Heidelberg Pharma Ag · XETR:HPHA
Heidelberg Pharma — International Myeloma Society 21st Annual Meeting & Exhibition 2024
13 slides from Heidelberg Pharma's conference presentation, Sep 25, 2024
Slide 1: HDP-101-01: First-in-Human, Phase I A Clinical Trial in Relapsed/Refractory Multiple Myeloma
International Myeloma Society 21st Annual Meeting & Exhibition Rio De Janeiro, Brazil September 25, 2024 HDP-101-01: First-in-Human, Phase I A Clinical Trial for Relapsed/Refractory Multiple Myeloma Patients Interim Results Investigators (enrolling in Cohort 1-5): M-S Raab (presenter), J.L. Kaufman,
Slide 2: Multi-relapsed and refractory multiple myeloma remain a challenge requiring novel treatment options
Multi-relapsed and refractory multiple myeloma (RRMM) remain a challenge requiring further development of novel treatment options • Anti-BCMA directed therapies improved the outcome of relapsed/refractory multiple myeloma (RRMM)1-5 • Belantamab mafodotin (single agent): ORR (DREAMM2) in relapsed/ref
Slide 3: HDP-101: BCMA-Targeted Amanitin-Payload Based Antibody Drug Conjugate (ADC)
HDP-101: BCMA-Targeted Amanitin-Payload Based Antibody Drug Conjugate (ADC) Anti-BCMA Antibody Preclinical efficacy: • Anti-myeloma effects at pM concentrations: • Effective with ultra-low BCMA expression • Overcomes pre-existing drug resistance • No resistance mechanisms against Amanitin known • Pr
Slide 4: HDP-101 Overcomes Limitations of Conventional ADCs & Standard of Care Medications
HDP-101 Overcome Limitations of Conventional ADCs & Standard of Care Medications (SOC) Overcomes resistance through antigen Effective in resting/non-proliferating Increased sensitivity in del17p/POLR2 escape by killing cells with ultra-low myeloma cells deficient myeloma cells antigen expression 125
Slide 5: HDP-101-01: Clinical Trial Overview, Safety, Efficacy
HDP-101-01: Clinical Trial Overview, Safety, Efficacy 7
Slide 6: Phase 1 Dose Escalation Schema (HDP-101 Monotherapy)
Phase 1 Dose Escalation Schema (HDP-101 Monotherapy) Key eligibility criteria: RR-MM with prior treatments of IMID, anti-CD38, Proteasome inh Phase I A, HDP-101 Monotherapy, q 3-week iv infusion 1 hr Phase II Dose-escalation goals: Safety, Maximum Tolerated Doses (MTD), Recommended Phase II Dose (RP
Slide 7: Patient Characteristics (enrolled and treated)
Patient Characteristics (enrolled and treated) Patient Characteristic n=18 (%) Age; median (range) 75 (60-79) Gender; female/male 40/60 Lines of therapy; median (range) 6 (2-14) HD-Mel/ABSCT 13 (72%) Triple-class exposed 18 (100%) • triple-class refractory 14 (77%) Penta-class exposed 8 (44%) • Pent
Slide 8: Safety of HDP-101: most common treatment-emergent AEs (TEAEs)
Safety of HDP-101: most common treatment-emergent AEs (TEAEs) Patients with Patients with Preferred Term any CTCAE Grade 3-4 (%) grade (%) N=18 Thrombocytopenia 10 (56%) 7 (39%) • No signs of ocular or renal toxicities, infusion reactions, myelosuppression or Arthralgia 6 (33%) 0 (0%) severe liver d
Slide 9: Paraprotein percent change from screening value
Percent Change of M-Protein per Cohort Relative Change from Screening in Paraprotein Level 246 250 Paraprotein percent change from screening value 200 177 154 150 100 72 50 35 18 7 0 0 0 -10 -15 -25 -28 -28 -50 -39 -53 -61 -100 -100 Cohort 1 - 4 Cohort 5 Note: Patients displayed with ‘0%’ were not e
Slide 10: IMWG Response Over Time for All Treated Patients
IMWG Response Over Time for All Treated Patients 12
Slide 11: HDP-101-01 Cohort #5: Case Summary
HDP-101-01 Cohort #5: Case Summary 70 ys old female patient in good condition Myeloma since 2002: Percentage change from Screening value (Electrophoresis value) for Cohort 5, by Weeks • ISS Stage II; IgG Kappa 0 9 prior lines of therapies including transplant, IMIDs, PIs, -20 Dara etc. last 3: -40 2
Slide 12: HDP-101-01 Phase 1 Clinical Trial: Summary and Conclusions
HDP-101-01 Phase 1 Clinical Trial: SUMMARY and CONCLUSIONS • HDP-101-01 demonstrated a mild and manageable safety profile characterized mainly by transient thrombocytopenia with recovery until next treatment cycle. • Until now no consistent evidence for other hematological adverse events. • HDP-101-
Slide 13: Thank You for Your Attention!
Thank You for Your Attention !
Heidelberg Pharma — International Myeloma Society 21st Annual Meeting & Exhibition 2024 on 6ix