Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE) announced that it has initiated dosing of patients in two studies evaluating its lung cancer candidate, pegzilarginase, in small cell lung cancer (“SCLC”).
A cohort expansion phase I study is evaluating pegzilarginase as monotherapy in SCLC patients. The other one is phase I/II study evaluating the candidate in combination with Merck’s (NYSE:MRK) anti-PD-1 therapy, Keytruda, in a similar indication.
Top-line data from the studies are expected in the fourth quarter of 2018.
Aeglea’s shares have risen 77.8% so far this year, against the industry’s loss of 4.9% during the period.
The SCLC expansion cohort is one of the three arms of the phase I study, which is evaluating pegzilarginase in cancer tumors that stop producing a certain amino acid, arginine. Depletion in arginine levels in the tumors causes cell death and promotes anti-tumor immune responses.
The phase I/II study is evaluating combination of pegzilarginase and Keytruda for overall response rate in patients with extensive disease SCLC whose disease has relapsed or progressed after receiving platinum-based chemotherapy.
Per the press release, only 6% of SCLC patients survive after five years of treatment, showing a significant unmet need.
Several pharma companies are developing therapies for treating SCLC. AstraZeneca (NYSE:AZN) is developing a combination of its PARP inhibitor, Lynparza, and chemotherapy, Temodar, in a phase I/II study. AbbVie (NYSE:ABBV) and Bristol-Myers have collaborated to develop rovalpituzumab tesirine in combination with Opdivo and Yervoy in a phase I study. G1 Therapeutics is also developing therapies in combination with chemotherapy for SCLC.
Apart from SCLC, Aeglea is also developing pegzilarginase in a phase I/II study in patients with Arginase 1 deficiency, a rare genetic disease. The company reported positive preliminary data from the study earlier this month.
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Aeglea currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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