Immunitybio, Inc. · NASDAQ:IBRX
Immunitybio — Investor Presentation (June 2021)
58 slides from Immunitybio's investor presentation, Jun 4, 2021
Slide 1: A Leading Immunotherapy Biotech Company
A Leading Immunotherapy Biotech Company Broad Late-Stage Clinical Platform of Antibody Cytokine Fusion Proteins, Albumin-Linked Chemo-Immunomodulators, Vaccine Vectors and Natural Killer cells NASDAQ:IBRX June 4, 2021 Exhibit 99.1
Slide 2: Forward-looking statements
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words suc
Slide 3: ImmunityBio: A Leading Immunotherapy Company
ImmunityBio: A Leading Immunotherapy Company 17 First in Human Immunotherapy Molecules and cells 40 Phase I / II / III Clinical Trials 1,800+ Patients Studied 25 Phase II / III Clinical Trials ~400,000 Square Feet of Manufacturing and R&D Facilities 5 Trillion Over 5 Trillion Natural Killer Cells Ma
Slide 4: Selected Clinical Pipeline Updates for June 2021
Selected Clinical Pipeline Updates for June 2021 Non-Muscle Invasive Bladder Cancer (NMIBC) Pancreatic Cancer Triple Negative Breast Cancer (TNBC) M-ceNK COVID-19 HIV Seminal Worldwide Patents
Slide 5: Selected Clinical Pipeline Updates for June 2021
Selected Clinical Pipeline Updates for June 2021 Non-Muscle Invasive Bladder Cancer (NMIBC) Pancreatic Cancer Triple Negative Breast Cancer (TNBC) M-ceNK COVID-19 HIV Seminal Worldwide Patents
Slide 6: BCG Unresponsive NMIBC CIS Registration Trial
BCG Unresponsive NMIBC CIS Registration Trial FDA Breakthrough Designation BCG + Anktiva Administered Intravesically Intravesical BCG Anktiva (N-803) Bladder Catheter Medication FDA BREAKTHROUGH THERAPY DESIGNATION for BCG-Unresponsive NMIBC CIS N=80 FULLY ENROLLED
Slide 7: Pivotal Registration Data (QUILT-3.032) in BCG-Unresponsive NMIBC CIS
Pivotal Registration Data (QUILT-3.032) in BCG-Unresponsive NMIBC CIS Primary Endpoint Met Secondary Endpoint Updated June 2021 CR at 12 months: 58% (95% CI: 42.9%, 71.1%) Probability of patients maintaining CR for 12 months Median Follow-Up Time: 16.1 Months Complete Response at 12 Months, Safety P
Slide 8: Efficacy & Safety in BCG-Unresponsive NMIBC CIS and Historical Comparison to Keytruda
Efficacy & Safety in Patients with BCG-Unresponsive NMIBC CIS in QUILT-3.032 and Historical Comparison to Keytruda Efficacy Endpoints KEYNOTE-057 Keytruda QUILT-3.032 Anktiva + BCG CR Rate (95% CI) At any time or 3 months 41% (31%, 52%) 70% (59%, 80%) Duration of Response in Responding Patients Medi
Slide 9: Selected Clinical Pipeline Updates for June 2021
Selected Clinical Pipeline Updates for June 2021 Non-Muscle Invasive Bladder Cancer (NMIBC) Pancreatic Cancer Triple Negative Breast Cancer (TNBC) M-ceNK COVID-19 HIV Seminal Worldwide Patents
Slide 10: QUILT 88: 3rd Line or Greater Metastatic Pancreatic Cancer
QUILT 88: 3rd Line or Greater Metastatic Pancreatic Cancer PHASE 2 & spIND SECOND LINE OR GREATER COHORT C N=50 N=17 QUILT 88 Exploratory haNK + PD-L1 Inhibitor (Avelumab) Median Overall Survival (OS) = 8.0 months (95% CI: 5.0, 12.3) PD-L1 t-haNK Median Overall Survival (OS) = 12.95 Months N = 42 (a
Slide 11: QUILT 88: 3rd Line or Greater Metastatic Pancreatic Cancer
QUILT 88: 3rd Line or Greater Metastatic Pancreatic Cancer PHASE 2 & spIND SECOND LINE OR GREATER COHORT C N=50 N=17 QUILT 88 Exploratory
Slide 12: Phase 1/2 Trial of haNK + PD-L1 in Advanced Metastatic Pancreatic Cancer
Phase 1/2 Trial of haNK + PD-L1 in Combination with Chemo Immunomodulation in Advanced Metastatic Pancreatic Cancer NCT03329248 (Closed) QUILT 3.039, 3.060, 3.070, 3.080 NANT Cancer Vaccine Preliminary Data Lock Patients (2nd Line or Greater) Weeks of Follow Up or Until Death 1 2 3 4 5 6 7 8 9 10 11
Slide 13: Exploratory Trial of PD-L1 t-haNK in Metastatic Pancreatic Cancer
Exploratory Trial of PD-L1 t-haNK in Combination with Chemo Immunomodulation in Advanced Metastatic Pancreatic Cancer PD-L1 t-haNK in Metastatic Pancreatic Cancer Median Overall Survival (OS) is 394 Days (13 Months) Historical >2L Survival Rate (12 weeks) Weeks of Follow Up or Until Death 1. Accesse
Slide 14: QUILT 88: 3rd Line or Greater Metastatic Pancreatic Cancer
QUILT 88: 3rd Line or Greater Metastatic Pancreatic Cancer PHASE 2 & spIND SECOND LINE OR GREATER COHORT C N=50 N=17 QUILT 88 Exploratory
Slide 15: Phase Trial of PD-L1 t-haNK in Metastatic Pancreatic Cancer
Phase 2 Trial of PD-L1 t-haNK in Combination with Chemo Immunomodulation in Advanced Metastatic Pancreatic Cancer NCT04390399 (QUILT-88) N=248 Actively Enrolling Historical >2L Survival Rate (12 weeks) Weeks of Follow Up or Until Death PD-L1 t-haNK + Chemo Immunomodulation in Locally Advanced or Met
Slide 16: QUILT-88: NANT Pancreatic Cancer Vaccine – Trial in Progress
QUILT-88: NANT Pancreatic Cancer Vaccine – Trial in Progress Open-label, randomized, comparative phase 2/3 study of combination immunotherapy plus standard-of-care chemotherapy and SBRT versus standard-of-care chemotherapy for the treatment of locally advanced or metastatic pancreatic cancer Abstrac
Slide 17: Selected Clinical Pipeline Updates for June 2021
Selected Clinical Pipeline Updates for June 2021 Non-Muscle Invasive Bladder Cancer (NMIBC) Pancreatic Cancer Triple Negative Breast Cancer (TNBC) M-ceNK COVID-19 HIV Patents
Slide 18: PD-L1 t-haNK Activity in Triple Negative Breast Cancer
PD-L1 t-haNK Activity in Triple Negative Breast Cancer
Slide 19: PD-L1 t-haNK Activity in Triple Negative Breast Cancer
PD-L1 t-haNK Activity in Triple Negative Breast Cancer ORR:67% Median PFS: 14.3 months Median OS: 20.2 months ImmunityBio Phase 1b / 2 TNBC Data (2nd Line or Greater) ORR was 33.3% (95% CI: 24.6, 43.1) Median response duration was 7.7 months (95% CI: 4.9, 10.8) April 2020 A historical comparison. No
Slide 20: TNBC Phase 1 Treatment Schema
TNBC Phase 1 / 2 Treatment Schema ImmunityBio Investigational Agents In TNBC Clinical Trial PD-L1 t-haNK Anktiva (N-803) Cytokine Cytokine Fusion Antibody (IgG1) TNBC – Triple Negative Breast Cancer Phase 1 Dose Finding Study
Slide 21: Selected Clinical Pipeline Updates for June 2021
Selected Clinical Pipeline Updates for June 2021 Non-Muscle Invasive Bladder Cancer (NMIBC) Pancreatic Cancer Triple Negative Breast Cancer (TNBC) M-ceNK COVID-19 HIV Patents
Slide 22: Liquid & Solid Tumor Cell Therapy Program
Liquid & Solid Tumor Cell Therapy Program Off-the-Shelf Natural Killer Cells (NK-92) In-Vivo NK and T Cell Activation (Anktiva) Memory Cytokine Enriched Natural Killer Cells (M-ceNK: Autologous/Allogeneic) Pancreatic Cancer (Ph 2/3) TNBC (Ph 1/2) Lung Cancer (Ph 3) Merkel Cell Carcinoma (Ph 2) Diffu
Slide 23: Liquid & Solid Tumor Cell Therapy Program
Liquid & Solid Tumor Cell Therapy Program Off-the-Shelf Natural Killer Cells (NK-92) In-Vivo NK and T Cell Activation (Anktiva) Memory Cytokine Enriched Natural Killer Cells (M-ceNK: Autologous/Allogeneic) Pancreatic Cancer (Ph 2/3) TNBC (Ph 1/2) Lung Cancer (Ph 3) Merkel Cell Carcinoma (Ph 2) Diffu
Slide 24: Most Clinically Developed Off-the-Shelf NK Cell Therapy
Most Clinically Developed Off-the-Shelf NK Cell Therapy: More Patients Dosed with Longer Follow-up in NK Cell Therapy
Slide 25: NK-92 Universal Cell Line, Off-the-Shelf NK
NK-92 Universal Cell Line, Off-the-Shelf NK aNK (NK-92) haNK PD-L1 t-haNK CD-19 t-haNK HER2 t-haNK EGFR t-haNK Innate Immunity Without Major Inhibitory Receptors NKG2D NKG2D NKG2D NKG2D NKG2D NKG2D High-Affinity CD16 X CD16 CD16 CD16 CD16 CD16 erIL2 X erIL2 erIL2 erIL2 erIL2 erIL2 CAR Insertion(s) X
Slide 26: Liquid & Solid Tumor Cell Therapy Program
Liquid & Solid Tumor Cell Therapy Program Off-the-Shelf Natural Killer Cells (NK-92) In-Vivo NK and T Cell Activation (Anktiva) Memory Cytokine Enriched Natural Killer Cells (M-ceNK: Autologous/Allogeneic) Pancreatic Cancer (Ph 2/3) TNBC (Ph 1/2) Lung Cancer (Ph 3) Merkel Cell Carcinoma (Ph 2) Diffu
Slide 27: Liquid Tumors: Indolent Non-Hodgkin Lymphoma (iNHL)
Liquid Tumors: Indolent Non-Hodgkin Lymphoma (iNHL)
Slide 28: Durable complete response in CD20 sensitive patients who failed Rituxan
Durable complete response achieved in 7 of 9 (78%) CD20 sensitive patients who failed Rituxan® therapy in Phase 1 liquid tumor trial Of those patients who responded to the combination therapy of Anktiva™ plus Rituxan, 7 out of 7 (100%) achieved a complete response Chemotherapy-free regimen with mini
Slide 29: Liquid & Solid Tumor Cell Therapy Program
Liquid & Solid Tumor Cell Therapy Program Off-the-Shelf Natural Killer Cells (NK-92) In-Vivo NK and T Cell Activation (Anktiva) Memory Cytokine Enriched Natural Killer Cells (M-ceNK: Autologous/Allogeneic) Pancreatic Cancer (Ph 2/3) TNBC (Ph 1/2) Lung Cancer (Ph 3) Merkel Cell Carcinoma (Ph 2) Diffu
Slide 30: M-ceNK: 3,000% Cell Expansion with Potent Killing
M-ceNK (N=20): 3,000% Cell Expansion with Potent Killing Across Multiple Cell Lines
Slide 31: Proprietary Method of M-ceNK Generation
Introducing ImmunityBio’s Proprietary Method of First in Human First in Class M-ceNK Generation From Autologous and Allogeneic Apheresis Patient Apheresis Product Healthy Donor or Cancer Patient Apheresis Material Intermediate (AMI) Cryopreservation Potential 10 Aliquots AMI Thaw of a Single Aliquot
Slide 32: Autologous Apheresis M-ceNK Process
Autologous Apheresis Patient White Cell Collection Day 1 Concentrate 0.3 – 1.0 x 109 NK Cells Day 17 Aliquot One Bag into 10 Lots for Cryopreservation Single Aliquot For Enrichment Autologous Apheresis White Cells Day 1 CD56 CD3 White Cells GMP-in-a-Box NK Cell Enrichment Cytokine Induced Proliferat
Slide 33: M-ceNK Cell Production From Twenty Donors
M-ceNK Cell Production From Twenty Donors: Healthy Donors (N=15) and Cancer Patients (N=5) Donors Apheresis collected Range of total nucleated cells (TNC) collected % of NK cells % of Expansion and Production of M-ceNK cells in 18-20 days Potential # of Doses Cryopreserved M-ceNK from One Apheresis
Slide 34: M-ceNK Production from Healthy Donor vs Cancer Patient Equally Potent
Donor 5 Donor 6 Donor 7 Cancer Patient Healthy Donor Donor 13 Donor 8 Donor 3 IFN-g CD56 IFN-g CD56 M-ceNK Production from Healthy Donor vs Cancer Patient Are Equally Potent
Slide 35: M-ceNK a potent killer of cancer cells
M-ceNK a potent killer of cancer cells across multiple solid and liquid tumor types 5/6/2021
Slide 36: Confirmation by NCI Researchers: M-ceNK Potent Activity
Confirmation by NCI Researchers: M-ceNK Potent Activity Across Multiple Cell Types Lysis by NK Cells: Ovarian Cancer Lysis by NK Cells: Small Cell Lung Cancer Lysis by NK Cells: Breast Cancer & NSCLC Provided under CRADA: Fousek/Palena Data, LTIB, NCI (National Cancer Institute)
Slide 37: M-ceNK Clinical Trial Authorized – NCT04898543
M-ceNK Clinical Trial Authorized – NCT04898543 (QUILT 3.076) Phase 1 – First in Human M-ceNK Trial
Slide 38: Selected Clinical Pipeline Updates for June 2021
Selected Clinical Pipeline Updates for June 2021 Non-Muscle Invasive Bladder Cancer (NMIBC) Pancreatic Cancer Triple Negative Breast Cancer (TNBC) M-ceNK COVID-19 HIV Patents
Slide 39: Routes of Administration Being Investigated
Routes of Administration Being Investigated Multiple Routes of Administration of Same Vaccine Construct to Achieve T Cell Mediated & Mucosal Immunity hAd5 S-Fusion + N-ETSD COVID Vaccine Subcutaneous (2-8°C) Oral Capsule (Room Temp) Sublingual (Room Temp) Intranasal (2-8°C) USA & South Africa USA &
Slide 40: Routes of Administration Being Investigated
Routes of Administration Being Investigated Multiple Routes of Administration of Same Vaccine Construct to Achieve T Cell Mediated & Mucosal Immunity hAd5 S-Fusion + N-ETSD COVID Vaccine Subcutaneous (2-8°C) Oral Capsule (Room Temp) Sublingual (Room Temp) Intranasal (2-8°C) USA & South Africa USA &
Slide 41: Single Prime hAd5 Dual Antigen Vaccination of Healthy Volunteers
Single Prime hAd5 Spike (S) + Nucleocapsid (N) Dual Antigen Vaccination of Healthy Volunteers Induces a Ten-Fold Increase in Mean S- and N- T-Cell Responses Equivalent to T-Cell Responses from Patients Previously Infected with SARS-CoV-2
Slide 42: Routes of Administration Being Investigated
Routes of Administration Being Investigated Multiple Routes of Administration of Same Vaccine Construct to Achieve T Cell Mediated & Mucosal Immunity hAd5 S-Fusion + N-ETSD COVID Vaccine Subcutaneous (2-8°C) Oral Capsule (Room Temp) Sublingual (Room Temp) Intranasal (2-8°C) USA & South Africa USA &
Slide 43: Complete Protection of Nasal and Lung Airways Against SARS-CoV-2
Complete Protection of Nasal and Lung Airways Against SARS-CoV-2 Challenge by Antibody Plus Th1 Dominant N- and S-Specific T-Cell Responses to Subcutaneous Prime and Thermally-Stable Oral Boost Bivalent hAd5 Vaccination in an NHP Study
Slide 44: Routes of Administration Being Investigated
Routes of Administration Being Investigated Multiple Routes of Administration of Same Vaccine Construct to Achieve T Cell Mediated & Mucosal Immunity hAd5 S-Fusion + N-ETSD COVID Vaccine Subcutaneous (2-8°C) Oral Capsule (Room Temp) Sublingual (Room Temp) Intranasal (2-8°C) USA & South Africa USA &
Slide 45: Positive Interim Phase 1 Safety Data of hAd5 COVID-19 Vaccine
ImmunityBio Announces Positive Interim Phase | Safety Data of hAd5 T-Cell COVID-19 Vaccine Candidate in Oral and Sublingual Formulations PRESS RELEASES Mar 15, 2021 enrolled in Q2 . to deli iblingual, and oral covio-19 + Robust T iter exposur CULVER CITY, Calif,, March 15, 2021 — immunityBio, Inc. (
Slide 46: Routes of Administration Being Investigated
Routes of Administration Being Investigated Multiple Routes of Administration of Same Vaccine Construct to Achieve T Cell Mediated & Mucosal Immunity hAd5 S-Fusion + N-ETSD COVID Vaccine Subcutaneous (2-8°C) Oral Capsule (Room Temp) Sublingual (Room Temp) Intranasal (2-8°C) USA & South Africa USA &
Slide 47: Dual-Antigen Ad5 COVID-19 Vaccine Intranasal Plus Subcutaneous Prime in Mice
The Dual-Antigen Ad5 COVID-19 Vaccine Delivered as an Intranasal Plus Subcutaneous Prime Elicits Th1 Dominant T-Cell and Humoral Responses in CD-1 Mice
Slide 48: Sisonke Universal Boost Trial in South Africa
Sisonke Universal Boost Trial in South Africa (Phase 1/2) Prime (Ad26) + Boost (hAd5 S-Fusion + N-ETSD)
Slide 49: Selected Clinical Pipeline Updates for June 2021
Selected Clinical Pipeline Updates for June 2021 Non-Muscle Invasive Bladder Cancer (NMIBC) Pancreatic Cancer Triple Negative Breast Cancer (TNBC) M-ceNK COVID-19 HIV Patents
Slide 50: Rationale for N-803 in HIV
Rationale for N-803 in HIV Activates CD4 T cells and induces virus from latency Causes activation and proliferation of NKs and CD8s which may have direct antiviral activity Concentrates in LN where the reservoir is Long half-life (physiologic levels 3-5 days after s.q. dose) No apparent anti-IL-15 a
Slide 51: Anktiva Sends SIV-Specific CD8+ T Cells to B-Cell Follicles
Anktiva Sends SIV-Specific CD8+ T Cells to B-Cell Follicles Webb GM, et al. Blood Adv. 2018 Jan 23;2(2):76-84. Post Anktiva (5d) Pre Anktiva HIV-Gag-specific Tetramer-positive CD8+ T cells Increased SIV-specific CD8+ T cells in B-cell follicle HIV-Gag-specific Tetramer-positive CD8+ T cells HIV-Gag-
Slide 52: ANKTIVA Clinical HIV Experience: Phase I Study
ANKTIVA Clinical HIV Experience: Phase I Study of Anktiva (N-803) in HIV Infected Patients to Clear Latent HIV Reservoirs Zachary Davis1, Jodi Anderson1, Ann Thorkelson1, Hing C. Wong2, Jonathan Karn3, Curtis Dobrowlski3, Jeffrey S. Miller1, Sarah Cooley1, Daniel C Douek4, Timothy W Schacker1 1Unive
Slide 53: N-803 Increases Homing of NK Cells to Lymph Node
N-803 Increases Homing of NK Cells to Lymph Node Davis et al., CROI 2018. Abstr 356 CD56 Staining of LN before (A) and 1 week after (B) the 3rd dose of N-803 in participant 2543 (3.0 mcg/kg SC). Before N-803 After N-803 Administration of N-803 results in accumulation of NK cells in lymph nodes where
Slide 54: N-803 Decreased Detectable HIV Reservoir in Lymphocytes
N-803 Decreased Detectable HIV Reservoir in Lymphocytes With ConA Stimulation Measure of the overall size of the inducible reservoir
Slide 55: ImmunityBio HIV Clinical Programs
ImmunityBio HIV Clinical Programs: Active Phase 1/2 Clinical Trials in Progress Phase 1 B Cell Follicle Study Principle Investigator: Tim Schacker, UMinn NCT04808908 10 HIV+ patients txt 3x N-803 2 enrolled to date Phase 1 ACTG 5386: N-803 +/- 2 bNABs in HIV+ subjects Principle Investigator: Tim Wil
Slide 56: Selected Clinical Pipeline Updates for June 2021
Selected Clinical Pipeline Updates for June 2021 Non-Muscle Invasive Bladder Cancer (NMIBC) Pancreatic Cancer Triple Negative Breast Cancer (TNBC) M-ceNK COVID-19 HIV Patents
Slide 57: Seminal Patents: By The Numbers
Seminal Patents: By The Numbers Antibody Cytokine Fusion Proteins Chemo Immuno Modulators Vaccine Technologies Natural Killer Cells 114 Worldwide 112 Worldwide 371 Worldwide 26 Worldwide ImmunityBio patent portfolio extends to 2040 Over 600 Issued Patents Worldwide Covering ImmunityBio Immunotherapy
Slide 58: ImmunityBio: A Leading Immunotherapy Company
ImmunityBio: A Leading Immunotherapy Company 17 First in Human Immunotherapy Molecules and cells 40 Phase I / II / III Clinical Trials 1,800+ Patients Studied 25 Phase II / III Clinical Trials ~400,000 Square Feet of Manufacturing and R&D Facilities 5 Trillion Over 5 Trillion Natural Killer Cells Ma