Tme Pharma N.v. · EURONEXT:ALTME
Tme Pharma — Key Opinion Leader Webinar (June 2023)
15 slides from Tme Pharma's conference presentation, Jun 26, 2023
Slide 1: Key Opinion Leader Webinar: New biomarker to select brain cancer patients for NOX-A12
KEY OPINION LEADER WEBINAR The new biomarker with potential to select brain cancer patients most likely to respond best to NOX-A12 treatment June 26, 2023 | 4 PM CET / 10 AM ET
Slide 2: Webinar Panel
WEBINAR PANEL Key Opinion Leaders: Joined by: Dr. Frank Giordano Aram Mangasarian Professor and Chair of the Dept. of CEO Radiation Oncology at the University TME Pharma Medical Center Mannheim, Germany, and Lead Investigator of NOX-A12 GLORIA Phase 1/2 Study Prof. Michael Hölzel Guillaume van Rente
Slide 3: TME Pharma Pipeline
TME Pharma Pipeline Next Inflection Partner/ Therapy & Indication Preclinical Phase 1/2 Phase 2 Phase 3 Point Collaborator NOX-A12 + Radiotherapy 15-month OS from FDA/EMA Brain cancer / Glioblastoma discussions when anti-VEGF Orphan Drug Status US & EU expansion arm OS data mature Expansion arms +an
Slide 4: Glioblastoma is a Devastating Orphan Brain Cancer where the TME Plays a Significant Role
Glioblastoma is a Devastating Orphan Brain Cancer where the TME Plays a Significant Role LACK OF EFFECTIVE THERAPIES & LOW OVERALL SURVIVAL HIGH UNMET NEED PATIENT SEGMENTS • MGMT unmethylated promoter – chemotherapy 5Y ineffective • Incomplete surgical removal of tumor tissue – poor Orphan prognosi
Slide 5: Biomarkers – Prognostic vs Predictive
Biomarkers – Prognostic vs Predictive • Prognostic Biomarkers • Predictive biomarkers A prognostic biomarker provides A predictive biomarker provides information about which outcomes information about the benefit of a are likely/unlikely based on markers specific treatment for an individual present
Slide 6: Established Predictive Biomarker in Glioblastoma
Established Predictive Biomarker in Glioblastoma MGMT promoter methylation status • MGMT unmethylated promoter = chemotherapy ineffective • Incomplete surgical removal of tumor tissue – poor prognosis NOX-A12 GLORIA trial focuses on MGMT unmethylated patients with residual tumor after surgery Source
Slide 7: Study Arms
Study Arms Dose Key inclusion criteria: RT • Newly-diagnosed supratentorial 60 Gy (2 Gy x 30) Escalation glioblastoma WHO IV 40.05 Gy (2.67 Gy x 15) • MGMT promoter unmethylated Cohorts • Incomplete resection/biopsy only NOX-A12 FU continuous i.v. infusion at three doses (200, 400, 600 mg/week) • EC
Slide 8: What did the team find?
3 6. What did the team find? - Michael CONFIDENTIAL content covered under NDA of your organization
Slide 9: CONFIDENTIAL
3 CONFIDENTIAL content covered under NDA of your organization
Slide 10: CONFIDENTIAL
3 CONFIDENTIAL content covered under NDA of your organization
Slide 11: CONFIDENTIAL
3 CONFIDENTIAL content covered under NDA of your organization
Slide 12: Value of Predictive Biomarkers
Value of Predictive Biomarkers A predictive biomarker is a measurable biological characteristic that provides information about the likelihood of an individual patient to respond to a specific treatment. Significance of a Predictive Biomarker: • Clinical Development: helps to identify target populat
Slide 13: Questions?
Questions?
Slide 14: Thank you.
Thank you. Contact us: tme@tmepharma.com
Slide 15: NOX-A12 + RT + Bevacizumab: Maturing Survival Data
NOX-A12 + RT + Bevacizumab: Maturing Survival Data 83% OS with 14-month Median Time on Study 14 months on study Patient 1 • 5 out of 6 patients alive with 14-month median time on study (cut-off date 21 May 2023) Patient 2 • Median overall survival (mOS) continues to improve Patient 3 • 5 out of 6 pa