- Therapy: Ambifect® immuno-enhancing Fc-fusion protein
- Target: PD-L1 in dogs with solid tumors
- Trial Focus: Safety, tolerability, early efficacy, immune biomarkers
- Current Status: First patient dosed (October 2025)
- Projected Milestone: Ambifect®: Conditional licensure targeted for 2029
Akston Biosciences recently started a clinical trial at Purdue University to evaluate its Ambifect® immuno-enhancing therapy, an investigational treatment designed to stimulate antibody production against PD-L1 in dogs with solid tumors.
The study’s first participant, Rocco, an 11-year-old Dutch Shepherd with soft tissue sarcoma, recently received the inaugural dose — marking a milestone in the development of Akston’s next-generation cancer immunotherapy platform.
Led by Dr. Shawna Klahn, DVM, and Dr. Nikolaos Dervisis, DVM, at the Purdue Werling Comparative Oncology Research Center, the study will assess safety and tolerability, while also tracking early signs of efficacy and immune biomarkers of response in dogs with naturally occurring cancers such as soft tissue sarcoma, melanoma, and mast cell tumors.
“With our Ambifect® therapy, we’re reimagining cancer treatment for pets,” said Todd Zion, Ph.D., co-founder and CEO of Akston. “By enabling the immune system to generate its own antibodies, we can reduce treatment frequency, lower costs, and expand access to advanced care for more families and their veterinarians.”
About the Ambifect® Platform
Akston’s Ambifect® Fc-fusion protein platform creates long-acting, immuno-enhancing therapies that stimulate the animal’s own immune response, potentially replacing traditional monoclonal antibody dosing schedules with simpler intramuscular injections. The approach is designed to improve scalability and accessibility of checkpoint inhibitor–type therapies in veterinary oncology.
The Ambifect® candidate builds on Akston’s anti-cPD-L1 monoclonal antibody (mAb) — currently in trials for canine bladder cancer and expected to receive USDA conditional approval in 2027. The company is targeting 2029 for conditional licensure of the Ambifect® formulation.
“This study is an important step toward delivering durable, immune-driven cancer care to dogs at a fraction of today’s biologic cost,” Zion said.
Information and quotes from a company press release.
