Double Bond Pharmaceutical

Double Bond Pharmaceutical International AB (publ) (“DBP”) and Vivo Biopharma LLC (“Vivo”), today announced an amendment to the Asset Purchase and Collaboration Agreements for DBP’s SI-053 and related assets, originally signed on September 17, 2023.  SI-053 is a locally acting formulation of temozolomide for the treatment of glioblastoma, which received Orphan Drug Designation from the European Medicines Agency in 2016. Recently, SI-053 received both Competent Authority and Ethics Committee approvals to initiate a Phase 1 clinical trial in two Western European countries.

The amendment to the agreements pertains to the initial territorial ownership of the asset, now defined as Australia, Canada, Israel and the United States of America.  The first milestone payment associated with the agreements is to be made to DBP after Vivo closes its Series A financing which Vivo is currently embarking on.  Vivo is targeting a close of this financing for second half of 2024.

DBP will continue to collaborate with Vivo to advance the SI-053 program.  Based on SI-053 achieving certain clinical, regulatory and commercial milestones, DBP is entitled to receive more than $150 million of milestone and royalty payments from Vivo. 

"Through the amendment to the agreements, Double Bond Pharmaceutical will retain proprietary rights to SI-053 in selected markets, providing DBP with the opportunity to participate in certain EU subsidy programs that offer non-dilutive funding," said Igor Lokot, Chief Executive Officer and founder of DBP. "This transaction aligns perfectly with our mission to discover and develop therapies for markets with high unmet needs. By utilizing unique delivery systems with proven active ingredients, we can accelerate development and bring critical therapies to patients more quickly."

“We are excited to sign the amendment to close these key territories and allow Vivo to pursue additional financing to advance the SI-053 program.  Vivo believes SI-053 brings hope for patients fighting a devastating disease.” said Albert Agro, PhD, Board member of Vivo.

More about initial agreement between Asset Purchase and Collaboration Agreements: 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.

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 Vivo Biopharma, LLC:

Vivo, a Delaware limited liability company focused on developing and commercializing SI-053 with a mission to develop and deliver novel targeted therapies for patients fighting malignant brain cancer.