Affimed N.V. · OTC:AFMDQ
Affimed — Investor Presentation (July 2024)
32 slides from Affimed's investor presentation, July 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 JULY 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 ICE Molecules
Affimed, Clinically Advancing ICE® Molecules Focused on Activating The Untapped Power Of The Innate Immune System ICE® Can Be Combined with NK Cells or a CPI to Target Innate ® Innate Cell Engagers (ICE ) activate and redirect innate cells via Immune Cells and Trigger an Adaptive Immune Response t
Slide 4: Experienced Leadership Team with Proven Track Record
Experienced Leadership Team with Proven Track Record Management Board: Experienced team with diverse backgrounds Andreas Harstrick, MD Wolfgang Fischer, PhD Denise Mueller Harry Welten Acting Chief Executive Officer & Chief Operating Officer Chief Business Officer Consulting Chief Financial Chief Me
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 on Acimtamig (AFM13) + NK cells is CD123 EGFR on advanced EGFR+ NSCLC in CD30 r/r AML where strong preclinical
Slide 6: Three Ongoing Clinical Programs Due to Deliver Data Readouts in 2024
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: AFM24-102: First Study of ICE 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 10: AFM24-102 NSCLC EGFRwt 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=17* NSCLC EGFRwt cohort N (Events) Age (years) Median (range) 65 (40-75) Serious related TEAEs 1 (1)1 ECOG PS (n (%)) Severe r
Slide 11: AFM24-102 EGFRwt Cohort Demonstrates Efficacy Competitive with 2L Therapies
AFM24-102 NSCLC EGFRwt Expansion Cohort Demonstrates Compelling Efficacy that is Competitive with Current 2L Therapies Best Percent Change From Baseline Efficacy Highlights and Considerations • Tumor shrinkage in 8 (47%) patients (n=172) • 71% disease control rate • 4 objective responses, 8 stable d
Slide 12: 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 Month) 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 According to RECIST 1
Slide 13: AFM24 and Atezolizumab NSCLC EGFRmut Expansion Cohort
AFM24 and Atezolizumab NSCLC EGFRmut Expansion Cohort; Recruitment Ongoing Patient Characteristics N = 21 NSCLC EGFRmut cohort Age (years) Median-Range 61 (32-76) Adverse Events Overview N = 21 Sex (n (%)) NSCLC EGFRmut cohort N [Events] • Male 6 (28.6) • Female 15 (71.4) Serious related TEAEs 5 [6]
Slide 14: AFM24 and Atezolizumab Induces Responses in Refractory EGFRmut NSCLC
AFM24 and Atezolizumab Induces Objective Responses and Tumor Control In Treatment Refractory EGFRmut NSCLC Patients Best Percent Change From Baseline Patients Recruited and Treated N=21 7 patients not evaluable by • 4 early PD RECIST 1.1 and thus not • 2 clinical PD included in the WF plot • 1 intra
Slide 15: AFM24 Potential to be First ICE 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 16: Acimtamig
Acimtamig ICE® for CD30+ Lymphomas
Slide 17: Acimtamig and Allogenic NK Cells Delivered Robust POC
Acimtamig, Monotherapy and 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 • Evolvin
Slide 18: AFM13-104 Results Basis for Continued Development in LuminICE-203
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 19: 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 HL (SIMON TWO-STAGE DESIGN) Cohort 1, DL1* NK cell dose, Simon Two-Stage Design Study (68 to 110 patients) Run-in N=6 pts 200 mg acimtamig (cHL) Cohort 2,
Slide 20: LuminICE-203: Potential to Address High Unmet Need in CD30+ Lymphomas
LuminICE-203: Potential to Address a High Unmet Need in an Increasing Relapsed/Refractory Patient Population of CD30+ Lymphomas Early data confirms previously reported efficacy and validates co-administration approach of acimtamig with an off-the-shelf, ORR 85.7% allogeneic, cryopreserved, NK cell p
Slide 21: LuminICE-203: Safety Profile Well Manageable
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 4/7 pts; 1 short lasting Grade 3 CRS in a p
Slide 22: Acimtamig + AlloNK Cells Hold Promise for HL Patients
Acimtamig + AlloNK Cells Hold Promise for HL Patients Who Relapse or are Refractory to BV & CPI Treatment Driving Future Clinical Development AFM13-203 Treatment History (Acimtamig+ AlloNK cell combo) N=7 Age, median (range) 42 (23–66) Gender (male/female) 5/2 ECOG 0 / ECOG 1 2/5 Diagnosis (classica
Slide 23: LuminICE-203 Case Study
LuminICE-203 Case Study Patient with Relapsed and Refractory Hodgkin Lymphoma in Complete Remission after first Cycle Patient Background & LuminICE-203: Treatment with 300 mg AFM13 and 2x109 AB-101 Treatment History (Cohort 2) Baseline Assessment after first cycle 36-year-old male Relapsed and refra
Slide 24: LuminICE-203: High Unmet Need in Double Refractory Population
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 25: AFM28
AFM28 ICE® in AML @neFreimeD
Slide 26: AFM28: Novel MoA in Acute Myeloid Leukemia
AFM28: Novel MoA with Potential to Improve Efficacy and Safety in Acute Myeloid Leukemia (AML) 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
Slide 27: AFM28-101: Status Update on Target Engagement
AFM28-101: Status Update - Desired Target Engagement at Doses Levels of 200 mg and Above for Relapsed /Refractory Acute Myeloid Leukemia Recent Progress for AFM28-101 Dose Level 6 300 mg (n=6) Predicted Predicted Dose Escalation of CD123 bispecific ICE in r/rAML Efficacious Efficacious Dose Level 5
Slide 28: AFM28-101: Promising Clinical Signals in Refractory AML
AFM28-101: Phase 1 Mono trial of CD123 bispecific Innate Cell engager shows Promising Clinical Signals in Treatment Refractory Acute Myeloid Leukemia AFM28 mono data in AFM28-101 confirms early signs of efficacy in treatment refractory AML patients to validate further 85.7% development in combinatio
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 Potential of 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!