A novel drug candidate for anthrax received orphan drug designation (ODD) by the US FDA.
BOSTON and SEOUL, Korea, June 6, 2022 /PRNewswire/ -- iNtRON Biotechnology ("iNtRON" or "Company") announced today that the company has successfully completed the GLP toxicology studies of BAL200.
The company has completed the general GLP toxicology and safety pharmacology studies with final test reports and has obtained data essential for a licensing deal discussion of BAL200.
iNtRON has conducted a single-dose toxicity study in rodents, a repeated-dose finding and toxicity study in rodents and non-rodents as part of the general toxicity study. The company has also completed safety pharmacology studies on the cardiovascular, respiratory and central nervous system. In particular, iNtRON performed a non-human primate (NHP) study in consideration of future licensing deals. The company also has secured key CMC data necessary for the subsequent drug development and regulatory process along with safety and efficacy data.
"Due to recent development progress including the completion of the GLP-TOX studies, most of required data are now secured for business development," said Sang Hyeon KANG, CTO of iNtRON. "Once the efficacy data against various anthrax that are currently being conducted through the US CRO are obtained, BAL200 will be ready for an Investigational New Drug Application (IND). Then, we plan to initiate specific activities for a global licensing deal discussion."
BAL200 is a new biological drug candidate being internally developed by iNtRON based on its various biotechnologies including bacteriophage, endolysin, protein engineering, and immunology technology. The US FDA has granted orphan drug designation (ODD) to BAL200 in 2018, and iNtRON is entitled to enjoy the number of benefits such as expedited drug approval, 7-year marketing exclusivity, waiver of BLA application fee, and tax credit during the development.
Currently, four types of FDA approved post-exposure prophylaxis (PEP) are allowed to be used in combination with anthrax vaccines, and antitoxin therapy that treats toxins produced by anthrax also can be used concurrently. However, because not only are bacteria getting resistant to the currently used PEPs, but the approved PEPs also do not have perfect bactericidal antibiotic properties, doubts about their effectiveness are increasing.
"Since relevant studies including GLP-TOX with CROs and related companies in overseas are getting back on track from the delay due to the COVID-19 shut- down, we were able to complete the related studies for BAL200 recently," said Kyung Won YOON, CEO of iNtRON. "BAL200 is a drug candidate will be developed under the Animal Rule of the US FDA, and we plan to highlight it during future global licensing discussion. We have high expectations for BAL200, because it has characteristics to overcome the therapeutic limitations of existing treatments and is effective against resistant bacteria even with a very low risk of resistance development."
About Orphan Drug Designation
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 20,000 persons in the US or meets cost recovery provisions of the act.
About Animal Efficacy Rule
The regulations commonly known as the Animal Rule (21 CFR 314.600-650 for drugs; 21 CFR 601.90-95 for biologics; effective July 1, 2002) allow for the approval of drugs and licensure of biological products based on the results for animal studies when human efficacy studies are not ethical and field trials to study the effectiveness of drugs or biological products are not feasible.
About iNtRON Biotechnology, Inc.
iNtRON is a leader in bacteriophage-based technology with aim to develop and investigate into the 'Immune & Immunotherapeutics' market. While pursuing global research and business development (R&BD) investments since their foundation and accelerated development after entering its IPO in KOSDAQ, the company honed in on innovating BIO New Drugs by developing various '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.
About iNtODEWORLD, Inc.
iNtRON has established its wholly owned US subsidiary, iNtODEWORLD, Inc. in 2017. iNtODEWORLD was initially registered in Delaware and the headquarter office is currently located in Boston. iNtODEWORLD provides news, updates and platform development progresses of iNtRON to its potential global partners and collaborators along with its own R&BD works in the US.
iNtRON Biotechnology, Inc.
#708, 148, Sagimakgol-ro, Jungwon-gu, Seongnam-si,
Gyeonggi-do, Republic of Korea
1500 District Avenue, Suite 2097, Burlington, MA 01803, USA
it is iNtRON.
SOURCE iNtRON Biotechnology, Inc.