On May 23, 2017 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, reported an AEB1102 program and corporate update (Press release, Aeglea BioTherapeutics, MAY 23, 2017, View Source [SID1234519276]). 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. Schedule your 30 min Free 1stOncology Demo! AEB1102 Program Update
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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.