Affimed N.V. · OTC:AFMDQ
Affimed — Investor Presentation (January 2025)
40 slides from Affimed's investor presentation, January 2025
Slide 1: The Most Advanced Innate Cell Engager Company
THE MOST ADVANCED INNATE CELL ENGAGER COMPANY FOCUSED ON CLINICAL DEVELOPMENT OF NOVEL THERAPIES FOR SOLID AND HEMATOLOGIC TUMORS NASDAQ: AFMD JANUARY 2025
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation and the accompanying oral commentary contain “forward-looking” statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation and the accompanying oral commentary, inclu
Slide 3: Affimed, Clinically Advancing Innate Cell Engagers (ICE) Molecules
Affimed, Clinically Advancing Innate Cell Engagers (ICE®) Molecules Focused on Activating The Untapped Power Of The Innate Immune System ICE® activate and redirect innate cells via tumor-specific ICE® Can Be Combined with NK Cells or a CPI to Target Innate targeting leveraging ADCC & ADCP Immune C
Slide 4: Experienced Leadership Team with Proven Track Record
Experienced Leadership Team with Proven Track Record Management Board: Experienced team with diverse backgrounds Shawn Leland, PharmD, RPh Andreas Harstrick, MD Wolfgang Fischer, PhD Denise Mueller Harry Welten Chief Executive Officer Chief Medical Officer Chief Operating Officer Chief Business Offi
Slide 5: Three Ongoing Clinical Programs Across Solid and Hematologic Tumor Populations
Three Ongoing Clinical Programs Across Solid and Hematologic Tumor Populations Candidate Therapy (Target) Study Name Indication Ph. 1 Ph. 2a/b Ph. 3 AFM24 AFM24 + atezolizumab Advanced/ Metastatic R/R NSCLC (EGFR) AFM24-102 (EGFRwt & EGFRmut cohorts) Acimtamig (AFM13) Acimtamig + AlloNK® R/R Classic
Slide 6: All Programs Have Demonstrated Clinical Efficacy Validating Affimed's Approach
All Programs Have Demonstrated Clinical Efficacy Validating Affimed's Approach to Leverage the Innate Immune System to Fight Cancer AFM24 in advanced EGFRwt & mut EGFR Acimtamig (AFM13) + NK CD123 EGFR CD30 AFM28 in r/r AML NSCLC in combination with PD-L1 cells in r/r HL AFM24 + atezolizumab: Ongoin
Slide 7: AFM24
AFM24 ICE® in EGFR-expressing Solid Tumors
Slide 8: Distinctive Approach to EGFR Expressing Solid Tumors
Distinctive Approach to EGFR Expressing Solid Tumors with Potential to Bring Benefit to a Broad Range of Patients AFM24 with its Differentiated Mode of Action Unleashes the Potential of Innate Immunity in Treating EGFR Expressing Solid Tumor Indications Current therapies rely on disruption The promi
Slide 9: AFM24 Has Potential to be the First Innate Cell Engager to Show Clinical Benefit
AFM24 Has Potential to be the First Innate Cell Engager to Show Clinical Benefit with a Manageable Safety Profile in Solid Tumors NSCLC is a Highly Aggressive Tumor and Current AFM24 + CPI Has the Potential to Address Options After First-Line Therapy are Limited Significant Unmet Need in 2L EGFRmut
Slide 10: AFM24-102: First Clinical Study of an Innate Cell Engager with a Checkpoint Inhibitor
AFM24-102: The First Clinical Study of an Innate Cell Engager in Combination with a Checkpoint Inhibitor (atezolizumab) Endpoints: • Primary endpoint: Overall response rate (ORR) by Investigator assessment (per RECIST v1.1) AFM24-102 Phase 2 (dose expansion) RP2D • Secondary endpoints: Progression f
Slide 11: AFM24-102 NSCLC EGFR Wild-type
AFM24-102 NSCLC EGFR Wild-type Cutoff: November 14, 2024
Slide 12: Heavily Pretreated NSCLC EGFRwt Patients: Patient Characteristics
Heavily Pretreated NSCLC EGFRwt Patients, Expansion Cohort: Patient Characteristics Patient Characteristics Patient Characteristics *FAS (N = 43) *PPS (N = 33) *FAS (N = 43) *PPS (N = 33) NSCLC EGFRwt cohort NSCLC EGFRwt cohort Age (years) Number of metastatic sites Median (Range) 67 (40-79) 68 (40-
Slide 13: AFM24 and Atezolizumab are Well Tolerated with No Unexpected Safety Findings
AFM24 and Atezolizumab are Well Tolerated with No Unexpected Safety Findings Most common AEs in >15% patients Most common AFM24-related AEs in >15% patients N = 43 N = 43 AEs Related AEs Any Grade Grade 3+ Any Grade Grade 3+ N (%) N (%) N (%) N (%) Any related AE 35 (81.4) 5* (11.6) Any AE 42 (97.7)
Slide 14: EGFRwt Expansion Cohort Demonstrates Early Compelling Efficacy
EGFRwt Expansion Cohort Demonstrates Early Compelling Efficacy That is Competitive With Current 2L/3L Therapies Best Percent Change From Baseline (N = 33, PPS) Efficacy Highlights and Considerations • Disease control rate 76% • Tumor shrinkage in 48% (16/33 pts1) • Objective response rate • 21% ORR
Slide 15: AFM24 Plus Atezolizumab Induced Durable Responses in EGFRwt NSCLC
AFM24 Plus Atezolizumab Induced Durable Responses in Heavily Pretreated EGFRwt NSCLC Patients with 36% of PPS Patients Ongoing Preliminary Median PFS (36% of patients ongoing) PFS: 5.6 months Median follow-up: 7.5 months Data cut: November 14, 2024. Data not validated, not cleaned, subject to change
Slide 16: Patient Population Matters: Prior Taxane Exposure Shows Lower Response Rate
Patient Population Matters: Patients with Prior Taxane Exposure Show a Lower Objective Response Rate and a Shorter Median PFS Objective Response Rate Median PFS Best Confirmed Prior Taxane: Prior Taxane: Preliminary Median PFS Response NO (N = 12) YES (N = 21) PFS: 7.4 vs. 4.4 months Complete Respon
Slide 17: AFM24-102 NSCLC EGFR Mutant
AFM24-102 NSCLC EGFR Mutant Cutoff: November 14, 2024
Slide 18: AFM24 + Atezolizumab in NSCLC EGFRmut Patients – Baseline Characteristics
AFM24 + Atezolizumab in Heavily Pretreated NSCLC EGFRmut Patients – Baseline Characteristics Patient Characteristics *PPS population N = 17 NSCLC EGFRmut cohort Age (years) Median (Range) 67 (32-76) Sex (N (%)) Male 3 (17.6%) Female 14 (82.4%) Race (N (%)) White 5 (29.4%) Asian 12 (70.6%) Histologic
Slide 19: AFM24 + Atezolizumab Show Meaningful Activity in Refractory NSCLC EGFRmut Patients
AFM24 + Atezolizumab Show Meaningful Activity in Treatment Refractory NSCLC EGFRmut Patients Best Percent Change From Baseline (N = 17, PPS) Efficacy Highlights and Considerations • Tumor shrinkage in 7/17 (41%) patients • 71% disease control rate • Objective response rate (24%) • 1 CR (confirmed) •
Slide 20: AFM24 + Atezolizumab Induce Durable Responses in EGFRmut Patients - Update
AFM24 + Atezolizumab Induce Durable Responses in Heavily Pretreated NSCLC EGFRmut Patients - Update of First 17 PPS Patients: 5 Patients Ongoing for >10 months Data cut: Nov 14, 2024. Data not validated, not cleaned, subject to change According to RECIST 1.1, a subsequent second scan is required for
Slide 21: AFM24 Post-Hoc Exposure-Response Analysis
AFM24 Post-Hoc Exposure- Response Analysis 21
Slide 22: Increasing Exposure Resulted in Higher Objective Response Rate
Increasing Exposure Resulted in Higher Objective Response Rate, More Stable Diseases and Higher Disease Control Rate Group Mean Group Mean Group Mean Group Mean Overall Through Through Through Through N = 44 Q1 (0-25%) Q2 (25-50%) Q3 (50-75%) Q4 (75-100%) N = 11 N = 11 N = 11 N = 11 Mean Trough Leve
Slide 23: Key Conclusions from AFM24 Clinical Data and Dose-Exposure Response Analysis
Key Conclusions from AFM24 Clinical Data and Dose-Exposure Response Analysis Confirmation: Updated data confirms meaningful clinical activity including response and durability in heavily pre-treated patients Prior taxane exposure matters: Patients without prior taxane exposure have a mPFS 7.4 mo
Slide 24: Acimtamig
Acimtamig ICE® for CD30+ Lymphomas
Slide 25: Acimtamig, Alone and in Combination with Allogenic NK Cells, Has Delivered Robust POC
Acimtamig, Alone and in Combination with Allogenic NK Cells, Has Delivered Robust POC Informing Future Clinical Development in Combination with NK Cells Acimtamig Selectively Redirects NK Cells Acimtamig + NK Cells (and Macrophages) to CD30+ Tumor Cells Program Opportunity and Highlights • Evolving
Slide 26: LuminICE-203: Potential to Address a High Unmet Need in Double Refractory Patients
LuminICE-203: Potential to Address a High Unmet Need in an Increasing Double Refractory Patient Population of CD30+ Lymphomas Evolving HL Landscape with Increasing Double Refractory Patients with Limited Options • Void of viable agents for r/r HL with more patients “double refractory” (to BV & CPIs)
Slide 27: LuminICE-203 Study Design: Aligned with FDA Feedback
LuminICE-203 Study Design: Aligned with FDA Feedback To Support Potential Accelerated Approval; Fast Track & RMAT Designation Granted PHASE 2 TRIAL, R/R HODGKIN LYMPHOMA (SIMON TWO-STAGE DESIGN)/NCT: 05883449 Cohort 1, DL1* NK cell dose, R/R HL: SIMON TWO-STAGE DESIGN Run-in N=6 pts 200 mg acimtamig
Slide 28: LuminICE-203: Relapsed/Refractory Hodgkin Lymphoma Patient Baseline Characteristics
LuminICE-203: Relapsed/Refractory Hodgkin Lymphoma Patient Baseline Characteristics Cohorts 1 – 4 Baseline Characteristics N=22 Age, median (range) 42.5 (23 – 80) Gender (male/female) 16 (72.7%) / 6 (27.3%) ECOG 0 / ECOG 1 8 (36.4%) / 14 (63.6%) Diagnosis (classical Hodgkin Lymphoma) 22 (100%) Extra
Slide 29: LuminICE-203: Treatment Related AEs Were Well-Managed
LuminICE-203: Treatment Related AEs Were Well-Managed – No GvHD or ICANS observed Most common acimtamig and/or AB-101 related AEs in >15% of patients N=22 Related Any Grade Grade >=3 AEs n (%) n (%) Any AE 18 (81.8) 6 (27.3)* Infusion related reaction 11 (50.0) 1 ( 4.5) Cytokine Release Syndrome 5 (
Slide 30: LuminICE-203: Outstanding Therapeutic Efficacy in Multi-Refractory Hodgkins Lymphoma
LuminICE-203: Outstanding Therapeutic Efficacy in Multi-Refractory Hodgkins Lymphoma Patients Cohort 1: Cohort 2: Cohort 3: Cohort 4: Efficacy Total AlloNK DL1 AlloNK DL1 AlloNK DL2 AlloNK DL2 (per Lugano + 200 mg + 300 mg + 200 mg + 300 mg Criteria) acimtamig acimtamig acimtamig acimtamig ORR 54.5%
Slide 31: LuminICE-203: Swimmer Plot (Best Response by Central Review)
LuminICE-203: Swimmer Plot (Best Response by Central Review, Oncologist): 4 PRs with option to deepen response Cohort # 1 1 1 2 • ORR of 86.4% in 22 patients 1 3 1 4 1 5 • CR in 54.5% as best 1 6 response 2 7 2 8 2 9 • 6/12 pts from cohort 1 and 10 2 11 2 in ongoing response; (2 2 2 12 pts received
Slide 32: AFM28
AFM28 ICE® in AML @nxereimeD
Slide 33: AFM28: Novel MoA with Potential to Improve Efficacy and Safety in AML
AFM28: Novel MoA with Potential to Improve Efficacy and Safety in Acute Myeloid Leukemia as well as Prevent or Delay R/R Disease AFM28 Selectively Redirects NK Cells to AFM28 Shows Promising CD123+ Leukemic Cells & Leukemic Stem Cells Preclinical Efficacy and Safety Data • Elimination of CD123-posit
Slide 34: AFM28-101: Status Update - Refractory Acute Myeloid Leukemia
AFM28-101: Status Update - Refractory Acute Myeloid Leukemia Dose escalation of CD123 bispecific ICE® in r/r AML Dose Level 6 300 mg (n=11)** Predicted Summary of safety across dose level 5 and 6 (17 patients): Efficacious Dose Level 5 Doses: 250 mg (n=6) • No dose limiting toxicity 200-300 mg • IRR
Slide 35: AFM28-101: Baseline Patient Characteristics of Effective Dose Levels
AFM28-101: Baseline Patient Characteristics of Effective Dose Levels (250 mg and 300 mg) and Overall Dose level 5 Dose level 6 All Patients in the Characteristic (250 mg) N = 6 (300 mg) N = 11 Safety Set N = 29 Mean age, n (range) 65 (28-81) 69 (46-78) 67 (28-82) The majority of the Male, N (%) 4 (6
Slide 36: AFM28-101: Phase 1 Monotherapy Trial Shows Promising Clinical Signals in r/r AML
AFM28-101: Phase 1 Monotherapy trial of CD123 Bispecific Innate Cell Engager Shows Promising Clinical Signals in r/r Acute Myeloid Leukemia (AML) AFM28 mono data in AFM28-101 confirms early signs of efficacy in Dose Level 5 Dose Level 6 r/r AML patients to validate further development in combination
Slide 37: AFM28-101: Best Response Across All Dose Levels
AFM28-101: Best Response Across All Dose Levels Dose Level 1 25 mg • DL5: 1/6 CR (16%) Dose Level 2 50 mg • 6.5M Ongoing treatment Dose Level 3 Best Response 100 mg CR or CRi • DL6: 4/10 (40%) CrC i (1CR; SD 3 Cri) PD Dose Level 4 200 mg Non evaluable Data pending • CR: 6.5M • All 3 responders with
Slide 38: 60% of AML Patients are Primary Refractory or Relapse Within 1 Year
60% of AML Patients are Primary Refractory or Relapse Within 1 Year of Initial Treatment, New Safer and Effective Options Are Needed AML is Characterized by High Unmet Need There is a Lack of Safe and Effective and a Significant Addressable Population Treatments Options for R/R AML Patients • Low ov
Slide 39: Affimed's Leading Innate Immune Portfolio: Three ICE Assets with Clinical Proof of Concept
Affimed’s Leading Innate Immune Portfolio: Three ICE® Assets with Clinical Proof of Concept Across Solid and Hematologic Malignancies Progressed all three clinical programs with promising results • All three assets continue to advanced in the clinic showing promise in r/r patients in NSCLC, AML and
Slide 40: Thank you!
Thank you!