Drugs / BIZALIMOGENE RALAPLASMID
BIZALIMOGENE RALAPLASMID
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | dysplasia of cervix | 2017-06-08 | “resulting in the FDA removing the clinical hold on this program.” inovio.com ↗ |
| Clinical hold | US (FDA) | — | dysplasia of cervix | 2016-10-24 | “FDA has placed a clinical hold on its proposed phase III clinical program for VGX-3100.” inovio.com ↗ |
Trials 10
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-05-21 | Inovio Pharmaceuticals | Results Positive Topline Results from a Phase 3 Trial for VGX-3100 in Cervical Dysplasia Patients Announced by ApolloBio, INOVIO's Partner in China inovio.com ↗
INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that its partner for VGX-3100 in China, ApolloBio, announced positive topline results from its pivotal Phase 3 trial of VGX-3100, INOVIO's investigational DNA immunotherapy being developed as a potential treatment for cervical dysplasia. |
| 2023-05-10 | Inovio Pharmaceuticals | Results INOVIO Reports First Quarter 2023 Financial Results and Operational Highlights inovio.com ↗
Trial results achieved statistical significance in all-participants population |
| 2023-03-01 | Inovio Pharmaceuticals | Results INOVIO Reports Fourth Quarter and Full Year 2022 Financial Results and Clinical Highlights inovio.com ↗
Announces topline results from REVEAL2, the second Phase 3 trial evaluating VGX-3100 as a treatment for cervical high-grade squamous intraepithelial lesions (HSIL) |
| 2021-12-14 | Inovio Pharmaceuticals | Results INOVIO Highlights Key Updates on Phase 3 Program for VGX-3100, its DNA-based Immunotherapy for the Treatment of Cervical HSIL Caused by HPV-16 and/or HPV-18 inovio.com ↗
In addition, participants treated with VGX-3100 who met the primary endpoint at Week 36 remained clear of HPV-16 and/or HPV-18 at Week 88. |
| 2021-03-01 | Inovio Pharmaceuticals | Results INOVIO Reports Fourth Quarter 2020 and Year-End Financial Results inovio.com ↗
On March 1, 2021, INOVIO announced that it met primary and secondary efficacy endpoints among all evaluable subjects for the REVEAL 1 ( R andomized E valuation of V GX-3100 a nd E lectroporation for the treatment of Cervical HSI L ) trial. |
| 2021-03-01 | Inovio Pharmaceuticals | Results INOVIO Announces Positive Results from REVEAL 1, a Phase 3 Pivotal Trial Evaluating VGX-3100, its DNA-based HPV Immunotherapy for the Treatment of High-grade Precancerous Cervical Dysplasia Caused by HPV-16 and/or HPV-18 inovio.com ↗
All secondary efficacy endpoints were achieved. |
| 2021-01-06 | Inovio Pharmaceuticals | Results INOVIO's VGX-3100 Demonstrates Positive Phase 2 Efficacy In Treatment of Precancerous Vulvar Dysplasia Caused by HPV-16/18 inovio.com ↗ |
| 2020-12-09 | Inovio Pharmaceuticals | Results INOVIO's VGX-3100 Demonstrates Positive Phase 2 Efficacy In Treatment of Precancerous Anal Dysplasia Caused by HPV-16/18 inovio.com ↗
DNA immunotherapy candidate VGX-3100 demonstrated resolution of HPV-16/18-associated precancerous anal lesions in 50% of treated patients six months after treatment |
| 2020-03-30 | Inovio Pharmaceuticals | Results INOVIO Interim Results of an Open-Label Phase 2 Trial of VGX-3100 Show Efficacy Against HPV-associated Vulvar Dysplasia inovio.com ↗
Based upon the available results, 80% (8 out of 10 subjects) had a reduction (2 cm 2 on average) in qualifying lesion area (average 60% reduction) of which 20% (2 of 10) completely resolved their vulvar HSIL and had no virus detectable in the healed area, 6 months following treatment. |
| 2020-03-26 | Inovio Pharmaceuticals | Results INOVIO Reports Positive Interim Phase 2 VGX-3100 Results In Patients with HPV-associated Anal Dysplasia inovio.com ↗
The results support the ability of VGX-3100 to effectively treat multiple HPV associated diseases and will be presented in the virtual session of the annual American Society for Colposcopy and Cervical Pathology (ASCCP) meeting titled: Preliminary Results of an Open-label Phase 2 Study of VGX-3100 for the Treatment of HPV16 and/or HPV-18 (HPV16/18) related Anal HSIL. |
| 2019-05-06 | Inovio Pharmaceuticals | Regulatory Inovio Receives European Medicines Agency Certification For Quality and Non-Clinical Data for Its Phase 3 Product, VGX-3100 inovio.com ↗
Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced that its lead Phase 3 product candidate, VGX-3100, has been granted an Advanced Therapy Medicinal Product Certificate for quality and non-clinical data. |
| 2017-11-29 | Inovio Pharmaceuticals | Results Inovio’s Further Analysis of VGX-3100 Phase 2b Data Reveals Immune Correlates and Biomarker Signatures That Predicted Clinical Efficacy inovio.com ↗
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that post-hoc analysis of data generated from its phase 2b trial of VGX-3100 identified immune correlates and biomarker signatures predictive of treatment success. |
| 2016-10-24 | Inovio Pharmaceuticals | Regulatory Inovio Announces FDA Request for Additional Information For Phase III Program; Trial Initiation Delayed inovio.com ↗
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that the U.S. Food and Drug Administration ( FDA ) has placed a clinical hold on its proposed phase III clinical program for VGX-3100. |
| 2009-10-05 | CEL-SCI Corporation | Results Small-Cap Biotech Stocks To Keep An Eye On cel-sci.com ↗
Finally, Inovio Biomedical Corporation (NYSE AMEX: INO) announced interim safety and immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial and that could make it a big gainer. |
All press releases naming this drug 26 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BIZALIMOGENE RALAPLASMID | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297247 ↗ |
| Known as | Bizalimogen ralaplasmido | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297247 ↗ |
| Known as | Bizalimogene ralaplasmide | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297247 ↗ |
| Known as | PGX-3002 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297247 ↗ |
| Known as | VGX 3100 | “VGX-3100 is an investigational DNA-based immunotherapy being developed as an alternative to surgery and ablation for cervical High-Grade Squamous Intraepithelial Lesion (HSIL)...” PMID 33175656 ↗ Nov 202010“6 mg of VGX-3100 (2 separate DNA plasmids respectively encoding E6 and E7 proteins of HPV 16 and HPV 18)” NCT02163057 ↗ “INO-3112 i.e. the combination of VGX-3100 and INO-9012, specifically:” NCT02501278 ↗ “Biological: VGX 3100” NCT01304524 ↗ |
| Modality | Vaccine | “VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins” PMID 26386540 ↗ Sep 2015 |
| Route | Intramuscular | “given intramuscularly at 0, 4, and 12 weeks” PMID 26386540 ↗ Sep 2015 |