Periodic Reporting for period 1 - TARGLIO (Improved glioblastoma treatment through targeted, local drug delivery)
Periodo di rendicontazione: 2019-05-01 al 2019-10-31
Glioblastoma Grade IV is a heterogeneous type of brain tumour of the glial cells characterized by its malignancy rapid progression and devastating mortality rates. Glioblastoma is the most common and aggressive malignant brain tumour in adults, and one of the most lethal human cancers, with a median survival of 14.6 months and only 2 to 3 % surviving after 24 months. Europe, it affects approximately 2-3 people in every 100,000 each year. It accounts for 50% of all brain tissue tumour cases and 15% of all tumours inside the skull. The disease progresses rapidly and patients deteriorate quickly. Despite the significant progress made in the treatment of other cancers, the prognosis for glioblastoma remains extremely poor. About 50% of patients diagnosed with glioblastoma die within one year, and a staggering 90% within three years. Furthermore, the 5-year survival rate is particularly poor (those known as extreme survivors), at less than 3%.
Double Bond has developed a gel formulation - SI053 - a unique polymer matrix that encapsulates the highly potent active pharmaceutical ingredient (API) temozolomide to radically increase therapeutic efficacy and locally treat brain tumours. At the same time, healthy tissues are protected from toxic effects by minimizing exposure. Following surgical removal of the tumour, SI053 can be placed in the tumour cavity (intracerebral application), where it can directly and slowly release high concentrations of temozolomide The matrix will then biodegrade once all the temozolomide is released.
Double Bond has performed a feasibility assessment in order to explore the clinical pathway to market and the ideal route to commercialization.
Double Bond has developed a gel formulation - SI053 - a unique polymer matrix that encapsulates the highly potent active pharmaceutical ingredient (API) temozolomide to radically increase therapeutic efficacy and locally treat brain tumours. At the same time, healthy tissues are protected from toxic effects by minimizing exposure. Following surgical removal of the tumour, SI053 can be placed in the tumour cavity (intracerebral application), where it can directly and slowly release high concentrations of temozolomide The matrix will then biodegrade once all the temozolomide is released.
Double Bond has performed a feasibility assessment in order to explore the clinical pathway to market and the ideal route to commercialization.
The clinical feasibility assessment has led us to produce the Phase I Clinical Protocol Synopsis and mark the pathway for future trials. We have gathered scientific advice from EMA and have received approval to move forward with this plan. We have also identified relevant partners for further clinical development and commercialization stages.
As a part of the market feasibility assessment, DBP has been able to confirm the need for the treat-ment and identify markets with the biggest potential.
Two different routes to commercialization have been contemplated during this project. The clinical validation performed with the support from EIC accelerator pilot will further strengthen the position of Double Bond in the market. The total funding requirements to validate SI053 to the next stage are estimated at 3.5 MEUR. Of this budget, 2.5 MEUR will be secured by the EIC accelerator while two of our investors have committed to raise the remaining for this project. We believe that, if successful, Double Bond could be finalized and on the market around the year 2028 providing a much-needed solution for Glioblastoma patients worldwide.
As a part of the market feasibility assessment, DBP has been able to confirm the need for the treat-ment and identify markets with the biggest potential.
Two different routes to commercialization have been contemplated during this project. The clinical validation performed with the support from EIC accelerator pilot will further strengthen the position of Double Bond in the market. The total funding requirements to validate SI053 to the next stage are estimated at 3.5 MEUR. Of this budget, 2.5 MEUR will be secured by the EIC accelerator while two of our investors have committed to raise the remaining for this project. We believe that, if successful, Double Bond could be finalized and on the market around the year 2028 providing a much-needed solution for Glioblastoma patients worldwide.
Si-053 will allow to apply temozolamide locally at tumour site allowing the following benefits.
• All patients are able to respond to temozolomide without risk of MGMT methylation.
• Application of the gel in the tumour cavity right after surgery means no additional invasive procedures are required.
• Local application using a slow-release mechanism (the matrix) means high concentration of temozolomide can be applied to the tumour without BBB limitations or high toxicity.
• Immediate application after surgery prevents a delay in chemotherapy.
• All patients are able to respond to temozolomide without risk of MGMT methylation.
• Application of the gel in the tumour cavity right after surgery means no additional invasive procedures are required.
• Local application using a slow-release mechanism (the matrix) means high concentration of temozolomide can be applied to the tumour without BBB limitations or high toxicity.
• Immediate application after surgery prevents a delay in chemotherapy.