OSE Immunotherapeutics SA · EURONEXT:OSE
OSE Immunotherapeutics SA — Investor Presentation (March 2024)
44 slides from OSE Immunotherapeutics SA's investor presentation, March 2024
Slide 1: Breaking Through the Therapeutic Ceiling with First-In-Class Immunotherapies
Breaking Through the Therapeutic Ceiling with First-In-Class Immunotherapies March 2024
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: OSE's strong foundation & recurrent track record of success
OSE’s 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 200 T
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: 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; €180m* already received Immuno-Inflammation Received BI 765063/BI 770371 OSE-230 FR104/VEL-101 Solid tumors Chronic Kidney Inflammation transplan
Slide 6: OSE's Clinical pipeline
OSE’s Clinical pipeline Combining a clinical portfolio of first-in-class immunotherapies and diversified assets in IO and I&I IND- Product candidate Target Indication Research Phase I Phase II Phase III enabling NSCLC Mono post-ICI 3L NSCLC Mono post-ICI 2L Neoepitope Proprietary Proprietary Tedopi®
Slide 7: OSE's Research platforms
OSE’s Research platforms Extra[not]Ordinary Research PowerHouse Pro-resolutive Cis-Targeted Myeloid mAb Augmented Cytokine Checkpoint Partnered Asset : Main Asset : Partnered Asset : Anti-ChemR23* Anti-PD1-IL7v Anti-SIRPa# Ongoing programs Ongoing programs Ongoing programs Undisclosed new Cis-Demask
Slide 8: Key catalysts
Key catalysts Readouts • Tedopi® Phase 3 results in NSCLC 2L • BI 765063/BI 770371 (partnered) Phase 2 results • FR104/VEL-101 (partnered) Readouts Progress Phase 2 results in Kidney Transplantation • Lusvertikimab • Tedopi® Phase 2 results in UC Phase 3 start in NSCLC 2L • OSE-230 (partnered) Phase
Slide 9: Investment highlights
Investment highlights Promising clinical data from the lead asset Tedopi® Late-stage 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 versus SOC Focu
Slide 10: Our plan to build a leading immunotherapy company
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 Solid Tumors Demonstrate Lusvertikimab (OSE-127) clinical activity Up to €1.1bn Phase 2 in UlcerativeUpColitis to €1.1
Slide 11: Proprietary clinical programs
Proprietary clinical programs 11
Slide 12: Tedopi: Most Advanced Therapeutic Cancer Vaccine
TEDOPI® Most Advanced Therapeutic Cancer Vaccine Bringing new hope to patients in the fight against ICI resistant NSCLC 12
Slide 13: Lack of Central Tolerance for T cells
TEDOPI® Cancer Antigens Immunogenicity Engineered Lack of Central Tolerance for T cells Pathogens T-cell neoepitopes (neoTAA) TCR/HLA Affinity maturation Tumor neoantigens (natural T-cell neoepitopes) Tumor-associated shared antigens Self- (TAA) antigens Tumor-specific expression of antigen 13
Slide 14: 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 15: Tedopi is a novel cancer vaccine with a strong biological rational 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 16: Clinically meaningful benefit of Tedopi
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
Slide 17: Position Tedopi as the best treatment option after ICI-failure
TEDOPI® Position Tedopi® as the best treatment option after ICI-failure in cancer patients Confirmed Increased Agencies Awaited and MoA in Identification Survival granted innovative patients of population Compassionate mechanism of (T-cell with Decreased Access action post-IO response significant To
Slide 18: Target population estimated at 100k patients/year in NSCLC post-ICI
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 19: 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 20: Further additional 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 21: 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 22: Lusvertikimab: Most advanced anti-IL-7R mAb
Lusvertikimab Most advanced anti-IL-7R mAb Strong biological rational in refractory IBD patients 22
Slide 23: IL-7 fuels chronic inflammation in tissues
Lusvertikimab 23 IL-7 fuels chronic inflammation in tissues Lusvertikimab controls pathogenic memory T-cell persistence
Slide 24: 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-IL-7R mAb1 and most advanced IL-7R
Slide 25: Lusvertikimab most advanced First-in-Class anti-IL-7R mAb
Lusvertikimab Lusvertikimab most advanced First-in-Class anti-IL-7R mAb Differentiated by its Mechanism of Action Isotype IgG4 IgG1 IgG1 IgG1 - Non-Internalizing1 - Internalizing - TSLP Antago - Internalizing - Full Antagonist IL7R - Antago + Partial Agonist IL7R - Antago + Partial Agonist IL7R MoA
Slide 26: Lusvertikimab - Targets a specific site 1/2b Epitope
Lusvertikimab 26 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 27: 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 27
Slide 28: 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 29: Significant opportunity in Ulcerative Colitis & Acute Lymphoblastic Leukemia targeted markets
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 30: Partnered clinical programs
Partnered clinical programs 30
Slide 31: OSE-230 - Resolving inflammation is an active immune process
OSE-230 OSE-230 - Resolving inflammation is an active immune process 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 are important in inflammatory
Slide 32: OSE-230 - Strong rationale in IBD
OSE-230 OSE-230 - Strong rationale in IBD High Neutrophil infiltrates in anti-TNFα refractory patients High ChemR23 expression in anti-TNFα refractory patients Ulcerative Crohn ChemR23 staining colitis disease Crohn Disease ChemR23 relative expression (log2 ) 2 *** ** *** * * 1 *** Ulcerative coliti
Slide 33: 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 34: 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 Ia Ib Ia escalation N 108 36 150 42 • Safety No hematotoxicity reported,
Slide 35: 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 36: 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 37: Our Innovative Discovery Engines
Our Innovative Discovery Engines Designed to deliver next generation first-in-class immunotherapies 37
Slide 38: 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 39: CLEC-1 - Another way to not get eaten
Research Platforms CLEC-1 - Another way to not get eaten Myeloid Blocking myeloid immune checkpoint from delivering another “Don’t-eat-me” signal checkpoint 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 team
Corporate Highlights An experienced Executive leadership team Nicolas Poirier, PhD Anne-Laure Dominique Costantini, MD Jean-Jacques Mention, PhD CEO, CSO Autret-Cornet Chief Development Chief Business Officer Chief Financial Officer & Strategy • 18+ year experience in • 15+ years of Research in • 30
Slide 42: A Board of Directors combining international expertise
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 Chairwoman, Chief Vice Chairwoman Director, Chief Independent Dire
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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