Anagram Therapeutics Announces Initiation of Clinical Study of ANG003 in People with Cystic Fibrosis

FOR IMMEDIATE RELEASE Anagram Therapeutics Announces Initiation of Clinical Study of ANG003 in People with Cystic Fibrosis Announces Expansion of Joint Product Development Collaboration with ATUM to Accelerate Development of Orally Delivered Enzymes for Malabsorption and Nutrient Metabolism Disorders FRAMINGHAM, Mass., September 27, 2023 — Anagram Therapeutics Inc., a clinical -stage biopharmaceutical company dedicated to improving the lives of people with cystic fibrosis (CF) and other rare diseases, today announced that the first participants have been dosed in a multicenter, randomized, parallel study to evaluate the safety and tolerability of orally administered ANG003 in adult subjects with CF -related exocrine pancreatic insufficiency (EPI). 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 office r, 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 .” Phase 1 Clinical Trial Design The primary objective of this Phase 1 multicenter, randomized, parallel study is to evaluate safety and tolerability with orally administered ANG003 in adult subjects with CF -related 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 absorpti on 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. Anagram and ATUM Expand Joint Product Development Collaboration Anagram and ATUM, a global specialist and industry leader in bioengineering solutions, announced the companies are extending their collaboration following a successful partnership that accelerated delivery of ANG003 into the clinic. 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 , together t he companies aim to advance a pipeline of orally delivered enzymes targeting malabsorption syndromes and nutrient metabolism disorders. -- more -- “Following successfully bringing ANG003 to the clinic, we believe that extending our collaboration with Anagram makes a lot of sense,” said Claes Gustafsson, chief commercial officer, ATUM. “Leveraging our experience with Anagram, we have the opportunity to build a platform that brings a deep pipeline of novel therapeutics into the clinic, targeting some of the most challenging diseases in infants, children and adults . We are already well on our way with Anagram to accelerating several additional promising clinical candidates using our technology.” “The core of our collaboration uses our collective expertise and combined technologies to drive target selection and design novel products for breakthrough treatments,” added Gallotto. “We are extremely impressed with ATUM’s track record of industry leadership, engineering and production excellence. We look forward to continuing to work with their highly skilled team to advance novel targeted enzyme therapies for people with rare diseases .” 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 www.atum.bio. 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. To learn more, visit www.anagramtx.com or follow us on LinkedIn and X. # # # Anagram Contact: ATUM Contact: Media Contact: Kathryn Kilroy Cheryl Sturgis Gina Cella Director, Operations Head of Marketing Cella Communications [email protected] [email protected] [email protected] (617) 466-3823 (510) 903-2301 (781) 799-3137 (mobile)

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