Double Bond Pharmaceutical International AB (publ) ("DBP") and Vivo Biopharma LLC ("Vivo") today announced an extension of their Asset Purchase and Collaboration Agreements for DBP's lead candidate, SI-053, and related assets. The companies are targeting the completion of the transition process by May 1, 2025, with a potential extension of up to 60 days to fulfil the first milestone payment.

The original agreements, signed on September 17, 2023, cover SI-053, a locally acting formulation of temozolomide designed for the treatment of glioblastoma. The drug candidate received Orphan Drug Designation from the European Medicines Agency (EMA) in 2016 and has recently obtained Competent Authority and Ethics Committee approvals to initiate a Phase 1 clinical trial in two Western European countries.

Upon completion of the transaction, Vivo will acquire SI-053 and related assets to advance the clinical program, with DBP providing support. Based on SI-053 achieving certain clinical, regulatory, and commercial milestones, DBP remains entitled to receive over $150 million in milestone and royalty payments from Vivo.

In June 2024, the agreement was renegotiated, limiting the licensed territories to the United States, Canada, Australia, and Israel. Vivo's initial milestone payment to DBP was tied to the successful completion of its Series A financing, which was initially targeted for the second half of 2024.

Igor Lokot, CEO of DBP International AB, commented:
"Our collaboration with Vivo Biopharma represents a major step forward in delivering SI-053 to glioblastoma patients. The extension of our agreement underscores our shared commitment to advancing this promising treatment and reflects the strong partnership we have built with Vivo".

More about initial agreements between DBP and Vivo: https://mb.cision.com/Main/12720/3994561/2842224.pdf, https://mb.cision.com/Main/12720/3838161/2304982.pdf. 

More about SI-053: SI-053, an enhanced reformulation of Temodex, is a locally acting formulation of temozolomide. SI-053 received Orphan Drug Designation from the European Medicines Agency in 2016 and received multiple Competent Authority and Ethics Committee approvals from 2021 to 2023 to initiate a Phase 1 clinical study.  In a proof-of-concept study with human subjects conducted in 2015, SI-053 demonstrated significant overall survival benefit when added to the standard of care for glioblastoma.  Video presentation: https://youtu.be/iweOQPq316o

More about phase I study of SI-053: A Dose Escalation Study to Estimate MTD, DLTs and Pharmacokinetics After a Single Intracranial Dose of SI-053 as an add-on to the Current Standard of Care, in Adult Patients With Newly Diagnosed GBM (TARGLIO) https://clinicaltrials.gov/ct2/show/NCT04967690  

More about Glioblastoma: Glioblastoma, the most common and aggressive malignant form of all primary brain tumours, affects glial cells and accounts for 52 % of all brain tissue tumour cases and 20 % of all tumours inside the skull.  Approximately 12,000 patients with glioblastomas are identified each year in the US and 250,000 globally.

The current standard of care is surgery followed by radiation and chemotherapy. SI-053 is a novel delivery format of temozolomide (gel format) directly administered at the site of the tumour following surgical removal, thus ensuring that the therapeutic effect is delivered precisely where it is needed and without the need to pass through the blood-brain barrier Temozolomide is a prodrug which destroys the tumour's DNA and triggers the death of tumour cells.