Akston launches clinical trial for novel canine cancer therapy

A new clinical study will evaluate a first–in–class immuno-enhancing therapy supported by the proprietary Fc–fusion protein platform Ambifect from the Akston biosciences company. The intramuscular injection therapy targets PD-L1 in dogs with solid tumors.¹

The study was launched by the Akston Biosciences Corporation in partnership with Purdue University in West Lafayette, Indiana, and its College of Veterinary Medicine. It’s first patient is Rocco, an 11-year-old Dutch shepherd dog. Rocco was first diagnosed with high-grade soft tissue sarcoma in 2025. After surgery, the dog’s tumor returned, leading Rocco to go back to Purdue University for treatment. There, Rocco recently received the first dose of the trial therapy, according to Akston.¹

Led by Shawna Klahn, DVM, and Nikolaos Dervisis, DVM, in the Purdue Werling Comparative Oncology Research Center, the trial aims to assess the safety and tolerability of the therapy in canine pets with naturally occurring cancer. Secondary objectives of the trial are to identify initial signals of efficacy and explore biomarkers for response. According to Akston, the trial will enroll client-owned dogs with a variety of solid tumors, including soft tissue sarcoma, melanoma, mast cell tumor, among others.¹

"By leveraging our proprietary platform, we believe we can effectively transform the dog's own immune system into a durable anti–cancer defense, reducing the number of treatments needed and dramatically improve access to life-saving veterinary care. This study is an important step in bringing advanced checkpoint inhibitor therapy to more dogs, at a fraction of the cost of traditional biologics,"Todd Zion, PhD, cofounder and CEO of Akston, said in a news release.¹

The Ambifect platform is designed to improve scalability and expand availability of cancer immunotherapy to a broader population of pets, including those previously unable to access or tolerate conventional monoclonal antibody treatments. This common platform enables the company to develop therapeutic candidates that interact with parts of the immune system related to the target disease while minimizing the effects off-target.²

Ambifect was recognized with the Most Innovative Award at the 2023 Animal Health Corridor Summit in Kansas City, Missouri.³ The platform’s versatility was demonstrated with the development of insulin drug products for canine and feline patients with diabetes that were designed to be injected once a week.⁴

The Ambifect version of the new trial drug builds on Akston's anti-cPD-L1 mAb, designed to target and block the cPD-L1 protein on cancer cells, which is currently in clinical trial for dogs with bladder cancer.¹ This drug is anticipated for conditional approval by the USDA in 2027.¹

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References

1. Akston pioneers a new generation of cancer therapy for dogs in clinical trial launch. News release. Akston. October 29, 2025. Accessed October 29, 2025. https://prnmedia.prnewswire.com/news-releases/akston-pioneers-a-new-generation-of-cancer-therapy-for-dogs-in-clinical-trial-launch-302597860.html
2. Zion T. Emerging Companies: Akston Biosciences. Presented at: 2023 Animal Health Summit; Kansas City, MO. August 28-29, 2023.
3. Akston Biosciences receives 2023 Most Innovative Award at Animal Health Summit. News release. Akston Biosciences. August 31, 2023. Accessed July 30, 2024. https://www.akstonbio.com/akston-biosciences-receives-2023-most-innovative-award-at-animal-health-summit/
4. Crossley KC. Therapeutic development platform demonstrates versatility. dvm360. March 12, 2024. Accessed October 29, 2025. https://www.dvm360.com/view/therapeutic-development-platform-demonstrates-versatility