Armed with Nestlé cash, Aimmune grabs experimental food allergy drug from Xencor

Aimmune has had a good few weeks: It’s just won approval for the first peanut allergy drug at the FDA, then got a $200 million boost from Nestlé, and today it’s using that cash to license a new drug from Xencor.

Less than a week ago, the FDA approved Aimmune's Palforzia (AR101) as a treatment for peanut allergy reactions, including anaphylaxis, making it the first drug approved in that indication and beating out rival DBV.

And, according to Evaluate Pharma, it’s a blockbuster approval: Palforzia could hit an estimated $1.28 billion in sales by 2024, the firm said, as an immunotherapy that uses gradual doses of peanut protein to fend off serious reactions.

That money is to come, but today it got a $200 million equity boost from backer Nestlé Health Science, the R&D unit of the consumer group, bringing its total outlay into the biotech to nearly half a billion dollars.

Some of that cash will be used to help boost the launch of Palforzia, but it’s immediately eyeing the future, spending a mere $10 million upfront, with $385 million in biobucks wedded to it, to license Xencor’s XmAb7195.

The drug, now renamed AIMab7195, had been in midstage tests for allergic asthma, but will now be put to use in trials as an adjunct to Palforzia in food allergies.

“As we look to the future of food allergy treatments, we are excited to explore the potential of oral immunotherapy to achieve greater levels of desensitization, and perhaps even remission, when combined with adjunctive biologics that target immune pathways,” said Jayson Dallas, M.D., president and CEO of Aimmune.

“In-licensing AIMab7195 demonstrates our commitment to enriching our pipeline and strengthening Aimmune’s global leadership in the evolving therapeutic landscape of food allergy treatments.”

Xencor gets $5 million upfront in the deal and another $5 million in equity. Under the pact, Aimmune will be solely responsible for costs related to the development of AIMab7195 and plans to “provide a development plan in the coming months.”

For Xencor, this comes amid a mixed 12 months: It started 2019 with a bit of a damper as Novartis handed back the rights to a bispecific antibody it licensed in a 2016 deal worth $150 million upfront but that was backloaded with up to $2.41 billion in milestones. A month later, a second asset from that deal ran into a clinical hold from the FDA due to a pair of patient deaths that were “at least possibly” treatment-related.

That program, XmAb14045, got back on track in April after Xencor worked with the FDA to change the protocol for the phase 1 study. It is testing the drug, which targets CD3 and CD123, in patients with relapsed or refractory acute myeloid leukemia and other blood cancers expressing CD123.

Although Xencor lost Novartis as a partner on one of its programs, it picked up a couple of new partners. It licensed its preclinical-stage IL-15 cytokine therapeutics to Genentech for $120 million upfront in February and struck an R&D deal with Astellas in April.

Since then, the company has started phase 1 studies for two more bispecific antibodies in advanced solid tumors: XmAb23104, which targets PD-1 and ICOS, and XmAb22841, which targets CTLA-4 and LAG-3. The latter treatment is being tested in combination with Keytruda in an effort to block three checkpoints at once.

Late last year, it also got a new chief medical officer in the form of Allen Yang, M.D., Ph.D., who joined the company from Jazz Pharmaceuticals.

“Aimmune’s focus, clinical success and regulatory expertise in food allergy demonstrate their capability to advance AIMab7195 with highly complementary CODIT pipeline programs to create new options for people living with food allergy,” added Bassil Dahiyat, Ph.D., president and CEO of Xencor.

“AIMab7195 is designed to reduce levels of IgE, a key mediator of allergic response, and there is strong scientific rationale that this reduction would synergize with the activity of desensitization therapies.”

Xencor’s shares were slightly off premarket by half a percent, while Aimmune was up by more than 7%.