Alladapt Initiates Buildout of New Manufacturing Facility for Production of Novel, Investigational Oral Immunotherapeutic Designed to Address a Broad Range of Food Allergies

Thursday, 19. August 2021 13:00

ADP101 is a singular optimized, pharmaceutical-grade oral immunotherapy candidate currently in a Phase 1/2 clinical trial for patients with mono- and multi-food allergies

Facility intended to support late-stage clinical supply of ADP101 and commercial product

MENLO PARK, Calif., Aug. 19, 2021 (GLOBE NEWSWIRE) -- Alladapt Immunotherapeutics Inc., a private, clinical-stage biopharmaceutical company focused on the development of prescription therapeutics to address IgE-mediated food allergy, today announced it has initiated the buildout of a new state-of-the-art manufacturing facility to support future production of its lead product candidate, ADP101. ADP101 is a novel, investigational oral immunotherapy designed to address allergies to one or to multiple foods associated with 90% of severe reactions. The 53,000 square foot manufacturing and warehouse facility is strategically located near the Company’s contract manufacturing organization (CMO) in the greater Philadelphia area.

“One of the great strengths of Alladapt is our technical operations team, which has spent years addressing the specialized, novel challenges associated with producing pharmaceutical-grade single-and multi-allergen oral immunotherapeutic agents,” said Mike Holfinger, PhD, Alladapt’s Chief Technical Officer. “With our Harmony Study actively enrolling, it is exciting to build on our technical achievements by initiating scale-up beyond our Phase 1/2-enabling processes.”

CEO Ashley Dombkowski, PhD added, “Securing this facility reflects our confidence in this program and marks an important step toward achieving full-scale production capacity to support our Phase 3 program and potential future commercial launch. These investments reaffirm our commitment to transforming the food allergy treatment landscape by advancing therapeutic options to broadly address this chronic and potentially life-threatening disease.”

About Food Allergy (FA)
FA is a common and serious condition that affects children and adults and is associated with severe reactions, including life-threatening anaphylaxis. Allergy to peanuts, tree nuts, fish, or shellfish is most commonly associated with fatal and near-fatal food-induced anaphylaxis (Jones, 2017). The standard of care for ~95% of an estimated 32 million U.S. patients with FA is food allergen avoidance. Despite efforts to avoid, accidental exposures occur and can cause rapid, multi-system and potentially life-threatening reactions that necessitate epinephrine as rescue treatment. With multi-allergy prevalence on the rise and an estimated 50% of FA patients having sought emergency care (Gupta, 2018 and 2019), there exists an urgent need for innovative treatment options to address this disease. There are no FDA-approved therapies to treat the majority of FA patients and oral immunotherapy (OIT) is a treatment approach that – based on foundational research – presents encouraging potential as a treatment for a range of causes of food allergy.

About Alladapt Immunotherapeutics
Alladapt Immunotherapeutics is a private, clinical-stage biopharmaceutical company developing prescription therapeutics targeting food allergy. The company is currently enrolling patients in The Harmony Study, a Phase 1/2, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ADP101 for the treatment of food allergy in children and adults. ADP101 is an investigational oral immunotherapy product candidate representing the nine food groups responsible for the vast majority of significant food allergic reactions.

Alladapt was co-founded in 2018 by allergist and protein biochemist Kari Nadeau, MD, PhD and biotechnology entrepreneur, Ashley Dombkowski, PhD. Food allergen specific OIT conducted by Dr. Nadeau and other food allergy experts is an approach that has shown consistently promising results through administration of increasing amounts of an allergen to individuals with food allergy to raise the threshold and decrease the severity of allergic responses to the allergenic food. This work, combined with research on disease mechanisms, pathways, and protein structures, led the founders to envision biopharmaceutical interventions capable of addressing food allergy due to a wide-ranging set of foods. Gurnet Point Capital, a private investment firm focused on the healthcare and life sciences sectors, is Alladapt’s primary investor.

For more information, please visit the Company's website at www.alladapt.com.

Source: Alladapt Immunotherapeutics, Inc.

Investor Contact:
Investor@alladapt.com

Media Contact:
Hannah Gendel
Solebury Trout
646-378-2943
hgendel@soleburytrout.com


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