Autoimmune disease drugs work by addressing a protein or pathway associated with inflammation, targeting it to suppress an excessive immune response. These drugs can treat a range of diseases, but they also pose safety risks—an ongoing concern because the chronic nature of these diseases means patients need to be on treatment for a long time. Nuvig Therapeutics takes a different tack, leveraging the built-in way the immune system resets. The biotech startup has now revealed some details about its approach and a $47 million funding round, putting it on the path to clinical trials.
this Series A financing The announcement on Wednesday was led by Novo Holdings and Platanus.
Nuvig’s approach to treating autoimmune diseases involves targeting a class of natural receptors found on immune cells. Co-founder and CEO Pamela Conley explained that these receptors regulate homeostasis. When the body has an inflammatory response, these receptors can turn off that response. The Redwood City, California-based startup is developing drugs that bind to these receptors, triggering events that suppress the immune response.
“It’s more of a natural rebalancing of natural immune function,” Conley said.
Conley first learned about this mechanism in his previous position at Portola Pharmaceuticals, the company whose research led to FDA-approved treatments for bleeding disorders. Her research at Portola includes inflammation, and one of the company’s scientific advisors is Jeffrey Ravetch, a professor of immunology, virology and microbiology at Rockefeller University. Ravetch discovered that the Fc receptor of an antibody called immunoglobulin G doesn’t just bind to the antibody. These receptors can also modulate immune responses, providing another way to suppress inflammation. Ravetch co-authored a paper describing the Fc receptor of IgG as a modulator of immune responses, which was post 2008 Nature Reviews Immunology.
back Alexion Pharmaceuticals to acquire Portola in 2020, Conley said she wanted to learn more about this approach to inflammation. She and another Portola veteran, Greg Coffey, co-founded Nuvig last year, licensing intellectual property from Rockefeller. Coffey serves as vice president of the biotechnology company responsible for immunology and clinical translational research.
Ravetch is Nuvig’s co-founder and scientific advisor. His Rockefeller research focused on how antibodies mediate immune responses. Conley declined to provide details about Nuvig’s lead molecule, other than to say that it is a recombinant protein. The receptors of interest are found on bone marrow cells and other cells of the immune system. One of these receptors triggers a pro-inflammatory response, while the other triggers an anti-inflammatory response. Nuvig molecules are genetically engineered to bind to anti-inflammatory receptors, Conley said.
Current treatments for chronic autoimmune diseases include steroids and drugs that block tumor necrosis factor, a pro-inflammatory signaling protein.A new type of therapy called Janus kinase (JAK) inhibitors has also gained approval for autoimmune diseases, but these drugs have recently received Increased FDA scrutiny as clinical data show higher cardiovascular and cancer risksAutoimmune drugs carry a long-term risk of opportunistic infections and cancer because patients take them for a long time, Conley said. This is one area where Nuvig Therapy can differentiate itself.
“We think the real advantage for us is that we can achieve similar efficacy, but with a better safety profile,” Conley said.
Nuvig is working to advance its lead molecule into human trials in a single indication. Conley declined to specify the indication, but said it could be an autoimmune disease in which the company can easily measure biomarkers of treatment response. Having established a proof of concept in a single metric, the research could pave the way for Nuvig to expand its approach to other areas, Conley said. In addition to recombinant proteins, Nuvig is also investigating the use of full-length therapeutic antibodies.
A growing number of companies are trying to harness the body’s inflammatory control mechanisms as new treatments for autoimmune and inflammatory diseases. last year, Merck to buy Pandion Therapeutics for $1.85 billion, a clinical-stage biotechnology whose therapeutics are proteins designed to selectively expand regulatory T cells (Tregs), immune cells that suppress excessive immune responses. Pandion’s primary disease target is ulcerative colitis.start up Abata Therapeutics is developing an autologous cell therapy consisting of a patient’s own Tregs Designed to locate diseased tissue. Last June, Abata raised $95 million to support research, including a lead program targeting multiple sclerosis. And last November, Quell Therapeutics closes $156 million financing With the clinical development of autologous Treg cell therapy to prevent organ rejection in liver transplant patients.
Other investors participating in Nuvig’s new financing include Bristol Myers Squibb, Digitalis Ventures and Mission BioCapital. Conley declined to provide a timetable for arriving at the clinic. The company is generating preclinical data to build on preclinical research conducted in Ravetch’s lab. As Nuvig’s investigational new drug application progresses, Conley said she expects some of that data to be shared at scientific meetings in the coming months.
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