Issue 4 2021

Acquisition International - Issue 4 2021 23 Feb21095 Patient Focused Aegle Therapeutics is a first in class biotechnology company specialising in isolating tiny particles secreted by mesenchymal stem cells (MSCs) as therapy. These particles are called extracellular vesicles (EVs), the smallest of which are exosomes. These particles carry most, if not all, of the signals of their parent stem cells and Aegle Therapeutics believes that they can be used in lieu of the cells as therapy. EV therapy can also be thought of as cell-free therapy. egle’s first disease target is recessive dystrophic epidermolysis bullosa (RDEB), a rare paediatric skin blistering disorder where patients do not produce the COL7 protein. Aegle has been cleared by the FDA to begin clinical trials in RDEB and enrollment in the trial is expected to begin later this year. Aegle has also been cleared by the FDA to do a second trial in burn patients. This trial has been funded by a grant and is expected to commence early 2022. In 2020, Aegle was awarded both Fast Track and Rare Paediatric Disease designations by the U.S. Food and Drug Administration for AGLE-102 for dystrophic epidermolysis bullosa. Aegle believes that its EV therapy holds promise for not only severe dermatological conditions but also for a broad range of other diseases. “Our vision is to deliver on the promise of cell-free therapy for individuals affected by severe dermatological disorders and beyond,” explains Chief Executive Officer, Shelley Hartman. “Our mission is to pioneer the development of advanced regenerativemedicine, enabling greater healing and reduced pain for our patient communities.” Shelley has served as the Chief Executive Officer of Aegle Therapeutics since August of 2014. Prior to Aegle, Shelley served for nine years as CEO of LifeSync Corporation, a start-up medical device company developing and marketing wireless medical technology to hospital customers. LifeSync was spun-off from LifeSync Holdings (f/k/a GMP Companies, Inc.), a development company focused on biopharmaceutical and medical device product development. Prior to LifeSync, she served for more than 18 years in the investment banking industry, most recently as Managing Director in the Healthcare Department of the Investment Banking Division at Goldman, Sachs & Co. Ms. Hartman holds a B.A. from Wellesley College. “Aegle is patient focused,” she elaborates, talking about the company and its core values. “We work with patient advocacy groups to understand the patient experience and tailor our approach to addressing the needs of that population.” The company operates as a close knit team where everyone plays a critical role in its success. When recruiting new talent, the management looks for not only smart, experienced people but also for people who know how to work together to solve problems and who celebrate each other’s accomplishments. “We seek people who can re- envision the way we think about regenerative medicine while keeping the patient first.” Shelley tells us that the Covid-19 pandemic has had a definite impact on Aegle’s progress, including causing supply delays in the manufacturing chain as well as raising concerns from clinical sites regarding trial commencement dates. However, overall, the company has continued to make significant progress and has found that the team works very well together in its remote workplace situation. Looking to the future, Shelley expects 2021 will be a critical year for Aegle, and the company has great plans. “Going forward, we plan to complete the transfer of our manufacturing to a commercial contract manufacturer with the capacity to supply product for not only clinical trials but for commercial launch. Aegle is targeting launching the first extracellular vesicle therapy study in the US in the rare disease RDEB. Finally, we will also be preparing to launch our second clinical study in burn patients.” Company: Aegle Therapeutics Corp. Contact: Shelley Hartman Website: A