Immuneonco Biopharmaceuticals (shanghai) Inc Class H · HKEX:1541
Immuneonco Biopharmaceuticals (shanghai) Inc Class H — Investor Presentation (September 2024)
46 slides from Immuneonco Biopharmaceuticals (shanghai) Inc Class H's investor presentation, September 2024
Slide 1: Corporate Presentation
Corporate Presentation September 2024
Slide 2: Disclaimer
Disclaimer THIS DOCUMENT OR THE INFORMATION CONTAINED HEREIN IS NOT INTENDED TO AND DOES NOT CONSTITUTE ANY OFFER OR INVITATION, SOLICITATION, COMMITMENT OR ADVERTISEMENT OF ANY OFFER FOR SUBSCRIPTION, PURHCASE OR SALE OF ANY SECURITIES, NOR SHALL ANY PART OF THIS DOCUMENT FORM THE BASIS OF OR BE RE
Slide 3: Table of Contents
Table of Contents Section 1 Company Overview 4 Section 2 Major Oncology Programs 9 Section 3 Non-Oncology Programs 26 Section 4 Other Oncology Programs 34 Appendix Our Approach 40 3
Slide 4: Company Overview
SECTION 1 Company Overview
Slide 5: Key Milestones
Key Milestones • 30 issued patents • Steady team with 10+ years coordination • 23 pending patent applications • 29 IND approvals from the NMPA and the FDA • 8 ongoing clinical programs 2015-2020 2021 2022 2023 2024 • 2015: ImmuneOnco was IMM01: IMM01: IMM01: IMM2510+ IMM27M in IMM01: lenalidomide fo
Slide 6: Management team
Management team Wenzhi Tian, MD, 30+ years academic and industrial experience in the field of immuno-oncology EMBA Founder, Chairman & 29 IND approvals from the NMPA and the FDA CEO 30 issued patents, 23 patent applications, and 30+ scientific publications Qiying Lu, MD Frank Xiaodong Gan, Pharm.D.
Slide 7: Integrated proprietary R&D platform
Integrated proprietary R&D platform Efficiently Conduct Screening Optimize Molecule Structure Cost-effectively Manufacture Next-generation Innovative and Druggability Analysis Design High-quality Drug In-house Oncology Therapies Target Selection and High-throughput CMC and IND-enabling Validation Dr
Slide 8: Comprehensive Pipeline Covering Oncology and non-Oncology Therapeutic Areas
Comprehensive Pipeline Covering Oncology and non-Oncology Therapeutic Areas IND/IND- Phase III/ Commercial Program (1) Target (Modality) Indication(s) Discovery Preclinical Phase Ia/I Phase Ib/II Partners Current Status / Upcoming Milestone Enabling Pivotal Rights IMM01 （Timdarpacept） CD47 IMM01 + A
Slide 9: Major Oncology Programs
SECTION 2 Major Oncology Programs
Slide 10: IMM01 (Timdarpacept) Overview and Competitive Advantage
IMM01(Timdarpacept) Overview and Competitive Advantage of IMM01(Timdarpacept) In Vivo Efficacy of IMM01 is Dependent on Effective Fc Function (HL-60 xenograft model) IMM01 Full activation of macrophages SIRPα Blocking “Don’t eat me” IMM01 IMM01M domain signal via interrupting CD47 CD47-SIRPα interac
Slide 11: Phase I Clinical Trial Results of IMM01 Monotherapy
IMM01(Timdarpacept) Phase I Clinical Trial Results of IMM01 Monotherapy One of the only two companies to have observed CR in monotherapy clinical trials with a well tolerated safety profile Potent Antitumor Activity and Encouraging Preliminary Clinical Efficacy Response Observed in Patients Treated
Slide 12: Phase I Clinical Trial Results of IMM01 Monotherapy: Safety
IMM01(Timdarpacept) Phase I Clinical Trial Results of IMM01 Monotherapy Safety Results The impact on hemoglobin or platelet is transient and insignificant following the administration of IMM01. HGB Changes Following Single-dose and Cycle 1 by Cohort Majority of TRAE is grade 1 and 2 150 145 50μg/kg
Slide 13: IMM01 + Tislelizumab: Phase II Efficacy in R/R cHL
IMM01 (Timdarpacept) + Tislelizumab (PD-1 mAb) Phase II Efficacy in Prior Anti-PD-1 Failed R/R cHL Best Percentage Change from Baseline in Target Lesion Duration of Treatment and Response Best Overall Response R/R cHL Received approval from the NMPA for the protocol of the Phase III clinical n (%) (
Slide 14: Phase II: Superior Efficacy in Anti-PD-1 Failed R/R cHL
IMM01 (Timdarpacept) + Tislelizumab (PD-1 mAb) Phase II: Superior Efficacy in Anti-PD-1 Failed R/R cHL Timdarpacept Favezelimab Tifcemalimab (SIRPα-Fc) + (Anti-LAG-3) + (Anti-BTLA) + Tislelizumab (PD-1) Pembrolizumab 1 Toripalimab (PD-1) 2 N 33 34 34 ORR 66.7% 29% 35.3% CR 24.2% 9% 0% Phase III star
Slide 15: IMM01 + Azacitidine in 1L CMML (Phase II)
IMM01 (Timdarpacept) + Azacitidine in 1L CMML ( Phase II ) Best Percent Change from Baseline in the Blast Cells in the Bone Marrow Duration of Treatment and Response Best Overall 1L CMML ≥4 months ≥6 months Response, n (%) (N=22) (N=16) (N=13) 16 14 11 ORR (72.7%) (87.5%) (84.6%) Phase III study of
Slide 16: IMM01 + Azacitidine in 1L CMML: Comparison
IMM01 (Timdarpacept) + Azacitidine in 1L CMML Comparison in Treating 1L CMML Response of Major Clinical Studies in CMML 85% • As indicated by the graph, the ORR and CR rates range from ORR CR 37% to 54% and 8% to 18% respectively in major clinical trials of azacitidine in CMML based on historical da
Slide 17: IMM01 + Azacitidine in 1L MDS (Phase II)
IMM01 (Timdarpacept) + Azacitidine in 1L MDS (Phase II) Duration of Treatment and Response Best Percentage Change from Baseline in the Blast Cells in the Bone Marrow (%) Best Overall 1L MDS ≥4 months ≥6 months Response (N=51) (N=34) (N=29) Phase III study of IMM01 in combination with azacitidine in
Slide 18: IMM01 + Azacitidine: Comparison of Safety Results
IMM01 (Timdarpacept) + Azacitidine Comparison: Safety results Magrolimab + AZA vs AZA alone MDS Ib AZA-001 MRCT Magrolimab + AZA (N=95) AZA alone (N=175) TRAE All grades, N(%) ≥Grade 3, N(%) All grades, N(%) ≥Grade 3, N(%) Compared to the trial of AZA alone, significant Anemia 49 (51.6%) 45 (47.4%)
Slide 19: IMM2510 (VEGF × PD-L1): mAb-Trap Structure
IMM2510 (VEGF × PD-L1) A bsAb with the mAb-Trap Structure Targeting VEGF and PD-L1 IMM2510 - Target Introduction and Molecule Structure IMM2510 binds multiple VEGF receptor ligands Avastin binding to various VEGFs IMM2510 binding to various VEGFs 5 5 IMM2510 Molecule Structure VEGF-A VEGF-A VEGF-B V
Slide 20: IMM2510: Key Competitor Landscape
IMM2510 (VEGF × PD-L1) Key Competitor Landscape IMM2510 PM8002 AK112 VEGF binding VEGF-A, VEGF-B, PLGF VEGF-A VEGF-A PD-1 or PD-L1 PD-L1 PD-L1 PD-1 ADCC Enhanced ADCC None None Superiority over Keytruda® in Multiple responses in 1L NSCLC: 47% ORR Key clinical 1L NSCLC patients with prior PD-1 1L TNB
Slide 21: IMM2510: Responses in Patients with Prior PD-1 Inhibitor
IMM2510 (VEGF × PD-L1) IMM2510 achieved multiple responses in patients with prior PD-1 inhibitor during dose escalation Squamous NSCLC Squamous NSCLC c Thymus adenosquamous carcinoma completed dose escalation up to 20 mg/kg Q2W with a manageable safety profile and no observed dose - limiting toxicit
Slide 22: IMM2510: Global Collaboration
IMM2510 (VEGF × PD-L1) Global Collaboration Developing One Owned Patent Family 1 issued patent in each of the U.S. and Japan; On August 1, 2024, we have reached a license and collaboration 1 issued patent in the PRC agreement with SynBioTx Inc., a wholly-owned subsidiary of Instil Bio, Inc. (NASDAQ:
Slide 23: Potential Global IMM2510/SYN-2510 Development
IMM2510 (VEGF × PD-L1) Potential Global IMM2510/ SYN-2510 Development 2024 2025 2026 2027 Ph1b 2L+ monotherapy NSCLC Ph2 1L chemo combo Ph3 1L NSCLC Ph2 2L+ monotherapy Ph1b 2L+ monotx TNBC Ph1b/2 1L chemo combo Ph3 1L TNBC Ph1b/2 Renal Cell Carcinoma China Hepatocellular Carc. Indication Expansion
Slide 24: IMM27M (CTLA-4 ADCC+)
IMM27M (CTLA-4 ADCC+) A CTLA-4 mAb with Enhanced ADCC Activity IMM27M - Mechanism of Action and Limitations of Approved Stronger In Vivo Antitumor Effects and Preliminary Ph1 data Molecule Efficacy Study in Colon Cancer (MC38) Syngeneic Mouse Model IMM27M Molecule Structure Blocking the interaction
Slide 25: IMM0306 (CD47×CD20)
IMM0306 (CD47×CD20) 1st CD47 and CD20 Dual-targeting Bispecific to Enter into the Clinical Stage Globally Overview Mechanism of Action IMM0306 Molecule Structure Full macrophage activation IgG4 CD47 mAb SIRPα-D1 SIRPα “Don’t eat me” blocked “Eat me” signal inactive Improved ADCP and ADCC activity CD
Slide 26: IMM0306 + Lenalidomide (CD47×CD20)
IMM0306 + Lenalidomide (CD47×CD20) 1st CD47 and CD20 Dual-targeting Bispecific to Enter the Clinical Stage Globally Best Percentage Change from Baseline in Target Lesion in Phase Ib Duration of Treatment and Response in Phase Ib IMM0306 + Lenalidomide Phase Ib Developing In-house and Own its IP and
Slide 27: Non-Oncology Programs
SECTION 3 Non-Oncology Programs
Slide 28: IMC-001 (IMM01, SIRPα-Fc)
IMC-001 (IMM01, SIRPα-Fc) Our CD47-targeted IMM01 presents a strong potential in treating atherosclerosis CD47 is highly expressed in human atherosclerotic plaque By blocking the CD47 signal, macrophages can phagocytose the atherosclerotic plaque in rat vessel Shrinkage of atherosclerotic plaque was
Slide 29: IMC-002 (IMM0306): B-cell depletion in autoimmune diseases
IMC-002 (IMM0306, CD47xCD20/mAb-Trap) B-cell depletion was observed in IMM0306 clinical studies, presents a strong potential in the treatments of autoimmune diseases A study conducted by Dr. Georg Schett at the University of Erlangen- Mechanism of Action Nuremberg showed that deep depletion of B cel
Slide 30: IMC-002: CD47 contributes to pathogenesis of lupus nephritis
IMC-002 (IMM0306, CD47xCD20/mAb-Trap) CD47 contributes to pathogenesis of lupus nephritis Knockout of CD47 reduces IgG levels and improves lupus nephritis CD47 knockout in Faslpr LN disease model resulted in remission of glomerular base membrane thickening and significantly reduced autoantibodies an
Slide 31: IMC-003 (IMM72, ActRIIA/Fc-fusion)
IMC-003 (IMM72, ActRIIA/Fc-fusion) ActRII biology in reducing fat mass while preserving muscle mass ActRII biology in muscle tissue ActRII biology in adipose tissue Signaling via ActRII receptors inhibits muscle growth and promotes Activin signaling via ActRII receptors directly promotes lipid stora
Slide 32: IMC-003: Preclinical Results
IMC-003 (IMM72, ActRIIA/Fc-fusion) Preclinical Results Compared to Sotatercept, IMC-003 has stronger binding and blocking capacity IMC-003 helps build muscle and lose weight Binding of ACVR2 Fc Fusion Protein to Activin-A Body weight increased substantially Skeletal muscle increased substantially by
Slide 33: IMC-004 (IMM7211c)
IMC-004 (IMM7211c, [undisclosed] x ActRIIA/mAb-Trap) A Bispecific molecule Targeting [undisclosed] and ActRIIA with Global First-in-Class Potential [undisclosed] [undisclosed] ⚫ The binding of [undisclosed] to its receptor triggers osteoclast precursors to differentiate into osteoclasts and results
Slide 34: IMC-004: Preclinical Results
IMC-004 (IMM7211c, [undisclosed] x ActRIIA) Preclinical Results IMC-004 (IMM7211) has stronger binding and blocking capacity than IMM7212 on Activin A and [non-disclosed]; and is similar to Denosumab on [non-disclosed] [undisclosed] [undisclosed] 34
Slide 35: Other Oncology Programs
SECTION 4 Other Oncology Programs
Slide 36: IMM2520 (CD47×PD-L1)
IMM2520 (CD47×PD-L1) Overview Mechanism of Action A CD47 and PD-L1 dual-targeting Full activation of IMM2520 macrophages bispecific molecule for the treatment of SIRPα-D1 solid tumors FcγR CD47 IMM2520 “Don’t eat me” blocked “Eat me” signal activated Anti-PD-L1 Unique structure to avoid RBC binding
Slide 37: IMM2520: Preclinical Results and Development Plan
IMM2520 (CD47×PD-L1) Preclinical Results Market Opportunities and Clinical Development Plan Efficacy Study in Colon Cancer (CT26) Mouse Model (1) Opportunities A huge market potential for IMM2520 ✓ A wide range of cancer indications with high macrophage infiltration Tumor Volume (mm3) ✓ Only about 1
Slide 38: IMM47 (CD24)
IMM47 (CD24) A Potential Global First-in-Class CD24-Targeted mAb IMM47 – Molecule Structure and Mechanism of Action IMM47 Molecule Structure Apoptosis Block CD24/Siglec-10 immune inhibitory signaling IMM47 CD24 mAb ADCC ADCP Fc Receptor Tumor Cell CD24 mAb Induce ADCC/ADCP IgG1 Fc with Lysosomes Enh
Slide 39: IMM47: Novel Target with Few Contenders
IMM47 (CD24) Novel Target Development with Only a Handful Contenders, Well-Recognized by Industry Pioneers IMM47 - Competition Landscape No approved drug targeting CD24 globally. Only one drug candidate recently receiving IND approval from the FDA for its Phase I clinical trial Global R&D race with
Slide 40: Our Approach
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Slide 41: Breaking Drug Resistance and Broaden Benefit
Breaking Drug Resistance and Broaden Benefit Research Has Shown PD-1/PD-L1 Inhibitors Are Only Expected to be Effective in Hot Tumors, Corresponding to its Limited Monotherapy Response Rates, The Activation of Innate Immune Cells is Able to Attract T Cells into Tumor Microenvironment, Turning Cold T
Slide 42: Differentiated molecule design based on drug-by-design (DbD)
Scientifically and structurally differentiated molecule design based on our “drug-by-design (DbD)” concept to achieve potent efficacy and favorable safety Mechanism of Action in the CD47-SIRPα Signaling Pathway Guided by the DbD concept, our differentiated molecule design tackles scientific barriers
Slide 43: Overview and Competitive Advantage of IMM01 (Timdarpacept)
Overview and Competitive Advantage of IMM01 (Timdarpacept) Overview Competitive Advantage of IMM01 Monotherapy - Safety Human RBC Binding Analysis of IMM01 350 Mean Fluorescence Intensity Donor Characteristics (n=100) 300 Male (n=62) First SIRPα-Fc fusion protein to enter 250 Female (n=38) the clini
Slide 44: Challenges for CD47-Targeted Drug Development
Challenges for CD47-Targeted Drug Development CD47 Antibody • Target affinity is too high • Severe “antigen-sink” • Much higher clinical dose (30-45mg/kg) • SAEs are inevitable Efficacy Safety 44
Slide 45: Magrolimab Has Very High Target Affinity and RBC Binding Activity
Magrolimab Has Very High Target Affinity and RBC Binding Activity Target affinity assay Without priming dose With priming dose (1mpk, 3mpk) Concerns Magrolimab Receptor Occupancy (RO) IMM01 Receptor Occupancy (RO) Concerns Receptor Occupancy of IMM01 PBMC • Bind to RBC, leading to hemolysis 60 • Too
Slide 46: Thank you!
Thank you!
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