Anivive Awarded $500,000 Grant by the FDA for Canine Cancer Studies

- Anivive is the first recipient to be awarded a MUMS grant during this round of funding

- Funding will accelerate ongoing canine lymphoma studies

- Anivive to initiate studies of verdinexor to treat other types of cancer

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Jul 08, 2021, 20:44 ET

LONG BEACH, Calif., July 8, 2021 /PRNewswire/ -- Anivive, a pet health technology company transforming the therapeutic discovery and development process, received $500,000 in grant funding to continue research on the use of LAVERDIA™ -CA1 (verdinexor) in the treatment of canine lymphoma.

The grant was received from the U.S. Food and Drug Administration as part of the agency's Minor Use/Minor Species program, developed to support new animal drugs intended for uncommon or undertreated diseases such as canine lymphoma. Anivive was one of four companies selected for the grants.

"We are honored to be a recipient of this grant from the FDA," said Anivive Chief Medical Officer David Bruyette, DVM, DACVIM. "These funds will help to defray some of the costs associated with this exciting work."

Anivive is working with Tufts University and will soon start enrolling patients for a prospective, randomized, placebo-controlled, double-masked, multi-site pivotal field safety and effectiveness study of LAVERDIA-CA1 in dogs with lymphoma. The study will include over 100 dogs, including patients with both B-cell and T-cell lymphoma, in both naïve and relapse cases.

"I am excited to serve as the primary investigator for this multi-center study and to build upon earlier work performed by our Associate Dean for Research Dr. Cheryl London," said Carrie Wood, DVM, DACVIM (O), a clinical assistant professor at the Cummings School of Veterinary Medicine at Tufts University.

In addition to the lymphoma project, Anivive is performing in vitro studies evaluating LAVERDIA-CA1 in cancers such as osteosarcoma, transitional cell carcinoma and histiocytic sarcoma. Enrollment will also soon begin for the study of LAVERDA-CA1 in combination with CCNU is canine patients with relapsed/refractory lymphoma.

LAVERDIA-CA1, the first oral tablet for canine lymphoma, was conditionally approved by the FDA on January 11, 2021.

About LAVERDIA™-CA1 (verdinexor)
LAVERDIA-CA1 is a new oral treatment option for canine lymphoma. It is the first small-molecule selective inhibitor of nuclear export (SINE) drug specifically designed for veterinarian use. It employs a novel targeted mechanism of action where it targets and binds to Exportin 1 (XPO1)—a "transport" protein that proliferates in certain types of cancer. Excessive amounts of XPO1 export important tumor suppressing proteins (TSPs)—necessary for fighting cancer—from the nuclei of cells, rendering them vulnerable to uncontrolled growth. With its targeted blocking of XPO1, LAVERDIA-CA1 allows for TSPs to be trapped inside the cell nucleus, triggering programmed cell death of lymphoma cells while sparing healthy cells. LAVERDIA-CA1's most commonly reported side effects for include anorexia, vomiting, diarrhea, weight loss, and lethargy. For complete safety information, view full product label.

About Anivive
Anivive is reinventing the drug development process in pet pharma. Our proprietary software accelerates the delivery of new, affordable treatments for pets.

Backed by over $45 million in seed funding, Anivive has gained conditional approval for LAVERDIA-CA1 (verdinexor), the first oral tablet to treat canine lymphoma and created a specialty sales force dedicated to supporting veterinarians. Anivive's pipeline includes 8+ first-in-class pharmaceuticals, biologics, and vaccines. For more information on how we address unmet needs for pets, visit anivive.com.

About the FDA MUMS Drug Grant Program
The Minor Use and Minor Species Animal Health Act (MUMS Act) was signed into law in 2004. The law is intended make more medications legally available to veterinarians and animal owners for the treatment of minor animal species, and for uncommon diseases in major animal species.

MUMS grants, which are dependent upon available funding, provide funding for clinical research aimed at evaluating the safety and efficacy of new animal drugs. To apply, the new animal drug must be on the MUMS designation list for the intended use(s) for which the drug is being studied and the FDA's Center for Veterinary must have already reviewed and accepted the proposed study protocol.

SOURCE Anivive Lifesciences Inc.