Alladapt Immunotherapeutics is laying the manufacturing groundwork on its mission to redefine treatment for a common disease with few present options.
The company is getting the ball rolling on a new production plant near the City of Brotherly Love, where it plans to crank out future supply of its experimental food allergy immunotherapy ADP101. The privately held biopharma Thursday said the build-out is now underway.
The 53,000-square-foot factory will double as a warehouse and be situated near the company’s contract manufacturing organization in the greater Philadelphia area, Alladapt said in a release.
Alladapt’s lead candidate ADP101 is taking aim at igE-mediated food allergies, where reactions are often swift and can trigger anaphylaxis. That serious and potentially deadly reaction needs to be treated with epinephrine and a follow-up trip to the emergency room, the Mayo Clinic notes.
The company is recruiting for a phase 1/2 study to test its oral immunotherapy in both kids and adults, and the build-out “reflects our confidence in this program,” co-founder and CEO Ashley Dombkowski, Ph.D., said in a statement. The facility will help shore up future clinical supply for ADP101’s phase 3 program, plus supply a potential commercial launch down the line, she said.
Alladapt is keeping its project investment close to the vest, the company told Fierce Pharma over email. It's also keeping its manufacturing partner, hiring plans and specific capacity needs under wraps, the company said.
The plant will come equipped with customized, automated high-throughput machines, the company said. It'll also mark Alladapt's first dedicated manufacturing facility.
Alladapt is angling to create a fundamental shift in the food allergy arena with meds that address the disease broadly, Dombkowski said. Oral immunotherapy ADP101 is designed to tackle allergies to one or multiple foods associated with 90% of severe reactions, the company said.
Peanut, tree nut, fish and shellfish comprise the food allergies most associated with fatal and near-fatal food-induced anaphylaxis, Alladapt noted. The current treatment standard for the vast majority of the estimated 32 million Americans with food allergies is to simply avoid those dishes, the company said. There are no FDA-approved therapies to treat the “majority” of food allergy patients, Alladapt added.
In short, the market potential for ADP101—if the drug makes it through the clinic and over the FDA finish line—could be huge.