Tme Pharma N.v. · EURONEXT:ALTME
Tme Pharma — NOXXON Pharma — Corporate Update (September 2019)
19 slides from Tme Pharma's corporate update, Sep 23, 2019
Slide 1: What's next in treatment of brain cancer patients?
What’s next in treatment of brain cancer patients? Testing NOX-A12 + Radiotherapy in a Phase 1/2 Clinical Trial 23 September 2019
Slide 2: Forward-looking Statements
Forward-looking Statements The information and opinions contained in this presentation and any other information discussed at this presentation are provided as at the date of this presentation and are therefore of a preliminary nature, have not been independently verified and may be subject to updat
Slide 3: Presenters
Presenters NOXXON lp H ARMA Exploring NOX-A12 in Brain Cancer Join Noxxon for a webinar and Q&A on the Phase 1/2 clinical trial in bain cancer th Date: : ptember 23, 2019 3 DSXe8H
Slide 4: Overview
Overview ▪ Glioblastoma – Description – Standard of care – Medical need ▪ Overview of recent clinical trials in Glioblastoma ▪ Glioblastoma tumor microenvironment ▪ NOX-A12 mechanism of Action ▪ Clinical trial testing NOX-A12 + radiotherapy – Patient population – Trial design – Timelines 4
Slide 5: Pipeline Assets Leverage Existing Anti-Cancer Therapies to Optimize their Efficacy
Pipeline Assets Leverage Existing Anti-Cancer Therapies to Optimize their Therapeutic Efficacy NOX-A12 Indication Combination Preclinical Phase 1 Phase 2 Phase 3 Solid tumors Phase 1/2 trial completed Pancreatic / Colorectal Immunotherapy Patient in follow-up ongoing Updated data at ESMO, Sep 2019 O
Slide 6: Background - Glioblastoma
Background - Glioblastoma ▪ Glioblastoma (GB, WHO Grade IV astrocytoma) is the most malignant and aggressive of all brain tumors ▪ Despite surgery, radiotherapy and chemo- therapy, the survival rate of these patients has not been shown to increase significantly ▪ Etiology of the disease unknown ▪ Me
Slide 7: Effects of Patient Profile on Overall Survival and Progression-Free Survival
Effects of Patient Profile on Overall Survival and Progression- Free Survival Surgical MGMT Methylation Progression Free Overall Surivival (OS) tumor Status Surivial (PFS) Months removal Methylated = benefit from Months chemotherapy Unmethlyated = no/little benefit from chemotherapy NOX-A12 + Incomp
Slide 8: Glioblastoma (GBM) Medical Need & Market
Glioblastoma (GBM) Medical Need & Market • Very poor prognosis • GBM as entry route to • Temozolomide (TMZ) sole blockbuster pharma approved option for 1st line development therapy GLIOBLASTOMA • Worldwide sales of • GBM with MGMT Temozolomide reached >1 unmethylated promoter, billion USD i.e. more
Slide 9: Current Developments - Chemotherapy
Current Developments - Chemotherapy Chemotherapy: – Temozolomide chemotherapy during and after radiotherapy is standard of care – A DNA repair protein called MGMT renders TMZ largely ineffective What‘s new? – “Classical“ chemotherapy: German CeTeG trial showed that the addition of lomustine (CCNU) i
Slide 10: Current Developments - Radiotherapy
Current Developments - Radiotherapy External-beam radiotherapy (EBRT): – Standard of care for all patients with GB, alone or in combination with chemotherapy – Hypofractionated irradiation schemes for elderly patients What‘s new? – Radiotherapy can be focused to the tumor by improved on-board imagin
Slide 11: Current Developments - Immunotherapy
Current Developments - Immunotherapy ▪ Vaccination Therapy: One of the most promising approaches in GBM, although negative results from several phase II and III trials challenge the current concept of vaccination as a single modality immunotherapy ▪ Checkpoint Inhibitors: Promising therapeutic activ
Slide 12: The Glioblastoma Tumor Microenvironment
The Glioblastoma Tumor Microenvironment A major hurdle for current therapies ▪ Glioblastoma is perceived as a poorly immunogenic1, “cold” tumor with – Only few tumor-infiltrating lymphocytes (TILs) that, moreover, express markers of exhaustion2,3 – High numbers of myeloid cells, such as microglia a
Slide 13: Attacking Glioblastoma by Blocking Key Tumor Micro-Environment Survival Mechanisms
Attacking Glioblastoma by Blocking Key Tumor Micro-Environment (TME) Survival Mechanisms Chain of events: Irradiation induces SDF-1 (=CXCL12) expression in tumors SDF-1 is a chemoattractant that recruits myeloid cells into the tumor Myeloid cells then form new vessels that re-nourish the tumor 13 Gr
Slide 14: NOX-A12 + Radiotherapy Significantly Increases Survival and Demonstrates Complete Regression
NOX-A12 + Radiotherapy Significantly Increases Survival and Demonstrates Complete Regression of Brain Tumors Autochthonous brain tumor model in rats Pregnant rats: ENU on gestational age day 17 - 18 Tumor recurrence detected only in 1/3rd of animals Key features: ▪ Spontaneous tumor development in i
Slide 15: External Clinical Validation for CXCL12 Axis Interference in Glioblastoma
External Clinical Validation for CXCL12 Axis Interference in Glioblastoma: Reported at ASCO 2018 ▪ Phase I/II study assessing the impact of CXCR4 blockade (PI: Lawrence D. Recht, Stanford, CA) ▪ Population: newly diagnosed adult GBM patients ▪ Initial results (presented at ASCO 2018): – 29 patients
Slide 16: NOX-A12: Recruiting Phase 1/2 Trial with Radiotherapy
NOX-A12: Recruiting Phase 1/2 Trial 1st Line, Chemotherapy Resistant, Unresectable Brain Cancer with Radiotherapy Overview Study population ▪ Newly diagnosed brain cancer (glioblastoma, recruit in cohorts of 3, wait for safety/efficacy signals after each triplet, then increase dose) ▪ Include only p
Slide 17: Questions ?
Questions ? 17
Slide 18: Thank you.
Thank you. For more information do not hesitate to contact us at BrainCancerEvent@noxxon.com 18
Slide 19: Available Models of Glioma/Glioblastoma and Their Strengths and Weaknesses
Available Models of Glioma/ Glioblastoma and Their Strengths and Weaknesses Model type (Epi)genetic Heterogeneity Immuno- Brain micro- Blood Stable/ reproducible make up competent environment brain barrier ENU-induced Partly relevant Genetically heterogeneous, Yes Relevant Yes No – but diversity of