Ose Immunotherapeutics Sa · EURONEXT:OSE
Ose Immunotherapeutics Sa — Corporate Update (June 2022)
27 slides from Ose Immunotherapeutics Sa's corporate update, Jun 7, 2022
Slide 1: ASCO results & Tedopi® update
Immuno-Oncology Immuno-Inflammation ASCO results & Tedopi® update June 7th 2022
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial project
Slide 3: Opening remarks
Opening remarks Dominique Costantini Chief Executive Officer
Slide 4: ASCO Tedopi® (OSE2101) Key Messages: Beyond Checkpoint Inhibitors
ASCO Tedopi® (OSE2101) Key Messages : Beyond Checkpoint Inhibitors 1 First T specific neoepitope immunotherapy showing efficacy in secondary resistance to Immune Checkpoint Inhibitors in ATALANTE-1 Phase 3 trial in NSCLC post-sequential CT-IO 2 Beyond Checkpoint Inhibitors: updated results with supe
Slide 5: Tedopi® Atalante-1 ASCO new results
Tedopi® Atalante-1 ASCO new results
Slide 6: Tedopi®: Differentiated Mechanism of Action
Tedopi® : Differentiated Mechanism of Action Strong Biological Rationale in Secondary Resistance of Immune checkpoint Inhibitors (ICI) Tedopi® - OSE2101: innovative combination of neoepitopes highly selected as strong binders on HLA-A2 HLA-A2 restricted epitopes targeting multiple tumor antigens (TA
Slide 7: Atalante-1 Study: 2-Step Design: NSCLC After Failure of IO
Atalante-1 Study :2-Step Design: NSCLC After Failure of IO - Advanced/metastatic NSCLC - HLA-A2+ (blood) Arm A: Tedopi® Failure to platinum-based CT and - IO, combined or sequenced Q3W for 6 subcutaneous injections, then Q8W up to Year 1, then Q12W until progression or Primary IO last line with prim
Slide 8: Background Trial Information
Background Trial Information • OSE2101 principal analysis in secondary resistance of IO as last line: presented at ESMO 2021 Tedopi is increasing median overall survival (OS) by 3.6 months with HR of 0.59 (p=0.017) versus chemotherapy (docetaxel or pemetrexed) in advanced and metastatic NSCLC patien
Slide 9: Atalante-1 Primary Endpoint: Overall Survival - Beyond Checkpoint Inhibitors
Atalante-1 Primary Endpoint: Overall Survival- Beyond Checkpoint inhibitors* Arm A Tedopi Arm B SoC (N=80) (N=38) Events N (%) 61 (76) 34 (90) HR (95%CI): 0.59 Median (95% CI) OS 11.1 7.5 (0.38, 0.91) (months) (8.6, 13.5) (4.7, 10.3) p stratified =0.017 OS rate at 12 months 44% in Tedopi versus 27.5
Slide 10: #9094: Quality of Life of OSE2101 in HLA-A2+ NSCLC Patients
#9094: Quality of Life (QoL) of OSE2101 in HLA-A2+ Non- Small Cell Lung Cancer (NSCLC) patients after failure to immune checkpoint inhibitors (IO): Final data of Phase 3 Atalante-1 randomized trial B. Besse, R.G Campelo, M. Cobo-Dols, E.A. Quoix, A. Madroszyk, E. Felip, F. Cappuzzo, F. Denis, W. Hil
Slide 11: Methods
Methods Quality of Life (QoL) and time to worsening ECOG Performance Status (PS) were compared between groups: ✓ Time to worsening ECOG PS was defined by the time from randomization to the earliest time when the ECOG becomes > 1 using Kapan Meier method. ✓ QoL by EORTC QLQ-C30/LC13 questionnaires an
Slide 12: Probability of Time to Worsening of ECOG
PoI: Time to Worsening of ECOG -PS >1 Prolonged 1.0 OSE2101 Median (95% CI)= 9.0 (6.3, ) Probability of Time to Worsening of ECOG SoC Median (95% CI)= 3.3 (2.3, 6.7) 0.9 HR (st rat ified) est imat e (95% CI)= 0.426 (0.228,0.798) 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 OSE2101 SoC 0 3 6 9 12 15 18 21 24
Slide 13: PROs: QLQ-C30 Global Health Status, Physical and Role functioning
PROs: QLQ-C30 Global Health Status, Physical and Role functioning Patient Reported Outcome PROs remained stable with Tedopi® whereas it deteriorated from the 1st cycle with SoC Global Health Status: rate of overall heath and QoL Improvement (score positive) Physical functioning: ability to perform a
Slide 14: QoL Symptoms Scores EORTC QLQ-C30 / LC-13
QoL Symptoms Scores EORTC QLQ-C30 / LC-13 QLQ-C30 QLQ-LC13 PoI in secondary resistance : Patients presented fewer symptoms typically related to adverse effects of chemotherapy (alopecia, mouth soreness, dysphagia, peripheral neuropathy) with OSE2101 than with SoC. Sensitivity analysis in the global
Slide 15: Conclusions
Conclusions First cancer therapeutic vaccine randomized trial with positive results beyond checkpoint inhibitor Strong biological rationale • Principal analysis: in advanced and metastatic HLA-A2+ NSCLC patients with IO Secondary Resistance to sequential CT-IO, Tedopi® significantly increases OS, Ti
Slide 16: Tedopi® Development plan in advanced NSCLC
Tedopi® Development plan in advanced NSCLC Beyond Checkpoint inhibitors
Slide 17: Tedopi® in NSCLC in Secondary Resistance After ICI
Tedopi® in NSCLC in Secondary Resistance After ICI First specific immunotherapy with clinically meaningful efficacy in ICI 2nd resistance Final positive results of Atalante-1 study in NSCLC secondary resistant patients after Immune Checkpoint failure presented at ASCO 2022 FDA meeting planned to rev
Slide 18: Current Landscape of Late-Stage Drug Development Post CT-IO
Current Landscape of Late-Stage Drug Development Post CT-IO Company Cell therapies Immunotherapy ADC Target Multi-epitope vaccine TKIs TILs TIM-3 TROP2 CEACAM5 c-MET Current Study ATALANTE-1 MRTX-500 CONTACT-01 LEAP-008 IOV-COM-202 COSTAR Lung Tropion-LUNG1 CARMEN-LC03 NCT04928846 118 (secondary n 5
Slide 19: Combination of Tedopi® with Leading IO Treatments or Chemotherapy
Combination of Tedopi® with Leading IO Treatments or Chemotherapy Investigator led Phase 2 studies in new indications / settings 2nd line post 1st line Chemo IO Maintenance setting post standard of care Combi-TED - NSCLC TEDOVA - Ovarian Cancer TEDOPaM - Pancreatic Cancer In Combination with nivolum
Slide 20: Tedopi® Clinical Update for TEDOPaM study in pancreatic cancer
Tedopi® Clinical Update for TEDOPaM study in pancreatic cancer
Slide 21: Patient Disposition at Interim Analysis
Patient Disposition at Interim Analysis Out of 162 screened Pts, 66 (41.9%) were HLA-A2 positive Arm A Arm B Arm C FOLFIRI TEDOPI TEDOPI + nivo N=9 N=10 N=10 Men, n (%) 5 (55.6) 4 (40.0) 6 (60.0) Median age, interquartile 59, 51-63 63.5, 54-71 66, 59-73 range (IQR) Metastatic stage, n (%) 8 (88.9) 8
Slide 22: Positive Interim Analysis Post-FOLFIRINOX
ACTIVITY Positive Interim Analysis Post-FOLFIRINOX 29 patients : n=9 in Folfiri group A ;n= 10 in Tedopi group B; n=10 in combination Nivolumab +Tedopi Group C • Primary endpoint achieved (Fleming futility analysis based on OS rate at one year -null hypothesis < 25%) M12-OS rate was 44% in Arm A Fol
Slide 23: Conclusions
Conclusions • Futility analysis: Primary endpoint achieved: 1 year OS rate at 40% with Tedopi monotherapy • Maintenance with OSE2101 monotherapy showed a favorable safety profile and encouraging Time to failure of strategy TFSn warranting further evaluation • OSE2101 + nivolumab was associated with
Slide 24: TEDOPaM – Phase II Study Design
TEDOPaM – Phase II Study Design Maintenance In Controlled Advanced PDAC After Folfirinox- modified by IDMC in 2 arms Total Duration: 24 months therapy 106 patients Proposed endpoints Arm A FOLFIRI n= 53 Phase II randomized Primary study R Q2W until progression, toxicity or consent 12-month OS (Overa
Slide 25: Complementary Platforms and Balanced Pipeline
Complementary Platforms and Balanced Pipeline Phase 1 Collaboration Asset Mono/ Combo Indication IND-Enabling Ph1a Ph1b Phase 2 Phase 3 Partner Mono NSCLC post ICI1 Tedopi® + Opdivo® NSCLC post ICI1 (Neoepitope vaccine) + Keytruda® Ovarian maintenance + Chemo Pancreatic maintenance + ezabenlimab MSS
Slide 26: Multiple Clinical Catalysts in the Next 18 Months
Multiple Clinical Catalysts in the Next 18 Months Disease area Program Partner Catalyst Timing NSCLC Tedopi® Regulatory Update Q4’ 22 Tumor indications BI 765063 Clinical Update Q4’ 22 Niche tumor OSE-279 Phase 1 initiation Q4’ 22 indication Phase 1 Study SC IV Transplantation FR104 / VEL101 Q4’ 22
Slide 27: Jaen
Jaen OSE ts
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