Akston Pioneers a New Generation of Cancer Therapy for Dogs in Clinical Trial Launch

Akston's first Ambifect® immuno-enhancing protein enters clinical trial at Purdue University, with Dutch Shepherd Rocco as the first patient

• Akston has launched a clinical study at Purdue University for its Ambifect® immuno-enhancing therapy designed to induce antibodies targeting PD-L1 in dogs with solid tumors.
  
  
• The novel Ambifect® therapy aims to dramatically reduce treatment frequency, lower cost, and increase compliance as an intramuscular injection, making advanced cancer care more accessible.
  
  
• USDA conditional licensure is targeted for 2029 following Akston's lead anti-cPD-L1 monoclonal antibody (mAb) product, expected in 2027.

BEVERLY, Mass. and WEST LAFAYETTE, Ind., Oct. 29, 2025 /PRNewswire/ -- Akston, the Biotech Built for Pets, in partnership with Purdue University and its College of Veterinary Medicine, announced today that it has initiated a clinical study to evaluate a first–in–class Ambifect® immuno-enhancing therapy targeting PD-L1 in dogs with solid tumors. Built on Akston's proprietary Fc–fusion protein platform, it is designed as an intramuscular injection that aims to transform access to advanced cancer care by reducing treatment frequency, lowering overall cost, and improving compliance - all while delivering a durable, immune–driven anti–cancer response.

The study's first participant, Rocco, is an 11-year-old Dutch Shepherd with a deep bond to his pet parent. He was first diagnosed with high-grade soft tissue sarcoma earlier this year and returned to Purdue this fall after the tumor returned soon after surgery. Recently receiving the first dose marks an important milestone in the trial and in Akston's effort to bring new hope to families navigating cancer diagnoses in their beloved pets, as well as bring new treatment options to veterinarians.

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

"With our Ambifect® immuno-enhancing therapy, we're reimagining cancer treatment for pets," said Todd Zion, Ph.D., co–founder and CEO of Akston. "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."

Akston's proprietary Fc-fusion protein platform creates long–acting, immuno-enhancing therapies that prompt the animal to generate its own antibodies against disease targets, reducing both the dose and frequency of treatment. This innovation 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.

The Ambifect® version builds on Akston's anti-cPD-L1 monoclonal antibody (mAb), designed to target and block the cPD-L1 protein on cancer cells, currently in clinical trial for dogs with urothelial (bladder) carcinoma, and on track for USDA conditional approval in 2027. Together, these candidates represent a multi–layered approach to tackling aggressive malignancies in dogs, with future potential to advance immunotherapy approaches for both canine and human cancer patients.

About Akston
Akston is a biotech company built for pets. Using our proprietary Fc-fusion protein platform, we develop immuno-enhancing and targeted protein treatments that aim to reduce treatment frequency while enhancing efficacy. Backed by a vertically integrated structure and state-of-the-art GMP biologics facility, we accelerate development from discovery to commercial manufacturing - ensuring innovation reaches veterinarians and the pets we love faster and more efficiently. Learn more at www.akstonbio.com.

About Purdue University
Purdue University is a public research institution demonstrating excellence at scale. Ranked among top 10 public universities and with two colleges in the top four in the United States, Purdue discovers and disseminates knowledge with a quality and at a scale second to none. More than 105,000 students study at Purdue across modalities and locations, including nearly 50,000 in person on the West Lafayette campus. Committed to affordability and accessibility, Purdue's main campus has frozen tuition 13 years in a row. See how Purdue never stops in the persistent pursuit of the next giant leap — including its first comprehensive urban campus in Indianapolis, the Mitch Daniels School of Business, Purdue Computes and the One Health initiative — at https://www.purdue.edu/president/strategic-initiatives.

Contact:
Julie Lawless
Lawless Strategic Communications
[email protected]
+1 615-585-5861

SOURCE Akston