Ose Immunotherapeutics Sa · EURONEXT:OSE
Ose Immunotherapeutics Sa — Investor Presentation (January 2025)
44 slides from Ose Immunotherapeutics Sa's investor presentation, January 2025
Slide 1: Breaking Through the Therapeutic Ceiling with First-In-Class Immunotherapies
Breaking Through the Therapeutic Ceiling with First-In-Class Immunotherapies January 2025
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation contains express or implied information and statements that might be deemed This presentation does not constitute an offer to sell the shares or soliciting an offer to purchase any of forward-looking information and statements in respect of OSE Immunothera
Slide 3: Investment highlights
Investment highlights Promising clinical data from the Phase 3 oncology asset Tedopi® Late-stage compelling products Positive Phase 2 IBD asset Lusvertikimab Focus on multi-billion $ markets Large market opportunities • I/O: NSCLC (2L, 3L), HCC (1L, 2L), HNSCC (2L), Leukemia • I&I: IBD (Ulcerative C
Slide 4: Delivering first-in-class immunotherapies from Target to Clinic
Delivering first-in-class immunotherapies from Target to Clinic Key strategic pharma partnerships driving long-term value • Founded in 2012 Phase 3 asset in Oncology • IPO/Euronext in 2015 Tedopi® most advanced cancer vaccine • 60+ FTEs NSCLC 2L post-CPI market: +$5b/year • 500+ granted patents Firs
Slide 5: Strong foundation & recurrent track record of success
Strong foundation & recurrent track record of success 10 years of validated innovation in immunology thanks to an Extra[not]Ordinary R&D engine Validated science Strong track record Recurrent revenues in high-impact publications of Pharma partnerships Robust first-in-class business model 219 M€ thro
Slide 6: Clinical pipeline
Clinical pipeline Combining a clinical portfolio of first-in-class immunotherapies and diversified assets in IO and I&I Product candidate Target Indication Research IND-enabling Phase Ia/Ib Phase II Phase III NSCLC Mono post-ICI 3L NSCLC Mono post-ICI 2L Pivotal Phase 3 Neoepitope Tedopi® PDAC Combo
Slide 7: Research platforms
Research platforms Extra(not) Ordinary Research PowerHouse Myeloid Checkpoint Cis-targeted Cytokine Pro-Resolutive mAb RNA Therapeutics Anti-SIRPα Anti-PD1/cytokine Anti-ChemR23 IL-35 mRNA Anti-CLEC-1 mAbs Cis-Demasking technology Undisclosed new Undisclosed programs pro-resolutive GPCRs Partnered A
Slide 8: Strategic partners provide industry-leading clinical support & strong financial foundations
Strategic partners provide industry-leading clinical support & strong financial foundations Immuno-Oncology Potential Over €2.1bn in potential milestones; €219m* already received Immuno-Inflammation Received BI 770371 ABBV-230 FR104/VEL-101 + anti-PD1/cytokine Chronic Kidney Solid tumors & Metabolic
Slide 9: Key potential catalysts
Key potential catalysts* Readouts • Tedopi® Phase 3 results in NSCLC 2L Phase 2 combination results • Lusvertikimab New study results Progress • BI 770371 (partnered) • Lusvertikimab Phase 1b onco + Phase 2 MASH results Readouts Strategic update • FR104/VEL-101 (partnered) • Lusvertikimab Phase 2 re
Slide 10: Proprietary clinical programs
Proprietary clinical programs
Slide 11: Tedopi: Most Advanced Therapeutic Cancer Vaccine
TEDOPI® Most Advanced Therapeutic Cancer Vaccine Bringing new hope to patients in the fight against ICI resistant NSCLC
Slide 12: Tedopi (OSE-2101): Product description
Tedopi® Tedopi® (OSE-2101): Product description Tedopi® is a therapeutic cancer vaccine composed of modified epitopes restricted to HLA-A2+ targeting 5 1 heteroclitic* 1 heteroclitic Tumor-Associated Antigens frequently expressed in 1 fixed-anchor** 1 fixed-anchor 1 fixed-anchor lung cancer1,2 1 fix
Slide 13: Foreignness / Immunogenicity
Tedopi® Cancer antigens immunogenicity Pathogens Foreignness / Immunogenicity Engineered Lack of Central Tolerance for T cells shared T-cell neoepitopes TCR/HLA Affinity maturation Tumor neoantigens (natural T-cell neoepitopes) Shared Tumor-associated antigens Self- (TAA) antigens Tumor-specific exp
Slide 14: Personalized vs Off-the-Shelf cancer vaccines
Tedopi® Personalized vs Off-the-Shelf cancer vaccines Neoepitope cancer vaccine Neoantigen cancer vaccine = Precision Medicine = Personalized Medicine -> Off-the-Shelf -> Custom TEDOPI® “Ready-to-Use” emulsion CDx-based selection (blood sample) Cons: Tumor biopsy, Cost, Time Homogeneous HLA-A2+ popu
Slide 15: An immunotherapy activating specific T-cells to revive anti-tumor response
Tedopi® An immunotherapy activating specific T-cells to revive anti-tumor response Most advanced Cancer Vaccine in clinical development • Unique combination of neoepitopes: small peptides deriving from tumor specific antigens* expressed in various cancers • Strong binding to HLA-A2 receptor (45% pop
Slide 16: Tedopi novel cancer vaccine in post-ICI secondary resistance
Tedopi® Tedopi® is a novel cancer vaccine with a strong biological rational in post-ICI secondary resistance Shifting paradigms with cancer vaccine immunotherapy Primary (intrinsic) resistance No T-cell Patients who do not respond to ICIs refractory with a rapid disease progression tumors → Immune r
Slide 17: Clinically meaningful benefit of Tedopi in 3rd line NSCLC
Tedopi® Clinically meaningful benefit of Tedopi® in 3rd line NSCLC Randomized Phase 3 with positive results vs. standard of care (SOC) OS rate at 12 months Overall Survival 44% Significantly safer than Chemo. secondary resistance post anti-PD(L)1 in Tedopi® vs. 11% vs 35% grade 3-5 AEs 27.5% in SoC
Slide 18: Tedopi delivers important clinical benefits vs competition
Tedopi® Tedopi® delivers important clinical benefits vs competition Better Safety profile and QoL in current landscape of late-stage drug development post CT-IO Company Checkpoint Inhibitors ADCs Target Multi-epitopes vaccine TKIs (anti-angiogenic) TIM-3 CTLA-4 TROP2 TROP2 CEACAM5 c-MET Current Stud
Slide 19: Tedopi in NSCLC: ARTEMIA study
Tedopi® Tedopi® in NSCLC : ARTEMIA study ARM A Tedopi® (n=242) PRIMARY ENDPOINT: KEY ELIGIBILITY CRITERIA Q3W for 6 subcut. inj., Overall Survival* then Q8W until end Year 1, - HLA-A2+ then Q12W up to end Year 2 SECONDARY ENDPOINTS: - Metastatic squamous & non-squamous NSCLC Until loss of clinical b
Slide 20: Tedopi answers to real medical need in NSCLC
Tedopi® Tedopi® answers to real medical need in NSCLC Tedopi® has the potential to become the new standard for recurrent patients in 2L NSCLC presenting HLA-A2 phenotype LUNG CANCER : Incidence of High prevalence, mortality and unmet need - worldwide advanced NSCLC • Highest mortality among 36 cance
Slide 21: Further potential clinical value in combination NSCLC, PDAC and OC
Tedopi® Further additional potential clinical value in combination NSCLC, PDAC and OC Phase 2 ISS trials in combination with immunotherapy or chemotherapy treatments 2nd line post 1st line chemo IO Maintenance setting post standard of care CombiTED - NSCLC TEDOVA - Ovarian Cancer TEDOPaM - Pancreati
Slide 22: OSE-279: Proprietary anti-PD1 mAb
OSE-279 OSE-279: Proprietary anti-PD1 mAb High affinity PD-1 antibody, recent patent granted in US, Europe, China, Japan Clinical Responses in registered anti-PD1 early Phase 1 studies OSE-279 P1 ❖ Potential of combo with 40% All subjects 10mg/kg or >500mg 36% internal asset 35% 33% 30% Subjects (%)
Slide 23: Lusvertikimab
Lusvertikimab Most advanced anti-IL-7R mAb Strong biological rational in refractory IBD patients
Slide 24: IL-7 fuels chronic inflammation in tissues
Lusvertikimab 24 IL-7 fuels chronic inflammation in tissues Lusvertikimab controls pathogenic memory T-cell persistence 24
Slide 25: Lusvertikimab/OSE-127 Pure IL-7 receptor antagonist mAb
Lusvertikimab Lusvertikimab/OSE-127 Pure IL-7 receptor antagonist mAb Tackling the fuel of memory T-lymphocytes while sparing Tregs A differentiated and highly qualified candidate • IL-7 produced by inflamed tissues sustain T-cell survival and chronicity, drives Th1 and Th17 T cell differentiation •
Slide 26: IL-7 downstreams mechanism of resistance in hyper-inflammatory IBD
Lusvertikimab IL-7 downstreams mechanism of resistance in hyper-inflammatory IBD The ‘angry’ cell concept and resistance to anti-cytokine therapies. “Recent evidence suggests the presence of highly pro- inflammatory — or ‘angry’ — cells in the intestinal mucosa in inflammatory bowel disease (IBD) th
Slide 27: Protective role of TSLP in intestinal immunity
Lusvertikimab Protective role of TSLP in intestinal immunity Lusvertikimab selectively blocks IL-7 but not TSLP axis • TSLP drives Th2 responses → Pathogenic role in allergic diseases & atopic responses • TSLP drives Foxp3+ Treg induction by DCs against commensal bacteria (Spadoni et al. Mucosal Imm
Slide 28: Mucosal IL-7R pathway over-expression in IBD tissues
Lusvertikimab Mucosal IL-7R pathway over-expression in IBD tissues High IL-7R expression in anti-TNF refractory patients IL7R pathway gene expression enrichment Colon gene expression IL7R correlation with IL7R expression anti-TNF resistance Anti-TNF Responder patients Anti-TNF Refractory patients 28
Slide 29: CoTikiS Phase 2 randomized study of Lusvertikimab
Lusvertikimab CoTikiS Phase 2 randomized study of Lusvertikimab Moderate-to-severe Ulcerative Colitis W0 W10 W34 Open Label Extension Full Analysis Set (FAS) : 134 patients Screening Induction OLE 50 pts Group 850mg Lusv 35 pts Group 450mg Lusv Lusvertikimab 85 pts pooled Groups (450 + 850) Two fixe
Slide 30: Clinical induction results at week-10
Lusvertikimab Clinical induction results at week-10 Clinically and statistically relevant clinical improvement in the Lusvertikimab groups Primary Endpoint: Modified Mayo Score Improvement (MMS)* Clinical Remission** Placebo 850mg 450mg 450+850mg (n=49) (n=50) (n=35) (n=85) 30 0 Δ 17.6% % of Patient
Slide 31: Clinical induction results at week-10: endoscopic improvement
Lusvertikimab Clinical induction results at week-10 Clinically meaningful and significant endoscopic improvement and remission UC Endoscopic Index of Severity Endoscopic Improvement* Endoscopic Remission** UCEIS*** 50 Δ 32% 40 Δ 22% Placebo 850mg 450mg % of Patients with Endoscopic Remisssion % of P
Slide 32: Significant opportunity in Ulcerative Colitis & Acute Lymphoblastic Leukemia
Lusvertikimab Significant opportunity in Ulcerative Colitis & Acute Lymphoblastic Leukemia targeted markets Ulcerative Colitis (UC) Acute Lymphoblastic Leukemia (ALL) • UC affects 3.3 million patients in IBD Global market projections • ALL is a rare disease with a diagnosed ALL Global market project
Slide 33: Partnered clinical programs
Partnered clinical programs
Slide 34: Resolution of inflammation
ABBV-230 Resolution of inflammation Pr. C. Serhan, Harvard seminal works (OSE SAB member) January 2015 34 Serhan CN: Nature Review Immunol 2013, Immunity 2014, Nature 2014, Science 2015, …
Slide 35: ABBV-230 - Resolving inflammation is an active immune process
ABBV-230 ABBV-230 - Resolving inflammation is an active immune process Restoration of homeostasis During chronic With ChemR23 inflammation agonistic mAbs Dying neutrophils send out ABBV-230 limits recruitment, inflammatory signals (e.g. survival & NETosis of NETosis) that are important in inflammato
Slide 36: SIRPα inhibition may have a synergistic antitumour effect when combined with ICIs
SIRPα program SIRPα inhibition may have a synergistic antitumour effect when combined with ICIs • Infiltrating myeloid cells promotes immune evasion, and this has generated interest in The use of SIRPα myeloid-immune targets1,2 antagonists to enhance o The CD47–SIRPα interaction transduces inhibitor
Slide 37: FR104/VEL-101 CD28 antagonist in organ transplantation
FR104 / VEL-101 FR104/VEL-101 CD28 antagonist in organ transplantation Selective CD28 antagonist mAb Ambitious Partnership & Development Plan in Kidney Transplantation with Veloxis CD28 antagonist (FR104) o Veloxis is a global leader in transplantation with leading product Envarsus XR (tacrolimus) r
Slide 38: FR104/VEL-101 - Transforming kidney transplant management
FR104 / VEL-101 FR104/VEL-101 - Transforming kidney transplant management Positive results of the FIRsT phase I/II clinical evaluation Kidney Transplant Market: in kidney transplantation1 A multi-billion-dollar commercial opportunity • 45k+ new kidney transplant annually for an estimated 500k+ Good
Slide 39: The OSE team
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Slide 40: An experienced executive leadership team
An experienced executive leadership team Nicolas Poirier, PhD Sonya Montgomery, MD Anne-Laure Autret-Cornet Fiona Olivier CEO CHIEF DEVELOPMENT OFFICER CHIEF FINANCIAL OFFICER CHIEF CORPORATE AFFAIRS & INVESTOR RELATIONS OFFICER • 20 years of experience in • 20+ years in Pharma / Biotech • 15+ years
Slide 41: A Board of Directors combining international expertise
Corporate Highlights A Board of Directors combining international expertise in medicines development, industry & finance, and experience in listed biotech companies Didier Hoch, MD Maryvonne Nicolas Poirier, PhD Anne-Laure Marc Dechamps Chairman Hiance Director, CEO Autret-Cornet Independant Vice &
Slide 42: International Scientific Advisory Board (SAB)
Corporate Highlights International Scientific Advisory Board (SAB) - renowned experts in IO and I&I Wolf-Hervé Fridman, MD Myriam Merad, MD, PhD Charles N. Serhan, PhD, DSc Jennifer Wargo, MD, M.M.Sc Bernard Malissen, PhD Sophie Brouard, PhD Chairman of the SAB, Professor Director of the Precision P
Slide 43: Key financial and shareholding structure
Key financial and shareholding structure Key financials Shareholding structure ISIN code FR0012127173 Founders, Management, Market Euronext Paris Board and Institutional Employees Shares outstanding 21 817 777 Investors and 27% Retail 73% Market cap (Sept 5, 2024) €193 m Level of Cash (June 30, 2024
Slide 44: Breaking through the therapeutic ceiling with first-in-class immunotherapies
Breaking through the therapeutic ceiling with first-in-class immunotherapies Immuno-Oncology & Immuno-Inflammation Head Office Paris Office 22, boulevard Bénoni Goullin 10, Place de Catalogne 44200 Nantes, France 75014 Paris, France Company Information: http://ose-immuno.com/en/
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