iNtRON Biotechnology has signed an “evaluation licence and option agreement” with Basilea Pharmaceutica, which grants Basilea the option to enter into an exclusive licence agreement for the antibacterial bio-drug SAL200, also known as Tonabacase.
Basilea, a Switzerland-based biopharmaceutical company, specialises in the development of anti-infective drugs and is already known for its development and commercialisation of Cresemba, which is used to treat invasive fungal infections, and Zevtera, a treatment for bacterial infections.
Basilea has extensive experience in late-stage clinical development and commercialisation in the field of anti-infectives.
As part of the agreement, Basilea has reviewed certain preclinical and clinical data related to SAL200 to assess its clinical potential. The two companies will collaborate on evaluation studies to determine the optimal future clinical development programme for SAL200.
Under the terms of the agreement, iNtRON will receive an initial upfront payment upon the agreement’s execution.
Additionally, iNtRON will receive an additional payment if Basilea chooses to exercise the option for an exclusive licence agreement after the evaluation period, which can extend up to one year.
The precise financial details of the agreement have not been disclosed due to confidentiality obligations between the two companies.
iNtRON has been actively engaging with Basilea regarding the exclusive license agreement for SAL200.
Given Basilea’s interest and expertise in the field of infectious diseases, it was determined that they are a suitable partner for the further development and commercialisation of SAL200.
Consequently, iNtRON signed the agreement to ensure the continued progress of SAL200’s development.
iNtRON CEO Yoon Kyung-won said: “Basilea is a suitable partner, since they have a strong track record of successfully developing and commercialising anti-infective drugs, and in particular, they are a stable company with ample clinical development experience, including a recent NDA submission to the US FDA.
“We are confident that the planned evaluation tests will significantly increase the probability of successful completion of a Phase 2 study. With a partner who already possesses commercialisation capabilities, we believe in the success of SAL200.”
SAL200 is an innovative anti-staphylococcal drug that is administered via injection. Its active pharmaceutical ingredient is the recombinant phage endolysin SAL-1, which is derived from the staphylococcus-specific bacteriophage SAP-1.
SAL200 has demonstrated its efficacy in the treatment of staphylococci-associated infections, including Methicillin-Susceptible Staphylococcus Aureus (MSSA), Methicillin-Resistant Staphylococcus Aureus (MRSA), and other highly resistant bacteria commonly referred to as superbugs. This effectiveness has been established through previous in vitro, in vivo, and clinical studies.
The development of SAL200 has progressed through various stages, including phase 1a, 1b MAD, and 2a clinical studies conducted in Korea.
Further development and clinical trials are anticipated to be conducted on a global scale. The Investigational New Drug (IND) application for the US Phase 2 study has received approval from the FDA, marking an important milestone in the drug’s development and its potential to address staphylococcal infections.