GX-19N / Genexine, Binex, GenNBio, PT Kalbe Farma - LARVOL DELTA

Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults (clinicaltrials.gov) - P1/2 | N=185 | Completed | Sponsor: Genexine, Inc. | Active, not recruiting ➔ Completed

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

Safety and Immunogenicity Study of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy Adults (clinicaltrials.gov) - P1/2 | N=60 | Terminated | Sponsor: Genexine, Inc. | Active, not recruiting ➔ Terminated; The sponsor decided to change the investigational product for a strategic reason.

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

Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Genexine, Inc. | Active, not recruiting ➔ Completed

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

Potentiating the Cross-Reactive IFN-γ T Cell and Polyfunctional T Cell Responses by Heterologous GX-19N DNA Booster in Mice Primed with Either a COVID-19 mRNA Vaccine or Inactivated Vaccine. (PubMed, Int J Mol Sci) - "Furthermore, the heterologous GX-19N boost induced higher S-specific polyfunctional CD4 and CD8 T cell responses than the homologous VP or mRNA prime-boost vaccinations. Our results provide new insights into booster vaccination strategies for the management of novel COVID-19 variants."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8 • IFNG

Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines (clinicaltrials.gov) - P2/3 | N=0 | Withdrawn | Sponsor: Genexine, Inc. | N=14000 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of two recombinant DNA COVID-19 vaccines containing the coding regions of the spike or spike and nucleocapsid proteins: an interim analysis of two open-label, non-randomised, phase 1 trials in healthy adults. (PubMed, Lancet Microbe) - P1/2 | "GX-19N shows lower neutralising antibody responses and needs improvement to enhance immunogenicity. The Korea Drug Development Fund, funded by the Ministry of Science and ICT, Ministry of Trade, Industry, and Energy, and Ministry of Health and Welfare."

Journal • P1 data • Fatigue • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity Study of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy Adults (clinicaltrials.gov) - P1/2; N=60; Active, not recruiting; Sponsor: Genexine, Inc.; Recruiting ➔ Active, not recruiting; N=210 ➔ 60; Trial primary completion date: Mar 2021 ➔ Dec 2021

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

Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults (clinicaltrials.gov) - P1/2; N=170; Active, not recruiting; Sponsor: Genexine, Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Mar 2022 ➔ Jun 2022

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

Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines (clinicaltrials.gov) - P2/3; N=14000; Not yet recruiting; Sponsor: Genexine, Inc.

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Genexine, Inc.

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

Soluble Spike DNA Vaccine Provides Long-Term Protective Immunity against SARS-CoV-2 in Mice and Nonhuman Primates. (PubMed, Vaccines (Basel)) - "Notably, when the immunized nonhuman primates were challenged at 10 weeks after the last vaccination with GX-19, they had reduced viral loads in contrast to non-vaccinated primates as a control. These findings indicate that GX-19 vaccination provides a durable protective immune response and also support further development of GX-19 as a vaccine candidate for SARS-CoV-2."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults (clinicaltrials.gov) - P1/2; N=170; Recruiting; Sponsor: Genexine, Inc.

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

South Korea approves human trial for Genexine's coronavirus treatment drug (WKZO) - "South Korean biotech firm Genexine Inc has received regulatory approval for a Phase I human clinical trial of its experimental coronavirus treatment drug, the Ministry of Food and Drug Safety said on Friday. Genexine has separately said it was conducting the Phase I trial of its coronavirus vaccine on 60 participants in South Korea and plans to announce its results in October."

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

Genexine: Pay Attention to HyFc Platform Technology (Business Korea) - "...Genexine is the first Korean player to begin phase I/II clinical trials for a Covid-19 vaccine—the results are expected to be announced around October....The company is forecast to begin phase II/III trials in December, with domestic approval expected to be won in 2H21."

New P2/3 trial • Non-US regulatory • P1/2 data • Infectious Disease • Novel Coronavirus Disease

Safety and Immunogenicity Study of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy Adults (clinicaltrials.gov) - P1/2; N=190; Recruiting; Sponsor: Genexine, Inc.

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

Turkish company Ilko joins Genexine's COVID-19 vaccine development (Ajunews Buisness Daily) - "Ilko Pharmaceuticals...will work with Genexine...for the development of GX-19, a DNA vaccine material for COVID-19 that has secured government approval to go ahead with clinical trials....Genexine said it has signed a memorandum of understanding with its Turkish partner, Ilko Pharmaceuticals, on cooperation in global clinical trials of GX-19 and the establishment of overseas licensing and supply chain."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease