Affimed N.V. · OTC:AFMDQ
Affimed — Investor Presentation (September 2024)
32 slides from Affimed's investor presentation, September 2024
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 LIQUID TUMORS NASDAQ: AFMD SEPTEMBER 2024
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: All Programs Have Demonstrated Clinical Efficacy
All Programs Have Demonstrated Clinical Efficacy Validating Affimed's Approach to Leverage the Innate Immune System to Fight Cancer AFM24 development is focused AFM28 development is focused Acimtamig (AFM13) + NK cells is CD123 EGFR on advanced EGFR+ NSCLC in CD30 on r/r AML with strong initial bein
Slide 6: Three Ongoing Clinical Programs Due to Deliver Meaningful Data Readouts
Three Ongoing Clinical Programs Due to Deliver Meaningful Data Readouts Across Hematologic and Solid Tumor Populations in 2024 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) A
Slide 7: AFM24
AFM24 ICE® in EGFR-expressing Solid Tumors
Slide 8: AFM24: Distinctive Approach to EGFR Expressing Solid Tumors
AFM24: 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+ Solid Tumor Indications Current therapies rely on disruption The promise
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 EGFR+ NS
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 EGFRwt Expansion Cohort; Patient Characteristics and Safety
AFM24-102 NSCLC EGFRwt Expansion Cohort; Patient Characteristics and Safety from First 17 Patients Patient Characteristics Adverse Events Overview N = 17 NSCLC EGFRwt cohort N = 171 NSCLC EGFRwt cohort N (Events) Age (years) Median (range) 65 (40-75) Serious related TEAEs 1 (1)2 ECOG PS (n (%)) Seve
Slide 12: AFM24-102 EGFRwt Expansion Cohort Demonstrates Compelling Efficacy
AFM24-102 NSCLC EGFRwt Expansion Cohort Demonstrates Compelling Efficacy that is Competitive with Current 2L Therapies Best Percent Change From Baseline Efficacy Highlights and Considerations1 • Tumor shrinkage in 8 (47%) patients (N = 172) • ORR of 24% (4/17): 1 CR / 3 PR (confirmed) • 71% DCR: 4 o
Slide 13: AFM24 and Atezolizumab Induce Durable Responses in EGFRwt NSCLC
AFM24 and Atezolizumab Induce Durable Responses in Heavily Pretreated EGFRwt NSCLC Patients (3 of 4 Responses Ongoing at > 7 Month1) 1 2 Median FU: 7.4 months 3 4 Median PFS: 5.9 months Ordered by treatment duration 5 6 7 8 9 10 11 12 à Indicates treatment ongoing 13 14 15 16 17 1 EGFRwt cohort upda
Slide 14: AFM24 + Atezolizumab EGFRmut Cohort - Patient Disposition & Characteristics
AFM24 + Atezolizumab NSCLC EGFRmut Expansion Cohort - Patient Disposition & Characteristics - Recruitment Ongoing Patient Characteristics Patients Disposition N = 17 (PPS) N = 17 (PPS) NSCLC EGFRmut3 cohort Patients in the FAS1 24 Age (years) Median-Range 67 (32-76) Patients with no valid scan (yet)
Slide 15: AFM24 + Atezolizumab EGFRmut Cohort - Clinical Activity
AFM24 + Atezolizumab NSCLC EGFRmut Expansion Cohort1 - Clinical Activity – Seven Patients with Tumor Shrinkage Best percentage change from baseline in sum on long diameter Activity N = 17 PPS (by CT per Investigator assessment) NSCLC EGFRmut cohort Per-protocol Set ORR 4/17 (23.5%) SD 8/17 (47.0%) D
Slide 16: AFM24 + Atezolizumab EGFRmut Cohort - Safety
AFM24 + Atezolizumab NSCLC EGFRmut Expansion Cohort1 - Safety Adverse Events Overview N = 17* NSCLC EGFRmut cohort N [Events] Serious related TEAEs 4 [5] 2 Severe related TEAEs 6 [8] 2 Note: None of these events resulted in treatment discontinuation Data cut: August 27, 2024. Data not validated, not
Slide 17: Acimtamig
Acimtamig ICE® for CD30+ Lymphomas
Slide 18: Acimtamig with Allogenic NK Cells Has Delivered Robust POC
Acimtamig, Monotherapy and Combination with Allogenic NK Cells, Has Delivered Robust POC Informing 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 HL l
Slide 19: LuminICE-203: Potential to Address a High Unmet Need in CD30+ Lymphomas
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 20: Exceptional Results in the AFM13-104 Study
Exceptional Results Seen in the AFM13-104 Study are the Basis for Continued Development of Acimtamig + NK cells in LuminICE-203 AFM13-104 Acimtamig + NK cells hold promise for HL patients who are relapsed or ORR refractory to BV & CPIs, driving future clinical development 97% CR • All patients were
Slide 21: LuminICE-203 Study Design: Aligned with FDA Feedback; Fast Track
LuminICE-203 Study Design: Aligned with FDA Feedback To Support Potential Accelerated Approval; Fast Track 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 (HL)
Slide 22: LuminICE-203: R/R Hodgkin Lymphoma Baseline Characteristics
LuminICE-203: Relapsed/Refractory Hodgkin Lymphoma Patient Baseline Characteristics in Safety Run-In (Cohorts 1 and 2) with High Unmet Need Baseline Characteristics N = 121 Age, median (range) 42.5 (23–80) Gender (male/female) 9/3 ECOG 0 / ECOG 1 2 / 10 Diagnosis (classical Hodgkin Lymphoma) 100% Cl
Slide 23: LuminICE-203: Best Objective Response Rate Cohort 1 and 2
LuminICE-203: Best Objective Response Rate Cohort 1 and 2 (Central Review) ORR CRR 83.3% Early data confirms previously reported efficacy and validates n = 12 50.0% co-administration approach of acimtamig with an off-the-shelf, allogeneic, cryopreserved, NK cell product in r/r HL LuminICE-203: Acimt
Slide 24: LuminICE-203: Safety Profile of Acimtamig and AlloNK
LuminICE-203: Safety Profile of Acimtamig and AlloNK were Well Manageable Well manageable safety profile observed with acimtamig and AlloNK in LuminICE-2031 Safety profile consistent with data reported for study AFM13-104 (MDACC)2 • Grade 1 or 2 IRR/CRS in 7/12 pts; 1 short lasting Grade 3 CRS in a
Slide 25: AFM28
AFM28 ICE® in AML @neFreimeD
Slide 26: 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 27: AFM28-101: Status Update - Refractory Acute Myeloid Leukemia
AFM28-101: Status Update - Refractory Acute Myeloid Leukemia Recent Progress for AFM28-101 Dose Level 6 300 mg (n=6) Predicted Dose escalation of CD123 bispecific ICE® in r/r AML Efficacious Dose Level 5 Doses: 250 mg (n=6) Summary of safety across dose level 5 and 6 (12 patients): 200-300 mg • No d
Slide 28: AFM28-101: Phase 1 Mono Trial Shows Promising Clinical Signals in r/r AML
AFM28-101: Phase 1 Mono trial of CD123 Bispecific Innate Cell Engager Shows Promising Clinical Signals in r/r Acute Myeloid Leukemia 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 Efficacy AFM
Slide 29: 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 30: Summary
Summary @neFreimeD
Slide 31: Three Ongoing Studies with ICE® Confirm the Potential of the Innate Immune System
Three Ongoing Studies with ICE® Confirm the Potential of the Innate Immune System in Fighting Cancer Progressed clinical programs to pivotal data readouts • All three assets advanced in the clinic showing promise in r/r patients Realized clinical proof of concept for all three ICE® in liquid and sol
Slide 32: Thank you!
Thank you!