Voclosporin

Dr. Neal M. Davies (left) and Dr. Robert Foster (right) at the 2019 White Coat and Awards ceremony where Dr. Foster was given the Outstanding Pharmacy Alumni award.

ALUMNUS’ DISCOVERED DRUG, VOCLOSPORIN, APPROVED BY THE FDA

BY KALYNA HENNIG

Dr. Robert Foster (BSc Pharm 1982, PharmD 1985, PhD 1988) left his tenured Associate Professor position at the Faculty of Pharmacy and Pharmaceutical Sciences in 1993 to pursue drug development and incorporate Isotechnika Pharma, where he served as the company’s Chairman and CEO until 2014. There, Dr. Foster discovered voclosporin, which 28 years later, has been approved by the U.S. Food and Drug Administration (FDA) as LUPKYNIS to treat patients with active lupus nephritis (LN).

LUPKYNIS, commercialized by Aurinia Pharmaceuticals Inc., is the first FDA-approved oral therapy for LN, which causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE).

“The whole purpose of creating a biotechnology company and developing drugs is to bring patients that are suffering into remission and to do it as quickly as possible with minimal side effects,” says Dr. Foster. “That’s what voclosporin—now LUPKYNIS—is currently doing. It’s the first oral medication to be approved by the FDA for the treatment of lupus nephritis. It is safe, well-tolerated and efficacious.”

According to Aurinia, clinical trials showed that patients treated with LUPKYNIS were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio—a standard measurement used to monitor protein levels in the kidney— twice as fast as patients on typical standard of care treatments alone. Early intervention and kidney response are linked to better long-term outcomes and prevent irreversible kidney damage. Patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically-active classes of LN studied.

“It’s cool looking back at it, because I started the company in a room in my basement,” says Dr. Foster. “That extra room ultimately became my son’s room, who is now 32. So, that just shows you that it’s an agonizing process. But Friday, January 22nd was one of the best days of my life to hear that it was finally approved.”

Today, the voclosporin molecule is worth nearly 3 billion Canadian dollars, and Foster is the CEO of his biotechnology company, Hepion Pharmaceuticals (Hepion)—based in New Jersey, with research labs in Edmonton. Hepion is working on all the early-stage molecules that Dr. Foster and his team originally discovered and is currently in phase II trials for a nonalcoholic steatohepatitis (NASH) indication. 