University of Alberta adjunct professor and alumnus’ discovered drug, voclosporin, approved by the FDA for novel oral therapy of lupus nephritis

Dr. Robert Foster (BSc Pharm 1982, PharmD 1985, PhD 1988) discovered voclosporin in 1993. Twenty-eight years later, it has been approved as LUPKYNIS, the first FDA-approved oral therapy to treat patients with active lupus nephritis.

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 do it as quickly as possible with minimal side effects,” says Dr. Foster. “That's what voclosporinnow LUPKYNISis 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 ratioa standard measurement used to monitor protein levels in the kidneytwice 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.

Discovering and developing voclosporin

Originally, Dr. Foster pursued voclosporin as an improvement to the drug Cyclosporinthe standard of care drug for organ transplant patients at the timewhich walked a fine line between helping the body avoid rejecting a new organ and a side effect that would ultimately cause damage to that same organ. When existing pharmaceutical companies wouldn’t take on his proposals for developing voclosporin, Dr. Foster decided he would do it himself. Along the way, he discovered that voclosporin also had the capacity to treat other conditions.

“After we started working on voclosporin for organ transplants, we realized that when you suppress the immune system, you can use it for treating autoimmune diseases like rheumatoid arthritis, psoriasis, or lupus nephritis,” says Dr. Foster. “Those are autoimmune diseases that need to tone down a patient’s immune system, because the body does not differentiate between self and foreign, so it starts to destroy itself.”

Following this discovery, Dr. Foster licensed the indication of voclosporin for lupus nephritis to Aurinia Pharmaceuticals, while he continued to work on it for the organ transplant indication. During the financial crisis in 2008, both Aurinia and Foster’s teams were struggling to secure financing because of the market meltdown, so Dr. Foster bought the molecule back in company stock in 2013, merging Aurinia with Isotechnika, and served as the company’s CEO and, later, its Chief Scientific Officer. 

Though he stepped away from the newly merged Aurinia in 2014 to found his biotechnology company, Hepion Pharmaceuticals, shortly after, he says that the announcement of LUPKYNIS’ (voclosporin) recent FDA approval brings him great joy and marks a turning point for the LN community. 

“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.

“My role was in the early stages in getting the drug and the company off the ground. If I hadn’t pursued this molecule, there would be nothing to commercialize,” says Dr. Foster. “But getting a drug to this point takes a village. At one point, Isotechnika had about 100 incredible employees dedicated to advancing voclosporin in nonclinical and clinical trials. But, full credit needs to be given to Aurinia’s current management and Board. Without their hard work and vision, this drug would never have been approved and would not have been commercialized for treatment of this important disease. Indeed, Aurinia’s team, led by Peter Greenleaf, has done a great deal of heavy lifting and they have done a remarkable job.”

Hepion Pharmaceuticals

Foster is currently the CEO of biotechnology company, Hepion Pharmaceuticals (Hepion)based in New Jersey, with research labs in Edmontonwhich he founded in 2014. Hepion bought all the early stage molecules from Aurinia that Dr. Foster and his team originally discovered.

“Today, Hepion is doing the whole process over again, but with the benefit in each one of our cases, almost 30 years of experience,” says Dr. Foster. 

The first indication that Hepion is tackling is nonalcoholic steatohepatitis (NASH), which is an autoimmune disease that causes liver inflammation and damage caused by a buildup of fat in the liver. It is part of a group of conditions called nonalcoholic fatty liver disease. 

“The NASH market potential is huge,” says Dr. Foster. “In the US, there are 17 million people that have NASH, whereas there are about 250 to 300 thousand people in the US that have lupus nephritis. So we’re going to focus on this larger market with this new molecule.” 

Currently, Hepion is in phase II trials for the NASH indication. 

The University of Alberta legacy

Dr. Foster also remains an Adjunct Professor in, and advocate for, the Faculty of Pharmacy and Pharmaceutical Sciences at the University of Alberta. 

“I can say with 100 percent certainty that the education at the Faculty of Pharmacy and Pharmaceutical Sciences at the University of Alberta is world class,” says Dr. Foster. “Everywhere I went around the world in my pre-COVID travels, I bumped into people from the University of Albertamedical directors, senior executives, global heads of pharmaceutical companiesit’s just top notch people all over the world.”

“People look at me and see I’ve come from this place called Edmonton that they’d never heard of, and ask ‘how do you create a drug from such a place?’ Usually they expect to hear about Stanford, Yale, Harvard, the Ivy Leagues. But no, not at all. You can easily get an education at the University of Alberta that is second to none. It’s really an absolutely world class school.”

To current students and new grads, he emphasizes the importance of passion.

“Whatever it is that you do, do something you are completely passionate about,” says Dr. Foster. “It’s going to feel like you’re getting paid for your favourite hobby. I can honestly say that's the case for me.”

“When you do identify your passion, give it all you have and stay focused. Focus is key. So, find something you're passionate about, find something you can dedicate time and focus to, and keep a sharp eye on it.”