FDA accepts Aeglea’s IND application for AEB1102 to treat hematological malignancies

Aeglea plans to start a phase 1 dose escalation study in the first half of this year in patients with relapsed and refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) to evaluate the safety, tolerability, and pharmacokinetics of AEB1102.

AEB1102 is derived from human Arginase I. Modifications including the substitution of cobalt for the manganese cofactor and PEGylation, impart on the drug increased catalytic activity and serum stability compared to native Arginase I.

It has a potential immunogenicity advantage over microbial enzymes with arginine degrading activity. The AEB1102 amino acid sequence is engineered from the native human amino acid sequence.

AEB1102 aims to replace the function of Arginase I in patients and return elevated blood arginine levels to the normal physiological range. The company said normalization of arginine levels may slow or stop the progression of disease in these patients.

Aeglea BioTherapeutics co-founder, president and CEO David Lowe said: "This represents our third open IND for AEB1102, which is an exciting achievement for Aeglea, a company founded just over two years ago.

"We look forward to starting our hematological malignancy Phase 1 clinical trial as we continue to expand the development of our lead product candidate in multiple indications."

Aeglea’s pipeline of other product candidates targeting key amino acids, include AEB4104, which degrades homocystine, a target for an inborn error of metabolism, and two potential treatments for cancer, AEB3103, that degrades cysteine/cystine, and AEB2109, which degrades methionine.