VTP-800 / Barinthus Bio, University of Oxford - LARVOL DELTA

VAccination in Early and ADvanced Prostate caNCEr (clinicaltrials.gov) - P1/2 | N=23 | Terminated | Sponsor: University of Oxford | Unknown status ➔ Terminated; COVID stopped all trials - and ADVANCE could not restart again after the pandemic

Trial termination • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Vaccitech Reports Third Quarter 2021 Financial Results and Recent Corporate Developments (GlobeNewswire) - "In the fourth quarter, the Company expects to initiate dosing in a Phase 1/2a trial of VTP-600 in patients with non-small cell lung cancer in combination with a checkpoint inhibitor and chemotherapy. The trial is currently open for enrollment; In the second quarter of 2022, the Company expects to initiate dosing in a Phase 1/2a clinical trial of VTP-800/850, in combination with a checkpoint inhibitor, in patients with prostate cancer."

New P1/2 trial • Non Small Cell Lung Cancer • Oncology • 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] 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

Coronavirus Updates: The Latest Treatments and Vaccines - "'That trial did not find any difference in outcomes between the treatment and placebo,' said Yvonne Maldonado....Dr. Aruna Subramanian...lead investigator for the inpatient trial, said the 21 hospitalized patients in the study receive a high dose like Trump, a lower dose or a placebo. Subramanian plans to expand the inpatient trial to 45 patients. The outpatient study has enrolled a little more than 40 of the 60 patients researchers intend to sign up. 'There's enough promising evidence that it helps people early in the infection,' Subramanian said. 'What we don't know is whether it helps people who are pretty sick but not critically ill.'"

Clinical • Novel Coronavirus Disease

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

Vaccitech and Oxford University announce promising phase 2a data on prostate cancer immunotherapy (PipelineReview) - P1/2, N=36; ADVANCE (NCT03815942); “In the 23 mCRPC patients who received VTP-800 in conjunction with an anti-PD-1, 5 patients (22%) had a >50% reduction in PSA level at any timepoint compared to the baseline (median of 88 ng/ml). This compares favourably to the 9% response rate reported from a previous anti-PD-1 monotherapy study, KEYNOTE-199, which evaluated 243 mCRPC patients with similar baseline PSA levels. Additionally, four of the five ADVANCE patients (17.4%) maintained that response when tested three weeks later versus 5.8% in the KEYNOTE-199 study. One ADVANCE patient had a response with a PSA level of 0 at 24 weeks.…Results of the ADVANCE study will be presented at a scientific conference in H2 2020.”

P1/2 data

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

Clinical • Trial completion • MRI