Periodic Reporting for period 1 - BAT-90 (A Novel ‘Radiotherapy from Within’ Platform Technology for the Targeted Treatment of Solid Tumours Called ‘BAT-90’)
Période du rapport: 2024-04-01 au 2025-02-28
After having generated some very exciting data using YntraDose in an advanced (“oncopig”) pre-clinical model of Pancreatic Ductal Adenocarcinoma (PDAC), for a broad range of reasons, including the potential to address an even greater unmet clinical need, BetaGlue have decided to prioritize this indication over unresectable HCC.
The WP3 change the scope from: “HCC Early Feasibility Clinical Study” to: “LA-PDAC Early Feasibility Clinical Study Readiness.
Some of the rationales to prioritise LA-PDAC over HCC as the go-to-market clinical indication (CHANGE in strategy reasons) include the Major Unmet Clinical Need & Go-To-Market Strategy.
30% of all pancreatic cancer patients present with unresectable Locally- Advanced Pancreatic Cancer (LA-PC)
YNTRADOSE (Previously named BAT-90): AN ADD-ON THERAPY TO FIRST-LINE STANDARD OF CARE CHEMOTHERAPY.
The WP3 change the scope from: “HCC Early Feasibility Clinical Study” to: “LA-PDAC Early Feasibility Clinical Study Readiness.
Some of the rationales to prioritise LA-PDAC over HCC as the go-to-market clinical indication (CHANGE in strategy reasons) include the Major Unmet Clinical Need & Go-To-Market Strategy.
30% of all pancreatic cancer patients present with unresectable Locally- Advanced Pancreatic Cancer (LA-PC)
YNTRADOSE (Previously named BAT-90): AN ADD-ON THERAPY TO FIRST-LINE STANDARD OF CARE CHEMOTHERAPY.
The product has been optimized, according to the Device Description record foreseen the YntraDose-90 only in the BSA chamber and WFI in glutaraldehyde chamber to keep the 4:1 ratio; simplifying the preparation of YntraDose.
The scope of the test has been refined to align with the current Company strategy (prioritize LA-PDAC over HCC indication).
Task 1.2: Homogeneity activity distribution of 90Y microspheres in BioGlue, completed at M12 with several experiments proving the product is homogeneous after mixing procedure.
Task 1.4: Definition of residual activity after delivery of BAT-90, completed at M12. The product have been analyzed to understand the amount of loss activity/volume during the preparation and administration steps.
Task 2.1: Dosimetry software release, completed at M6. The software has been customized for BetaGlue’ s needs to asses the treatment planning and the post treatment dosimetry of the patient.
Task 3.1: Full study synopsis (Now LA-PDAC), completed at M12 for pancreas indication.
Task 3.2: Feasibility questionnaire (Now LA-PDAC), completed at M12 for pancreas indication.
Task 4.3: e-QMS implementation, completed at M13 for pancreas indication for an early feasibility study.
Task 4.4: Integration and refinement of clinical specifications into the QMS, completed at M13, the related SOPs have been implemented in the QMS.
The scope of the test has been refined to align with the current Company strategy (prioritize LA-PDAC over HCC indication).
Task 1.2: Homogeneity activity distribution of 90Y microspheres in BioGlue, completed at M12 with several experiments proving the product is homogeneous after mixing procedure.
Task 1.4: Definition of residual activity after delivery of BAT-90, completed at M12. The product have been analyzed to understand the amount of loss activity/volume during the preparation and administration steps.
Task 2.1: Dosimetry software release, completed at M6. The software has been customized for BetaGlue’ s needs to asses the treatment planning and the post treatment dosimetry of the patient.
Task 3.1: Full study synopsis (Now LA-PDAC), completed at M12 for pancreas indication.
Task 3.2: Feasibility questionnaire (Now LA-PDAC), completed at M12 for pancreas indication.
Task 4.3: e-QMS implementation, completed at M13 for pancreas indication for an early feasibility study.
Task 4.4: Integration and refinement of clinical specifications into the QMS, completed at M13, the related SOPs have been implemented in the QMS.
Several activities have been already completed as described in the section above.
Many have been initiated and are undergoing to complete the development of the YntraDose platform project.
For biocompatibility over 170 samples have been prepared to fulfil the needs and conduct the ISO 10993 study tests. All the studies have been initiated according to the schedule. First results are promising.
For the ISO certification of the Company, as part of the ISO 13485:2016 certification process with the Notified Body (BSI), the Stage 1 audit was successfully held with a positive outcome and confirmation that BetaGlue’s Quality Management System (QMS) is ready to proceed to a Stage 2 audit. The certification is expected by the end of December 2025 (M21), subject to the Stage 2 outcome.
For the V&V plan everything has been planned, scheduled and the activities have been initiated with very positive results from the pilot runs.
Many have been initiated and are undergoing to complete the development of the YntraDose platform project.
For biocompatibility over 170 samples have been prepared to fulfil the needs and conduct the ISO 10993 study tests. All the studies have been initiated according to the schedule. First results are promising.
For the ISO certification of the Company, as part of the ISO 13485:2016 certification process with the Notified Body (BSI), the Stage 1 audit was successfully held with a positive outcome and confirmation that BetaGlue’s Quality Management System (QMS) is ready to proceed to a Stage 2 audit. The certification is expected by the end of December 2025 (M21), subject to the Stage 2 outcome.
For the V&V plan everything has been planned, scheduled and the activities have been initiated with very positive results from the pilot runs.