bizalimogene ralaplasmid (VGX-3100) / Inovio, ApolloBio - LARVOL DELTA

VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: AIDS Malignancy Consortium | Trial completion date: Jan 2027 ➔ Jun 2026 | Trial primary completion date: Jan 2026 ➔ Jun 2025

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Oncology • CD4

VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: AIDS Malignancy Consortium | Recruiting ➔ Active, not recruiting | N=80 ➔ 35 | Trial completion date: Sep 2029 ➔ Jan 2027 | Trial primary completion date: Sep 2029 ➔ Jan 2026

Enrollment change • Enrollment closed • IO biomarker • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Oncology • CD4 • PD-L1

Dezhan Health (000813.SZ): The VGX-3100 project is an ongoing research project of the company’s joint-stock company Dongfanglue Company [Google translation] (163.com) - "Dezhan Health...stated on the investor interaction platform that the VGX-3100 project is an ongoing research project of the company’s joint-stock company Dongfanglue Company. The project is currently undergoing Phase III clinical trials in China."

Clinical • Oncology • Solid Tumor

A Review of Clinical Trials of Cancer and Its Treatment as a Vaccine. (PubMed, Rev Recent Clin Trials) - "This brief discussion of vaccines and their varieties with examples also discusses vaccine clinical trials in relation to cancer diseases in this DNA and RNA-based cancer vaccine that has had successful clinical trials like the cervical cancer drug VGX-3100, the kidney cancer drug Pembrolizumab, MGN-1601, the prostate cancer drug pTVG-HP with rhGM-CSF, the melanoma cancer drug proteasome siRNA, and the lung cancer drug FRAME-001."

Journal • Review • Bladder Cancer • Cervical Cancer • Genito-urinary Cancer • Infectious Disease • Kidney Cancer • Lung Cancer • Melanoma • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: AIDS Malignancy Consortium | Trial completion date: May 2024 ➔ Sep 2029 | Trial primary completion date: May 2024 ➔ Sep 2029

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Oncology • CD4

REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (clinicaltrials.gov) - P3 | N=203 | Completed | Sponsor: Inovio Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Gynecology • IFNG

VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: AIDS Malignancy Consortium | Trial completion date: Aug 2022 ➔ May 2024 | Trial primary completion date: Aug 2022 ➔ May 2024

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Oncology • CD4

INOVIO Reports First Quarter 2022 Financial Results and Program Developments (PRNewswire) - "Based on feedback from the U.S. Food and Drug Administration (FDA), INOVIO has changed its development plans for VGX-3100 for HPV-16/18-associated cervical HSIL to a biomarker-selected population. In a recent preliminary letter, the FDA advised INOVIO that the REVEAL2 Phase 3 study would not be sufficient to support approval of a potential marketing application for VGX-3100 in that population....INOVIO will continue its REVEAL2 trial to completion and assess the path forward for the VGX-3100 program following analysis of the REVEAL2 results. Given the likelihood for at least one additional trial, INOVIO no longer expects to submit a BLA in 2023 for VGX-3100."

BLA • FDA event • Trial status • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Therapeutic DNA Vaccines against HPV-Related Malignancies: Promising Leads from Clinical Trials. (PubMed, Viruses) - "In 2014 and 2021, two nucleic-acid vaccine candidates named MAV E2 and VGX-3100 completed phase III clinical trials in Mexico and U.S., respectively, for patients with human papillomavirus (HPV)-related, high-grade squamous intraepithelial lesions (HSIL)...The major roadblocks to a highly efficacious and practical product remain challenging and can be classified into five categories: (i) getting the vaccines into the right cells for efficient expression and presentation of HPV antigens (fusion proteins or epitopes); (ii) having adequate coverage of oncogenic HPV types, beyond the current focus on HPV-16 and -18; (iii) directing immune protection to various epithelial niches, especially anogenital mucosa and upper aerodigestive tract where HPV-transformed cells wreak havoc; (iv) establishing the time window and vaccination regimen, including dosage, interval and even combination therapy, for achieving maximum efficacy; and (v) validating therapeutic efficacy in patients..."

Journal • Review • Cervical Cancer • Infectious Disease • Oncology • Solid Tumor

The Efficacy of Therapeutic DNA Vaccines Expressing the Human Papillomavirus E6 and E7 Oncoproteins for Treatment of Cervical Cancer: Systematic Review. (PubMed, Vaccines (Basel)) - "Five different DNA therapeutic vaccines (GX-188E, VGX-3100, pNGVL4a-CRT/E7(detox), pNGVL4a-Sig/E7(detox)/HSP70, MEDI0457) were well-tolerated and clinically effective. Clinical implementation of DNA therapeutic vaccines into treatment regimen as a sole approach or in combination with conservative treatment holds great potential for effective cancer treatment."

Journal • Review • Cervical Cancer • Gene Therapies • Gynecology • Oncology • Solid Tumor

REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (clinicaltrials.gov) - P3; N=203; Active, not recruiting; Sponsor: Inovio Pharmaceuticals; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Gynecology • IFNG

"$INO 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 https://t.co/od7wRQBB3j" (@stock_titan)

[VIRTUAL] VGX-3100 FOR TREATMENT OF HPV16/18 RELATED CERVICAL HSIL: RESULTS FROM A PHASE 3 STUDY (IPVC 2021) - No abstract available

P3 data

[VIRTUAL] VGX-3100 FOR THE TREATMENT OF HPV-16/18 ATTRIBUTABLE VULVAR HSIL: RESULTS OF A PHASE 2, OPEN LABEL TRIAL OF EFFICACY AND SAFETY (IPVC 2021) - No abstract available

Clinical • P2 data

"GX88, VGX3100, DNA vaccines for cervical cancer" (@aLwOmbaT)

Clinical • Cervical Cancer • Oncology • Solid Tumor

Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3) (clinicaltrials.gov) - P2; N=33; Completed; Sponsor: Inovio Pharmaceuticals; Active, not recruiting ➔ Completed; Trial completion date: Jul 2021 ➔ Dec 2020

Clinical • Combination therapy • Trial completion • Trial completion date • Oncology • IFNG

"Are you looking at HPV VGX-3100 vaccine from @InovioPharma" (@Dahar4322)

Clinical

VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL) in Individuals Seronegative for Human Immunodeficiency Virus (HIV)-1/2 (clinicaltrials.gov) - P2; N=22; Completed; Sponsor: Inovio Pharmaceuticals; Active, not recruiting ➔ Completed

Trial completion • Anal Carcinoma • Human Immunodeficiency Virus • Immunology • Infectious Disease • Oncology • Pain • PCR

REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (clinicaltrials.gov) - P3; N=201; Completed; Sponsor: Inovio Pharmaceuticals; Active, not recruiting ➔ Completed

Clinical • Trial completion • Gynecology • IFNG

REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (clinicaltrials.gov) - P3; N=198; Recruiting; Sponsor: Inovio Pharmaceuticals; Trial completion date: May 2021 ➔ Aug 2022; Trial primary completion date: Apr 2021 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • Gynecology • IFNG

REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (clinicaltrials.gov) - P3; N=198; Recruiting; Sponsor: Inovio Pharmaceuticals; Trial completion date: Aug 2020 ➔ Apr 2021; Trial primary completion date: Aug 2019 ➔ Apr 2020

Clinical • Trial completion date • Trial primary completion date • Gynecology • IFNG

REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (clinicaltrials.gov) - P3; N=200; Active, not recruiting; Sponsor: Inovio Pharmaceuticals; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Gynecology • IFNG

REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (clinicaltrials.gov) - P3; N=198; Not yet recruiting; Sponsor: Inovio Pharmaceuticals

Clinical • New P3 trial • Gynecology • IFNG

REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (clinicaltrials.gov) - P3; N=198; Recruiting; Sponsor: Inovio Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gynecology • IFNG

VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions (clinicaltrials.gov) - P2; N=80; Recruiting; Sponsor: AIDS Malignancy Consortium; Trial completion date: Sep 2021 ➔ Aug 2022; Trial primary completion date: Jan 2021 ➔ Aug 2022

Clinical • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Oncology • CD4