▶ To maintain the US FDA-approved IND for the future out-licensing deal
▶ Plan to proceed Phase 2 with a new out-licensing partnership
▶ AMR problem became much more serious than ever
▶ SAL200 will be AMR solution as a strong candidate for innovative new drugs
BOSTON & SEOUL, August 23, 2022 – iNtRON Biotechnology (“iNtRON”, www.intodeworld.com), announced today that the sponsorship transfer process for the US Phase 2 clinical trial of SAL200 has been completed.
iNtRON has completely taken over the sponsor right of the US FDA IND for SAL200, a new first-in-class biological drug targeting superbugs, from Lysovant. iNtRON will retain all associated rights for the US clinical trials of SAL200 and plans to proceed with them through a new out-licensing partnership to build in the future.
Mr. YOON, Kyung Won, CEO of iNtRON said, “Currently we are proceeding with the tech transfer process of receiving all rights and clinical data related to SAL200 from Lysovant. As it is proceeding smoothly in a friendly partnership between the two companies, all procedures expect to be completed soon.” He added “In this regard, the FDA IND take-over process has completed smoothly as well”
Mr. YOON continued, “SAL200 has received FDA IND approval for the US clinical trial, which makes SAL200 to be far more advanced status than the previous licensing time in 2018. So we can assure that the value of SAL200 as an innovative drug to solve the Antimicrobial Resistance (AMR) issue has been significantly increased now.”
In fact, US Center for Disease Control (CDC) has recently published the special report <COVID-19 U.S. IMPACT ON ANTIMICROBIAL RESISTANCE>, and it warns that the AMR problem became much more serious than ever due to the excessive use of antibiotics during the COVID-19 pandemic situation.
Mr. YOON said, “The seriousness of the AMR problem continues to be seriously alarmed and at the same time the need for SAL200 as a strong candidate for innovative new drugs to address it will be even greater. We will do our best to find a new out-licensing partner of SAL200, targeting global pharmaceutical companies that are trying to solve the AMR problem as well as Big Pharma.”
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 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.