Drugs / GLS-5300
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02670187 | Feb 2016 → May 2017 | — | GeneOne Life Science, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03721718 | Aug 2018 → May 2019 | — | GeneOne Life Science, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2020-04-28 | Inovio Pharmaceuticals | Results INOVIO and GeneOne Life Science Report Positive Phase 1/2a Clinical Data With DNA Vaccine INO-4700 for MERS Coronavirus at the American Society of Gene & Cell Therapy (ASGCT) Conference inovio.com ↗
Vaccine recipients demonstrated strong antibody and T cell immune responses after 2 or 3 doses with 0.6 mg of INO-4700, a DNA vaccine that targets the MERS-CoV Spike (S) glycoprotein, delivered with intradermal CELLECTRA® device. |
| 2019-07-25 | Inovio Pharmaceuticals | Results Inovio's Positive First-in-Human MERS Vaccine Results Published in The Lancet Infectious Diseases inovio.com ↗
Subjects vaccinated with INO-4700 displayed robust levels of MERS antigen-specific antibody and T cell responses at week 14 (two weeks post-third dose). |
| 2018-06-27 | Inovio Pharmaceuticals | Results Inovio’s MERS Vaccine Generates High Levels of Antibodies and Induces Broad-based T Cell Responses in Phase 1 Study inovio.com ↗
Results for INO-4700, which is being co-developed by Inovio and GeneOne Life Science Inc. (KSE:011000), showed that the drug was well-tolerated and demonstrated overall high levels of antibody responses in roughly 95% of subjects, while also generating broad-based T cell responses in nearly 90% of study participants. |
| 2017-09-18 | Inovio Pharmaceuticals | Regulatory Inovio and Partners Initiate Phase 1/2a Clinical Trial To Further Advance Its Vaccine Against Deadly MERS Infection inovio.com ↗
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that the Korean Ministry of Food and Drug Safety approved the initiation of a study to evaluate GLS-5300, Inovio’s vaccine against the MERS virus (Middle East Respiratory Syndrome), in a phase 1/2a trial. |
| 2017-02-23 | Inovio Pharmaceuticals | Results Inovio Reports New Positive Clinical Data on Vaccine Advances in the Fight Against Emerging Infectious Diseases inovio.com ↗
Significant immune responses observed in 100% of Zika-vaccinated subjects and 98% of MERS-vaccinated human subjects in separate phase I studies |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-04-28 | Inovio Pharmaceuticals | INOVIO and GeneOne Life Science Report Positive Phase 1/2a Clinical Data With DNA Vaccine INO-4700 for MERS Coronavirus at the American Society of Gene & Cell Therapy (ASGCT) Conference inovio.com ↗ |
| 2019-07-25 | Inovio Pharmaceuticals | Inovio's Positive First-in-Human MERS Vaccine Results Published in The Lancet Infectious Diseases inovio.com ↗ |
| 2018-06-27 | Inovio Pharmaceuticals | Inovio’s MERS Vaccine Generates High Levels of Antibodies and Induces Broad-based T Cell Responses in Phase 1 Study inovio.com ↗ |
| 2017-09-18 | Inovio Pharmaceuticals | Inovio and Partners Initiate Phase 1/2a Clinical Trial To Further Advance Its Vaccine Against Deadly MERS Infection inovio.com ↗ |
| 2017-02-23 | Inovio Pharmaceuticals | Inovio Reports New Positive Clinical Data on Vaccine Advances in the Fight Against Emerging Infectious Diseases inovio.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GLS-5300 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03721718 ↗ |
| Modality | Vaccine | “GLS-5300 is a DNA plasmid vaccine” NCT02670187 ↗ |
| Route | Intramuscular | “administered by trained clinical site staff via a single intramuscular 1 mL injection” PMID 31351922 ↗ Jul 2019 |