What You Need to Know About Aeglea

What You Need to Know About Aeglea
December 2, 2015
By Mark Terry, BioSpace.com Breaking News Staff

Aeglea was founded in December 2013 to develop engineered human enzymes that were invented in the laboratory of George Georgiou of The University of Texas at Austin.

The company is working to develop novel treatments for inborn errors of metabolism (IEM), as well as therapies targeting tumor metabolism. IEM are a set of rare metabolic diseases, and certain cancers, that are dependent on arginine, a specific amino acid.

Company Leadership
David Lowe—co-founder, president and chief executive officer of Aeglea Biotherapeutics. Prior to joining Aeglea, Lowe was a venture capitalist at Skyline Venture in Palo Alto, Calif.

Charles York—chief financial officer. Prior to joining Aeglea, he was the chief financial officer in various companies, including tech, aerospace, medical devices and pharmaceuticals.

Henry Hebel— vice president of product development. Prior to joining Aeglea, he was the vice president of drug development for Terapio. Prior to that, Hebel was chief operating officer of VGXI.

Scott Rowlinson—vice president of research. Prior to joining the company, Rowlinson was with Eli Lilly and Company .

Joseph Tyler—as vice president of manufacturing.

Ann Lowe—consulting chief medical officer.

Company Financing
The company started with a $12 million funding round. This included $2.5 million in equity from KBI BioPharma of North Carolina, which is also taking care of the manufacturing processes needed before its clinical trial phase.

In March 2015, the company announced it had closed on a $44 million Series B financing round. It was led by existing investors Lilly Ventures and Novartis Venture Fund, along with participation by University of Texas Horizon Fund. They were joined by new investors OrbiMed, Jennison Associates, Venrock, RA Capital Management, Rock Springs Capital, Ally Bridge Group and Cowen Investments.

“New treatments for individuals with inborn errors of metabolism or hematologic and solid malignancies are urgently needed,” said Lowe in a statement at the time, “and this financing enables us to advance our lead molecule into the clinical setting as well as pursue the preclinical development of our pipeline products to address significant unmet medical needs.”

Pipeline
The company has four drugs in its pipeline. AEB1102 entered Phase I/II proof-of-concept clinical trials in both hyperarginemia and cancer in the second half of 2015. Dosing started for Phase I in solid tumors in October 2015. A trial for Arginase I deficiency with AEB1102 is expected to start in 2016. AEB1102 is being developed as an enzyme replacement therapy in patients who have a rare inborn error of metabolism hyperarginemia (HA) that is caused by Arginase I deficiency. For its cancer trials, it will target abnormal tumor metabolism characterized by arginine dependence.

“We initiated a Phase I clinical trial of our lead candidate, AEB1102, in October 2015,” said Lowe in an exclusive interview with BioSpace , “which will be an open-label dose escalation study for the treatment of patients with advanced solid tumors.”

Aeglea also has three other drug candidates in preclinical development. AEB4104 degrades homocystine, and is being evaluated as a potential treatment for homocystinuria. AEB3103, which degrades cysteine/cystine, is being developed to increase oxidative street through glutathione depletion for treatment of hematologic and solid malignancies. AEB2109, which degrades methionine, is being studied for the treatment of solid tumors.

“Beyond AEB1002, our pipeline includes AEB4104,” says Lowe, “which is designated to degrade homocysteine and is currently in preclinical development for the treatment of classical homocystinuria; AEB3101, which degrades cysteine and we believe may exploit a vulnerability in certain tumors to oxidative stress; and AEB2109, which targets methionine and is in preclinical development to target methionine dependence in certain cancers.”

The company’s products were in-licensed from the University of Texas at Austin, or were assigned by one of the company’s founders.

Market Competition
Competitors include Foundation Medicine and Agios . Agios, in particular, focuses on metabolism and metabolic errors in cancer. Others involved in this area include Celgene , which has a strategic deal with Agios, as well as Cornerstone Pharmaceutical and Advanced Cancer Therapeutics. AstraZeneca has worked in this area with the Cancer Research Technology, Cancer Research UK’s commercialization and development arm.

“Since our lead product is in development to treat a disease, Arginase I deficiency, which currently has no FDA approved treatments, there are not many direct competitors that we can point to,” Lowe told BioSpace. “Other companies who are working in the general enzyme replacement therapy space include Genzyme and Shire . However, to our knowledge, we are the only company that is developing enzyme replacement therapies from engineered human enzymes.”

Dollars and Deals
An additional investor is UT-Austin Technology, a tech incubator, which has supplied initial research space for the company. The company has also received grant funding from the Cancer Prevention and Research Institute of Texas.

In September 2015, Aeglea filed an amended S-1 form with the U.S. Securities and Exchange Commission (SEC) regarding an initial public offering (IPO). No terms have been described, but the underwriters are UBS Investment Bank, BMO Capital Markets and Wedbush PacGrow. The company intends to file on the Nasdaq Global Market under the symbol AGLE. It hopes to raise $75 million.

What to Look For
With one clinical trial already started and another beginning in early 2016, expect some data to be released in 2016. Also, look for an IPO in the near future.

The company hopes to advance its clinical trial program for AEB1102 in Arginase 1 deficiency, as well as identifying solid tumors and/or hematological malignancies that can be pursued for the cancer indication. “Additionally,” Lowe told BioSpace, “we hope to identify and advance a second product candidate into clinical development in that timeframe. We also intend to build our own research organization to provide in-house drug discovery capabilities and continue to work with the University of Texas at Austin to expand our portfolio of product candidates.”

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