VTP-850 / Barinthus Bio, University of Oxford - LARVOL DELTA

Barinthus Bio Reports Second Quarter 2025 Financial Results and Updates on Corporate Developments (GlobeNewswire) - "Phase 1 trial of VTP-850 in patients with prostate cancer: The trial is now complete, with no treatment related SAEs reported. Data shows encouraging signs of immunogenicity and will be used to facilitate partnering discussions."

Trial status • Prostate Cancer

Barinthus Bio Reports Full Year 2024 Financial Results and Updates on Corporate Developments (GlobeNewswire) - "Topline results from the Phase 1 PCA001 clinical trial evaluating safety and efficacy of VTP-850 in men with rising prostate-specific antigen after definitive local therapy for prostate cancer (i.e., biochemical recurrence) are expected in the second quarter of 2025."

P1 data • Prostate Cancer

Prime-boost Immunotherapeutic Trial in Men with Biochemical Recurrence After Definitive Local Therapy for Prostate Cancer (clinicaltrials.gov) - P1/2 | N=22 | Terminated | Sponsor: Barinthus Biotherapeutics | N=144 ➔ 22 | Trial completion date: Apr 2027 ➔ Feb 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Aug 2026 ➔ Feb 2025; The trial was discontinued following completion of the Phase 1 portion. This discontinuation was not based on safety concerns.

Enrollment change • IO biomarker • Trial completion date • Trial primary completion date • Trial termination • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Barinthus Bio Reports Third Quarter 2024 Update on Corporate Developments and Financial Results (GlobeNewswire) - "In the first half of 2025, we expect to announce results of the Phase 1 PCA001 trial of VTP-850 in men with rising PSA after definitive local therapy for prostate cancer (i.e., biochemical recurrence)."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Barinthus Bio Completes Enrollment for…Phase 1 PCA001 Clinical Trial in Prostate Cancer (GlobeNewswire) - "Barinthus Biotherapeutics plc...announced the completion of enrollment for...PCA001, a Phase 1 clinical trial of VTP-850 in men with rising prostate-specific antigen (PSA) after definitive local therapy for prostate cancer (i.e., biochemical recurrence)....Data update for PCA001 anticipated in H1 2025."

Enrollment closed • P1/2 data • Prostate Cancer

Prime-boost Immunotherapeutic Trial in Men With Biochemical Recurrence After Definitive Local Therapy for Prostate Cancer (clinicaltrials.gov) - P1/2 | N=144 | Active, not recruiting | Sponsor: Barinthus Biotherapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • IO biomarker • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD4 • CD8 • MSI

Barinthus Bio Reports Full Year 2023 Financial Results and Update on Corporate Developments (GlobeNewswire) - "Research and development expenses: Research and development expenses were $44.9 million in 2023 compared to $42.4 million in 2022, demonstrating the progression of our pipeline through the clinic. Direct research and development expenses reduced $0.6 million, comprising of a...$2.3 million reduction as a result of VTP-850 getting into the clinic in a Phase 1/2 clinical trial in prostate cancer."

Commercial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Immunotherapeutic trial in men with biochemical recurrence after definitive local therapy for prostate cancer: A clinical trial in progress (SITC 2023) - P1/2 | "gov Identifier: NCT05617040 Background VTP-850 is a novel antigen-specific immunotherapeutic consisting of 2 nonreplicating viral-vectored components: ChAdOx1-PCAQ, based on an adenoviral vector, and MVA-PCAQ, based on a modified vaccinia virus Ankara (MVA) vector...They cannot have received ADT within 6 months prior to Day 1 and cannot have received prior chemotherapy, immunotherapy or experimental agent for prostate cancer. The trial is open in multiple centers in the USA."

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ACPP • IFNG • PSAP • STEAP1

Prime-boost Immunotherapeutic Trial in Men With Biochemical Recurrence After Definitive Local Therapy for Prostate Cancer (clinicaltrials.gov) - P1/2 | N=137 | Recruiting | Sponsor: Vaccitech (UK) Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Vaccitech Doses First Patient in PCA001, a Prostate Cancer Phase 1/2 Clinical Trial of VTP-850 Immunotherapeutic Candidate in Men with Rising PSA after Definitive Local Therapy (GlobeNewswire) - "Vaccitech plc...announced the dosing of the first patient in the PCA001 clinical trial (NCT05617040). PCA001 is a multi-centre, Phase 1/2 clinical trial designed to determine the recommended Phase 2 regimen and evaluate the safety, efficacy, as measured by prostate-specific antigen (PSA) response, and T cell response of VTP-850 monotherapy in men with rising PSA after definitive local therapy for their disease (i.e., biochemical recurrence). VTP-850 is a next-generation prostate cancer immunotherapeutic candidate which utilizes Vaccitech’s sequential dosing approach of two proprietary nonreplicating viral vectors, ChAdOx and MVA....The first phase of the trial is enrolling participants in the US, with plans to open further sites in Italy and Spain."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Prime-boost immunotherapeutic trial in men with biochemical recurrence after definitive local therapy for prostate cancer. (ASCO 2023) - P1/2 | "Background: VTP-850 is a heterologous prime-boost immunotherapeutic consisting of 2 nonreplicating viral-vectored components: ChAdOx1-PCAQ, based on an adenoviral vector, and MVA-PCAQ, based on a modified vaccinia virus Ankara (MVA) vector...Vardeu A et al 2022. Clinical trial information: NCT05617040."

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ACPP • IFNG • PSAP • STEAP1

Vaccitech Reports Full-Year 2022 Financial Results and an Update on Corporate Developments (GlobeNewswire) - "In 2023, the Company expects to: Announce the dosing of the first patient in PCA001, a Phase 1/2 clinical trial of VTP-850 designed to evaluate the safety, PSA response, and immunogenicity of the VTP-850 heterologous immunotherapeutic as monotherapy in men with rising PSA after definitive local therapy for their disease (i.e., biochemical recurrence)....Submit IND applications for its two lead SNAPvax candidates, VTP-1000 for the treatment of celiac disease and VTP-1100 for the treatment of HPV-associated cancers."

IND • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Prime-boost Immunotherapeutic Trial in Men With Biochemical Recurrence After Definitive Local Therapy for Prostate Cancer (clinicaltrials.gov) - P1/2 | N=137 | Not yet recruiting | Sponsor: Vaccitech (UK) Limited

New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Vaccitech Reports Third Quarter 2022 Financial Results and Recent Corporate Developments (GlobeNewswire) - "Upcoming Milestones - In the first quarter of 2023, the Company:...Expects to have FPFV for VTP-850 in our prostate cancer program; In 2023, the Company expects to...Have FPFV for VTP-1100 in our HPV cancer program."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Vaccitech Reports Second Quarter 2022 Financial Results and Recent Corporate Developments (GlobeNewswire) - "Upcoming Milestones: (i) In the fourth quarter of 2022, the Company expects to initiate dosing in a Phase 1/2 clinical trial of VTP-850 in patients with prostate cancer; (ii) In 2023, the Company expects to submit Investigational New Drug (IND) applications for its two lead SNAPvax candidates, VTP-1000 for the treatment of celiac disease and VTP-1100 for the treatment of HPV-associated cancers."

IND • New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor