On March 8, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, reported the dosing of the first uveal and cutaneous melanoma patients with pegzilarginase (AEB1102) in its open-label Phase 1 cohort expansions (Press release, Aeglea BioTherapeutics, MAR 8, 2018, View Source [SID1234524966]). The Company expects to report topline data, including safety and clinical activity, in the fourth quarter of 2018.

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"Given our encouraging dose escalation data with pegzilarginase, the start of these Phase 1 cohort expansions is an important next step in targeting the advanced solid tumors that we believe are vulnerable to arginine depletion," said Anthony Quinn, MB ChB, Ph.D., interim chief executive officer of Aeglea. "This is an exciting time at Aeglea as we assess the clinical activity of sustained arginine depletion in melanoma. We expect to report topline data in the fourth quarter of this year."

Aeglea also initiated studies with pegzilarginase in small cell lung cancer as monotherapy and in combination with pembrolizumab. Additionally, the Company is conducting an open-label Phase 1/2 trial and a long term extension study in patients with Arginase 1 Deficiency, a rare genetic disease. Regarding Arginase 1 Deficiency, Aeglea plans to report adult repeat dose data this month and adult and pediatric repeat dose data, along with pivotal trial design, in the second half of this year.