- |||||||||| GNOS-PV02 / Geneos Therap, Keytruda (pembrolizumab) / Merck (MSD)
Personalized DNA neoantigen vaccine (GNOS-PV02) in combination with plasmid IL-12 and pembrolizumab as second-line (2L) treatment for advanced hepatocellular carcinoma (HCC) (205ABC) - Aug 4, 2022 - Abstract #SITC2022SITC_193; P1/2 Methods Patients with unresectable or metastatic HCC and progression or intolerance on first-line therapy with tyrosine kinase inhibitors (sorafenib or lenvatinib) are enrolled...Conclusions GNOS-PV02 + INO-9012 combined with pembrolizumab in the 2L setting was well tolerated and induced tumor-neoantigen-directed CD8+ T cells and TILs...Trial Registration NCT04251117 Ethics Approval For GT-30 trial, the protocols were approved by Johns Hopkins Medicine Review Boards (CR00039002/IRB00227771), Icahn School of Medicine-Program for the Protection of Human Subjects (20-00076 GCO#1), and Northern A Health and Disability Ethics committee (Ethics ref: 20/NTA), respectively. Written informed consent was obtained from each patient prior to the patient participating in the trial.
- |||||||||| neoantigen DNA vaccine / Washington University School of Medicine in St. Louis, AstraZeneca
Trial completion date, Trial primary completion date: Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - Jul 28, 2022 P1, N=12, Recruiting, Written informed consent was obtained from each patient prior to the patient participating in the trial. Trial completion date: Nov 2023 --> Nov 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| neoantigen DNA vaccine / Washington University School of Medicine in St. Louis, AstraZeneca
Trial completion date, Trial primary completion date: Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov) - Jul 1, 2022 P1, N=12, Recruiting, Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2022 --> Dec 2022 Trial completion date: Jul 2023 --> Nov 2023 | Trial primary completion date: Aug 2022 --> Dec 2022
- |||||||||| bizalimogene ralaplasmid (VGX-3100) / Inovio
Trial completion date, Trial primary completion date: VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions (clinicaltrials.gov) - Jun 21, 2022 P2, N=80, Recruiting, Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2022 --> Dec 2022 Trial completion date: Aug 2022 --> May 2024 | Trial primary completion date: Aug 2022 --> May 2024
- |||||||||| INO-5401 / Inovio, suratadenoturev (OBP-301) / Oncolys BioPharma, FHD-609 / Foghorn Therap
Journal: Targeted Therapy for Adrenocortical Carcinoma: A Genomic-Based Search for Available and Emerging Options. (Pubmed Central) - Jun 11, 2022 We identified TP53-modulating drugs to be possibly effective in 20-26% of patients, followed by the Wnt signaling pathway inhibitors (15%), Telomelysin and INO5401 (13%), FHD-609 (13%), etc. According to our data, 67% of ACC patients exhibited genomic alterations that might be targeted by FDA-approved drugs or drugs being tested in current clinical trials. Although there are not many current therapy options directly targeting reported ACC alterations, this study identifies emerging options that could be tested in clinical trials.
- |||||||||| AZD8076 / AstraZeneca, Inovio, AZD5396 / Inovio, AstraZeneca
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date: dMAbs for Prevention of COVID-19 (clinicaltrials.gov) - Jun 1, 2022 P1, N=24, Recruiting, These results support further development of INO-4800 for use as primary vaccine and booster. Not yet recruiting --> Recruiting | N=18 --> 24 | Trial completion date: May 2023 --> Nov 2023 | Trial primary completion date: May 2023 --> Nov 2023
- |||||||||| INO-4201 / Inovio
Trial completion, Trial primary completion date: Boost-EBOV: INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees (clinicaltrials.gov) - May 23, 2022 P1, N=46, Completed, Not yet recruiting --> Recruiting | N=18 --> 24 | Trial completion date: May 2023 --> Nov 2023 | Trial primary completion date: May 2023 --> Nov 2023 Not yet recruiting --> Completed | Trial primary completion date: Apr 2022 --> Jan 2022
- |||||||||| Journal: Immunotherapy for the Breast Cancer treatment: Current Evidence and Therapeutic Options. (Pubmed Central) - Apr 13, 2022
Immune checkpoint inhibitors (anti-PD-1/ anti-CTLA-4) and anti-cancer vaccines (NeuVax, Muc-1, AVX901, INO-1400 and CEA), either alone or in combination with other therapies have created new paradigm in therapeutic world. In this review, we highlighted the current immunotherapeutic aspects and their ongoing trials towards the better treatment regimen for BC.
- |||||||||| GNOS-PV02 / Geneos Therap
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: GT-30: GNOS-PV02 Personalized Neoantigen Vaccine, INO-9012 and Pembrolizumab in Subjects With Advanced HCC (clinicaltrials.gov) - Mar 31, 2022 P1/2, N=36, Recruiting, In this review, we highlighted the current immunotherapeutic aspects and their ongoing trials towards the better treatment regimen for BC. N=24 --> 36 | Trial completion date: Feb 2022 --> Aug 2023 | Trial primary completion date: Dec 2021 --> Jun 2023
- |||||||||| INO-4800 / Inovio, The Wistar Institute
Ino-4800! (Twitter) - Mar 28, 2022
- |||||||||| AZD8076 / AstraZeneca, Inovio, AZD5396 / Inovio, AstraZeneca
New P1 trial: dMAbs for Prevention of COVID-19 (clinicaltrials.gov) - Mar 23, 2022 P1, N=18, Not yet recruiting,
- |||||||||| bizalimogene ralaplasmid (VGX-3100) / Inovio
Review, Journal: Therapeutic DNA Vaccines against HPV-Related Malignancies: Promising Leads from Clinical Trials. (Pubmed Central) - Mar 17, 2022 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 with poor prognosis because of advanced, recurrent or non-resectable malignancies. Overall, the room for improvements is still large enough that continuing efforts for research and development will very likely extend into the next decade.
- |||||||||| MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Enrollment closed, Trial primary completion date, Metastases: DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov) - Feb 14, 2022 P2, N=77, Active, not recruiting, Recombinant vaccines against COVID-19 are continuously being applied, and new clinical trials have been tested by interchangeability studies of viral vaccines developed by classical and next-generation platforms. Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| rocakinogene sifuplasmid (INO-9012) / Inovio, INO-5401 / Inovio
Trial completion date, Trial primary completion date, Combination therapy, Metastases: INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma (clinicaltrials.gov) - Jan 18, 2022 P1/2, N=35, Active, not recruiting, 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. Trial completion date: Dec 2021 --> Jun 2022 | Trial primary completion date: Dec 2021 --> Jun 2022
- |||||||||| rocakinogene sifuplasmid (INO-9012) / Inovio, INO-1400 / Inovio, INO-1401 / Inovio
Clinical, P1 data, Journal, PD(L)-1 Biomarker, IO biomarker: Phase 1 study of safety, tolerability and immunogenicity of the human telomerase (hTERT)-encoded DNA plasmids INO-1400 and INO-1401 with or without IL-12 DNA plasmid INO-9012 in adult patients with solid tumors. (Pubmed Central) - Jan 12, 2022 Trial completion date: Dec 2021 --> Jun 2022 | Trial primary completion date: Dec 2021 --> Jun 2022 Plasmid DNA-encoded hTERT/IL-12 DNA immunotherapy was well-tolerated, immune responses were noted across all tumor types, and a specific CD8+ phenotype increased by the immunotherapy was significantly correlated with survival in patients with pancreatic cancer.
- |||||||||| bizalimogene ralaplasmid (VGX-3100) / Inovio
Enrollment closed: REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (clinicaltrials.gov) - Jan 11, 2022 P3, N=203, Active, not recruiting, Plasmid DNA-encoded hTERT/IL-12 DNA immunotherapy was well-tolerated, immune responses were noted across all tumor types, and a specific CD8+ phenotype increased by the immunotherapy was significantly correlated with survival in patients with pancreatic cancer. Recruiting --> Active, not recruiting
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