PR92688

SEOUL, South Korea and SILVER SPRING, Md., Oct. 29, 2021 /PRNewswire=KYODO JBN/ --

ImmunoForge (Co-CEOs Sung-Min Ahn, Kiho Chang), a company specializing in

developing new drugs for rare musculoskeletal diseases, has reported that their

new drug candidate PF1801 which is in development for treatment of Duchenne

Muscular Dystrophy(DMD) and Polymyositis (PM) has received Orphan Drug

Designation (ODD) from the U.S. FDA for the treatment of Polymyositis.

The FDA designates solutions for rare incurable diseases or life-threatening

diseases as Orphan Drugs. With this Orphan Drug Designation, ImmunoForge will

receive various benefits such as exemption from NDA/BLA application fees, tax

credits for qualified clinical trials, and exclusive rights for seven years

upon marketing approval.

Polymyositis is a disease in which muscles weaken due to inflammatory

reactions; the cause of the disease has not yet been identified. Duchenne

Muscular Dystrophy(DMD) is a rare disease caused by the lack or alteration of a

gene called Dystrophin, and patients of the disease (usually young boys)

experience muscle loss and eventually leads to death. ImmunoForge's Co-CEO

Dr.Sung-Min Ahn states that "This Orphan Drug Designation is of great

significance in confirming the potential of PF1801 as a treatment for rare

musculoskeletal diseases, and we hope that it will serve as a source of hope

for patients suffering from rare diseases with the various new drugs we are

developing."

This is the 2nd time that ImmunoForge has received ODD from the FDA for PF1801.

Last year they received Orphan Drug Designation for PF1801 for the treatment of

Duchenne Muscular Dystrophy(DMD) and for the Polymyositis indication, they are

currently preparing for a PMDA pre-IND meeting with their Japanese partner and

are in discussions to proceed with licensing contracts and technology transfer

within this year.

ImmunoForge has recently completed Series B funding from several investment

development companies and is preparing the manufacturing of clinical trial

drugs necessary for PF1801 to enter Phase 2 clinical research abroad early next

year, as well as preparing data for FDA IND approval according to development

schedules.

ImmunoForge also has a branch in the U.S. and has strengthened its global

competitiveness by recruiting Dr. Jim Ballance, who previously served as the

Vice President at PhaseBio, the original developer of PF1801, as the President

of the U.S. Branch.

ImmunoForge is a company co-founded in 2017 by Dr.Sung-Min Ahn, the head of the

Gachon Genetic Science Research Institute at Gachon University Gil Hospital,

and Kiho Chang, who has developed new drugs and gained experience in global

technology transfer for over 25 years at Dong-A Pharmaceuticals, LG Life Sciences, and Anguk Pharmaceutical, etc., and aims to grow into a world-class company such as Alexion in the field of rare

musculoskeletal diseases. ImmunoForge's co-CEO Kiho Chang states that "Based on

the recent Series B funding and the U.S. FDA's ODD designation, ImmunoForge

will push for global clinical development and global technology transfer of the

new drugs, and are aiming to be listed on the KOSDAQ by 2023. ImmunoForge will

grow to become a global bio-venture in the field of rare musculoskeletal

disease that currently lack appropriate treatments."

media contact : lena@immunoforge.com

Source: ImmunoForge