MEDIA & PRESS UPDATES
December 1st, 2023
ADAPTVAC'S PHASE III VALIDATED cVLP PLATFORM CENTRAL TO NEW NIPAH VIRUS PANDEMIC PREPAREDNESS EFFORT
AdaptVac, a VICI-Disease consortium member, announces awarding of EU Horizon Europe grant for a Nipah virus vaccine development programme. The award amounts to €8M to develop vaccines against Nipah, Marburg and Sudan viruses pre-clinically and translate a Nipah virus vaccine to PhI/IIa safety and proof-of-concept clinical study within four years.
September 1st, 2023
EXCELLENT ABNCoV2 SAFETY DATA CONFIRMED IN PHASE 3 TRIAL, WHILE LATEST VARIANT REQUIRES UPDATE
The safety data for the ABNCoV2 phase 3 clinical trial from 4,205 individuals followed up for 2 months post vaccination showed that ABNCoV2 to be well-tolerated with no serious adverse events being reported. Additional safety data will be report for 6-month post vaccination at a later time point. Also, the primary endpoint was met by demonstrating non-inferiority to the market leader Pfizer/BioNtech Comirnaty® for the original SARS-CoV-2 variant (Wuhan index virus). However, ABNCoV2 and the comparator vaccine demonstrated a significantly reduced level of neutralizing antibodies against a circulating variant (Omicron XBB.1.5). This dictates that an update would be required to address the currently circulating and very distantly related Omicron variants, as is currently required for all marketed COVID-19 vaccines.
June 27, 2023
ABNCoV2 COVID-19 BOOSTER VACCINE CANDIDATE SUCCESFULLY MET ITS PRIMARY OBJECTIVE, DEMONSTRATING NON-INFERIORITY TO COMIRNATY® mRNA VACCINE IN PHASE 3 TRIAL
Bavarian Nordic reports:
- Booster study successfully met its primary objective, demonstrating non-inferiority to mRNA-vaccine
- Regulatory pathway will depend upon the outcome of secondary endpoints, reporting in the third quarter of 2023
The two-part study enrolled a total of 4,205 adults who either previously completed primary vaccination or had already received one booster dose of a licensed COVID-19 vaccine. The active, controlled part enrolled 622 participants who were randomized 1:1 to receive either a single 100 µg dose of ABNCoV2, or a single 30 µg adult booster dose of Comirnaty. The results from this group showed that ABNCoV2 was non-inferior to Comirnaty® in terms of neutralizing antibodies against the SARS-CoV-2 (Wuhan wild type), thus meeting the study’s primary objective.
The second part of the study, which is evaluating the safety and tolerability of a single 100 µg dose of ABNCoV2, has enrolled 3,583 participants into 2 cohorts according to whether they had completed primary vaccination only or primary plus booster vaccination. Results from this group will become available in the third quarter of 2023.
June 16, 2023
ABNCoV2 COVID-19 BOOSTER VACCINE CANDIDATE DEMONSTRATES DURABLE ANTIBODY RESPONSE 12 MONTHS AFTER VACCINATION IN PHASE 2 CLINICAL TRIAL
Bavarian Nordic reports: Results from 36 subjects, who had not received a booster dose outside of the trial and had no reports of COVID-19 disease or a positive PCR results for SARS-CoV-2 since vaccination in the study, showed that 12 months post booster with ABNCoV2, neutralizing antibodies against the Wuhan strain and the previous variants of concern (Beta, Delta and Omicron BA.4/5) remained at levels known to be associated with a high levels of protection (>90%). In a separate analysis the sera from a subset of subjects (n=40) enrolled into the Phase 2 trial were tested against a more distant Omicron variant (XBB.1.1). Two weeks post the ABNCoV2 booster, neutralizing antibodies against XBB.1.1 were induced in 43% of the subjects, at levels associated with a reduced level of efficacy (78%) compared to the original Wuhan strain.
January 19, 2023
ABNCoV2 COVID-19 VACCINE PHASE I CLINICAL STUDY RESULTS PUBLISHED IN THE LANCET MICROBE
The results from Adaptvac's COVID-19 vaccine candidate Phase I trial was published in the prestigious Lancet Microbe journal with the title: First-in-human use of a modular capsid virus-like vaccine platform: an open-label, non-randomised, phase 1 clinical trial of the SARS-CoV-2 vaccine ABNCoV2.
The study demonstrated excellent safety and strong immunogenicity for the ABNCoV2 Covid-19 vaccine, licensed to Bavarian Nordic, which is currently in a pivotal PhIII clinical study.
October 18, 2022
ABNCoV2 COVID-19 BOOSTER VACCINE CANDIDATE DEMONSTRATES DURABLE ANTIBODY RESPONSE SIX MONTHS AFTER VACCINATION IN PHASE 2 CLINICAL TRIAL
Bavarian Nordic reports: Six months post booster vaccination with ABNCoV2, the neutralization antibody titers against Wuhan and the Omicron variant remained high and at levels associated with a greater than 90% efficacy.
September 2, 2022
PHASE III COVID-19 CLINICAL TRIAL INITIATED TO COMPARE ABNCOV2 TO COMIRNATY®
AdaptVac, a PREVENT-nCoV consortium member, announces that a phase III clinical trial to evaluate ABNCoV2 capsid virus-like particle (cVLP) based COVID-19 vaccine has been initiated by Bavarian Nordic. The double-blind, controlled, non-inferiority trial will compare the neutralizing antibodies induced by non-adjuvanted ABNCoV2 and market leader Pfizer/BioNtech Comirnaty®, the licensed mRNA vaccine. Initial trial results are expected end-2022.
June 14, 2022
NEW EUROPEAN-AFRICAN PARTNERSHIP TO CONTRIBUTE TO THE FIGHT
AGAINST PLACENTAL MALARIA
AdaptVac, an ADVANCE-VAC4PM consortium member is pleased to announce that the EU has awarded €10 million to the consortium to advance the development of a safe, effective, and affordable placental malaria vaccine to protect pregnant women and their babies.
May 5, 2022
BAVARIAN NORDIC REPORTS OMICRON DATA FROM PHASE 2 TRIAL OF ABNCOV2 COVID-19 BOOSTER VACCINE CANDIDATE
Bavarian Nordic, the exclusive licensee of ABNCoV2 COVID-19 vaccine, today announced additional results from its Phase 2 clinical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 vaccine candidate. Data from subjects, who were previously vaccinated with approved mRNA or adenoviral vaccines, demonstrated that vaccination with ABNCoV2 induced a significant boost to the neutralizing antibodies against the Omicron variant in the majority of subjects 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.
March 25, 2022
ADAPTVAC WINS EY ENTREPRENEUR OF THE YEAR 2021 IN CATEGORY LIFE SCIENCES, DENMARK
Copenhagen, Denmark, March 25, 2022 – AdaptVac, announces winning the EY Entrepreneur Of The Year 2021 in the Life Sciences category for Denmark. The jury particularly emphasized the company's use of innovative technology, which opens up more opportunities in the future, as well as AdaptVac’s efforts towards development of the Danish COVID-19 vaccine.
December 5, 2021
POSITIVE TOPLINE RESULTS REPORTED FOR ABNCOV2 PHASE II COVID-19 VACCINE CLINICAL TRIAL
Hørsholm, Denmark, December 5, 2021 – AdaptVac, a PREVENT-nCoV consortium member, announces that the ABNCoV2 vaccine demonstrated a strong boosting effect in the clinical Phase II trial conducted by Bavarian Nordic. The existing levels of SARS-CoV-2 neutralizing antibodies increased by 2-40-fold, depending on the initial levels of antibodies, with no serious adverse events reported. Furthermore, this strong increase was observed to be similar for all variants tested (Wuhan, Alpha, Beta and Delta). The topline results confirm the vaccine’s excellent profile as a non-adjuvanted universal COVID-19 booster vaccine.
August 23, 2021
THE ABNCOV2 COVID-19 VACCINE PROGRAM RECEIVES UP TO DKK 800 MILLION FROM THE DANISH MINISTRY OF HEALTH
Bavarian Nordic, the exclusive licensee of the ABNCoV2 COVID-19 vaccine, will receive up to DKK 800 million in funding from the Danish Ministry of Health for a Phase III trial to confirm safety and demonstrate efficacy as a booster vaccine, the experimental development of the necessary production processes, and the works related to the required regulatory authorisations.
August 23, 2021
PHASE II COVID-19 CLINICAL TRIAL INITIATED TO EVALUATE ABNCOV2 AS A BOOSTER VACCINE
Hørsholm, Denmark, Aug 23, 2021 – AdaptVac, a PREVENT-nCoV consortium member, announces that a phase II clinical trial to evaluate the ABNCoV2 capsid virus-like particle (cVLP) based COVID-19 vaccine has been initiated by Bavarian Nordic. The trial will investigate the potential of ABNCoV2 as a booster vaccine for individuals with previous COVID-19 disease or vaccination. Initial trial results are expected in Q3/Q4 2021.
August 9, 2021
ABNCOV2 PHASE I/II SHOWS HIGH-LEVEL AND BROAD IN VITRO EFFICACY WITH LOW REACTOGENICITY
Hørsholm, Denmark, Aug 9, 2021 – AdaptVac, a PREVENT-nCoV consortium member, announces that the analysis for all dose groups in the ABNCoV2 phase I/II study demonstrated an excellent safety and reactogenicity profile and high-level SARS-CoV-2 in vitro live virus neutralization levels (up to 12 fold vs. convalescent sera) compared to reported levels for leading mRNA COVID-19 vaccines (up to 4.1 fold convalescent sera). High in vitro efficacy was achieved in all groups receiving ABNCoV2, including non-adjuvanted formulations. Importantly, high levels of cross-variant live viral in vitro neutralization were shown for variants of concern, including the dominant Delta and the escape Beta variant.
March 8, 2021
APPROVAL AND INITIATION OF THE COVID-19 CLINICAL PHASE I/II STUDY FOR THE ABNCOV2 VACCINE
Hørsholm, Denmark, March 08, 2021 – AdaptVac, a PREVENT-nCoV consortium member, announces that the clinical trial application (CTA) for a clinical phase I/II study for the ABNCoV2 capsid virus-like particle (cVLP) based COVID-19 vaccine has been approved by the Central Committee on Research Involving Human Subjects (CCMO) in the Netherlands. The clinical study is now planned to start March 12th with the enrolment of 42 study participants to investigate safety and secondary efficacy parameters.
February 2, 2021
ADAPTVAC SIGNS AV001 LICENSE AGREEMENT WITH EXPRES2ION
Hørsholm, Denmark, February 02, 2021 – AdaptVac announces that the company has signed the final License Agreement with ExpreS2ion Biotechnologies (“ExpreS2ion”) whereby ExpreS2ion exclusively licenses in AV001 (HER2-cVLP), a preclinical-stage novel breast cancer vaccine candidate, which ExpreS2ion plans to develop towards human clinical studies. According to the Agreement, ExpreS2ion pays an upfront fee of DKK 2.5 million (approx. EUR 0.34 million) upon signing, followed by aggregated milestone-based payments of DKK 215 million (approx. EUR 29 million) during development until market approval, and a lower single-digit percentage royalty based on net sales. Furthermore, as a consequence of exercising the option and signing the Agreement, the Shareholder Agreement between ExpreS2ion and NextGen Vaccines ApS (“NextGen”) is adjusted, with ExpreS2ion now owning 34% of AdaptVac, and NextGen owning 66% of AdaptVac.
November 16, 2020
SUCCESSFUL MANUFACTURE OF COVID-19 CVLP VACCINE
Hørsholm, Denmark, November 16, 2020 – AdaptVac, a PREVENT-nCoV consortium member, hereby announces that its capsid virus like particle (cVLP) based SARS-CoV-2 subunit vaccine has been successfully manufactured, full batch release to follow after final quality analysis. The project remains on track for delivery of initial PhI/IIa results in Q1 2021. Furthermore, the cVLP technology and the manufacturing processes were designed to enable rapid manufacture of new vaccines in response to potential COVID-19 mutations.
January 12, 2021
STRONG PRECLINICAL IMMUNIZATION DATA FOR THE ABNCOV2 CVLP BASED COVID-19 VACCINE PUBLISHED IN NATURE COMMUNICATIONS
Hørsholm, Denmark, January 12, 2021 – AdaptVac, a PREVENT-nCoV consortium member, hereby announces the publication of strong virus neutralization animal proof-of-concept data for its capsid virus like particle (cVLP) based SARS-CoV-2 subunit vaccine in Nature Communications. 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. The project remains on track for delivery of initial PhI/IIa results in Q1 2021.
July 22, 2020
BAVARIAN NORDIC AND ADAPTVAC SIGN FINAL LICENSE AGREEMENT ON COVID-19 VACCINE
Hørsholm, Denmark, July 22, 2020 – AdaptVac, a PREVENT-nCoV consortium member, hereby announces that AdaptVac has entered into a final license agreement with Bavarian Nordic, to license the proprietary capsid virus like particle (cVLP) based SARS-CoV-2 subunit vaccine. Under the terms of the agreement, Bavarian Nordic will make an upfront payment of 4 MEUR to AdaptVac, in addition to potential future development and sales milestones and single to double-digit percentage-tiered royalties. The total deal value, excluding royalties is up to 136 MEUR.
July 17, 2020
STRONG PROOF-OF-CONCEPT FOR BROADLY PROTECTIVE FLU CVLP
VACCINE FURTHER STRENGTHENS CONFIDENCE IN CORONAVIRUS VACCINE
Hørsholm, Denmark, July 17, 2020 – AdaptVac, today announced publication of a paper in the journal Vaccines, where its broadly protective Flu cVLP vaccine induced a more potent, long-lasting immune response and was able to protect mice against both homologous and heterologous H1N1 influenza challenge, even after a single dose.
June 09, 2020
COVID-19 CVLP VACCINE DEMONSTRATED AS EFFECTIVE IN MICE
Hørsholm, Denmark, June 09, 2020 – AdaptVac, a PREVENT-nCoV consortium member, today announced that its COVID-19 cVLP vaccine induced high levels of virus neutralizing 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.
May 6, 2020
BAVARIAN NORDIC ENTERS AGREEMENT WITH ADAPTVAC TO ADVANCE
COVID-19 VACCINE PROGRAM
Hørsholm, Denmark, May 06, 2020 – AdaptVac, a PREVENT-nCoV consortium member, today announced that it has entered into an exclusive head of terms agreement with Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY), to license AdaptVac’s proprietary capsid virus like particle (VLP) based SARS-CoV-2 subunit vaccine. The parties seek to enter into the final license agreement within the next two months.
April 24, 2020
MANUFACTURING AGREEMENT WITH AGC BIOLOGICS ACCELERATES
COVID-19 VACCINE PROGRAM
Hørsholm, Denmark, April 24, 2020 – AdaptVac, a PREVENT-nCoV consortium member, announces signing of agreement with AGC Biologics 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. This partnership has the potential to advance the initiation of the first clinical trial to the end of 2020.
March 9, 2020
ADAPTVAC’S GROUND-BREAKING TECHNOLOGY CENTRAL TO NEW €2.7M EU GRANT FUNDED COVID-19 VACCINE EFFORT
Hørsholm, Denmark, March 09, 2020 – AdaptVac announces that the company, as part of the PREVENT-nCoV consortium, has won a Horizon 2020 EU grant with total value of €2.7M. AdaptVac’s universal viral Capsid-Like Particle (CLP) will be employed to deliver an optimal vaccine against the SARS-CoV-2 virus ( COVID-19). The ambitious goal is to have the vaccine complete initial human clinical testing to show safety and efficacy within 12 months.
March 9, 2020
PREVENT-NCOV CONSORTIUM ANNOUNCES EU GRANT AWARD FOR COVID-19 VACCINE DEVELOPMENT PROGRAMME
Hørsholm, Denmark, March 09, 2020 – PREVENT-nCoV consortium announces awarding of EU Horizon 2020 grant for COVID-19 (SARS-CoV-2) Coronavirus vaccine development programme. The award amounts to 2,7 MEUR to develop and test the vaccine in PhI/IIa clinical studies within 12 months. The consortium members are AdaptVac; Institute for Tropical Medicine (ITM) at University of Tübingen; Department of Medical Microbiology, Leiden University Medical Center; Department of Immunology and Microbiology, University of Copenhagen; ExpreS2ion Biotechnologies; and Laboratory of Virology, Wageningen University.
February 26, 2020
ADAPTVAC SIGNS AV001 OPTION TO LICENSE AGREEMENT WITH EXPRES2ION
Hørsholm, Denmark, February 26, 2020 – AdaptVac announces that the company has signed an Option to License Agreement (“Agreement”) with ExpreS2ion Biotechnologies (“ExpreS2ion”) whereby ExpreS2ion may call an option to exclusively license in AV001 (HER2-cVLP), a preclinical-stage novel breast cancer vaccine candidate, which ExpreS2ion plans to develop towards human clinical studies. According to the Agreement, ExpreS2ion has the right to call the option to license in AV001 within 12 months. The option can entail a maximum amount of DKK 1.2M during the full option term.
February 25, 2020
DANISH AND DUTCH RESEARCH ORGANISATIONS RECEIVE A EUROSTARS GRANT FOR THE DEVELOPMENT OF A HIGHLY IMMUNOGENIC HER2-VACCINE AGAINST BREAST CANCER BY COMBINING THEIR STATE-OF-THE-ART TECHNOLOGIES
Hørsholm, Denmark; Oss, the Netherlands; February 25, 2020 – A consortium of Danish and Dutch research organisations led by AdaptVac ApS has been awarded a EUROSTARS grant for the further development of the AV001 vaccine against breast cancer. The combination of state-of-the art technologies revealed a highly immunogenic vaccine against human epidermal growth factor receptor 2 (HER2) expressed by cancer cells. With the support of EUROSTARS, we will be able to prove safety and immunogenicity in different in vivo models, finalize the production process and prepare for further clinical development. The envisaged vaccine could be an effective tool in the treatment of patients and in the delay of recurrence. The consortium consists of AdaptVac, ExpreS2ion Biotechnologies, and University of Copenhagen (Denmark), and LiteVax BV and the Biomedical Primate Research Centre (the Netherlands).
January 7, 2020
GRANTING OF ADAPTVAC’S CORE PLATFORM TECHNOLOGY PATENT IN THE UNITED STATES
Hørsholm, Denmark, January 07, 2020 – AdaptVac announces granting of its U.S. patent “Virus-like particle with efficient epitope display" by the USPTO. The patent provides intellectual property protection for the U.S. market of AdaptVac’s novel viral capsid-like particle (CLP) technology platform, and any vaccine produced using it (e.g. our Her2 immunotherapy, AV001). Furthermore, granting of the patent in the U.S. validates the patentability of AdaptVac’s technology platform patent portfolio, and represents a significant value inflection point for the company.
October 17, 2019
ADAPTVAC RECEIVES INNOBOOSTER GRANT TO SUPPORT PRE-CLINICAL DEVELOPMENT OF A HER2 VIRAL CAPSID-LIKE PARTICLE VACCINE (AV001)
Hørsholm, Denmark, October 17, 2019 – AdaptVac announces that it has been awarded an InnoBooster grant by the Danish Innovation Foundation worth 0.8M DKK. The grant provides further support for the viral-capsid based vaccine platform technology by potentially demonstrating a safe and effective treatment for pet dogs diagnosed with DER2+ cancer, the canine protein homologous to human epidermal growth factor receptor 2 (HER2). This project forms part of our pre-clinical development in support of a human clinical development program.
19 February, 2019
ADAPTVAC RECEIVES DKK 2.6 MILLION GRANT FOR VACCINE PROJECT TO DRAMATICALLY REDUCE ANTIBIOTIC USE IN THE SWINE INDUSTRY
Hørsholm, Denmark, February 19, 2019 – AdaptVac announces its participation in a new vaccine development project aimed at preventing post-weaning diarrhea (PWD), a major cause of antibiotic use in the swine industry. The project has been awarded a Grand Solutions grant worth DKK 11 million by the Danish Innovation Foundation, of which DKK 5 million supports Virus-Like Particle (VLP) platform technology development with DKK 2.6 million earmarked for AdaptVac.
20 December, 2018
ADAPTVAC RECEIVES INDUSTRIAL POST-DOCTORAL GRANT TO SUPPORT AV001 PRE-CLINICAL DEVELOPMENT
Hørsholm, Denmark, December 20, 2018 – AdaptVac announces that it has been awarded an Industrial grant by the Danish Innovation Foundation worth 1.2M DKK. The grant supports a three-year Ind. Post-Doctoral project focused on demonstrating AV001 as a safe and effective treatment for pet dogs diagnosed with HER2+ cancer. This project forms part of AV001’s pre-clinical development in support of AdaptVac’s human clinical development program.
20 December, 2018
ADAPTVAC RECEIVES INDUSTRIAL PHD GRANT AND INITIATES NEW VACCINE DEVELOPMENT RESEARCH PROGRAM IN CARDIOVASCULAR DISEASE
Hørsholm, Denmark, December 20, 2018 – AdaptVac announces that it has been awarded an Industrial PhD grant by the Danish Innovation Foundation worth DKK 1 million. The grant will support a three-year virus-like particle vaccine Ind. PhD research program focused on PCSK-9, a billion-dollar monoclonal antibody validated cardiovascular disease target.
10 September, 2018
GRANTING OF ADAPTVAC’S HER2 CANCER VACCINE PATENT IN THE UNITED STATES
Hørsholm, Denmark, September 10, 2018 – AdaptVac announces allowance of its U.S. divisional patent application “Virus-like particle with efficient epitope display" by the USPTO. The divisional patent provides intellectual property protection for the U.S. market of AdaptVac’s novel vaccine targeting HER2-positive cancer (AV001). Furthermore, allowance of the divisional patent in the U.S. validates the patentability of AdaptVac’s virus-like particle technology platform patent portfolio.
28 November, 2017
PROOF OF CONCEPT IN ANIMALS FOR ADAPTVAC’S BREAST CANCER VACCINE PUBLISHED IN SCIENTIFIC JOURNAL
AdaptVac announces that the scientific article "Virus-like particle display of HER2 induces potent anti-cancer responses" is published in the peer reviewed journal ´OncoImmunology´, and will be available online on November 28, 2017. The paper presents proof of concept in animals (POCA) for AV-001, AdaptVac’s novel vaccine targeting HER2 positive breast cancer tumours. The vaccine is demonstrated to be effective both in prevention and therapy of mammary carcinomas in HER2 transgenic mice.
18 October 2017
ADAPTVAC REACHES PROOF OF CONCEPT IN ANIMALS FOR BREAKTHROUGH BREAST CANCER VACCINE TREATMENT
AdaptVac announces that it has reached proof of concept in advanced animal models (POCA) for AV-001, its novel vaccine treatment against breast cancer tumours. This is a significant milestone for the Company in the progress towards clinical development. The Company will now initiate discussions with large pharmaceutical companies regarding a license or collaboration agreement for the clinical development of the project.