EuCorVac-19 / EuBiologics - LARVOL DELTA

Interim safety and immunogenicity analysis of the EuCorVac-19 COVID-19 vaccine in a Phase 3 randomized, observer-blind, immunobridging trial in the Philippines. (PubMed, J Med Virol) - P3 | "These data establish a relatively favorable safety and immunogenicity profile for ECV-19. The trial is registered on ClinicalTrials.gov (NCT05572879)."

Clinical • Journal • P3 data • P3 data: top line • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults (clinicaltrials.gov) - P3 | N=2600 | Completed | Sponsor: EuBiologics Co.,Ltd | Active, not recruiting ➔ Completed | Trial completion date: May 2024 ➔ Feb 2024

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

A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older (clinicaltrials.gov) - P3 | N=2852 | Completed | Sponsor: EuBiologics Co.,Ltd | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jan 2024 | Trial primary completion date: Jun 2024 ➔ Jan 2024

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older (clinicaltrials.gov) - P3 | N=4000 | Recruiting | Sponsor: EuBiologics Co.,Ltd | Trial completion date: May 2024 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Engineering Escherichia coli for constitutive production of monophosphoryl lipid A vaccine adjuvant. (PubMed, Biotechnol Bioeng) - "Monophosphoryl lipid A (MPLA) is a potent and safe adjuvant used in human vaccines, including the Shingles vaccine, Shingrix. Then, we applied EcML purified from KHSC0055 as an adjuvant for a COVID-19 vaccine candidate (EuCorVac-19) currently in clinical trial stage III in the Philippines. By probing the efficacy and safety of EcML in humans, we established KHSC0055 as an efficient cell factory for MPLA adjuvant production."

Journal • Herpes Zoster • Infectious Disease • Novel Coronavirus Disease • Varicella Zoster

A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults (clinicaltrials.gov) - P3 | N=2600 | Active, not recruiting | Sponsor: EuBiologics Co.,Ltd | Recruiting ➔ Active, not recruiting | N=4000 ➔ 2600 | Trial completion date: Nov 2023 ➔ May 2024

Enrollment change • Enrollment closed • Trial completion date • Infectious Disease • Novel Coronavirus Disease

Liposome-display of antigens: A powerful approach for vaccine development (VACCINES SUMMIT 2023) - "This approach has recently completed Ph3 testing in the EuCorVac-19 COVID-19 vaccine. Recent findings on this approach for rapid nanoparticle-based vaccine prototyping and emerging vaccine candidates using this technology will be discussed."

Infectious Disease • Novel Coronavirus Disease

One-year Antibody Durability Induced by EuCorVac-19, a Liposome-Displayed COVID-19 RBD Subunit Vaccine, in Healthy Korean Subjects. (PubMed, Int J Infect Dis) - P1/2 | "These data establish antibody durability of ECV-19, using a framework to analyze COVID-19 vaccine-induced antibodies during periods of high infection."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older (clinicaltrials.gov) - P3 | N=4000 | Recruiting | Sponsor: EuBiologics Co.,Ltd | Trial completion date: Oct 2023 ➔ May 2024 | Trial primary completion date: Jun 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Safety, Tolerance and Immunogenicity of EuCorVac-19 for the Prevention of COVID-19 in Healthy Adults (clinicaltrials.gov) - P1/2 | N=279 | Completed | Sponsor: EuBiologics Co.,Ltd | Active, not recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Sep 2022

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

A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older (clinicaltrials.gov) - P3 | N=4000 | Recruiting | Sponsor: EuBiologics Co.,Ltd | Trial primary completion date: Mar 2023 ➔ Jun 2023

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults (clinicaltrials.gov) - P3 | N=4000 | Recruiting | Sponsor: EuBiologics Co.,Ltd | Trial primary completion date: Mar 2023 ➔ Jun 2023

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Safety, Tolerance and Immunogenicity of EuCorVac-19 for the Prevention of COVID-19 in Healthy Adults (clinicaltrials.gov) - P1/2 | N=280 | Active, not recruiting | Sponsor: EuBiologics Co.,Ltd | Trial completion date: Jan 2023 ➔ Jun 2023

Trial completion date • Infectious Disease • Novel Coronavirus Disease

Safety, Tolerance and Immunogenicity of EuCorVac-19 for the Prevention of COVID-19 in Healthy Adults (clinicaltrials.gov) - P1/2 | N=280 | Active, not recruiting | Sponsor: EuBiologics Co.,Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

Interim analysis from a phase 2 randomized trial of EuCorVac-19: a recombinant protein SARS-CoV-2 RBD nanoliposome vaccine. (PubMed, BMC Med) - P1/2 | "ECV19 was generally well-tolerated and induced antibodies in a dose-dependent manner that neutralized SARS-CoV-2. The unique liposome display approach of ECV19, which lacks any immunogenic protein components besides the antigen itself, coupled with the lack of increased adverse events during boosting suggest the vaccine platform may be amenable to multiple boosting regimes in the future. Taken together, these findings motivate further investigation of ECV19 in larger scale clinical testing that is underway."

Journal • P2 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Respiratory Diseases

A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older (clinicaltrials.gov) - P3 | N=4000 | Recruiting | Sponsor: EuBiologics Co.,Ltd

New P3 trial • Infectious Disease • Novel Coronavirus Disease

A Phase III Study to Evaluate Immunogenicity and Safety of COVID-19 Vaccine EuCorVac-19 in Healthy Adults (clinicaltrials.gov) - P3 | N=4000 | Recruiting | Sponsor: EuBiologics Co.,Ltd

New P3 trial • Infectious Disease • Novel Coronavirus Disease

Safety, Tolerance and Immunogenicity of EuCorVac-19 for the Prevention of COVID-19 in Healthy Adults (clinicaltrials.gov) - P1/2; N=280; Recruiting; Sponsor: EuBiologics Co.,Ltd

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

EuBiologics Gets an IND Approval for Phase I/II Clinical Trial of ’EuCorVac-19’ in Korea (Businesswire) - "...EuCorVac-19, a COVID-19 vaccine candidate developed by EuBiologics, was approved to conduct Phase I/II clinical trials by the Ministry of Food and Drug Safety, immediately entering into the Phase I trial. The Phase I trial is designed for 50 healthy adults aged from 19 to 50 years old...The Phase II trial will be subsequently carried out for 230 adults aged from 19 to 75 years old...EuBiologics plans to consult with the Korean Ministry of Food and Drug Safety in order to progress the Phase III clinical trial later this year based on the interim results of the Phase I/II trial available no later than June 2021 and receive an emergency use approval of EuCorVac-19, as early as possible."

New P1/2 trial • P1/2 data • Infectious Disease • Novel Coronavirus Disease