VaxCell-Bio said it received approval for Korea's first immunotherapy for dogs, Vaxleukin-15m, from the approval granted by the Animal and Plant Quarantine Agency on Thursday.

Vaxleukin-15 is a recombinant canine interleukin-15, a cytokine derived from canine leukocytes. It won the nod as an adjuvant therapy for dogs undergoing surgery for mammary tumors.

VaxCell-Bio conducted a clinical trial on 55 dogs that had received mammary tumor surgery, with 27 in the experimental group and 28 in the control group.

The results demonstrated that dogs treated with Vaxleukin-15 significantly improved in clinical symptoms and quality of life compared to those that underwent surgery alone. Besides, no adverse effects were observed post-administration, and safety was confirmed through physical and hematological examinations.

Notably, the trial showed a significant increase in interferon-gamma, a substance secreted by NK (natural killer) cells that induces the destruction of tumor cells, in the experimental group compared to the control group.

Also, the levels of vascular endothelial growth factor (VEGF), which stimulates tumor growth by promoting blood vessel formation around tumors, were significantly lower in the experimental group. Key safety indicators, including CRP (C-reactive protein) and D-dimer levels, remained within normal ranges throughout the clinical trial.

“Most pet cancer treatments currently on the market worldwide are repurposed human chemotherapy drugs, which pose a risk of adverse effects when used on animals,” VaxCell-Bio CEO Lee Je-jung said. “Vaxleukin-15 shows minimal side effects and high efficacy when combined with standard cancer treatments.”

The company plans to expand the indications of Vaxleukin to other types of cancer, including lymphoma, and is also developing an immunotherapy for cats.”

With the approval of Vaxleukin-15 in Korea, VaxCell-Bio is set to pursue technology transfer, exports, and expansion into international markets, the company said.