DXNVX "Reviewing OVM-200 In-House Clinical Trials"

DxVx is promoting the in-house development of the therapeutic anticancer vaccine 'OVM-200' by introducing it from the UK-based Oxford Vacmedix (OVM). Currently, the vaccine has completed Phase 1a clinical trials in the first half of this year and is about to start Phase 1b trials.

OVM-200 secured satisfactory results in the Phase 1a clinical trial and recently published a research paper in the online journal Advanced Therapeutics. The Phase 1b trial is being negotiated to be conducted by OVM in the UK and by DxVx in Korea, China, and other parts of Asia.

'OVM-200' is a therapeutic vaccine that enters the body to eliminate cancer cells. Even if new cancer cells develop over time, immune cells remember and eradicate them.

In particular, the ROP (Recombinant Overlapping Peptides) technology applied to the OVM-200 anticancer vaccine significantly enhances immunity, thereby increasing the vaccine's effectiveness. Additionally, targeting Survivin, which is expressed in some cancers, and the fact that DxVx has a large team with experience and know-how throughout the entire process from drug development to commercialization are also considered differentiating factors.

OVM-200 is highly safe as it is a peptide vaccine. Vaccines using mRNA or virus particles, which gained attention during the COVID-19 pandemic, cannot be completely free from safety concerns. In contrast, recombinant protein-based vaccines have been clinically proven safe over a long period, offering a significant advantage in terms of safety.

Moreover, the approach of selecting a single antigen peptide works only for a limited range of human leukocyte antigens (HLA), which are identification molecules that help the immune system distinguish between self and foreign substances. However, peptide complexes are likely to act on a wider variety of HLAs (about 30 types), which is expected to improve therapeutic efficiency.

Furthermore, the ROP (Recombinant Overlapping Peptides) platform technology owned by OVM has superior advantages in production and cost compared to the conventional peptide complex technology, which produces and mixes multiple peptides separately. The ROP platform technology creates one long overlapping peptide that is cleaved into individual peptides by human enzymes in vivo. Therefore, it has advantages in CMC, production processes, and cost.

DxVx anticipates that once data show that OVM-200 helps improve the prognosis of cancer patients and prevents recurrence, it will also be possible to develop it as a preventive anticancer vaccine.

Safety is paramount for preventive vaccines, which are administered to healthy individuals who have not yet been diagnosed. Even minimal toxicity is unacceptable. OVM-200, as a traditional recombinant protein vaccine with clinically proven safety over a long period, is considered highly likely to succeed.

A DxVx official stated, "We plan to complete technology transfer within this year and conduct Phase 1b and Phase 2 trials in major Asian countries (Korea, China, and potentially India). We aim to launch the vaccine through accelerated approval before all clinical trials are completed around 2027, so that patients can quickly benefit from effective drugs. Of course, if necessary, we are also considering collaboration with global big pharma companies (joint development or technology transfer) during this period."

DxVx is currently in mutual agreement with OVM on licensing and is finalizing the last detailed conditions.

Meanwhile, OVM is a spin-off company from the University of Oxford in the UK, in which DxVx acquired about 43% of shares in 2018, becoming the largest shareholder. The company is developing anticancer vaccines based on ROP (Recombinant Overlapping Peptides) technology.