Affimed N.V. · OTC:AFMDQ
Affimed — Conference Presentation (January 2019)
31 slides from Affimed's conference presentation, January 2019
Slide 1: Actualizing the Untapped Potential of the Innate Immune System
Actualizing the Untapped Potential of the Innate Immune System Affimed’s Approach to Advancing Immuno-oncology January 2019
Slide 2: Forward-Looking Statements / Safe Harbor
Forward-Looking Statements / Safe Harbor 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 com
Slide 3: Affimed Overview
Affimed Overview PRODUCTS PLATFORM • Versatile innate cell engagers • Fit-for-Purpose ROCK® platform targeting hematologic and solid generates customizable innate tumors cell engagers with proprietary • Only company with clinically CD16A target Giving patients validated innate cell engagers back the
Slide 4: Immunotherapies Need to Overcome Tumor Immune Evasion
Immunotherapies Need to Overcome Tumor Immune Evasion Immunosurveillance Tumor growth NK cell Macrophage T cell Tumor cell Elimination Evasion Adapted from Dunn et al. Nat. Immunol. 2002. 4
Slide 5: Affimed Brings a New Approach to Counter Tumor Immune Evasion
Affimed Brings a New Approach to Counter Tumor Immune Evasion Through the Innate Immune System Current Treatments • Advanced I-O agents demonstrate it is possible to activate the immune system to trigger tumor killing • Despite these advances, a cure remains elusive and more options are needed to tr
Slide 6: Innate Cell Engagers Give Patients Back Their Innate Ability to Fight Cancer
Affimed’s Innate Cell Engagers Can Give Patients Back their Innate Ability to Fight Cancer Cancer Patient’s Innate Immune System Affimed’s unique approach activates innate cells through proprietary CD16A targeting Innate Cell Engagers Tumor lysis Tumor recognition • Increase binding of CD16A (ADCC t
Slide 7: CD16A Engagers Bridge Innate Immune and Tumor Cells Through ROCK-based Antibodies
CD16A Engagers Bridge Together Innate Immune and Tumor Cells Through Proprietary ROCK®-based Antibodies Bridging of innate Stimulation of tumor Restoration of cytotoxicity and tumor cells lysis through ADCC in tumor cell killing Innate cell engager CD16A receptor NK cell Tumor cell Recognize Activat
Slide 8: Innate Immunity in Tumor Recognition and Killing
Innate Immunity Plays an Important Role in Tumor Recognition and Killing, as well as Initiating an Adaptive Response Innate Immunity, First Line of Defense Adaptive Immunity, Second Line of Defense NK cell Tumor cell Dendritic cell T cell CD16A receptor Initiation of adaptive response CD16A receptor
Slide 9: Fit-for-Purpose ROCK Platform Allows Innate Cell Engagers
Fit-for-Purpose ROCK® Platform Allows Innate Cell Engagers to be Designed for Specific Indications ROCK® Platform is Affimed’s proprietary technology to generate in-house innate cell engagers Versatile Platform Strong Engineering Proprietary Target Tailor tetravalent, bispecific Proven record in bui
Slide 10: CD16A-Targeted Cell Engagers Activate Innate Cell Cytotoxicity
CD16A-Targeted Cell Engagers Are Highly Effective in Activating Innate Cell Cytotoxicity Innate cell engagers, bispecific antibodies created by the ROCK® platform, feature: Clinical signs Evidence of of efficacy & Tolerable ADCC* safety profile* CD16A Tumor target target High affinity New epitope bi
Slide 11: Genentech Invested in Affimed's CD16A Engager Capabilities
Genentech Invested in Affimed’s CD16A Engager Capabilities and Expertise in Innate Immunity Strategic partnership driven by our clinical stage CD16A-targeted innate cell engagers • Clinical efficacy • Tolerable safety profile • Synergy with other I-O agents $96M Upfront, near term funding “This coll
Slide 12: Differentiated and Versatile Innate Cell Engagers
Differentiated and Versatile Innate Cell Engagers to Target Hematological and Solid Tumors AFM13 Disease Target CD30 Immune Cell Target CD16A Hodgkin lymphoma + PD-1 Phase 1 (Collaboration) Innate Cell Engagers Hodgkin lymphoma Phase 2 (IST) Hodgkin lymphoma + adoptive NK cells Pre-IND (Collaboratio
Slide 13: Innate Cell Engagers in Hematologic Tumors
Innate Cell Engagers in CD16A Hematologic Tumors target Treatment with AFM13 CD30 target 13
Slide 14: AFM13 Has Shown Promising Efficacy in CD30 Positive Lymphoma
In Clinical Studies, AFM13 Has Shown Promising Efficacy in Patients With CD30 Positive Lymphoma CD30-Positive Lymphoma (PTCL, CTCL) R/R Hodgkin Lymphoma Treatment: Treatment: • AFM13 monotherapy • AFM13 in combination with Merck’s Keytruda® (pembrolizumab) Total of 9 patients treated to date: • Inve
Slide 15: AFM13: Broad Clinical Development Potential
AFM13: Broad Clinical Development Potential PTCL CTCL HL • Lack of standard of care in • Potential for small trial and • Emerging vacuum of effective R/R – very high unmet need accelerated timelines for Mycosis options in R/R as current Fungoides therapies move to earlier lines • Establish new stand
Slide 16: AFM13 US Opportunity: ~6000 Patients
AFM13 US Opportunity: Commercial Potential to Treat ~6000 Patients PTCL CTCL HL ~200 ~2600 eligible ~3000 eligible patients patients eligible patients R/R CD30+: ~2500 patients R/R CD30+ Advanced Post-BV & Post-PD-1: ~600 patients (AFM13 Monotherapy) Stage MF: ~200 patients (AFM13 Monotherapy) (AFM1
Slide 17: Multiple Clinical Development Opportunities With AFM13
Multiple Clinical Development Opportunities With AFM13 • AFM13 monotherapy in PTCL Initial registration path - Potential for accelerated approval Affimed-sponsored study • Confirmatory study for PTCL • AFM13 monotherapy in CTCL (TMF) Affimed-sponsored study Next registration path • AFM13 + Anti-PD-1
Slide 18: AFM13 Delivers Clinically Meaningful Efficacy in CD30+ Tumors
AFM13, a First-in-Class Innate Cell Engager, Delivers Clinically Meaningful Efficacy as Monotherapy or Combination Therapy in CD30+ Tumors Achievements Opportunities and Next Steps • Lead agent demonstrated clinical • Initiating pivotal clinical trial as proof of concept for ROCK® innate monotherapy
Slide 19: Innate Cell Engagers in Solid Tumors
Innate Cell Engagers CD16A in Solid Tumors target Treatment with AFM24 EGFR target 19
Slide 20: AFM24: Novel Approach to EGFR-Overexpressing Solid Tumors
AFM24 is a Novel Approach to Treat Many Types of Solid Tumors that Overexpress EGFR EGFR Expressing Tumors & Affimed’s Solution to EGFR Tumors is AFM24 Current EGFR Targeting Therapies (CD16A/EGFR) • EGFR is overexpressed in several tumors • Innate cell engager bridging NK cells and (CRC, NSCLC, HNS
Slide 21: AFM24 Demonstrated Potent Tumor Cell Killing via NK Cells and Macrophages
AFM24’s Innate Mechanism Demonstrated Potent Tumor Cell Killing through Activation of NK cells and Macrophages AFM24 demonstrated potent killing of target cells AFM24 elicited macrophage induced through NK cells as effector cells (ADCC) killing of EGFR+ target cells (ADCP) Cytotoxicity assay with A-
Slide 22: AFM24 Reduced Inhibition of EGFR Phosphorylation
AFM24 Reduced Inhibition of EGFR Phosphorylation May Indicate an Improved Safety Profile With Less Skin Toxicity Inhibition of EGFR Phosphorylation 3 AFM24 demonstrated a b s o r b a n c e (4 5 0 n m ) n e g . c trl 2 A FM 24 reduced inhibition of EGFR phosphorylation 1 relative to cetuximab c e tu
Slide 23: AFM24 Demonstrated Potent in vivo Tumor Cell Killing and Improved Safety
AFM24 Demonstrated Potent in vivo Tumor Cell Killing and Improved Safety AFM24 demonstrated dose-dependent tumor AFM24 showed favorable safety profile in a dose growth inhibition in an in vivo mouse model range finding toxicity study in cynomolgus monkeys In vivo • All animals were clinically well t
Slide 24: AFM24 Could Address Clinical Unmet Need Among EGFR-Targeted Therapies
AFM24 Could Address Clinical Unmet Need Among EGFR-Targeted Therapies Current Therapies AFM24 US Market Opportunity 2,500 Actively Treated Stage IV Patients in 2016, US2 2,000 1,500 NSCLC Colorectal Cancer (millions) Sales 1,000 19,731 14,861 11,088 22,827 13,513 11,355 500 0 2011 2012 2013 2014 201
Slide 25: AFM24, a New Mode of Action in EGFR+ Solid Tumors
AFM24, a New Mode of Action to Initiate Innate Immunity in EGFR+ Solid Tumors, such as CRC, NSCLC, and Others Achievements Opportunities and Next Steps • Demonstrated potent cell killing • New MOA to address patients capabilities in pre-clinical studies currently not responding - Indicates potent ef
Slide 26: Adaptive Cell Engagers
CD3 Adaptive Cell Engagers target Treatment with AFM11 CD19 target 26
Slide 27: Affimed's T-Cell-targeting Platform and AFM11 Study Update
Affimed’s T-Cell-targeting Platform Is a Differentiated Approach to Optimize T Cell Engagement T Cell Platform AFM11 (CD3/CD19) Study Update* • No non-specific activation • Phase 1 dose-escalation trials in • Phase 1 study of 17 patients of T cells in absence of R/R ALL and NHL on HOLD after with R/
Slide 28: Recent Highlights and Upcoming Milestones
Recent Highlights and Upcoming Milestones Highlights Upcoming Anticipated Milestones ASH2018 AFM13 • Update on AFM13 Phase 1b combination study with • H1 2019: 12-month data for AFM13 + Keytruda® Keytruda® (pembrolizumab) in HL (pembrolizumab) • Data from AFM13 monotherapy Phase 1b/2a study in • H1
Slide 29: Affimed is Actualizing the Next Great Advancement in I-O
Affimed is Actualizing the Next Great Advancement in I-O Giving patients back their innate ability to fight cancer • Fit-for-Purpose ROCK® platform utilizes CD16A Innate cell engagers • Effective as monotherapy or combination therapy • Foundation to offer novel medicines • AFM13: Lead agent with reg
Slide 30: Experienced Management Team
Experienced Management Team Proven track record in biotech, pharma, product development, and finance Dr. Adi Hoess Dr. Florian Fischer Chief Executive Officer (CEO) Chief Financial Officer (CFO) Extensive background in general Strong financial background, lead advisor management, product commerciali
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