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Aeglea BioTherapeutics Provides AEB1102 Program and Corporate Update

--Announces three single agent expansion arms for AEB1102 solid tumor trials--

--Provides update on AEB1102 program in Arginase 1 Deficiency--

--Company names Aaron Schuchart as chief business officer--

AUSTIN, Texas, May 23, 2017 (GLOBE NEWSWIRE) -- Aeglea BioTherapeutics, Inc., (NASDAQ:AGLE) a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat rare genetic diseases and cancer, today provided an AEB1102 program and corporate update. AEB1102, the company’s lead investigational molecule, is an engineered human enzyme designed to degrade the amino acid arginine and is being developed to treat two extremes of arginine metabolism.

AEB1102 Program Update

Selection of Single Agent Solid Tumor Expansion Cohorts

Aeglea is currently conducting a Phase 1 clinical trial in cancer patients with advanced solid tumors to assess the safety, tolerability and pharmacokinetics of AEB1102, which has demonstrated clinical proof of mechanism. The trial is designed to include a dose escalation phase to determine maximum tolerated dose and an expansion phase to obtain additional single agent data in specific tumor types.

Aeglea has selected three single agent solid tumor expansion arms: cutaneous melanoma, uveal melanoma and small cell lung cancer, all of which have been shown in studies to demonstrate a dependence on arginine. The primary endpoint of the expansion arms is to assess safety in patients with specific tumor types. Secondary endpoints include assessment of pharmacokinetics, pharmacodynamics and clinical response. Each expansion arm will enroll up to 12 patients and are planned to initiate in the fourth quarter of 2017 or first quarter of 2018, following completion of the dose escalation phase.

Regulatory Update on Pediatric Dosing for Arginase 1 Deficiency Clinical Trial

In March 2017, the Company received an information request from the United States Food and Drug Administration (FDA) that additional data may be needed to support the inclusion of pediatric patients in the ongoing Phase 1/2 trial in Arginase 1 Deficiency. The Company recently received written feedback from the FDA based on supporting data provided in March and a follow-up meeting with the Agency in late April.

“Based on discussions with the FDA, we were unable to resolve a difference in opinion at this time on the data needed to support inclusion of pediatric patients. We anticipate continuing our dialogue with the FDA on this topic,” said David Lowe, Ph.D., chief executive officer of Aeglea. “This results in a delay in our plan to initiate dosing in pediatric patients in the United States. We will continue to focus on our Phase 1/2 trial, which we expect to begin enrolling adult patients in the middle of 2017.”

To date, Aeglea has received two Institutional Review Board (IRB) approvals for the Phase 1/2 protocol in the United States, and has an open Clinical Trial Application (CTA) in Canada which includes treatment of both adult and pediatric patients.

Aeglea names Aaron Schuchart to the position of chief business officer

Aaron Schuchart joined Aeglea as chief business officer on May 22, 2017 where he will be responsible for overseeing business development activities and facilitating corporate strategy.

“Aeglea’s Phase 1 clinical data in Arginase 1 Deficiency, along with encouraging preclinical data supporting a possible combination approach in cancer, highlights the potential of AEB1102 and puts us in a strong partnering position,” said Mr. Schuchart. “Aeglea has a pipeline of exciting opportunities in rare disease and cancer and I look forward to working with the team to identify new business opportunities to maximize our impact in these areas.” 

Previously, Mr. Schuchart served as senior vice president of business development and strategic alliances at Coherus Biosciences where he played a role in growing the company from early platform stage to a fully integrated, late-stage clinical company. Prior to Coherus, Mr. Schuchart was head of business development and strategic planning at Novartis’ diagnostics division until its acquisition by Grifols. Earlier in his career, Mr. Schuchart served in various leadership roles at Mendel Biotechnology and Amgen. Mr. Schuchart holds a bachelor’s degree in accounting from Texas Tech University and an MBA from the UCLA Anderson School of Management.

About AEB1102

AEB1102 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 1 Deficiency, as well as some cancers which have been shown to have a metabolic dependency on arginine. In patients with Arginase 1 Deficiency, AEB1102 is intended for use as enzyme replacement therapy to restore the function of arginase 1 in patients and return elevated blood arginine levels to the normal physiological range. Aeglea is currently recruiting patients for its ongoing Phase 1/2 trial for the treatment of Arginase 1 Deficiency. Aeglea is also conducting two Phase 1 trials in cancer patients with advanced solid tumors and with hematological malignancies to evaluate the safety and tolerability of AEB1102. Data from these trials 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 enzyme-based therapeutics in the field of amino acid metabolism to treat rare genetic diseases and cancer. The company’s engineered human enzymes are designed to modulate the extremes of amino acid metabolism in the blood to reduce toxic levels of amino acids in inborn errors of metabolism or target tumor metabolism for cancer treatment. AEB1102, Aeglea’s lead product candidate, is currently being studied in two ongoing Phase 1 clinical trials in patients with advanced solid tumors and acute myeloid leukemia/myelodysplastic syndrome (AML/MDS). Additionally, Aeglea is recruiting patients into its ongoing Phase 1/2 trial of AEB1102 for the treatment of patients with Arginase 1 Deficiency. The company is building a pipeline of additional product candidates targeting key amino acids, including AEB4104, which degrades homocystine, a target for an inborn error of metabolism, as well as two potential treatments for cancer, AEB3103, which degrades cysteine, and its oxidized form cystine, and AEB2109, which degrades methionine.

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Safe Harbor / Forward Looking Statements

This 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 our future partnership opportunities and the potential therapeutic benefits and economic value of our lead product candidate or other product candidates. 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 March 31, 2017 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.
Pure Communications

Investor Contact:
Charles N. York II
Chief Financial Officer

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