USDA determines reasonable expectation of efficacy from trial data on the treatment of osteosarcoma

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ELIAS Animal Health announced today that the USDA for Veterinary Biologics determined the data from its ECI-OSA-04 pivotal combined safety and efficacy study demonstrated a reasonable expectation of efficiency. This determination is a critical milestone on the licensure pathway.

"We are thrilled to achieve this important milestone with our first cancer product," said Tammie Wahaus, CEO of ELIAS Animal Health, in an organizational release.¹ "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."

According to the release, the two-arm field safety and efficiency (n=100) study is currently one of the largest clinical trials to be conducted in canine cancer and is the first to evaluate a start-of-the-art adoptive cell therapy to treat canine cancer.¹ The treatment being tested, the ELISA Cancer Immunotherapy (ECI), works by training the patient’s immune system to recognize the patient’s unique cancer to then deliver activated killer T cells to target and attack those specific cancer cells.

ECI will continue to be available as an experimental biologic for veterinary use before its commercial launch, which ELISA disclosed is expected to be later in 2024, under its existing 9 CFR 103.3 authorization while remaining regulatory actions are finalized. This will secure a first-class Autologous Prescription Product License.¹

ELIAS has plans to raise $10 million Series A to help support manufacturing expansion and a commercial launch of the ECI product. The company will also use the money raised to continue developing its product pipeline, including oncolytic immunotherapy, a pilot study that will combine ECI with a conditionally approved checkpoint inhibitor, and a pilot study evaluating adoptive cell therapy in large breed dogs through a sophisticated surgical technique to help avoid amputation.

Reference

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 January 17, 2024. https://prnmedia.prnewswire.com/news-releases/usda-agrees-clinical-trial-data-for-the-elias-cancer-immunotherapy-eci-demonstrates-reasonable-expectation-of-efficacy-for-the-treatment-of-bone-cancer-in-dogs-302036500.html