TroVax (MVA 5T4) / Oxford Biomedica - LARVOL DELTA

A randomized phase II trial to examine modified vaccinia Ankara-5T4 vaccine in patients with relapsed asymptomatic ovarian cancer (TRIOC). (PubMed, Int J Gynecol Cancer) - P2 | "The majority of patients who received MVA-5T4 had clinical intervention later than those assigned to placebo. NCT01556841."

Clinical • Journal • P2 data • Gynecology • Obstetrics • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Characterization Of PD-1 And PD-L1 Expression In The Tumour Microenvironment Of Ovarian Cancer Using Fluorescence Immunohistochemistry: Results From The TRIOC Trial (ESGO 2024) - "Figure 1 shows an example of multiplex staining demonstrating the presence of PDL1 expression. Conclusion The expression of PD-L1, PD-1, and CD8, in ovarian tumour tissue, does not correlate with clinical response to the MVA-5T4 vaccination."

IO biomarker • Tumor microenvironment • Oncology • Ovarian Cancer • Solid Tumor • CD68 • CD8 • FOXP3 • PD-1 • PD-L1

VANCE: First-in-human phase I study of a novel ChAdOx1-MVA 5T4 vaccine in low and intermediate risk prostate cancer. (ASCO 2018) - P1; "However, neither of the two clinically most advanced PCa vaccines, Sipuleucel-T and ProstVac, induced strong T cell immunity. We report for the first time, that ex vivo T cell responses to a tumour self-antigen can be elicited in the majority of PCa patients. A Phase II study is starting to test this vaccine in combination with PD1 blockade in early stage and metastatic PCa."

P1 data • Prostate Cancer

[VIRTUAL] Phase I/II open label nonrandomized safety and efficacy study of the viral vectored ChAdOx1-MVA 5T4 immunotherapy in combination with PD-1 checkpoint blockade in intermediate-risk localized or locally advanced prostate cancer and advanced metastatic prostate cancer. (ASCO 2020) - P1, P1/2 | "Background: Antigen-specific immunotherapy (Sipuleucel-T) is licenced for the treatment for castrate resistant prostate cancer, but has modest clinical efficacy and is complex to administer to patients... Study design: ADVANCE, an open label non-randomised phase I/II study, will recruit 12 patients with intermediate-risk prostate cancer patients (Gleason score ≤ 7, local tumour stage ≤T3c, PSA≤ 20 ng/ml) scheduled to undergo radical prostatectomy (Cohort 1) and 24 mCRPC patients with disease progression on anti-androgen therapy with either enzalutamide or abiraterone (Cohort 2). Cohort 1 will receive one cycle of ChAdOx1-MVA 5T4 immunotherapy and a single nivolumab infusion...Research Funding: Grant agreement No. 602705"

Checkpoint inhibition • Clinical • Combination therapy • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

[VIRTUAL] TRIOC-A randomised phase II trial to examine MVA-5T4 vaccine in patients with relapsed asymptomatic epithelial ovarian, fallopian tube or primary peritoneal cancer (ESMO 2020) - P2 | "Funding: Oxford Biomedica. Clinical trial identification: EudraCT: 2011-001836-44."

Clinical • P2 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CA125

[VIRTUAL] Results from ADVANCE: A phase I/II open-label non-randomised safety and efficacy study of the viral vectored ChAdOx1-MVA 5T4 (VTP-800) vaccine in combination with PD-1 checkpoint blockade in metastatic prostate cancer (ESMO 2020) - P1, P1/2 | "Methods ADVANCE recruited mCRPC patients with disease progression on anti-androgen therapy with either enzalutamide or abiraterone. Patients received 2 cycles of ChAdOx1-MVA 5T4 (VTP-800) vaccination and three nivolumab infusions...602705 (Project IMPROVE) and Vaccitech Ltd. Clinical trial identification: NCT03815942."

Checkpoint inhibition • Clinical • Combination therapy • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

VANCE: First-in-human phase I study of a novel ChAdOx1-MVA 5T4 vaccine in low and intermediate risk prostate cancer. (ASCO 2018) - P1; "However, neither of the two clinically most advanced PCa vaccines, Sipuleucel-T and ProstVac, induced strong T cell immunity. We report for the first time, that ex vivo T cell responses to a tumour self-antigen can be elicited in the majority of PCa patients. A Phase II study is starting to test this vaccine in combination with PD1 blockade in early stage and metastatic PCa."

P1 data • Prostate Cancer

Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19 (clinicaltrials.gov) - P2/3; N=394; Active, not recruiting; Sponsor: NPO Petrovax; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

VAccination in Early and ADvanced Prostate caNCEr (clinicaltrials.gov) - P1/2; N=23; Active, not recruiting; Sponsor: University of Oxford; Recruiting ➔ Active, not recruiting; N=36 ➔ 23; Trial primary completion date: Dec 2020 ➔ Mar 2021

Checkpoint inhibition • Clinical • Combination therapy • Enrollment change • Enrollment closed • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety and immunogenicity of novel 5T4 viral vectored vaccination regimens in early stage prostate cancer: a phase I clinical trial. (PubMed, J Immunother Cancer) - P1 | "An excellent safety profile and T-cell responses elicited in the circulation and also detected in the prostate gland support the evaluation of the ChAdOx1-MVA 5T4 vaccine in efficacy trials. It remains to be seen if this vaccination strategy generates immune responses of sufficient magnitude to mediate clinical efficacy and whether it can be effective in late-stage PCa settings, as a monotherapy in advanced disease or as part of multi-modality PCa therapy. To address these questions, the phase I/II trial, ADVANCE, is currently recruiting patients with intermediate-risk PCa, and patients with advanced metastatic castration-resistant PCa, to receive this vaccine in combination with nivolumab."

Clinical • Journal • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD8 • KLK3

[VIRTUAL] DEVELOPMENT OF A NEXT GENERATION 24-VALENT PNEUMOCOCCAL CONJUGATE VACCINE USING SITE-SPECIFIC CARRIER PROTEIN CONJUGATION (ISPPD 2020) - "These results demonstrate the utility of CFPS technology in the production of the eCRM carrier protein that enables site-specific conjugation, creating the foundation for a next generation broad-valency PCV."

Infectious Disease

A single centre phase II trial to assess the immunological activity of TroVax® plus pemetrexed/cisplatin in patients with malignant pleural mesothelioma - the SKOPOS trial. (PubMed, Oncoimmunology) - "Translational immunology studies revealed a circulating baseline immune signature that was significantly associated with long-term (>20 months in n = 8/23, 34.8%) survival. In this phase 2 trial, TroVax® with pemetrexed-cisplatin chemotherapy showed robust immune activity, acceptable safety and tolerability to warrant further investigation in a phase 3 setting."

Clinical • Journal • P2 data • Biosimilar • Lung Cancer • Mesothelioma • Oncology • Solid Tumor • Thoracic Cancer

"#SutroVax Announces Name Change to #Vaxcyte https://t.co/3huRU04yzX" (@1stOncology)

Intratumoral delivery of modified vaccinia virus Ankara expressing human Flt3L as cancer immunotherapy (SITC 2016) - Ambassador: Jedd Wolchok; Abstract #P339; P=NA, N=NA; "Our results show that intratumoral injection of MVA or MVAΔE3L
leads to alteration of tumor immune suppressive microenvironment, which facilitates tumor antigen presentation, recruitment and activation of anti-tumor CD8+ and CD4+ T cells. MVAΔE3L is a stronger immune activator than MVA. Intratumoral delivery of MVAΔE3L-TK−-hFlt3L is more efficacious than MVAΔE3L. Current studies focuses on tumor infiltrating immune cells including CD103+ DCs and CD8+ cytotoxic T cells in MVAΔE3L-TK−-hFlt3L vs. MVAΔE3L-treated mice."

Preclinical • Melanoma KOL Tracker

Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19 (clinicaltrials.gov) - P2/3; N=394; Recruiting; Sponsor: NPO Petrovax

Clinical • New P2/3 trial

"SutroVax lands another $100M+ in upstart quest against Pfizer’s blockbuster Prevnar 13 https://t.co/t0XoVw2D4h" (@endpts)

Vaccination in Prostate Cancer (VANCE) (clinicaltrials.gov) - P1; N=40; Completed; Sponsor: University of Oxford; Active, not recruiting ➔ Completed

Clinical • Trial completion • MRI

TRIOC: The Activity of TroVax® Versus Placebo in Relapsed Asymptomatic Ovarian Cancer (clinicaltrials.gov) - P2; N=94; Completed; Sponsor: University College, London; Active, not recruiting ➔ Completed

Clinical • Trial completion

Safety, Reactogenicity, Immunogenicity, and Efficacy of Quadrivalent Inactivated Subunit Influenza Vaccine Grippol® Quadri and Trivalent Inactivated Polymer-Subunit Vaccine Grippol® Plus in Volunteers (clinicaltrials.gov) - P2/3; N=609; Completed; Sponsor: NPO Petrovax

Clinical • New P2/3 trial

VAccination in Early and ADvanced Prostate caNCEr (clinicaltrials.gov) - P1/2; N=36; Recruiting; Sponsor: University of Oxford

Checkpoint inhibition • Clinical • Combination therapy • New P1/2 trial