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.

      

This disclosure contains information that DBP is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 10-03-2025 06:00 CET.

     

Full Company Name:   Double Bond Pharmaceutical International AB (publ)

Corporate identity:       556991-6082

Stock short name:       DBP B

Share ISIN code:          SE0007185525

 

For more info, contact

Igor Lokot, CEO

Homepage: http://www.doublebp.com/

E-mail: info@doublebp.com

 

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Information about Double Bond Pharmaceutical AB:

DBP is a pharmaceutical company with the primary focus on development of therapies against cancer based on the company’s own developed drug delivery technology BeloGal®. The company was granted Orphan Drug Designation status by European Medicines Agency (EMA) in June 2015 for its first product, SA-033, for treatment of hepatoblastoma. Double Bond Pharmaceutical acquired rights to Temodex in October 2015, and was granted Orphan Drug Designation status by EMA for in July 2016 for this formulation of temozolomide for the treatment of glioma. The formulation is now being further developed for registration in EU and globally and has a working name SI-053 in DBP pipeline.

 

Information about Sauvie Inc. and Vivo Biopharma, LLC:

Vivo, a subsidiary of Sauvie Inc.: https://sauvieinc.com , is focused on developing and commercializing SI-053 and supporting Sauvie Inc.’s mission to develop and deliver novel therapies that target proven disease pathways to get back life for patients suffering from cancer.  Sauvie Inc. is a private biopharma organization and currently advancing a novel immuno-oncology technology, a bispecific camelid nanobody platform for multiple cancer indications through its subsidiary Sauvie BiKE, LLC.