COMPANY OVERVIEW January 2018
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1 COMPANY OVERVIEW January
2 The Company Emerging leader in antigen-directed immunotherapies for cancer Artificial Immune Modulation (AIM TM ) Platform Core technology: artificial Antigen Presenting Cells (aapc) that act as synthetic dendritic cells to activate and expand antigen-specific T cells Lead Product: AIM ACT (Adoptive Cellular Therapy) consists of donor derived Tumor Antigen-Specific CD8+ T cells being developed for Heme malignancies Differentiation: AIM ACT expands T cells from the natural repertoire and directs them against multiple tumor relevant antigen targets IND filing for AIM ACT expected mid-2018 Strong IP portfolio supports multiple aspects of core technology through 2036 Recent $25M Series A financing provides funds to support Phase I/II clinical trial 22
3 AIM aapc: Key Platform Differentiation Attributes Novel approach to cellular therapy that leverages the ability to direct antigen-specific T cell function using T cells from the natural repertoire (non genetically-engineered); Versatility for other applications. - Ability to direct T cell function appropriate to therapeutic goal (activation, suppression, destruction) - Direct engagement with targeted T cell receptors do not require antigen processing and presentation by host Dendritic Cells - Generating T cells directed against multiple disease-relevant antigens enhances clinical effectiveness and reduces chance of target escape - Naturally-selected T cells minimize risk of autoimmune toxicity - High proportion of Central Memory T cells increases durability of response and reduces risk of relapse - Simple, scalable and cost-efficient manufacturing system (fully automated, fully enclosed cellular expansion system) 33
4 AIM Platform artificial Antigen Presenting Cells (aapc) 44 4
5 AIM artificial Antigen Presenting Cell (aapc) antigenic peptides PLGA-PEG or Fe aapc Synthetic Core nanoparticle Signal 1 HLA-IgG4 hinge dimer Signal 2 acd28 co-stim HLA-A2 (Class I)-Ig dimer fusion protein that can incorporate multiple peptide antigens HLA dimer can be readily modified for multiple HLA-subtypes Co-stimulatory or inhibitory ligands provide specific instructions to target cells (naïve and memory) MOA is direct engagement with target cells and subsequent activation, suppression, or selfdestruction as directed by signal 2 ligand ~80nm core nano-particle optimized for size, ligand density / ratio, and site-directed orientation Coupling of surface ligands to synthetic core via covalent bonds 55 5
6 AIM aapc engage directly with targeted T cells Programmed to deliver highly specific and polarizing signals Antigen-specific aapc successfully engage, activate and expand targeted T cell populations through naturally occurring signaling mechanisms 1000 s of aapc interactions per T cell T Cell 80 nanometers 5-7 microns 66 6
7 Lego-like construct enables broad utility Ability to customize aapc (T cell direction) for intended use anti-4-1bb MHC-Ig anti-cd28 anti-cd2 B7.1-Ig anti-pd1 anti-fas CD83-Ig CD1d-Ig anti-cd44 KaAPC PLGA-PEG or Fe + aapc Restore Tolerance Break Tolerance aapc Direct Other Immune Cell Types 77
8 Product development opportunities in immunooncology Adoptive Cell Therapy Activated T Cells Product: AIM ACT AIM E+E aapc Pharmaceutical Product: AIM
9 AIM ACT (Adoptive Cellular Therapy) T cell therapy directed against multiple tumor-relevant antigens 99
10 Cellular Expansion System 10 10
11 11 Expansion of therapeutically-relevant levels of tumor specific T cells within 14 days Antigen-specific T cells Tumor-Specific antigen Control Antigen
12 AIM ACT Clinical Trial Rationale Phase I/II Proof of Concept in AML/MDS IND planned for mid-2018 Clear unmet medical need for novel therapies ~70% of AML patients have poor outcomes despite current therapies Allogeneic hematopoietic stem cell transplantation (allo-hsct) is standard of care for most patients Most patients relapse after initial allo-hsct (90% one-year mortality rate in high risk patients) Good understanding of immunological targets in AML (WT1, PRAME, Cyclin A-1, Survivin) Emerging early stage clinical results add insight and confidence to NexImmune Phase I/II program Orphan population with significant unmet need 12 12
13 % specific T cells AIM ACT Product: Specificity Multiplexed manufacturing generates highly specific T cell product n= WT1 (37) WT1 (126) PRAME (142) PRAME (425) Survivin (95) Total AML specificity AML specific Antigen (epitope) 13 13
14 Total Number of AML Specific T Cells AML-specific T cells: Average of 9,000-12,000 fold expansion in 14 days Based on range of T cell precursor frequencies Day 0 Day 14 Precursor Frequency Day 0 Day 14 Fold Change 1 in x x 1 in x x
15 CD62L % CD3/CD8+ T cells Phenotype of expanded T cells are >90% Memory Equal proportions of central and effector memory T cells CM naive TemRA 10 EM 0 CM EM CM EM CD45RA
16 % of Antigen-Specific Lysis AIM ACT Product: In vivo functionality Robust antigen-specific killing of AML tumor cells All at 40:1 E:T ratio NexImmune #1 NexImmune #2 Bollard Yao #1 Yao #2 Antigens Targeted WT1, PRAME, survivin WT1, PRAME, survivin, cyclin A1 WT1, PRAME, NE, Pr3, MAGE A3 PRAME PRAME Target Cells THP-1 Cells THP-1 Cells Peptide-loaded PHA blasts THP-1 Cells THP-1 Cells Effector Cells AIM E+E generated CTLs AIM E+E-generated CTLs DC-generated CTLs DC-generated CTLs DC-generated CTLs Time to generate cells 14 days 14 days 3 rounds stim (3+ wks) 2 rounds stim (3+ wks) 2 rounds stim (3+ wks) Assay (hrs) Reference Unpublished Data Unpublished Data Weber et al, Leukemia, 2013 Yao et al, Plos One, 2013 Yao et al, Plos One,
17 Clinical Advisors and Phase I/II Sites Memorial Sloan Kettering Cancer Center* - Sergio Giralt, MD Chair, BMT Services - Miguel Perales, MD Vice Chair, BMT Services; Director, MSKCC IRB Ohio State University* - Steve Devine, MD Chair, BMT Services - Sumi Vasu, MBBS, Assistant Professor, Hematology Florida Hospital* - Steve Goldstein, MD Director BMT Services - Juan Varela, MD PhD Hematology Children s National Hospital - Catherine Bollard, MD, PhD *Phase I Sites 17 17
18 Phase I/II Study Schema in AML/MDS Expansion Cohorts to include other heme tumors Allo-SCT Relapse Chemo (1-2 course) AIM-ACT Infusion IL-2 (14 days) N=3-5 Enrollment N=3-5 N=3-5 Expansion Cohorts (other Heme tumors) 18 18
19 NexImmune AIM ACT Based on Pre-IND Guidance and Site Feasibility Analysis Q Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Pre-IND Mtg File IND IND Approved IRB Approved 1 st site activated AML Dose Level 1 (50MM T cells) 1 st patient dosed 1mo data Dose Level 1 I Yr data FPI 6mo data Dose Level 1 Timeline Assumptions 28 days from AZA initiation to ACT infusion 28 days between 1 st and 2 nd patients dosed Cohort 1 28 days between dosing Cohort 1 and Cohort 2 No safety issues (hold), and pt. enrollment per feasibility assumptions Expansion cohorts open at same time as AML dose level 2 AML Dose Level 2 (100MM T cells) Expansion Cohorts (100MM T cells) Initiate Dosing AML Dose Level 3 (200MM T cells) Initiate Dosing 1mo data Initiate Enrollment
20 20 AIM 101: An off-the-shelf immunotherapy AIM 101 aapc engage target T cell populations at multiple sites (lymph node, peripheral blood, tumor) Demonstrated ability to generate tumor-infiltrating lymphocytes (TILS) directed against multiple tumor relevant antigens; additive benefit when combined with Check Point Inhibitor Broad potential for treatment of solid tumors and hematological malignancies Core aapc for AIM 101 optimized for size, ligand density, biodistribution
21 21 Versatility of the AIM TM Platform: Multiple applications for future development Therapy Areas Cancer Solid and Liquid tumors Personalized immunotherapy Infectious Diseases Opportunistic viral infections Pandemic response / Bio-defense AutoImmmunity Type 1 Diabetes Multiple Sclerosis Transplant Rejection GVHD
22 22 NexImmune Management Highly Experienced Team Scott Carmer Kristi Jones, PharmD Executive Leadership President, COO CBO Genentech, Amgen, MedI/AZ Genentech, MedI/AZ Alain Cappeluti CFO HGS, CoGeneSys, Teva Mathias Oelke PhD Dan Bednarik, PhD Juan Varela, MD,PhD Ken Carter, Ph.D. VP, Cell Biology SVP, Protein Eng. Lead, Clinical Dev. Senior Advisor Johns Hopkins Univ. Intrexon, HGS Johns Hopkins Uinv., MUSC Avalon, Noble, HGS
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