ELIAS Animal Health Clinical Dataset Supports FDA Fast Track Designation for TVAX Biomedical

Exciting progress in the fight against cancer for both pets and humans

On April 27, the US Food and Drug Administration (FDA) approved the application by our development partner, TVAX Biomedical, for Fast Track Designation for treatment of glioblastoma multiforme (GBM) with the immunotherapy technology ELIAS Animal Health is also using for treatment of osteosarcoma in dogs.

Founded on the principle of translational medicine, ELIAS is especially pleased to have supported this major achievement. The efficacy and safety data from the previously completed canine osteosarcoma study conducted by ELIAS was an important component of the TVAX Fast Track application and we are pleased that the results of that study contributed to the FDA’s approval of the GBM Fast Track application.

This is a significant accomplishment in that Fast Track Designation is not easily granted by the FDA and requires TVAX to provide evidence of its ability to successfully treat a disease whose treatment is a serious unmet medical need. Fast Track Designation provides TVAX with facilitated communication and guidance from the FDA with regard to clinical plans, product development, data collection and other benefits. Additionally, it affords TVAX with the opportunity to obtain Accelerated Marketing Approval and rolling review of sections of the BLA application. This process significantly reduces the time required to obtain marketing approval for a new human cancer treatment.

ELIAS is continuing the development of this exciting immunotherapy in osteosarcoma and other canine cancers in pursuit of licensure from the USDA Center for Veterinary Biologics.