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Aeglea BioTherapeutics Announces Clinical Collaboration with Merck to Evaluate the Combination of Aeglea’s AEB1102 (pegzilarginase) with Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Small Cell Lung Cancer

AUSTIN, Texas, Oct. 16, 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 announced it has entered into a clinical collaboration agreement with Merck (known as MSD outside the United States and Canada) to evaluate the combination of Aeglea’s AEB1102 (pegzilarginase) with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for the treatment of patients with small cell lung cancer (SCLC).

“Earlier this year, we selected SCLC as one of the single agent expansion arms for our ongoing Phase 1 clinical trial based on preclinical and biomarker data indicating that SCLC may be responsive to arginine depletion with pegzilarginase.  In addition, our preclinical data demonstrated a synergistic effect of pegzilarginase in combination with checkpoint inhibitors,” said James Wooldridge, M.D., chief medical officer of Aeglea. “Given the emerging relevance of checkpoint inhibitors, such as KEYTRUDA in SCLC, this collaboration represents an exciting step forward for Aeglea as we investigate the potential of pegzilarginase to treat this devastating disease.”

The multicenter Phase 1/2 study will evaluate overall response rate in patients with extensive disease SCLC who have relapsed or progressed after receiving platinum-based chemotherapy. Enrollment is expected to begin in the first quarter of 2018. Additional details of the collaboration were not disclosed.

The collaboration agreement is between Aeglea BioTherapeutics and Merck, through a subsidiary.

About AEB1102 in Cancer

AEB1102 (pegzilarginase) is an engineered human arginase 1 enzyme designed to degrade the amino acid arginine. Aeglea is developing pegzilarginase to treat cancers which have demonstrated a metabolic dependency on arginine. Dysregulation of amino acid metabolism has been shown to be a key event in tumor growth and development. Unlike healthy cells, these tumors cells have an abnormally high appetite for certain amino acids and are unable to create their own supply, making them vulnerable to starvation through depletion of that amino acid in the blood. Pegzilarginase is intended to address an unmet need for the treatment of these tumor types by degrading arginine in the blood, reducing its level below the normal range to starve the tumor. Aeglea is currently conducting two Phase 1 trials in cancer patients with advanced solid tumors and the hematological malignancies acute myeloid leukemia/myelodysplastic syndrome to evaluate safety and tolerability. Data from these trials have demonstrated that pegzilarginase reduces blood arginine levels, providing initial human proof of mechanism. The company plans to initiate expansion arms of the advanced solid tumor trial in cutaneous melanoma, uveal melanoma and small cell lung cancer in the fourth quarter of 2017 or the first quarter of 2018.

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.

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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, the timing and success of our clinical collaboration with Merck, 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 June 30, 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.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA

Media Contact:
Kelly Boothe, Ph.D.
Pure Communications

Investor Contact:
Charles N. York II
Chief Financial Officer
Aeglea BioTherapeutics

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