USDA approves new canine cancer therapy

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ELIAS Animal Health, a companion animal cancer therapeutics company, shared today that the USDA Center for Veterinary Biologics (USDA CVB) issued a full approval for its ELIAS Cancer Immunotherapy (ECI). This latest treatment is the first autologous prescription product to receive approval from the USDA-CVB for treating canine osteosarcoma.

“At ELIAS Animal Health, our commitment to advancing animal health and improving the lives of pets and their families is at the core of everything we do,” said Tammie Wahaus, CEO of ELIAS Animal Health, in an organizational release.¹ “The approval of ECI represents the culmination of years of dedicated research and development, and we are proud to offer a new treatment option that meets the highest regulatory standards and offers significant benefits to both veterinarians and their patients.”

According to the organizational release, ECI works by first conditioning the immune system to recognize the patient’s unique cancer, then delivers an ‘army’ of activated killer T cells that target and then attack the cancer cells. The treatment is administered at authorized treatment centers, which has 100 locations across the United States. In order the pursue ECI, the decision must be made prior to surgery so cancer tissue can be collected to manufacture treatment. Any veterinary professionals interested in learning more to educate their clients, or become an authorized treatment center, are encouraged to contact ELIAS Animal Health.

“Immunotherapies such as ECI® are at the forefront of new treatment options which use the patient’s own immune system to fight their cancer,” expressed Noe Reyes, DVM, chief medical officer of ELIAS Animal Health. “We are excited to bring the first licensed adoptive cell therapy to the veterinary community and provide clinicians with an important new treatment option.””

On January 17, 2024, ELIAS Animal Health announced that the USDA CVB determined data from the ELIAS ECI-OSA-04 pivotal combined safety and efficacy study showed a reasonable expectation of efficacy, which is a crucial milestone for the licensure pathway.

ECI-OSA-04 is one of the largest clinical trials conducted in canine oncology, and the first of its kind to evaluate adoptive cell therapy for treating cancer in canine patients.² The study is a 2-armed field safety and efficacy study to determine if ELIAS Cancer Immunotherapy worked. In order to participate, patients must complete a 7-11 week protocol conducted at the University of Missouri Veterinary School of Medicine, plus periodic follow up visits, Treatment includes limb-sparing surgery to remove primary tumor, followed by vaccine-enhanced adoptive T cell therapy combined with a novel adjuvant, and then be monitored for 12 months post-diagnosis.

“We are thrilled to achieve this important milestone with our first cancer product,” Wahaus expressed when the news of the study was announced.³. “I want to thank the pet owners who enrolled their dogs in the ECI-OSA-04 study, the veterinarians for their perseverance to complete the study during a pandemic, and my team for their tireless dedication. We are excited to bring this advanced personalized medicine to the veterinary market and provide a new tool in the fight against cancer.”

References

1. ELIAS Animal Health Receives Full Approval from USDA for the ELIAS Cancer Immunotherapy (ECI®), First-In-Class Treatment for Canine Osteosarcoma. News release. ELIAS Animal Health. March 19, 2025. Accessed March 19, 2025.
2. Canine Osteosarcoma Limb-Sparing Clinical Trial (ECIP-OSA-01). ELIAS Animal Health. Accessed March 19, 2025. https://eliasanimalhealth.com/clinical-trials/canine-osteosarcoma-limb-sparing/
3. USDA Agrees Clinical Trial Data for the ELIAS Cancer Immunotherapy (ECI®) Demonstrates Reasonable Expectation of Efficacy for the Treatment of Bone Cancer in Dogs. News release. ELIAS Animal Health. January 17, 2024. Accessed March 19, 2025. https://eliasanimalhealth.com/press-releases/usda-agrees-eci-demonstrates-reasonable-expectation-efficacy-canine-cancer/