicity and adverse events data from phase I/II trial in COVID-2019 infections released by Bavarian Nordic [6] Updated 12 Aug 2021 |
| 09 Aug 2021 | Trial Update | Bavarian Nordic completes enrolment in its phase I/II COUGH-I trial in COVID-2019 infections (Prevention) in Netherlands [6] Updated 12 Aug 2021 |
| 29 Apr 2021 | Scientific Update | Pharmacodynamics data from a preclinical study in COVID-2019 infections released by Bavarian Nordic [7] Updated 04 May 2021 |
| 12 Mar 2021 | Phase Change - I/II | Phase-I/II clinical trials in COVID-2019 infections (Prevention) in Netherlands (Parenteral) [12] Updated 18 Mar 2021 |
| 11 Mar 2021 | Trial Update | Bavarian Nordic plans a phase III trial for COVID-2019 infections [25] Updated 11 Mar 2021 |
| 09 Mar 2021 | Trial Update | AdaptVaC plans a phase I/IIa trial for COVID-2019 infections (Prevention) in Netherlands (Parenteral) in the March 2021 [25] Updated 18 Mar 2021 |
| 09 Mar 2021 | Trial Update | Bavarian Nordic plans a phase II trial for COVID-2019 infections [25] Updated 11 Mar 2021 |
| 08 Mar 2021 | Regulatory Status | Central Committee on Research Involving Human Subjects (CCMO) approves clinical trial application (CTA) application for ABNCoV2 cVLP based COVID-2019 vaccine in COVID-2019 infections (Prevention) in Netherlands [13] Updated 15 Mar 2021 |
| 08 Mar 2021 | Scientific Update | Pharmacodynamics data from preclinical study in COVID-2019 infections (Prevention) released by Bavarian Nordic [15] Updated 09 Mar 2021 |
| 13 Jan 2021 | Regulatory Status | AdaptVac files an clinical trial application with the Central Committee on Research Involving Human Subjects in the Netherlands for COVID-2019 infections (Prevention) [14] Updated 18 Jan 2021 |
| 13 Jan 2021 | Scientific Update | Pharmacodynamics data from preclinical study in COVID-2019 infections released by AdaptVac, University of Copenhagen and ExpreS2ion Biotech [20] [14] Updated 18 Jan 2021 |
| 26 Aug 2020 | Regulatory Status | Bavarian Nordic intends to gain regulatory approval for COVID-2019 infections, before the end of 2021 Updated 27 Aug 2020 |
| 22 Jul 2020 | Licensing Status | Bavarian Nordic and AdaptVac signs license agreement on coronavirus vaccine [2] Updated 23 Jul 2020 |
| 09 Jun 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in Denmark (Parenteral) before June 2019 [21] Updated 11 Jun 2020 |
| 09 Jun 2020 | Scientific Update | Pharmacodynamics data from preclinical study in COVID-2019 infections released by AdaptVac [21] Updated 11 Jun 2020 |
| 06 May 2020 | Licensing Status | Corona virus vaccine licensed to Bavarian Nordic [1] Updated 10 May 2020 |
| 12 Mar 2020 | Licensing Status | Coronavirus vaccine - AdaptVac is available for licensing as of 12 Mar 2020. https://www.adaptvac.com/ Updated 12 Mar 2020 |
| 09 Mar 2020 | Phase Change | Early research in COVID-2019 infections (Prevention) in Denmark (Parenteral) [26] Updated 12 Mar 2020 |
| 07 Jan 2020 | Patent Information | AdaptVac has patent protection for viral capsid-like particle (CLP) technology platform and vaccines based on it in USA [28] Updated 12 Mar 2020 |
| 15 Jan 2015 | Patent Information | University Of Copenhagen has patents pending for virus like particle-based vaccine in Canada, Europe, Australia, Germany, Russia and World [29] Updated 12 Mar 2020 |
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