AskBio announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for the LION-101 gene therapy program.
Category: News
AskBio Announces IND for LION-101, a Novel Investigational AAV Gene Therapy for the Treatment of Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9), Cleared to Proceed by U.S. FDA
The U.S. FDA has cleared AskBio’s Investigational New Drug (IND) application for LION-101 to proceed in a Phase 1/2 clinical study.
AskBio Named 2021 Life Sciences Awards Company of the Year Winner by Triangle Business Journal
AskBio announced that it has been honored as one of the Triangle Business Journal’s (TBJ) 2021 Life Sciences Award winners in the Company of the Year category.
AskBio Announces Presentations at Upcoming American Society of Gene and Cell Therapy’s 24th Annual Meeting
AskBio today announced that the Company will present abstracts and participate in sessions at the upcoming American Society of Gene & Cell Therapy (ASGCT) Virtual 2021 Annual Meeting.
Selecta Biosciences and AskBio Announce Updates to Methylmalonic Acidemia (MMA-101) Program
Methylmalonic Acidemia (MMA) program to become wholly-owned by Selecta. Selecta to postpone IND submission until at least the fourth quarter of 2021. Empty capsid (SEL-399) study remains on track
Selecta and AskBio Initiate First-in-Human Dose-Escalation Study to Evaluate ImmTOR in Gene Therapy
Clinical trial commences in healthy adult volunteers to determine appropriate dose of ImmTOR™ to mitigate formation of antibodies to AAV capsids used in gene therapy.
AskBio Adds CNS Gene Therapy Programs in Parkinson’s Disease and Multiple System Atrophy
AskBio gains two active clinical programs, proprietary delivery technologies and unique clinical expertise in CNS indications with addition of the Brain Neurotherapy Bio team.
Gene Therapy Leader Katherine High Joins AskBio as President, Therapeutics
Katherine High, MD, has joined the company in the newly formed role of President, Therapeutics and will also serve on its Board of Directors.
AskBio Applauds Commencement of Pfizer’s Pivotal Trial for Duchenne Muscular Dystrophy
Pfizer initiates first pivotal gene therapy trial for DMD based on AskBio’s technology and clinical studies initiated in 2006.
AskBio Welcomes Brain Neurotherapy Bio to Expand Clinical Pipeline for Neurodegenerative Diseases
Led by Dr. Krys Bankiewicz, this team will focus on the clinical translation and development of GDNF gene therapy for Parkinson’s disease and other neurological conditions, such as multiple system atrophy.
