Corvus Pharmaceuticals’ founder and CEO Dr. Richard Miller isn’t as interested in simply making incremental treatment improvements.
“Why not change the game if you can?” he said.
As co-founder of Idec, the company that developed the first FDA-approved monoclonal antibody for cancer, Rituxan, Miller knows something about changing the game. Now, at Corvus, Miller believes he’s once again at the helm of something transformative, thanks to the company’s lead candidate, soquelitinib, which showed the possibility of long-term remission in atopic dermatitis even after stopping therapy.
“It's Rituxan all over again,” said Miller. “I mean, it's different. It’s not an antibody. But philosophically, I think it's Rituxan all over again.”
Like Rituxan, which is approved in both oncology, autoimmune and rheumatologic indications, Corvus believes soquelitinib has potential to treat cancers as well as allergic and autoimmune diseases.
“I like to say that lymphoma and autoimmunity are sort of two sides of the same coin,” said Miller, who was also a Stanford University School of Medicine oncologist for more than 40 years. “That's the Corvus paradigm. We set out to make drugs that could address this interface of lymphoma and autoimmunity.”
Soquelitinib is a potential first-in-class, oral small molecule that works by selectively inhibiting the enzyme ITK (interleukin-2-inducible T-cell kinase) to possibly suppress autoimmune and inflammatory reactions.
Corvus is currently enrolling for a phase 3 registration trial comparing soquelitinib to standard chemotherapy in patients with relapsed/refractory peripheral T-cell lymphoma. In addition, the company recently presented positive results of a phase 1 trial that tested the drug in patients with moderate-to-severe atopic dermatitis.
“A lot of the work that enabled us to move rapidly into atopic dermatitis and obtain extraordinarily good, not only efficacy results but safety and various biomarker immunologic markers, was really predicated or leveraged off of what we were able to learn in our lymphoma work,” Miller said.
Soquelitinib is also being studied in the chronic inflammatory skin disease hidradenitis suppurativa, asthma, autoimmune lymphoproliferative syndrome and solid tumors.
Multi-target success in trials
Those diagnosed with relapsed/refractory peripheral T-cell lymphoma are dealt a difficult hand, with a median survival rate of less than a year, Miller said.
Yet patients in a soquelitinib clinical trial, which Corvus presented at the American Society of Hematology’s annual meeting in December, had a median overall survival of 28.1 months, which Miller called a “striking result.” It’s also a well-tolerated oral tablet that’s demonstrated good safety outcomes versus the IV-administered chemotherapy comparator in the phase 3 lymphoma study, which causes side effects like neutropenia, thrombocytopenia and mucositis, Miller said.
“It's not a chemotherapy. It's a targeted agent,” he said.
The FDA granted soquelitinib orphan drug designation for T-cell lymphoma and fast track designation for adult patients with relapsed or refractory PTCL after at least two lines of systemic therapy.
While the company also had good safety and efficacy results in atopic dermatitis, Miller said he’s most excited that the results persisted even after the patients stopped treatment, which Miller referred to as “rebalancing” the immune system.
“We were able to show that there was an increase in the T regulatory suppressor cells in the blood on treatment. But here's the really great thing. After you stop the treatment, those T regulatory cells persist. We stopped measuring after 90 days. So I would say it's at least 90 days, but it could be longer,” he said.
He compared it to other common drugs like Sanofi and Regeneron’s megablockbuster drug Dupixent or Eli Lilly’s recently approved Ebglyss that require continuous dosing.
While there’s still “a lot more work required to prove this,” Miller said, “now that we've reset the immune system or modified the underlying biology of the disease ... longer-term remissions are going to be possible [and] there might be a remittive effect without ongoing continuous therapy.”
He added that he believes the market for soquelitinib to treat allergic diseases is “at least comparable … if not greater” than the market for Dupixent or JAK inhibitors like Rinvoq. Moreover, he said their drug isn’t offering incremental improvements on existing treatments.
“We're changing paradigms. We have, I think, developed a revolutionary product,” he said.
