OVM-200 / Dx&Vx - LARVOL DELTA

Oxford Vaccine Medix (OVM), whose largest shareholder is DXVX, announced on the 20th that it recently achieved the Last Patient Out (LPO) milestone in the Phase 1 clinical trial of its flagship anticancer vaccine, OVM-200. [Google translation] (HIT News) - "36 patients with non-small cell lung cancer, prostate cancer, and ovarian cancer participated in the treatment for up to six months at four major hospitals in the UK."

Trial status • Non Small Cell Lung Cancer • Ovarian Cancer • Prostate Cancer

OVM-200-100: First-in-human Study of OVM-200 As a Therapeutic Cancer Vaccine (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Oxford Vacmedix UK Ltd. | Trial completion date: Dec 2024 ➔ Jan 2026 | Trial primary completion date: Dec 2024 ➔ Nov 2025

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

Turning the tumour-associated antigen survivin into a neoantigen-like cancer therapeutic vaccine (SITC 2024) - P1 | "Trial Registration First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine ClinicalTrials.gov ID NCT05104515 Sponsor Oxford Vacmedix UK Ltd...You should not expect to receive anything further relating to this application. Please now work with participating NHS organisations to confirm capacity and capability, in line with the instructions provided in the 'Information to support study set up' section towards the end of this letter.Download figure Open in new tab Download powerpoint Abstract 153 Figure 1 Patients groupingDownload figure Open in new tab Download powerpoint Abstract 153 Figure 2 T cell activityDownload figure Open in new tab Download powerpoint Abstract 153 Figure 3 Antibody levelDownload figure Open in new tab Download powerpoint Abstract 153 Figure 4 Cancer Biomarker"

Tumor-specific neoantigens • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • BIRC5 • CD4 • CD8 • KRAS

Dx&Vx Completes Due Diligence on UK OVM Anti-Cancer Vaccine [Google translation] (Medipana) - "DXVX announced on the 28th that it has successfully completed an on-site inspection with Oxford Vacmedix (OVM) in the UK for the license-in of its anti-cancer vaccine OVM-200 and discussions with Oxford University for joint research...During this on-site inspection, DXVX directly confirmed the excellent safety and efficacy of OVM-200 by checking the patent for OVM’s core technology, ROP (Recombinant Overlapping Peptide), the results of the UK phase 1a clinical trial, and the progress of phase 1b....In addition to the on-site inspection of OVM-200, discussions were held regarding collaboration with OVM and scientists at the University of Oxford. DX&VX plans to build an active cooperative relationship, including discussing new joint research projects with expert researchers at the University of Oxford to develop an innovative new drug pipeline."

Commercial • Trial status • Oncology • Solid Tumor

Dx&Vx and Medirama Sign MOU for Strategic New Drug Development [Google translation] (Medipana) - "DXVX announced on the 30th that it signed a business agreement (MOU) for strategic new drug development with Medirama, an anticancer drug development strategy consulting firm...This agreement was signed to accelerate the clinical development and commercialization of the DXVX pipeline by incorporating Medirama's clinical protocols and other clinical know-how, and to establish a new drug development strategy and implementation system....Through this MOU, DXVX plans to maximize synergy across all areas of new drug development, including clinical development and global business development strategies, starting with the therapeutic anticancer vaccine 'OVM-200'. In particular, clinical trials for the OVM-200 anticancer vaccine, which is about to sign a licensing agreement, are expected to begin in earnest."

Licensing / partnership • Oncology • Solid Tumor

DX&VX “Prototype mRNA anti-cancer vaccine, confirmed preclinical anti-cancer effect” [Google translation] (HIT News) - "DXVX announced on the 24th that its independently designed and synthesized circular messenger ribonucleic acid (mRNA) anticancer vaccine candidate showed excellent anticancer effects in the preclinical stage...DX&VX's prototype mRNA anti-cancer vaccine candidate mainly targets melanoma, and is also developing indications for various cancer types, including breast cancer. In this preclinical cell line test, it was confirmed that it had superior expression efficacy and excellent anticancer effect compared to linear mRNA, and is planning to enter the next stage of animal testing....Based on the results of this prototype mRNA preclinical study, DX&VX has applied for material patents for the recombinant overlapping peptide (ROP)-based anticancer vaccine of 'OVM-200', which is scheduled to be introduced within the year, and the research and development (R&D) pipeline under development in-house. I plan to prepare a presentation at an academic conference."

Preclinical • Oncology • Solid Tumor

First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Oxford Vacmedix UK Ltd. | Trial completion date: Mar 2024 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

DX&VX introduces anti-cancer vaccine ‘OVM-200’ and agrees on its own clinical trial [Google translation] (HIT News) - "DX&VX...announced on the 6th that it had agreed to introduce the anti-cancer vaccine 'OVM-200...with Oxford Vacmedix (OVM) of the UK...DX&VX and Oxford BackMedics agreed on a term sheet containing key details related to the license of OVM-200. The company explained that the outline of the down payment (Upfront) and amount for each milestone appears to have been revealed when signing this contract in the future....Currently, OVM-200 has completed phase 1a clinical trials and is currently undergoing phase 1b clinical trials. DX&VX plans to conduct domestic and overseas clinical trials of OVM-200 in various cancer types. He said that this term-sheet agreement is expected to speed up phase 1b clinical development and subsequent clinical development and commercialization."

Licensing / partnership • Trial status • Oncology • Solid Tumor

DxVx, plans to make a license-in agreement of OVM-200 and conduct clinical trials in Asia (PRNewswire) - "DxVx announces today that it will conduct its own clinical trials of OVM-200, an anti-cancer vaccine from Oxford Vacmedix (OVM) by license-in agreement and develop further with its own new drug development knowledge...Phase 1b clinical trials are under discussion to be conducted in the UK by OVM and in Asia, including Korea and China, by Dx&Vx...DxVx official said that they plan to complete the license-in process soon and proceed with Phase 1b and Phase 2 clinical trials in major Asian countries (Korea, China and considering India in the future). They will try to launch it through an accelerated approval that will allow patients to benefit early from effective drugs before all clinical trials are completed around 2027.....Dx&Vx is currently in the process of agreeing the licensing terms with OVM and coordinating the final details."

Licensing / partnership • Trial status • Oncology • Solid Tumor

DxVx Co., Ltd.'s affiliated company, Oxford Vacmedix (OVM) successfully completed Phase 1a in clinical trial of novel cancer vaccine OVM-200 (PRNewswire) - "DXVX announces that its affiliated company Oxford Vacmedix (OVM) has completed Phase 1a trial of cancer vaccine and plans to proceed Phase 1b trial of OVM-200....Oxford Vacmedix, the UK-based biopharma company focused on the development of vaccines to treat cancer announced today the successful completion of a Phase 1 trial of OVM-200 (OVM-200 is a cancer vaccine developed using OVM's novel recombinant overlapping peptide (ROP) platform)."

Trial status • Genito-urinary Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Oxford Vacmedix UK Ltd. | Trial completion date: Jan 2023 ➔ Mar 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • BIRC5 • MUC16

First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Oxford Vacmedix UK Ltd. | Trial primary completion date: Aug 2022 ➔ Dec 2022

Trial primary completion date • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • BIRC5 • MUC16

First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Oxford Vacmedix UK Ltd.

Clinical • New P1 trial • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • BIRC5 • MRI • MUC16