Drugs / GX-188E
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01634503 | Nov 2012 → Feb 2014 | cervical intraepithelial neoplasia grade 2/3 | Genexine, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03444376 | Jun 2018 → Apr 2022 | cervical cancer | Genexine, Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05280457 | Apr 2022 → Jan 2027 expected | head and neck squamous cell carcinoma | Yonsei University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02596243 | Aug 2015 → Mar 2018 | cervical intraepithelial neoplasia | Genexine, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT02139267 | Jul 2014 → Mar 2016 | cervical intraepithelial neoplasia | Genexine, Inc. | Completed | Mixed |
| Phase not applicable1 trial | ||||||
| — | NCT03206138 | May 2017 → Oct 2018 | cervical intraepithelial neoplasia grade 2/3 | Seoul St. Mary's Hospital | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT05286060 Background | Mar 2022 → Oct 2026 expected | head and neck squamous cell carcinoma | Yonsei University | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2024-01-28 | NeoImmuneTech | Regulatory Phase II Study Expansion Investigating NeoimmuneTech’s NT-I7 in Head and Neck Cancer neoimmunetech.com ↗
NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a clinical-stage T cell-focused biopharmaceutical company, today announced the approval of additional cohorts in the Phase 2 study in head and neck cancer by the Korean Ministry of Food and Drug Safety (MFDS) |
| 2023-05-26 | Genexine, Inc. | Results Genexine abstract on GX-188E and GX-I7 triple combination therapy in HNSCC is released at 2023 ASCO Annual Meeting genexine.com ↗
Seven patients (63.6%) showed a major pathological response (MPR), and four patients (36.3%) achieved a pathological complete response (pCR), indicating satisfactory primary evaluation variables. |
| 2023-01-19 | Genexine, Inc. | Regulatory Genexine Receives Fast Track Designation from Korean Health Authority (MFDS) for its promising DNA vaccine for advanced cervical cancer genexine.com ↗
Genexine (KOSDAQ: 095700), a publicly traded, clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, today announced it received Fast Track Designation (FTD) from the Korean Ministry of Food and Drug Safety (MFDS) for GX-188E (tirvalimogene teraplasmid), its first-in-class proprietary therapeutic DNA vaccine. |
| 2023-01-09 | Genexine, Inc. | Results Genexine to present final Phase 2 clinical data on its cervical cancer program showing a 35.0% overall response rate and provide a corporate overview during JP Morgan conference genexine.com ↗
With a disease control rate (DCR) of 57.0%, the combination therapy was found effective in more than half of the patients. |
| 2022-09-09 | Genexine, Inc. | Results Genexine’s First-in-Class Therapeutic DNA Vaccine Shows Significant Potential to Extend Survival in Late-Stage Cervical Cancer genexine.com ↗
Late-Breaking presentation of phase 2 results from a clinical trial of GX-188E in combination with KEYTRUDA® (pembrolizumab) demonstrates anti-tumor benefit in heavily pre-treated, recurrent and advanced cervical cancer |
| 2021-05-20 | Genexine, Inc. | Results Genexine’s Cervical cancer therapeutic vaccine abstract released at ASCO 2021 genexine.com ↗
Additionally, PFS was 4.1 months and OS was 16.7 months which is highly upgraded data when it is compared to the Keytruda®’s monotherapy. |
| 2020-04-24 | Genexine, Inc. | Results Genexine presents cervical cancer DNA vaccine GX-188E and kytruda combined clinical results at Plenary session of the AACR in April genexine.com ↗
The combination therapy with DNA vaccine GX-188E has been significantly shown improved efficacy in patients with end-stage cervical cancer who have already received anti-cancer drugs and radiation therapy. |
| 2020-02-16 | Genexine, Inc. | Results Genexine attends the 38th JP Morgan Healthcare Conference genexine.com ↗
The HPV treatment vaccine, GX-188E, is undergoing phase 2a clinical trials with keytruda in patients with recurrent and metastatic cervical cancer, and has achieved the targeted treatment response rate early. |
| 2019-07-02 | Genexine, Inc. | Results Genexine’s HPV Therapeutic DNA Vaccine, GX-188E in Combination with KEYTRUDA® (pembrolizumab) enters into Stage 2 of Phase II Cervical Cancer Trial genexine.com ↗
Genexine Inc., a clinical stage biotechnology company developing innovative biologics, announced that GX-188E in combination with KEYTRUDA® (pembrolizumab) Phase II cervical cancer trial is entering into Simon Stage 2, after achieving targeted response rate in Stage 1. |
| 2017-06-19 | Genexine, Inc. | Regulatory Genexine Receives Approval to Initiate Phase Ib/II Trial of GX-188E, HPV Therapeutic DNA Vaccine, in Combination with KEYTRUDA® (pembrolizumab), for … genexine.com ↗ |
All press releases naming this drug 11 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GX-188E | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05280457 ↗ |
| Modality | Vaccine | “GX-188E, a DNA-based therapeutic vaccine” NCT01634503 ↗ |
| Route | Intramuscular | “intramuscular injection of GX-188E” NCT01634503 ↗ |