Key leadership appointment adds expertise in strategic and technical aspects of pharmaceutical manufacturing to support ADP101, a broad-spectrum oral biopharmaceutical candidate targeting food allergy
MENLO PARK, Calif., April 28, 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 the appointment of Michael Holfinger, PhD, as Chief Technical Officer. Dr. Holfinger will oversee all aspects of Alladapt’s technical operations including global supply chain, manufacturing, CMC regulatory and quality. His responsibilities will span technical operations to support ongoing work streams related to Alladapt’s existing clinical activities along with manufacturing scale-up for Phase 3 clinical studies of ADP101 and beyond.
“With our Phase 1/2 Harmony Study successfully enrolling food allergic patients across the United States, we have begun looking ahead to additional development opportunities including our Phase 3 scale up activities and the globalization of our lead program,“ said Ashley Dombkowski, PhD, Alladapt’s Chief Executive Officer and co-founder. “Mike brings more than 20 years of relevant experience to Alladapt, notably spanning all strategic, regulatory and technical aspects of pharmaceutical manufacturing. In addition to his accomplishments, he is a driven and compassionate leader who is an excellent cultural fit with our mission-driven team.”
Before joining Alladapt, Dr. Holfinger was Vice President of Chemistry Manufacturing and Controls at Pliant Pharmaceuticals where he was responsible for all process/product development, manufacturing/supply, and analytical development/quality control activities to support clinical development of multiple small molecule drug candidates. Prior to this, he spent five years as SVP Technical Operations at Aimmune Therapeutics where he was responsible for all process/product development, manufacturing, supply chain, and analytical development/quality control activities to support clinical development and commercialization of Palforzia™, an FDA-approved biologic oral immunotherapy product for the treatment of pediatric peanut allergy. Dr. Holfinger's earlier career included increasingly responsible positions at Alexza, Affymax, Pfizer, Pharmacia and Upjohn. He earned a PhD in Chemical Engineering from the University of Wisconsin-Madison, and dual Bachelor of Science degrees in Applied Science and Chemistry from Miami University.
“Alladapt’s ADP101 is an elegant drug candidate that may enable the treatment of many types of mono-allergic and multi-allergic patients by harnessing its broad coverage of the most commonly allergenic food-sourced proteins,” said Dr. Holfinger. “The Alladapt team has solved notable challenges associated with precise oral delivery of an extensive set of standardized, pharmaceutical grade antigens across a wide range of dosages. At the same time ADP101 incorporates patient-centric features such as flavor masking and the elimination of refrigeration requirements. I am truly excited to be joining Alladapt at this critical juncture as we anticipate our future clinical and commercial needs.”
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 P1/2, 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. Academic clinical research conducted by Dr. Nadeau has demonstrated that a food allergic immune system in an individual person can be receptive to remodeling by gradually increasing exposure under tightly controlled clinical supervision to the proteins that activate the inappropriate cascade of reactions. This work, combined with research illuminating disease mechanisms, pathways, and protein structures, led the founders to envision biopharmaceutical interventions capable of addressing food allergy provoked by a wide-ranging set of antigens. 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.
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