BOSTON and SEOUL, Korea, Jan. 26, 2023 /PRNewswire/ -- iNtRON Biotechnology ("iNtRON", www.intodeworld.com) has announced today that it has completed the efficacy evaluation study of BAL200, a novel endolysin-based biologic for the treatment of 'Inhalational Anthrax', which was granted an Orphan Drug Designation (ODD) by the US FDA.
The efficacy of BAL200 was evaluated for its antibacterial activity against various anthrax strains (Bacillus anthracis), in particular its lytic activity for how quickly it lyses the target strain. The evaluation studies were performed with dozens of Bacillus anthracis strains including the Ames. The results demonstrated that BAL200 has the most potent bactericidal ability that any other Post-Exposure Prophylaxis (PEP) antibiotics in the market cannot exhibit. The Ames is the anthrax strain that was exploited in the 2001 Amerithrax attacks and is the most infectious and dangerous strain among the many different anthrax strains exist in the world.
According to the Company official, iNtRON plans to promote an out-licensing process based on the efficacy evaluation results obtained this time and already secured safety data. The Company plans to conduct required studies to be subject to the Animal Efficacy Rule with a new partner afterwards.
Dr. KANG, Sang Hyeon, CTO of iNtRON said, "We believe that the recently secured efficacy results are very important and required data to seek a licensing partner for the collaboration of the further developments. We will prepare a data package that emphasizes the competitiveness of BAL200 well so it leads to the successful out-licensing deal."
As BAL200 provides a complete bactericidal activity unlike any other existing drugs, it rapidly eradicates infected anthrax strains from the body. Having a rapid lytic effect with high safety, BAL200 can provide competitiveness in the treatment of anthrax infection with a completely different mode-of-action (MOA) over the existing drugs.
Dr. KANG added, "Since the existing drugs act in a way that inhibits the physiological mechanism of bacteria, the effectiveness of the existing drugs is not rapid enough to prevent occurrence of bacterial resistance, and is limited by the relationship between the number of drug molecule and bacteria. On the other hand, BAL200 provides a non-stoichiometric characteristic due to its completely different MOA, which makes BAL200 to be a drug that can provide robust therapeutic effects with only a small amount of dose."
About BAL200
BAL200 is an ODD granted bacteriophage-derived endolysin biologic drug that has bactericidal activity against Bacillus anthracis strains via cell wall hydrolysis.
BAL200 has demonstrated its activity against various Bacillus anthracis strains, including PEP antibiotics-resistant strains. iNtRON is expecting BAL200 to become a novel solution to overcome limitations of Standard-of-Care PEPs. For the further development of BAL200 including IND enabling and Animal Rule required studies, iNtRON is seeking to a suitable partner for an out-licensing and/or research collaboration.
About iNtRON Biotechnology, Inc.
iNtRON (www.iNtODEWORLD.com) is a bio-new drug developing venture company and a leader in bacteriophage-based technology for human with aim to develop and investigate into the 'Immune & Immunotherapeutics' market. While pursuing global research and business development (R&BD) investments since the foundation and accelerated development after entering its IPO in KOSDAQ, the company honed in on innovating BIO New Drugs by developing various 'First-in-Class" and "First-in-Concept' bio-drugs and conducting clinical studies in phases. The Company is committed to development of innovative innovation in the infectious diseases and 'Immune & Immunotherapeutics' area.
Contact Us
YOON, Kyung Won (Kevin) / CEO, Vice President / kwyoon@intron.co.kr
SHIN, Tae Kyu (TK) / BD Team Leader / tkshin@intron.co.kr
BD Team / partner@intron.co.kr
www.intodeworld.com
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