VaxCell-Bio applies for approval of anti-cancer drug for dogs

South Korea’s VaxCell Biotherapeutics Co. (VaxCell-Bio) on Tuesday announced its application for approval for Vaxleukin-15, an anti-cancer drug candidate for pet dogs, with the Animal and Plant Quarantine Agency.

In preclinical trials on normal dogs, the company confirmed that the candidate drug activated and proliferated natural killer (NK) and T cells that remove cancerous cells. When measuring the tumor biomarkers TK1 and VEGF, the concentration of such biomarkers tended to decline after Vaxleukin-15 was administered, it added, with effectiveness and nearly no side effects seen.

Clinical trials were conducted on 120 dogs -- 60 for mammary tumors and 60 for lymphoma – at 29 veterinary institutions in the Seoul metropolitan area and 13 in Gwangju and South Jeolla Province. Application for product approval followed the trials for the tumors, which account for a high rate of cancer incidence in dogs.

VaxCell-Bio will apply for expanded approval as soon as its trials for the candidate drug’s effect on lymphoma are done.

With anti-cancer treatments for pets sold worldwide developed for human use, the company said Vaxleukin-15 is the world’s first of its kind specifically for dogs based on the canine genome, not that of a human. With practically no side effects, the candidate drug is highly effective when administered with standard treatment for each type of cancer.

At the end of this month, VaxCell-Bio will submit an abstract on preclinical data on Vaxleukin-15 to the Korean Society of Veterinary Science and at year’s end, it will make an official announcement about it at the organization’s international conference.

For entering the medical market for companion animals, VaxCell-Bio is opening a pet healthcare headquarters and building and inspecting a mass production plant for Vaxleukin-15. It plans to sell the latter through veterinary hospitals nationwide after obtaining approval next year.

Write to Ye-Na Kim at yena@hankyung.com