OSE Immunotherapeutics SA · EURONEXT:OSE
OSE Immunotherapeutics SA — Investor Presentation (October 2023)
44 slides from OSE Immunotherapeutics SA's investor presentation, October 2023
Slide 1: Breaking Through the Therapeutic Ceiling with First-In-Class Immunotherapies
Breaking Through the Therapeutic Ceiling with First-In-Class Immunotherapies October 2023
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: Corporate Highlights
Corporate Highlights Delivering first-in-class immunotherapies from Target to Clinic Key In-house expertise and capabilities to identify and develop First-In-Class immunotherapies • Founded in 2012 121 M€ : Partnerships • IPO/Euronext in 2015 Paris • Merged with Effimune in 2016 20 M€ : Grants Nante
Slide 4: OSE Immunotherapeutics pipeline
Corporate Highlights OSE Immunotherapeutics pipeline Combining a clinical portfolio of first-in-class assets with unique, highly productive R&D platforms IND- Product candidate Target Indication Research Phase I Phase II Phase III Market enabling NSCLC Mono post-ICI 3L Compassionate (EU) New NSCLC M
Slide 5: Strategic partners provide industry-leading clinical support and strong financial foundations
Corporate Highlights Strategic partners provide industry-leading clinical support and strong financial foundations Over €1.4bn in potential milestones; €121m* already received since 2016 OSE-172/BI 765063 FR-104/VEL-101 HNSCC and HCC Kidney MSS Endometrial / MSS CRC transplant €65.3m received Up to
Slide 6: Multiple short-term anticipated catalysts
Corporate Highlights Multiple short-term anticipated catalysts Readouts Readouts • TEDOPI® • Lusvertikimab/OSE-127 Phase 3 results in NSCLC 2L Phase 2 results in UC • Lusvertikimab/OSE-127 (to partner) Readouts • TEDOPI® Phase 3 start • TEDOPI® Phase 2 results in PDAC Regulatory update (Europe, US)
Slide 7: Investment Highlights
Corporate Highlights Investment Highlights Promising clinical data from the lead asset Tedopi® Compelling product • Met primary overall survival endpoint in monotherapy in PoI pivotal NSCLC post-ICI study • Significant better Safety profile & Quality of Life with positive Net Treatment Benefit versu
Slide 8: Our plan to build a leading immunotherapy company
Corporate Highlights Our plan to build a leading immunotherapy company Position Tedopi® as the best treatment option after ICI-failure in cancer patients Leverage the clinical advantage of anti-SIRPα in the DON’T Eat Me landscape in Solid Tumors Demonstrate Lusvertikimab (OSE-127) clinical activity
Slide 9: Proprietary clinical programs
Proprietary clinical programs 9
Slide 10: TEDOPI
TEDOPI® Most Advanced Therapeutic Cancer Vaccine Bringing new hope to patients in the fight against ICI resistant NSCLC 10
Slide 11: 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 12: Tedopi is a novel cancer vaccine with a strong biological rationale in post-ICI secondary resistance
TEDOPI® Tedopi® is a novel cancer vaccine with a strong biological rationale 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
Slide 13: Clinically meaningful benefit of Tedopi
Clinically meaningful benefit of Tedopi® First 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 Tedopi Delta OS: 3.6
Slide 14: Position Tedopi as the best treatment option after ICI-failure in cancer patients
TEDOPI® Position Tedopi® as the best treatment option after ICI-failure in cancer patients Confirmed Agencies MoA in Identification Increased granted Awaited and patients of population Survival Early Access/ innovative (T-cell with Compassionate mechanism of response significant Decreased Access act
Slide 15: Target population estimated at 100k patients/year in NSCLC post-ICI (2nd line)
TEDOPI® Target population estimated at 100k patients/year in NSCLC post-ICI (2nd line) PD-(L)1 NSCLC market is growing (US$bn)1 Expending the potential in 2L post-ICI in G7 years • Lung cancer is the leading cause of cancer mortality worldwide, accounting for about 1.8m deaths each year.2 • NSCLC is
Slide 16: 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 CEACAM5 c-MET Current Study ATAL
Slide 17: Further additional potential clinical value in combination in NSCLC, PDAC and OC
TEDOPI® Further additional potential clinical value in combination in 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 Combi-TED - NSCLC TEDOVA - Ovarian Cancer TEDOPaM - Pancr
Slide 18: OSE-279: Proprietary PD-1 - Value generator
OSE-279 OSE-279: Proprietary PD-1 - Value generator High affinity PD-1 antibody, recent patent granted in US, Europe, China, Japan* Potential of combo with internal Backbone of the BiCKI® platform PD1 inhibition asset • Develop first-in-class monovalent Isotype control • First positive clinical effi
Slide 19: Lusvertikimab
Lusvertikimab Most advanced anti-IL-7R mAb Strong biological rational in refractory IBD patients 19
Slide 20: IL-7 fuels chronic inflammation in tissues
Lusvertikimab 20 IL-7 fuels chronic inflammation in tissues Lusvertikimab controls pathogenic memory T-cell persistence
Slide 21: Lusvertikimab/OSE-127 - Differentiated MoA as full IL-7 receptor antagonist
Lusvertikimab Lusvertikimab/OSE-127 - Differentiated MoA as full IL-7 receptor antagonist Tackling the fuel of memory T-lymphocytes while sparing Tregs A differentiated and highly qualified candidate • Lusvertikimab, first non-internalizing (fully antagonist) anti-IL7R mAb1 and most advanced IL-7R a
Slide 22: Lusvertikimab most advanced First-in-Class anti-IL7R mAb
Lusvertikimab Lusvertikimab most advanced First-in-Class anti-IL7R mAb Differentiated by its Mechanism of Action Isotype IgG4 IgG1 IgG1 IgG1 - Internalizing - Internalizing - Internalizing - Non-Internalizing1 - Antago + Partial Agonist IL-7R - Antago + Partial agonist IL-7R MoA - Full Antagonist IL
Slide 23: Lusvertikimab – Targets a specific site 1/2b Epitope
Lusvertikimab 23 Lusvertikimab – Targets a specific “site 1/2b” Epitope Full antagonist, preventing receptor internalization & signaling Pfizer mAbs Dual Agonist/Antagonist mAb-induced GSK mAbs receptor internalization OSE-127 Full Antagonist No internalization Belarif et al. Nature Com 2018
Slide 24: 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 24
Slide 25: Lusvertikimab in moderate-to-severe ulcerative colitis
Lusvertikimab Lusvertikimab in moderate-to-severe ulcerative colitis Positive Recent Futility Analysis1 Screening Induction Open Label Extension • Futility analysis conducted on 33% of the total patient enrolment (n=150) Lusvertikimab • Primary endpoint is the efficacy • 150 patients (OSE-127) asses
Slide 26: Significant opportunity in Ulcerative Colitis and Acute Lymphoblastic Leukemia targeted markets
Lusvertikimab Significant opportunity in Ulcerative Colitis and 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 proje
Slide 27: Partnered clinical programs
Partnered clinical programs 27
Slide 28: 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 29: Clinical development overview
SIRPα program Clinical development overview Most advanced clinically-tested SIRPα Dose Escalation & Expansion studies ONGOING Studies Trial number NCT03990233 NCT04653142 NCT05249426 NCT05327946 Key takeaways from dose Phase Ia + Ib Ib Ib Ia escalation N 108 36 150 42 • Safety No hematotoxicity repo
Slide 30: FR104/VEL-101 CD28 antagonist in transplantation
FR104 / VEL-101 FR104/VEL-101 CD28 antagonist in transplantation Phase 1 results: Selective CD28 antagonist FR104 Ongoing Phase 1/2 trial persistently reduces antibody responses in kidney transplantation CD28 antagonist2 (FR104) • Good safety1 - demonstrated o Absence of clinical or biological event
Slide 31: FR104/VEL-101 – Transforming kidney transplant management
FR104 / VEL-101 FR104/VEL-101 – Transforming kidney transplant management Ambitious Partnership with Veloxis Kidney Transplant Market Opportunity • Deal value: EUR 315m1 and tiered royalties on sales • 40k+ new kidney transplant annually for an estimated 500k+ o Veloxis is a global leader in transpl
Slide 32: Our Innovative Discovery Engines
Our Innovative Discovery Engines Designed to deliver next generation first-in-class immunotherapies 32
Slide 33: OSE-230 - Resolving inflammation is an active immune process
Research Platforms OSE-230 - Resolving inflammation is an active Pro- resolutive immune process mAb Restoration of homeostasis During chronic With ChemR23 inflammation agonistic mAbs Dying neutrophils send out OSE-230 limits recruitment, inflammatory signals (e.g. survival & NETosis of NETosis) that
Slide 34: OSE-230 – Preclinical data demonstrate strong effect on neutrophils and leucocytes
Research Platforms OSE-230 – Preclinical data demonstrate strong effect on neutrophils and leucocytes Higher ChemR23 expression in anti-TNFα refractory patients Ulcerative colitis U lcerativ e C ro h n Ulcerative c o8litis Crohn d is e a s e TNFa R responders Colitis *Disease Relative fraction (%) 4
Slide 35: OSE-230 significantly inhibits human neutrophils NETosis
Research Platforms OSE-230 significantly inhibits human neutrophils NET OSIS NETosis time-course NETosis inhibition ChemR23 targeting 100 ✱✱ 125 No agonist 75 % Reduction of NETs Isotype_10µg/mL 100 OSE-230_10µg/mL 50 RvE1_10nM Relative NETs Chemerin_10nM 75 25 0 50 -25 25 -50 ist nM ag αCh nM 1_ L
Slide 36: OSE-230 promotes pro-resolutive human Macrophages reprograming
Research Platforms OSE-230 promotes pro-resolutive human Macrophages reprograming Deep macrophage transcriptomic reprograming, Increases IL-10 secretion Inflammatory Macrophages Pro-resolutive Macrophages Proresolutive M (TGFβ-polarized) M1 8000 800 * *** IL-10 secretion (pg/mL) control OSE-230 600
Slide 37: Next-generation anti-PD1 bispecifics
Research Platforms Next-generation anti-PD1 bispecifics Anti-PD1 bispecifics Improving the quality of tumor-specific T-cell responses both in TME & Lymph Nodes Targeting the RIGHT T-cells… …at the right place Selective targeting of Tumor-specific PD1+ T cells Selective Biodistribution in TME + Lymph
Slide 38: BiCKI OSE-279/IL-7 demonstrates high preclinical efficacy
Research Platforms BiCKI® OSE-279/IL-7 demonstrates high preclinical efficacy Superior efficacy in PD-1 resistant models In vivo preclinical efficacy in Ex vivo reactivation of PD1 resistant mouse model anti-PD1 resistant human TILs HCC orthotopic model hPD1 humanized mice Resected tumor Ex vivo 100
Slide 39: CLEC-1 - Another way to not get eaten
Research Platforms CLEC-1 - Another way to not get eaten Myeloid checkpoint Blocking myeloid immune checkpoint from delivering another “Don’t-eat-me” signal Tumor homeostasis CLEC-1 mAbs disrupt tumor homeostasis2 Don’t Eat-Me Don’t Eat-Me SIRPα CD47 Anti-CLEC-1 mAbs increase killing efficacy of mye
Slide 40: The OSE team
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Slide 41: An experienced executive leadership committee supported by an expert team
Corporate Highlights An experienced executive leadership committee supported by an expert team Nicolas Poirier, PhD Anne-Laure Dominique Costantini, Jean-Pascal CEO, CSO Autret-Cornet MD Conduzorgues • 18+ years experience in Chief Financial Officer Chief Development Chief Pharmaceutical & Strategy
Slide 42: A Board of Directors combining international expertise in drug development, industry & finance
Corporate Highlights A Board of Directors combining international expertise in drug development, industry & finance & experience in listed biotech companies Dominique Costantini, MD Maryvonne Hiance Nicolas Poirier, PhD Elsy Boglioli Eric Leire, MD Chairwoman, Chief Vice Chairwoman Director, CEO & C
Slide 43: International SAB - Renowned experts in IO and I&I
Corporate Highlights International SAB - Renowned experts in IO and I&I Wolf-Hervé Fridman, MD Myriam Merad, MD, PhD Charles N. Serhan, PhD, DSc Jennifer Wargo, MD, Bernard Malissen, PhD Sophie Brouard, PhD Chairman of the SAB, Professor Director of the Precision Professor of Anaesthesia M.M.Sc Grou
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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