Colorado-based VetDC, which specializes in taking experimental drugs cast off by pharma companies and turning them into veterinary therapies, just got one step closer to its first FDA approval. The company has completed the technical filings required to win approval for Tanovea (rabacfosadine), a drug it acquired from Gilead ($GILD) and has been developing for use in dogs with lymphoma.
The company expects to complete its request for FDA approval later this year, and if it’s granted, Tanovea will be ready for commercialization in early 2017, VetDC said in a press release. It would be the first FDA-approved therapy for dogs with lymphoma.
Tanovea is a novel compound that targets tumor-causing lymphocytes and interferes with their ability to divide. One they can no longer grow, they undergo apoptosis, or programmed cell death.
In June, VetDC announced that Tanovea produced an 81% response rate in a trial that involved 54 dogs with lymphoma. The drug was given in alternating doses with the chemotherapy treatment doxorubicin. Median progression-free survival was 200 days, which was superior to survival rates achieved with doxorubicin alone. The treatment can be completed in 6 veterinary visits, as opposed to the 16 visits often required to complete traditional chemotherapy.
An estimated one in 15 dogs is at risk of developing lymphoma, making it one of the most common canine cancers. Aratana Therapeutics ($PETX) tried to crack the market with its two USDA-approved lymphoma drugs, Blontress (AT-004) and Tactress (AT-005), but both have been disappointing so far.
VetDC CEO Steven Roy estimates Tanovea could hit peak annual sales of $40 million. There are other animal health companies working on canine lymphoma therapies, including Sweden-based Oasmia ($OASM), which is developing a special formulation of doxorubicin. But VetDC seems to be ahead in the race to market.
VetDC, which was spun off from Colorado State University, is currently completing safety studies of Tanovea in cats. It also acquired PWT33597 (now VDC-597) from Pathway Therapeutics, and is now exploring the drug as a treatment for several animal cancers. VDC-597 inhibits two proteins, PI3K and mTOR, with have been linked to lymphoma and some types of sarcoma and solid tumors.
- here’s the press release