News
2024.02.14
Recently, Dx&Vx has reached agreement on key licensing terms, marking a significant milestone in the development of the anticancer vaccine OVM-200. The 36-month stability test was conducted by an independent institution. The finished pharmaceutical product was manufactured by Euro Amatsigroup N.V. through Good Manufacturing Practice (GMP).
OVM-200 is an immune anticancer agent manufactured using recombinant overlapping peptide (ROP) technology. Clinical trial phase 1a targeting ovarian cancer, prostate cancer, and lung cancer patients was completed across five major hospitals in the UK. The phase 1a results showed robust immune responses without stability issues. Currently, a phase 1b trial assessing the anticancer effects is underway in the UK, conducted by Oxford Backmedics, while Dx&Vx plan to conduct phase 1b/2 trials and expedite commercialization in countries including Korea, China, and India.
In contrast to the conventional method of chemically synthesizing peptides, Oxford Backmedics utilized Escherichia coli to enhance stability. Conducting a 36-month stability test for the peptide, comprising 287 amino acids, in aqueous solution poses challenges, particularly if there is not enough formulation confidence. In reality, the 'long-term stability testing' of a new drug is fraught with failure factors, prompting the Food and Drug Administration (FDA) in the United States to sometimes only review the testing plan through a special process called 'special protocol assessment' for companies applying for it.
A Dx&Vx spokesperson stated, "Securing stability for 36 months serves as evidence that the substance remains unchanged in quality over that period. From a clinical development perspective, it signifies the advantage of being able to administer the substance without issues over an extended period of clinical trials." They further added, "This indicates that the manufacturing process for this substance is adequately established to produce drugs of sufficient quality. OVM-200 could be developed as a product with a shelf life of at least 3 years, and preparations for its commercialization are progressing smoothly, providing evidence of readiness."
Meanwhile, Dex&VX is on the verge of finalizing the contract with Oxford Backmedics for the introduction of OVM-200, having agreed upon a Term Sheet. Clinical trials are scheduled to be conducted in Korea, China, and India within the year 2024 following the adoption of OVM-200.