- TONABACASE, the first registered INN by WHO for Endolysin
- First-in-Class Endolysin-based Drug against Superbugs
- US FDA Phase 2 IND Approval for TONABACASE, SAL200
- Roivant has returned the rights for the asset just before the first patient injection
BOSTON and SEOUL, South Korea, June 28, 2022 /PRNewswire/ -- iNtRON Biotechnology ("iNtRON") announced today that SAL200, a endolysin-based novel antibacterial treatment for Staph superbugs including MRSA, has come back to the market and is now on-the table for an out-licensing deal. Lysovant had acquired the global exclusive right of SAL200 in 2018 and was about to initiate the US phase 2 study under the IND approval by the US FDA. However, Lysovant has decided to return the asset to iNtRON based on an internal reason of the company.
Mr. Yoon, Kyung Won, CEO of iNtRON, has shared the future plan that the company will seek a new partner by utilizing more complemented and structured clinical data of SAL200. Mr. Yoon also said "Since the actual patient injection was about to begin based on the study preparation process including the IND approval in January of this year following the application submission in December of the previous year, investigator meeting, and clinical sites selection, this asset return translates into the internal strategic decision of Roivant. Although all data and rights of SAL200 has been returned to us, the upfront payment from Lysovant will not be refunded."
Dr. Kang, Sang Hyeon, CTO of iNtRON, said "Regardless of the situation, as SAL200 is in good shape ever and completeness of the asset has been significantly increased through years of development and partnership, and the asset was returned merely due to the internal reason of the partner, it is believed that the value of SAL200 is not impaired at all. We assure that we will find a new partner to pursue the clinical development of SAL200 very soon".
Mr. Yoon said "The fact that the endolysin-based first-in-class new drug pipeline has acquired the IND approval by the US FDA is a significant progressive, so the partnership with Lysovant was valuable enough to us", and he said "Lysovant has made tens of million dollars investment for asset to receive the US Phase 2 IND approval since they acquired the asset, the additional data and know-how achieved through the capital investment by the partner will be very meaningful technological assets for the future development of SAL200, we are truly grateful for the friendly partnership of Lysovant".
Mr. Yoon said "The accumulated data will be transferred and returned to the company by setting the T/F team of the both companies, we believe it will be a great help for the development progress of other endolysin pipelines of the company. We will do our best to find a new clinical partner so that the challenge of developing a first-in-class drug named as 'TONABACASE' by the WHO for the first time in the world does not stop. We have more advanced and complemented technology now, and will definitely continue the challenge by finding a new clinical partner as a blessing in disguise" continuously said Mr. Yoon, "Since the company has developed many different pipelines even after SAL200 was out-licensed, we will be pursuing actively the additional development and out-licensing deal for those pipelines as well. iNtRON will focus all its capabilities on the development of innovative new drugs through unremitting efforts despite any difficulties."
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.
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Gyeonggi-do, Republic of Korea
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