SAN FRANCISCO—Concerned about a government shutdown, Aimmune took care to file the BLA for its oral immunotherapy for peanut allergy by Dec. 21. That application is under review, said Chief Medical Officer Dan Adelman, but other programs weren’t so lucky. These include its egg allergy treatment and its walnut program, which could potentially become a single treatment targeting multiple nut allergies.
And though the FDA continues to review AR101, the peanut treatment—Aimmune made sure to wire the agency the 2019 PDUFA fee early—the company isn’t sure if that funding will outlast a government shutdown.
“In a perfect world where we weren’t in a government shutdown, our 60-day window would be Feb. 19. But now we will have to see. Nobody knows how long it’s going to last,” Adelman said at the J.P. Morgan Healthcare Conference.
The company is also trying to start phase 2 trials of its egg allergy treatment. It submitted an IND for that program, also in December, but that application is currently in limbo.
“We have been informed that those documents not accompanied by a PDUFA fee are not being reviewed by FDA at this time. It’s normally a 30-day wait and then we hear back, but [the IND] is not being reviewed and we don’t know when we will hear back,” Adelman said.
Aside from programs in peanut and egg, the Brisbane, California-based biotech is also working on treatments for milk allergy and walnut allergy. It’s also partnering with Sanofi and Regeneron on an exploratory phase 2 study combining AR101 with the latter companies’ dupilumab, which is approved for the treatment of atopic dermatitis. Regeneron, which is running that trial, started enrollment in October.
Aimmune has been plugging away at the walnut protein it will eventually use in its immunotherapy, but has turned up a new question. It’s learned that more people are allergic to multiple nuts than are allergic to a single nut, making the pursuit of an allergy treatment for multiple nuts an attractive option, Adelman said. But the company doesn’t know if it can begin working on a multinut program, or if it needs to work serially—that is, get a walnut treatment approved, followed by other single-nut treatments for, say, hazelnut and cashew. It needs to have a conversation with the FDA to figure that out.
“We will be thoughtful and careful about which nuts to choose, and we are very interested in understanding the regulatory path for multinut approval,” Adelman said. The choice of nut is important as some tree nuts cross-react with others—that is, desensitizing patients against one nut could protect it from allergic reactions to another nut because they are immunologically related, he said. This is the case for walnut and pecan.
But the choice of nuts, and other “technical stuff,” as Adelman puts it, is “of secondary importance to the regulatory question.”
“We need to develop the appropriate source material for those other nuts and we’ve gotten quite good at that as far as figuring out how to process proteins and turn them into drugs,” Adelman said.
Aimmune is just waiting for the FDA to reopen so it can get cracking.
Editor's note: The headline of this story was edited to specify that while Aimmune's egg and multinut allergy programs face delays, the company filed the BLA for AR101, its peanut allergy treatment, ahead of the FDA shutdown and that the application is under review. It is unclear if the agency will make a decision by its action date, but as of now, the AR101 submission is not yet delayed.