Including the contract transfers of the external studies planned for the successful out-licensing and commercialization of SAL200
BOSTON and SEOUL, South Korea, Jan. 12, 2023 /PRNewswire/ — iNtRON Biotechnology (“iNtRON”, www.intodeworld.com) has announced today that the Tech Transfer process of SAL200, endolysin-based new biologic, is in the final stage.
According to the Company official, the Tech Transfer process took a little longer than expected due to the massive volume of data transferred from the previous Partner. Along with the data that have been transferred during the last three months, it was required to take over the studies of external institutions that the previous partner had been conducting. Through the renewal of the contracts with the external institutions, the Company has taken various measures to continue the clinical study of SAL200.
The Tech Transfer process has been carried out well as most materials including the US FDA approved SAL200 IND related documents have been secured except few from the CRO, and the follow-up studies are also in progress as planned.
The follow-up studies are being conducted through a number of external institutions according to the transferred rights, which are necessary for the clinical trial of SAL200 to be conducted as planned by the US clinical experts.
The Company official explained, since the data generated by the follow-up studies will be important for the out-licensing of SAL200, the Company has focused on transfer of the documents and studies by the external institutions in a while, and the Company will be able to focus more on the out-licensing of SAL200 when the Tech Transfer process is fully completed soon.
Dr. KANG, Sang Hyeon, CTO of iNtRON said, “We believe that our strategy and the clinical trial plan for SAL200 has been very well prepared through the consultation with clinical experts. We will make much of efforts to take over the rights of external studies that support our well established plan and to ensure that those progresses lead to good results in out-licensing of SAL200.”
About SAL200, TONABACASE
SAL200 is a novel endolysin-based anti-staphylococcal drug formulated for injection. Its active pharmaceutical ingredient is the recombinant phage endolysin SAL-1, derived from the staphylococcus-specific bacteriophage SAP-1. SAL200 is proven to be effective in treating staphylococci-associated infections including MSSA, MRSA, and other so-called superbugs through the previous in vitro, in vivo and clinical studies. The phase 1a, 1b MAD and 2a study for SAL200 was completed successfully in Korea and the further development is going to be conducted in global. The IND application for the US Phase 2 study has been approved by FDA in January, 2022.
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.
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.