Immuneonco Biopharmaceuticals (shanghai) Inc Class H · HKEX:1541
Immuneonco Biopharmaceuticals (shanghai) Inc Class H — Investor Presentation (August 2024)
60 slides from Immuneonco Biopharmaceuticals (shanghai) Inc Class H's investor presentation, August 2024
Slide 1: Corporate Presentation
Corporate Presentation August 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 Our Approach 9 Section 3 Major Oncology Programs 20 Section 4 Non-Oncology Programs 38 Section 5 Other Oncology Programs 47 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: DLBCL dosed fir
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: Our Approach
SECTION 2 Our Approach
Slide 10: 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 11: Breaking Drug Resistance and Broaden Benefit
Breaking Drug Resistance and Broaden Benefit Our Pipeline Harnessing Both Innate and Adaptive Immunities Macro- NK Tumor phage Cell Cell FcγR SIRPα Macro- NK Tumor Teff Tumor phage Cell Cell Teff Treg CD47 TAA FcγR SIRPα Cell o IMM01 (CD47) PD-L1 • IMM01 + Azacitidine CD47 CD24 VEGF TAA • IMM01 + In
Slide 12: Differentiated molecule design based on drug-by-design concept
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 13: 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 14: 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 14
Slide 15: Our Differentiated Approaches: Overview and Competitive Advantage of IMM01
Our Differentiated Approaches 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-SIR
Slide 16: Our Differentiated Approaches (cont'd)
Our Differentiated Approaches (cont’d) 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 prote
Slide 17: Phase I Clinical Trial Results of IMM01 Monotherapy
Our Differentiated Approaches (cont’d) 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 i
Slide 18: Clinical Trial Results of IMM01 Monotherapy: Safety
Our Differentiated Approaches (cont’d) 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 1
Slide 19: Bispecific molecules developed by our mAb-Trap platform
Bispecific molecules developed by our mAb-Trap platform to achieve potent efficacy and favorable safety How Our Differentiated Design Improves Safety and Efficacy – CD47-based Bispecific Molecules The structure of our bispecific molecules was deliberately designed through a series of rigorous studie
Slide 20: Major Oncology Programs
SECTION 3 Major Oncology Programs
Slide 21: Our differentiated approach targeting innate and adaptive immune checkpoints
Our differentiated approach to developing therapies targeting CD47-based and other promising innate and adaptive immune checkpoints Our Approach to Seize Market Opportunities Innate Immunity Innate & Adaptive Immunity Adaptive Immunity IMM01 IMM0306 IMM2902 IMM2520 IMM47 IMM4701 IMM2510 IMM27M IMM40
Slide 22: IMM01 (Timdarpacept) - Competitive Landscape
IMM01 (Timdarpacept) - Competitive Landscape One of the only two companies to have observed CR in monotherapy clinical trials with a well tolerated safety profile Drug Name Company Molecule Fc isotype RBC binding 1st in human Monotherapy CR Latest Stage IMM01 ImmuneOnco 宜明昂科 SIRPαFc IgG1 No 2019.9 Y
Slide 23: 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 24: IMM01 + Tislelizumab: Superior Efficacy in Anti-PD-1 Failed R/R cHL
IMM01 (Timdarpacept) + Tislelizumab (PD-1 mAb) (cont’d) 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
Slide 25: 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 26: 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 27: 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 28: 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 29: IMM01 (Timdarpacept) - Market Opportunities
IMM01 (Timdarpacept) - Market Opportunities Increased CD47 Expression is Correlated with Poor Clinical Outcomes for Various Cancers Strong Potentials of CD47-based Therapies AML1 NSCLC2 CD47 Low MFI of CD47 in WBC ✓ CD47 is overexpressed on the surface of numerous tumor cells, including NSCLC, SCLC,
Slide 30: 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 31: IMM0306 (CD47×CD20): Preclinical Results
IMM0306 (CD47×CD20) (cont’d) Preclinical Results In Vivo Efficacy Study Efficacy Study in Lymphoma (Daudi) Xenograft Mouse Model Efficacy Study in Lymphoma (Raji) Xenograft Mouse Model Rituximab Vehicle PBS, IV, QWx4W, n=8 (5mg/kg) IMM0306, 0.5mg/kg, IV, QWx4, n=8 4000 3000 CR=37.5% IMM0306, 1.5mg/k
Slide 32: IMM0306: Favorable Safety Profile with No RBC Binding
IMM0306 (CD47×CD20) (cont’d) Preclinical Results Favorable Safety Profile with No Human Red Blood Cell Binding In Vitro, with Only Minor Cytokine Storm Human RBC Binding Analysis of IMM0306 350 Donor Characteristics (n=100) Male (n=62) Mean Fluorescence Intensity Female (n=38) 300 Type A blood group
Slide 33: 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 34: IMM2510 (VEGF × PD-L1)
IMM2510 (VEGF × PD-L1) A bsAb with the mAb-Trap Structure Targeting VEGF and PD-L1 IMM2510 - Target Introduction and Molecule Structure IMM2510 - Mechanism of Action IMM2510 Molecule Structure PD-L1 By connecting VEGF and PD-L1, IMM2510 can VEGFR1-D2 Tumor cells expressing PD-L1 can bind to PD-1 on
Slide 35: IMM2510: Clinical Development Plan and Global Collaboration
IMM2510 (VEGF × PD-L1) (cont’d) Clinical Development Plan Global Collaboration Q4 2023 November 2023 July 2024 Aug 2021 Phase I IND approval for Phase Ib/II: Initiated the Phase On August 1, 2024, we have reached a license and collaboration IMM2510 + dose-escalation IMM2510 + Chemo (TNBC, II clinica
Slide 36: IMM2510: Phase I Efficacy Summary
IMM2510 (VEGF × PD-L1) (cont’d) Phase I: Efficacy Summary in advanced solid tumors Duration of Treatment and Response Best Percentage Change from Baseline in Target Lesion Of 25 response-evaluable patients as of June 30, 2024, 3 patients had confirmed PR, and 7 patients achieved SD, with 4 of them o
Slide 37: 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 38: Non-Oncology Programs
SECTION 4 Non-Oncology Programs
Slide 39: 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 40: IMC-002 (IMM0306, CD47xCD20/mAb-Trap)
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 41: 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 42: 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 43: 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 44: IMC-004 (IMM7211c, [undisclosed] x ActRIIA/mAb-Trap)
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 45: 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] 45
Slide 46: Other Oncology Programs
SECTION 5 Other Oncology Programs
Slide 47: 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 48: IMM2520: Preclinical Results and Development Plan
IMM2520 (CD47×PD-L1) (cont’d) 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) ✓ Onl
Slide 49: IMM2902 (CD47×HER2)
IMM2902 (CD47×HER2) The only CD47×HER2 bispecific molecule that has entered into clinical trial globally Overview Market Opportunities and Competition HER2 overexpression is prevalent in many major cancer types, such as BC, GC, lung cancer, IMM2902 CRC, EC, BTC, HNSCC and CC, presenting a huge marke
Slide 50: IMM2902: MoA and Competitive Advantages
IMM2902 (CD47×HER2) (cont’d) MoA and Competitive Advantages Enhanced ADCC, ADCP, potentially ADCT, and accelerated Mechanism of Action HER2 degradation Expression Analysis of HER2 and p-HER2 by Western Blot (1) • Preclinical study showed that IMM2902 could accelerate the endocytosis and degradation
Slide 51: IMM2902: Strong In Vivo Antitumor Efficacy
IMM2902 (CD47×HER2) (cont’d) Preclinical Results – Strong In Vivo Antitumor Efficacy Efficacy Study in Herceptin-sensitive Breast Cancer Efficacy Study in Herceptin-resistant Breast Cancer (BT474) Xenograft Mouse Model (HCC-1954) Xenograft Mouse Model 1500 DPBS, IP, B1Wx4W, n=10 DPBS, IP, BIWx4W, n=
Slide 52: IMM2902: Preclinical Results and Clinical Development Plan
IMM2902 (CD47×HER2) (cont’d) Preclinical Results and Clinical Development Plan Favorable safety profile with no human RBC binding in vitro Clinical Development Plan • Phase I/II trial initiated in China in February 2022 • Evaluated for treatment of advanced HER2-positive and HER2-low • With an engin
Slide 53: 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 54: IMM47: CD24 is a Promising Target
IMM47 (CD24) (cont’d) CD24 is a Promising Target with Wide Expression and Broad Therapeutic Potential across Various Tumor Types Broadly overexpressed on many types of tumor tissues, including B-cell lymphomas, erythroleukemia, gliomas, SCLC, ESCC, HCC, CCA, PAAD, UC, OC, BC, primary NECs, and PC1 R
Slide 55: IMM47: Competitive Advantages
IMM47 (CD24) (cont’d) Competitive Advantages Proof-of-Concept Study in Colon Cancer (MC38-hCD24) Syngeneic Model in hSiglec-10 Tg C57BL/6 Mice Compelling Tumor Killing Capabilities Complete Tumor Eradication Means of Tumor Volume (mm3) Means of Tumor Volume (mm3) 6000 PBS, i.p., BITW*8 times 6000 IM
Slide 56: IMM47: Strong synergy with PD-1 mAb
IMM47 (CD24) (cont’d) Strong synergy between IMM47 and PD-1 mAb Proof-of-Concept Study in MC38-hCD24/hPD-L1 syngeneic tumor model in hPD-1 Tg C57 BL/6 mice Vehicle, i.p,Q10D*3 times Control Vehicle, i.p,Q10D*3 times IMM47, 0.5 mpk, i.p., Q10D*3 times Opdivo, 2 mpk, i.p., Q10D*3 times 1000 4000 Tumor
Slide 57: IMM47: Novel Target Development with Few Contenders
IMM47 (CD24) (cont’d) 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 r
Slide 58: IMM4701 (CD47 × CD24)
IMM4701 (CD47 × CD24) A Bispecific Molecule Targeting CD24 and CD47 with Global First-in-Class Potential IMM4701 - Mechanism of Action Strong and Robust Antitumor Activities Efficacy Study in Triple-negative Breast Cancer (MCF-7) Xenograft Mouse Model IMM4701 Molecule Structure Activating key innate
Slide 59: IMM40H (CD70)
IMM40H (CD70) A Humanized IgG1 CD70 mAb with Potential to Combo with IMM01 IMM40H – Mechanism of Action Potent In Vivo Antitumor Effects in Combination with IMM01 IMM40H Molecule Structure Signaling IMM40H Efficacy Study in Lymphoma (Raji) Orthotopic Mouse Model 1 Inhibition CD70 mAb Groupl PBS IV B
Slide 60: Thank you!
Thank you!
ImmuneOnco Biopharmaceuticals (Shanghai) — Investor Presentation (August 2024) on 6ix