VaxCell-Bio, a Korean biotech company, said it has applied for product authorization with the Animal and Plant Quarantine Agency for Vaxleukin-15, which aims to become "the world's first immunotherapy exclusively for dogs."

The company submitted the application after conducting clinical trials in 42 veterinary clinics nationwide, targeting 120 dogs with mammary tumors and lymphoma.

The trial phase for mammary tumors, a common cancer in dogs, has been completed, leading to the product authorization application. The company also plans to apply for an extended product authorization once the lymphoma trial concludes.

During pre-clinical trials involving healthy dogs, Vaxleukin-15 was shown to activate and proliferate natural killer (NK) cells and T-cells that target and kill cancer cells.

Notably, the concentration of tumor biomarkers, thymidine kinase 1 (TK1) and vascular endothelial growth factor (VEGF), exhibited a decreasing trend post-administration of the drug.

Also, there was no indication of any hematological or blood-chemical abnormalities or electrolyte imbalance.

Most cancer therapies for pets available globally had been originally developed for humans, potentially resulting in adverse reactions when administered to animals.

However, the company said that Vaxleukin-15 is different as it developed the treatment based on the pet's genome, not the human genome.

As a result, it poses minimal side effects and is anticipated to show increased efficacy when combined with standard cancer therapies.

According to the World Veterinary Association (WVA), one in four dogs globally is estimated to suffer from cancer. For those aged over ten, the number rises to over half. Considering that an estimated 4.73 million pet dogs are in Korea (as per the 2023 Korea Pet Report by KB), this translates to approximately 1.18 million dogs battling cancer.

"The cancer incidence rate in dogs is higher than in humans," VaxCell-Bio CEO Lee Je-jung said. "Many dogs silently suffer from cancer, and current therapies, being human-centric, pose low efficacy and side effects."

Vaxleukin-15, developed based on canine genomes, appears to show significant therapeutic efficacy with minimal side effects, Lee added.

Lee stressed that VaxCell-Bio plans to submit an abstract containing pre-clinical data of Vaxleukin-15 to the Korean Veterinary Medical Association and will officially announce the results at the 2023 annual conference.

In anticipation of Vaxleukin-15 authorization, VaxCell-Bio has established a new pet healthcare division within the company and is gearing up to enter the pet medical market.

The company is currently setting up and inspecting mass production facilities for Vaxleukin-15, with plans to sell the drug through veterinary clinics nationwide next year.

Separately, they are also preparing to launch an immune function supplement next month, suitable for both healthy dogs and those with cancer.