Results of Preclinical Study In vivo treatment of a colon cancer mouse model (CT26) with AEB1102 showed an increased life span with AEB1102 monotherapy compared to the untreated control group (46%, p<0.001). CT26 mice dosed with standard monotherapy using antibodies targeting PD-1 and PD-L1 increased life span by 0% (p=0.5) and 29% (p=0.002), respectively. Most notably, combination therapy of AEB1102 with PD-1 or PD-L1 inhibitors resulted in increased life spans compared to either AEB1102 or immunotherapy monotherapy. Treatment with AEB1102 in combination with PD-1 or PD-L1 inhibitors increased life span by 67% (p<0.001) in both cases. The improved response is currently believed to be the result of AEB1102 directly inhibiting tumor growth through depletion of arginine levels as well as potentially further sensitizing tumors to immunotherapy treatment. These findings suggest that combining AEB1102 with PD-1 or PD-L1 inhibitors may have the potential to further improve outcomes in cancer patients.About AEB1102AEB1102 is an engineered human arginase I enzyme designed to degrade the amino acid arginine. Aeglea is developing AEB1102 to treat two extremes of arginine metabolism, including arginine excess in patients with Arginase I deficiency, as well as some cancers which have been shown to have a metabolic dependency on arginine. In patients with Arginase I deficiency, AEB1102 is intended for use as enzyme replacement therapy to restore the function of arginase I in patients and return elevated blood arginine levels to the normal physiological range. Aeglea is currently conducting a Phase 1 trial in cancer patients with advanced solid tumors to evaluate the safety and tolerability of AEB1102. Data from this trial demonstrated that AEB1102 has the ability to reduce blood arginine levels, providing initial human proof of mechanism. About Aeglea BioTherapeutics Aeglea is a biotechnology company committed to developing engineered human enzymes for the treatment of rare diseases and cancers associated with abnormal amino acid metabolism. The company's engineered human enzymes are designed to degrade specific amino acids in the blood in order to reduce toxic levels of amino acids in genetic rare diseases or to deprive tumors dependent on amino acids by reducing levels below the normal range. Aeglea's clinical program for its lead product candidate, AEB1102, includes three Phase 1 trials, studying AEB1102 for the treatment of patients with Arginase I deficiency, advanced solid tumors and hematological malignancies. The company is building a pipeline of additional product candidates targeting key amino acids, including AEB4104, which degrades homocystine, a target for a genetic rare disease, as well as two potential treatments for cancer, AEB3103, which degrades cysteine/cystine, and AEB2109, which degrades methionine. For more information, visit http://aegleabio.com. Safe Harbor / Forward Looking StatementsThis press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, statements we make regarding the timing, objectives and success of our clinical trials, data from our preclinical studies and potential data from future clinical trials, and the potential therapeutic benefits and economic value of our lead product candidate, AEB1102. Further information on potential risk factors that could affect our business and its financial results are detailed in our most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, filed with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Media Contact: Kelly Boothe, Ph.D. BrewLife email@example.com Investor Contact:Charles N. York II Chief Financial Officer Aeglea BioTherapeutics firstname.lastname@example.org