The Japanese drug giant Takeda Pharmaceuticals, the largest biopharma employer in Massachusetts, said it would acquire an experimental autoimmune disease pill from Nimbus Therapeutics for $4 billion upfront and up to $2 billion in potential milestone payments.
Nimbus — an 80-person biotech that recently moved from its longtime Cambridge headquarters near Central Square to the Seaport neighborhood — believes its drug will have vast potential for treating many autoimmune and inflammatory diseases.
The company recently finished testing the drug in an intermediate stage clinical trial for moderate-to-severe psoriasis. An advanced study in that condition is planned for 2023. The drug is also being tested in psoriatic arthritis and Takeda plans to test it in inflammatory bowel disease and other autoimmune diseases.
“We are very keen to develop this across multiple indications,” Andrew Plump, Takeda’s president of research and development, said in an interview. “There’s a whole series of additional indications that we’ll be evaluating.”
Nimbus was founded in 2009 with the ambition to design drugs on computers — a strategy that has since become increasingly common among biotech startups. The company got its first big break in 2016 when Gilead Sciences paid $400 million upfront for an experimental liver disease drug. Nimbus has also struck deals with Celgene, Eli Lilly and Company, and Genentech.
The company previously raised $125 million from private investors in September who were excited about the drug’s broad applications. That announcement came on the heels of the Food and Drug Administration’s approval of a competitor’s drug: Sotyktu, a once-daily pill made by Bristol Myers Squibb to treat moderate-to-severe plaque psoriasis.
Sotyktu and the Nimbus drug are both inhibitors of an immune system protein called tyrosine kinase 2. People with genetic mutations in the enzyme are less likely to develop inflammatory or autoimmune diseases, and drug companies are hoping that TYK2 inhibitors that selectively stop the enzyme, but not closely related ones, could become a major class of blockbuster drugs.
“What’s amazing about these folks who don’t have correct TYK2 signaling is they’re just fine. In fact, they’re actually protected from autoimmune disease,” Nimbus chief executive Jeb Keiper said in an interview. The company’s pill attempts to mimic those benefits and bestow them upon people with normal TYK2 genes who are suffering from autoimmune diseases.
Takeda’s interst in TYK2 inhibitors stemmed from its focus on inflammatory bowel disease. The firm’s drug Entyvio is approved to treat both types of IBD — ulcerative colitis and Crohn’s disease. Takeda expects to make $5.4 billion from sales of the drug this year, and projects peak sales could reach $9 billion.
But since Entyvio was approved in 2014, the firm has sought a follow-up that might be even better, Plump said. “We’ve looked at every mechanism out there,” he said. “And we feel that this TYK2 class has the potential to be as or more innovative and important for IBD patients as Entyvio.”
Takeda said the milestone payments for Nimbus will be doled out in two $1 billion sums if the drug achieves net sales of $4 billion and $5 billion.
The TYK2 enzyme belongs to a family of related proteins, and drugs known as JAK inhibitors that target some of those proteins can carry serious risks. JAK inhibitors used to treat rheumatoid arthritis or ulcerative colitis carry warnings the drugs may increase the chance of blood clots, cancer, heart attack, stroke, and death.
Companies hope TYK2 inhibitors will avoid most of those problems, although they are not without side effects. Bristol Myers found that people who got Sotyktu in a clinical trial were more likely to have upper respiratory tract infections.
“Our expectation is that we’ll be able to dose it up higher, achieve greater efficacy, and avoid JAK-related toxicities,” Plump said, adding that the ultimate test of that hypothesis will come in larger clinical trials.
Two weeks ago, Nimbus said its drug met the primary endpoints in its clinical trial for psoriasis. The company didn’t disclose any data publicly, but Takeda has seen the results. The firms said the data will be shared at a medical conference early next year.
Nimbus also has an early clinical stage drug program for cancer and four preclinical stage programs for autoimmune disease, cancer, and metabolic disorders. The Indianapolis pharma firm Eli Lilly struck a deal worth up to $496 million with Nimbus in October to develop a drug that activates a metabolism-boosting protein called AMPK.
Ryan Cross can be reached at firstname.lastname@example.org. Follow him on Twitter @RLCscienceboss.