Company to Manufacture Clinical-Grade Supplies for Forthcoming Clinical Trial in Community-Acquired Pneumonia

BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – November 26, 2013) BioAegis Therapeutics announced that it has engaged Debra Barngrover Ph.D. to oversee the company’s recombinant manufacturing of plasma gelsolin. Dr. Barngrover is a pharmaceutical process development expert with extensive experience in protein development. She provides regulatory advice and prepares and reviews the Chemistry, Manufacturing and Controls (CMC) sections of regulatory filings. Most recently, she was Vice President, Technology Development, at Genzyme Corporation. During her tenure at Genzyme, she led the process development team for a recombinant protein from initial product concept through approval to market launch in more than 40 countries.


Company to Evaluate Orphan Diseases as Secondary Indications

BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – July 28, 2013) BioAegis Therapeutics announced that the FDA has transferred Orphan Designations for cystic fibrosis and bronchiectasis to the company. The FDA Office of Orphan Products Development (OOPD) provides support and incentives for sponsors to develop products for rare diseases. For example, The OOPD administers extramural grant programs such as The Orphan Products Clinical Trials Grants Program which provides funding for clinical research. Cystic fibrosis is an inherited chronic disease that affects the lungs and digestive system of about 30,000 children and adults in the United States and an additional 70,000 worldwide. Bronchiectasis is a chronic condition where the walls of the bronchi are thickened from inflammation and infection with approximately 110,000 known cases in the US.


BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – July 26, 2013) BioAegis Therapeutics announced today that a patent has been granted in Japan that that covers the diagnostic claims of the therapeutic and diagnostic application. Further Japanese applications for therapeutic claims in inflammation are pending.


Bolognese to Provide Statistical Design of Biomarker-Driven Phase 2b Human Efficacy Study in Severe Community-Aquired Pneumonia

BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – June 15, 2013) BioAegis Therapeutics announced today that it has engaged Jim Bolognese, Senior Director of Strategic Consulting at Cytel Inc., a leading firm in the design and conduct of adaptive trials. Prior to joining Cytel, Jim Bolognese worked for Merck & Company for 37 years designing clinical trials in various indications.


Supplies to be Used in Forthcoming Human Trials

BOSTON MASSACHUSSETTS and MORRISTOWN, NEW JERSEY–(BIOAEGIS THERAPEUTICS – April 15, 2013) BioAegis Therapeutics announced today that it has engaged the Billingham, UK group of Fujifilm Diosynth—a first-tier
contract biologics manufacturer, to manufacture clinical-grade supplies of recombinant human plasma gelsolin, the body’s 4th most abundant plasma protein that becomes depleted in myriad disease condtions and injuries. . BioAegis is preparing for human clinical trials to demonstrate that repletion of plasma gelsolin can prevent prevent excess inflammation that results in organ damage while boosting the body’s response to pathogens. FujiFilm Diosynth Biotechnologies is a tier-1 cGMP Contract Development and Manufacturing Organization (CDMO) that supports the development and production of therapeutic candidates.