- Exclusive license to evaluate tonabacase in preclinical studies
- Exclusive option to license tonabacase at pre-agreed terms
Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland, October 31, 2023
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company, committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has entered into an exclusive evaluation license and option agreement for tonabacase, with iNtRON Biotechnology, Inc. (KOSDAQ: 048530), a company based in the Republic of Korea. Tonabacase is a potential first-in-class clinical-stage antibacterial of the endolysin class. Over the course of 2024, Basilea will investigate various hypotheses in a number of preclinical studies to determine the optimal future clinical development program for tonabacase. Upon successful completion of the preclinical evaluation phase, Basilea will have the exclusive option to license tonabacase for further clinical development and commercialization.
The use of endolysins represents a novel and innovative approach in the treatment of bacterial infections. Endolysins are recombinant proteins derived from bacteriophages, i.e. viruses that infect bacteria. They cause a rapid destabilization of the bacterial cell wall, leading to the death of bacteria. In addition, endolysins have shown significant advantages over conventional antibiotic treatments including activity against biofilms, a frequent cause of persistent and recurring infections, synergy with other antibiotics and a low risk of resistance development.1
Tonabacase has shown activity in vitro and in preclinical animal models of infection against methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA and MSSA) as well as in-vitro activity against coagulase-negative staphylococci.2, 3 In phase 1 studies, tonabacase single and multiple dose administrations were shown to be well-tolerated.4, 5
Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “There continues to be a high medical need for new treatment options for patients with persistent infections caused by Gram-positive bacteria and tonabacase is an exciting and innovative asset for us to evaluate over the coming months. If the outcome of our evaluation is positive and we enter into a full license agreement, we may be able to start directly a phase 2 clinical study in 2025.”
Under the terms of the agreement, Basilea is making an undisclosed upfront payment to iNtRON and will make one additional payment if Basilea decides to exercise its exclusive option and execute the license agreement at pre-agreed financial terms. This transaction has no impact on Basilea’s financial guidance for 2023, provided on August 15, 2023.
Full PR available here