ATUM Partners with Anagram Therapeutics to Extend Collaboration to Develop Orally Delivered Enzyme Therapies for Malabsorption and Nutrient Metabolism Disorders

2023-10-04

临床1期

Announces Initiation of Clinical Study of ANG003 in People with Cystic Fibrosis NEWARK, Calif.--(BUSINESS WIRE)-- ATUM, a global specialist and industry leader in bioengineering solutions, today announced an expanded partnership with Anagram Therapeutics Inc., a clinical-stage biopharmaceutical company dedicated to improving the lives of people with cystic fibrosis (CF) and other rare diseases. The expanded relationship follows a successful partnership that accelerated delivery of ANG003 into a clinical study recently initiated in people with cystic fibrosis. Together, the companies aim to advance a pipeline of orally delivered enzymes targeting malabsorption syndromes and nutrient metabolism disorders, by combining ATUM’s expertise in enzyme engineering, bioanalytics, and machine learning with Anagram’s expertise in gastrointestinal physiology and enzyme development, as well as its global clinical and scientific thought leader network. "We are excited by the initiation of the ANG003 clinical study, an enzyme replacement therapy engineered using our multidimensional optimization GPS platform," said Claes Gustafsson, Chief Commercial Officer at ATUM. "The bioengineering platform combines systematic variance and machine learning to efficiently search almost infinite sequence space in many fitness dimensions simultaneously using only a few hundred samples. It has been an honor to work closely with the Anagram team to harness this technology for the purpose of addressing malabsorption and nutrient metabolism disorders." The first participants have been dosed in the multicenter, randomized, parallel Phase 1 study to evaluate the safety and tolerability of orally administered ANG003 in adult subjects with CF-related exocrine pancreatic insufficiency (EPI). Additionally, the study aims to demonstrate absorption of the byproducts of digestion in plasma using sensitive biomarkers of absorption. The study design includes up to four possible combinations of orally delivered lipase, protease, and amylase administered with a test meal. A series of robust preclinical studies suggest ANG003 may improve absorption of the most beneficial fats and other key macronutrients in a dose dependent manner. This Phase 1 trial of ANG003 is being conducted through the Cystic Fibrosis Therapeutics Development Network at approximately twenty national CF care centers in the U.S. ANG003 is a novel broad-spectrum orally delivered enzyme replacement therapy for the treatment of malabsorption and EPI. EPI is a condition which occurs when the body does not produce enough pancreatic (digestive) enzymes to break down foods and absorb nutrients. EPI can lead to malnutrition, fatty acid abnormalities, profound gastrointestinal symptoms, a significant decrease in quality of life and reduced life expectancy. “We are pleased to have rapidly advanced ANG003 into the clinic, representing a big step toward providing a meaningful new treatment for people living with cystic fibrosis,” said Robert Gallotto, President and Chief Executive Officer, Anagram Therapeutics. “Initiating this clinical study and dosing the first patient is a significant milestone, as we continue to evolve orally delivered enzymes as therapeutics for malabsorption and nutrient metabolism disorders.” About ATUM ATUM is a fully integrated California based CRDO (Contract Research & Development Organization) biotechnology industry leader. ATUM, over the last two decades, has served life science researchers by delivering the highest quality services including but not limited to Gene Design and Gene Synthesis, Protein Engineering, Protein Production, Leap-In Transposase®, Cell Line Development, and Master Cell Banking (MCB). With a state-of-the-art machine learning platform, proprietary algorithms and thanks to its fully integrated Laboratory Information Management System (LIMS), ATUM takes you from virtual sequence to MCB with a click of a button. ATUM provides a continual commitment to innovation where services are built on bioengineered solutions to bring speed to market, supporting you from pre-clinical research through IND and beyond. Contact us today for more information at atum.bio or follow us on LinkedIn. About Anagram Therapeutics Anagram Therapeutics Inc. is a clinical stage biopharmaceutical company developing novel, orally delivered enzyme therapeutics for the treatment of serious diseases caused by malabsorption syndromes and nutrient metabolism disorders that prevent the body from properly processing or absorbing certain fats, sugars, proteins, vitamins, or other key nutrients. The company is leveraging proprietary enzyme technologies and expertise in gastrointestinal diseases to solve complex problems and advance a pipeline of products that can make a life-changing impact for people and their families living with cystic fibrosis and other rare diseases. ANG003, Anagram’s lead product for the treatment of malabsorption and exocrine pancreatic insufficiency, is a new class of broad-spectrum digestive enzyme replacement therapy in clinical trials in people with cystic fibrosis. Anagram is a privately held company headquartered in Framingham, MA. 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