Immuneonco Biopharmaceuticals (shanghai) Inc Class H · HKEX:1541
Immuneonco Biopharmaceuticals (shanghai) Inc Class H — 2024 ASCO Annual Meeting
24 slides from Immuneonco Biopharmaceuticals (shanghai) Inc Class H's conference presentation, Jun 4, 2024
Slide 1: ImmuneOnco 2024 ASCO Data
ImmuneOnco 2024 ASCO Data June 4， 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: Pipeline
Pipeline IND/IND- Phase III/ Commercial Program (1) Target (Modality) Indication(s) Discovery Preclinical Phase Ia/I Phase Ib/II Current Status / Upcoming Milestone Enabling Pivotal Rights IMM01 CD47 IMM01 + Azacitidine MDS China (NMPA) Received Phase III approval from CDE in May; initiated Phase II
Slide 4: Latest Results of a Phase 2 Study of IMM01 Combined with Azacitidine in Higher Risk MDS
1 Latest Results of a Phase 2 Study of IMM01 Combined with Azacitidine (AZA) As the First-Line Treatment in Adults with Higher Risk Myelodysplastic Syndromes (MDS)
Slide 5: Introduction
Introduction • CD47 is an innate immune checkpoint that binds signal regulatory protein alpha (SIRPα) , and serves as a mechanism of immune surveillance evasion and suppress macrophage phagocytosis1,2. • IMM01 (Timdarpacept) is a SIRPα IgG1 fusion protein that exerts anti-tumor activity via blocking
Slide 6: Study Design
Study Design This is an open-label, multi-center, phase 2 study (NCT05140811) that evaluated safety and efficacy of IMM01 (Timdarpacept) in combination with AZA as the first-line treatment for patients with higher-risk MDS. IMM01 2mg/kg D1,8,15,22 key eligible criteria: + • ≥ 18 years of age Primary
Slide 7: Baseline Characteristics of Patients
Baseline Characteristics of Patients Characteristics 1L MDS (N =57) Characteristics 1L MDS (N =57) Median age, yrs (range) 64 (30-83) 2016 WHO of MDS (Subtype) Gender MDS with ring sideroblasts (MDS-RS) 1 (1.8%) Male 41 (71.9%) MDS with excess blasts-1 (MDS-EB-1) 20 (35.1%) Female 16 (28.1%) MDS wit
Slide 8: IMM01 Combined with AZA Showed Robust Response in Higher-risk MDS Patients
IMM01 Combined with AZA Showed Robust Response in Higher-risk MDS Patients Best response rate, n ES ≥4 months ≥6 months 100.0% 89.7% (%) N=51 N=34 N=29 90.0% 85.3% CR 17 (33.3) 17 (50.0) 17 (58.6) 80.0% PR 0 0 0 70.0% 64.7% 58.6% mCR+HI 8 (15.7) 7 (20.6) 6 (20.7) 60.0% 50.0% mCR 6 (11.8) 3 (8.8) 2 (
Slide 9: Duration of Response
Duration of Response Figure 1. Waterfall plot for best percent change from baseline in the blast cells in the bone Figure 2. Swimmer plot for duration of treatment response marrow • Medium time to response (TTR) was 1.9 months. • Medium follow-up time was 15.9m • Median duration of response (DoR) wa
Slide 10: Improvement on HGB/PLT Levels and Transfusion
Improvement on HGB/PLT Levels and Transfusion Postbaseline hematologic 1L MDS (N =51) improvement Baseline hematological 51/51 (100%) abnormalities Erythroid 19/49 (38.8%) Platelet 19/42 (45.2%) Neutrophil 7/32 (21.9%) IMM01+AZA combination treatment led to the significant recoveries of HGB and PLT
Slide 11: Summary of TRAE
Summary of TRAE Overview of TRAE 1L MDS (N=57) n, (%) 1L MDS (N=57) n, (%) TRAE (≥ 20%) All Grade TRAE 56 (98.2) All Grades ≥ G3 ≥3TRAEs 52 (91.2) Leukopenia 47 (82.5) 45 (78.9) TRAE leading to permanent Thrombocytopenia 41 (71.9) 38 (66.7) 3 (5.3) discontinuation Neutropenia 38 (66.7) 38 (66.7) Tre
Slide 12: Conclusion
Conclusion ➢ Latest data showed that IMM01 (Timdarpacept) combined with AZA as the first- line treatment in adult patients with higher-risk MDS were well tolerated. ➢ IMM01 does not require priming dosing and no new safety signals emerged in combination with azacitidine. ➢ The combination of IMM01 a
Slide 13: Latest Results of a Phase 2 Study of Timdarpacept with Tislelizumab in cHL
2 Latest Results of a Phase 2 Study of Timdarpacept (IMM01) in Combination with Tislelizumab in Prior Anti-PD-1 Failed Classical Hodgkin Lymphoma (cHL)
Slide 14: Background
Background • Anti-PD-1 mAb was approved for R/RcHL, with an ORR of 70% to 90%. However, most patients eventually relapse with a mPFS of 13-15 month, even for patients who achieved CR, more than half will progress within 2–3 years of starting treatment1,2,3. • There is no standard treatment for these
Slide 15: Study Design
Study Design • This is an open-label, multi-center, Phase II study of timdarpacept plus tislelizumab in anti-PD-1 failded R/R cHL. Key eligibility criteria Treatment Endpoints • Diagnosed histologically Timdarpacept: Primary endpoint: with cHL 2.0mg/kg IV QW • ORR per Lugano 2014 • Failed at least 2
Slide 16: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics Characteristic N=33 Age, years Median (range) 35 (19-77) • 33 patients with R/R cHL were Gender, n (%) Male 23 (69.7) enrolled. Female 10 (30.3) ECOG PS, n (%) 0 22 (66.7) • The median lines of prior systemic 1 11 (33.3) Ann Arbor Staging, n (%) II 1 ( 3.0)
Slide 17: Timdarpacept Combined with Tislelizumab Showed High Response in Anti-PD-1 Failed cHL Patients
Timdarpacept Combined with Tislelizumab Showed High Response in Anti-PD-1 Failed cHL Patients Best Response N=33 Tumor Response by investigator: CR, n (%) 8 (24.2) 14 (42.4) PR, n (%) • 33 patients were efficacy-evaluable. SD, n (%) 9 (27.3) PD, n (%) 2 (6.1) • Best overall response rate was 66.7%,
Slide 18: Tumor Size Change after Treatment
Tumor Size Change after Treatment • 87.9% patients had target lesion size reduction. • Two patients achieved PMR by PET-CT. Data cut-off date: March 01, 2024 18
Slide 19: Duration of Response
Duration of Response With the median follow-up time of 6.87 months: • Median progression-free survival (mPFS) was not reached. • Median duration of response (mDOR) was not reached. Data cut-off date: March 01, 2024 19
Slide 20: Summary of Safety Profile
Summary of Safety Profile Any grade TRAEs with incidence of ≥10% Overview of TRAE N (%) Patients（n=33） All grade TRAE 33 (100) PT n(%) ≥ G3 TRAE 15 (45.5) All Grades G3-4 TRAE leading to dose interruption 18 (54.5) White blood cell count decreased 17 (51.5) 4 (12.1) TRAE leading to permanent treatme
Slide 21: Conclusion
Conclusion IMM01 (Timdarpacept) in combination with tislelizumab showed robust anti-tumor efficacy in anti-PD-1 failed cHL patients with acceptable safety profile: ➢ Remarkable anti-tumor efficacy: - ORR 66.7%, CR rate 24.2%. - mPFS was not reached. ➢ Safety: - Generally well tolerated, most common
Slide 22: IMM0306 (CD47xCD20) & IMM2510 (VEGFxPD-L1)
3 IMM0306 (CD47xCD20) & IMM2510 (VEGFxPD-L1) 1
Slide 23: Poster Session and Publication
Poster Session and Publication Preliminary results from a phase I study of IMM0306 in patients with relapsed orrefractory CD20-positive B-cell non-Hodgkin's lymphoma (ABSTRACT #442254) Program Guide – ASCO Meeting Program Guide Phase I safety and preliminary efficacy of IMM0306 in combination with l
Slide 24: Thank you
Thank you ImmuneOnco Building 15, Zhangheng Road 1000 Pudong District Shanghai, China Email ir@immuneonco.com
ImmuneOnco Biopharmaceuticals (Shanghai) — 2024 ASCO Annual Meeting on 6ix