ABNCoV2 / University of Copenhagen, Leiden University Medical Center, Bavarian Nordic, AdaptVac, ExpreS2ion, University of Tuebingen - LARVOL DELTA

ABNCoV2 Vaccine in SARS-CoV-2 (COVID-19) Seronegative and Seropositive Adult Subjects (clinicaltrials.gov) - P2 | N=197 | Completed | Sponsor: Bavarian Nordic | Active, not recruiting ➔ Completed | Trial completion date: Feb 2024 ➔ Oct 2023

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Protection of K18-hACE2 Mice against SARS-CoV-2 Challenge by a Capsid Virus-like Particle-Based Vaccine. (PubMed, Vaccines (Basel)) - "Finally, the RBD-cVLP vaccine has a similar antigen composition to the clinical ABNCOV2 vaccine, which has shown non-inferiority to the Comirnaty mRNA vaccine in phase I-III trials. Therefore, our study provides evidence that this vaccine design is highly immunogenic and confers full protection against severe disease in mice."

Journal • Preclinical • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

ABNCoV2-03: ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2 (clinicaltrials.gov) - P3 | N=4223 | Completed | Sponsor: Bavarian Nordic | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

ABNCoV2-03: ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2 (clinicaltrials.gov) - P3 | N=4000 | Active, not recruiting | Sponsor: Bavarian Nordic | Recruiting ➔ Active, not recruiting | Trial completion date: May 2023 ➔ Sep 2023 | Trial primary completion date: Dec 2022 ➔ Apr 2023

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

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. (PubMed, Lancet Microbe) - P1 | "Immunisation with ABNCoV2 was well tolerated, safe, and resulted in a functional immune response. The data support the need for additional clinical development of ABNCoV2 as a second-generation SARS-CoV-2 vaccine. The modular cVLP platform will accelerate vaccine development, beyond SARS-CoV-2."

Journal • P1 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • IFNG

ABNCoV2-03: ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2 (clinicaltrials.gov) - P3 | N=4000 | Recruiting | Sponsor: Bavarian Nordic | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of ABNCoV2, a virus-like particle based vaccine against COVID-19 in a phase 2 trial in healthy adults (V-Congress 2022) - No abstract available

Clinical • P2 data • Infectious Disease • Novel Coronavirus Disease

A Capsid Virus-Like Particle-Based SARS-CoV-2 Vaccine Induces High Levels of Antibodies and Protects Rhesus Macaques. (PubMed, Front Immunol) - "Upon SARS-CoV-2 challenge, a significant reduction in viral load was observed for both vaccine groups relative to the challenge control group, with no evidence of enhanced disease. Remarkably, neutralizing antibody titers against an original SARS-CoV-2 isolate and against variants of concern were comparable, indicating a potential for broad protection afforded by ABNCoV2, which is currently in clinical testing."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"Frontiers in Immunology publishes article about ABNCoV2 https://t.co/HCx0Aug35d" (@CisionNews)

Immunology

ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2 (clinicaltrials.gov) - P3 | N=4000 | Not yet recruiting | Sponsor: Bavarian Nordic

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COUGH-1: Safety and Tolerability of COVID-19 Vaccine (ABNCoV2) (clinicaltrials.gov) - P1 | N=45 | Completed | Sponsor: Radboud University Medical Center | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

ABNCoV2 Vaccine in SARS-CoV-2 (COVID-19) Seronegative and Seropositive Adult Subjects (clinicaltrials.gov) - P2 | N=197 | Active, not recruiting | Sponsor: Bavarian Nordic | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"The week ahead Events #GI22: abstracts release - 18 Jan at 11pm CET / 5pm ET $ASND: TransCon PTH Ph3 data in hypoparathyroidism - Q1'22 $AUTL: Obe-cel Ph1 data in peripheral CNS lymphoma - Q1'22 $BAVA: ABNCoV2 additional Ph2 data booster study - Q1'22 1/2" (@KempenLS)

CNS Lymphoma • Endocrine Disorders • Gastrointestinal Cancer • Hematological Malignancies • Hypoparathyroidism • Lymphoma • Oncology • Renal Disease

COUGH-1: Safety and Tolerability of COVID-19 Vaccine (ABNCoV2) (clinicaltrials.gov) - P1; N=45; Active, not recruiting; Sponsor: Radboud University; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

ABNCoV2 Vaccine in SARS-CoV-2 Seronegative and Seropositive Adult Subjects (clinicaltrials.gov) - P2; N=210; Recruiting; Sponsor: Bavarian Nordic

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COUGH-1: Safety and Tolerability of ABNCoV2 (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: Radboud University

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Bavarian Nordic publishes annual report for 2020 (GlobeNewswire) - "In March 2021, the company published promising preclinical results for the COVID-19 vaccine candidate ABNCoV2, which is in-licensed from AdaptVac. Subsequently, the first human experiment has been started....In 2021, research and development costs of approx. DKK 750 million, of which approx. DKK 550 million is expected to be recognized in the income statement. The largest single project in 2021 is the RSV program...The remaining approx. DKK 200 million will be capitalized and related to the COVID-19 program and includes a Phase 2 trial as well as upscaling of production as part of the preparations for a Phase 3 trial."

Commercial • Preclinical • Trial status • Infectious Disease • Novel Coronavirus Disease

Bavarian Nordic Enters Agreement with AdaptVac to Advance COVID-19 Vaccine Program (GlobeNewswire, Bavarian Nordic A/S) - "Bavarian Nordic A/S...today announced that it has entered into an exclusive head of terms agreement with AdaptVac...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.... AdaptVac’s technology has the potential to mimic a virus to the body’s immune system, giving the optimal stimulus to generate a fast, long-lasting immune response that offers a highly efficacious protection....AdaptVac is working with AGC Biologics for the manufacture and scale-up of the vaccine. Bavarian Nordic will support the consortium to achieve clinical proof of concept and takes responsibility for clinical development and global commercialization of the vaccine. Current plan is to initiate a clinical study later this year."

Clinical • Commercial • Licensing / partnership • New molecule • New trial • Infectious Disease • Novel Coronavirus Disease

AdaptVac partners with AGC Biologics to develop & produce Covid-19 vaccine (PRNewswire) - "AGC Biologics...announced it is partnering with AdaptVac to develop and produce a COVID-19 vaccine. AdaptVac, together with its EU Horizon 2020 sponsored PREVENT-nCoV consortium partners, are developing a SARS-CoV-2 vaccine....AdaptVac's technology allows the rapid development of a COVID-19 vaccine to begin clinical trials in late 2020."

Licensing / partnership • New molecule • Infectious Disease • Novel Coronavirus Disease