Periodic Reporting for period 2 - BAT-90 (A Novel ‘Radiotherapy from Within’ Platform Technology for the Targeted Treatment of Solid Tumours Called ‘BAT-90’)
Período documentado: 2025-03-01 hasta 2025-12-31
After having generated some very exciting data using YntraDose in an advanced (“oncopig”) pre-clinical model of Pancreatic Ductal Adenocarcinoma (PDAC) and in a murine xenograft study in vivo at Charité University in Berlin, 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. PDAC is the most common pancreatic cancer subtype with poor prognosis, marked by low survival and limited treatment options.
In Q4 2025, BetaGlue has obtained the authorization to initiate an early feasibility study in LA-PDAC from Italy, UK and Belgium Competent Authority. It will be a multicenter, open label, prospective, feasibility clinical investigation to assess the safety, tolerability and feasibility of YntraDose following percutaneous administration under US/CT guidance.
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. PDAC is the most common pancreatic cancer subtype with poor prognosis, marked by low survival and limited treatment options.
In Q4 2025, BetaGlue has obtained the authorization to initiate an early feasibility study in LA-PDAC from Italy, UK and Belgium Competent Authority. It will be a multicenter, open label, prospective, feasibility clinical investigation to assess the safety, tolerability and feasibility of YntraDose following percutaneous administration under US/CT guidance.
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.
All activities included in the project have been already completed. All the studies have been conducted according to the project. First results are promising. ISO 13485:2026 certification has been obtained for design, development, manufacture and distribution of medical device.
Based on evidence and study conducted, the Company obtained the authorization to conduct an early feasibility study in 10 patients to (i) evaluate the safety and tolerability of YntraDose administered in combination with chemotherapy regimen assigned to each patient as per clinical profile, (ii) to evaluate the feasibility of YntraDose percutaneous administration under US/CT guidance, (iii) to evaluate quality of life, (iv) to evaluate changes in the level of the tumor market carbohydrate antigen and (v) to evaluate the metabolic tumor response.
However to bring YntraDose to market larger randomized control clinical studies must be conducted to proof not only safety but efficacy and survival improvement over current standard of care. The studies may need to involve a larger patient populations (100 pts in phase II and 300 pts in phase IIII) and require significant capital investment (25-30 m€ phase II and 75-80m€ phase III).
Note that PDAC is the most common pancreatic cancer subtype with poor prognosis, marked by low survival and limited treatment options. Its risk factors include pancreatitis, type 2 diabetes, tobacco smoking and obesity or metabolic syndrome. The incidence increases with age. In EU there are 15k/20k YntraDose LA_PDAC eligible populations and the number is increasing annually at 1.3%.
Based on evidence and study conducted, the Company obtained the authorization to conduct an early feasibility study in 10 patients to (i) evaluate the safety and tolerability of YntraDose administered in combination with chemotherapy regimen assigned to each patient as per clinical profile, (ii) to evaluate the feasibility of YntraDose percutaneous administration under US/CT guidance, (iii) to evaluate quality of life, (iv) to evaluate changes in the level of the tumor market carbohydrate antigen and (v) to evaluate the metabolic tumor response.
However to bring YntraDose to market larger randomized control clinical studies must be conducted to proof not only safety but efficacy and survival improvement over current standard of care. The studies may need to involve a larger patient populations (100 pts in phase II and 300 pts in phase IIII) and require significant capital investment (25-30 m€ phase II and 75-80m€ phase III).
Note that PDAC is the most common pancreatic cancer subtype with poor prognosis, marked by low survival and limited treatment options. Its risk factors include pancreatitis, type 2 diabetes, tobacco smoking and obesity or metabolic syndrome. The incidence increases with age. In EU there are 15k/20k YntraDose LA_PDAC eligible populations and the number is increasing annually at 1.3%.