Immunitybio, Inc. · NASDAQ:IBRX
Immunitybio — Investor Presentation (March 2021)
45 slides from Immunitybio's investor presentation, Mar 17, 2021
Slide 1: A Leading Immunotherapy Biotech Company
A Leading Immunotherapy Biotech Company Broadest Late-Stage Clinical Platform of Antibody Cytokine Fusion Proteins, Albumin-Linked Chemo-Immunomodulators, Vaccine Vectors and Natural Killer cells NASDAQ:IBRX Exhibit 99.1
Slide 2: Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words s
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 3 Trillion Over 3 Trillion Natural Killer Cells Man
Slide 4: Highly Experienced Management Team with Proven Track Record
Highly Experienced Management Team with Proven Track Record Patrick Soon-Shiong, MD Executive Chairman David Sachs, MBA Chief Financial Officer Rich Adcock, MBA Chief Executive Officer Bobby Reddy, MD Chief Medical Officer Lennie Sender, MD Chief Operating Officer Fabio Benedetti, MD Chief Strategy
Slide 5: A Leading Immunotherapy Platform in Oncology and Infectious Diseases
A Leading Immunotherapy Platform in Oncology and Infectious Diseases Aldoxorubicin Anktiva (N-803) Adenovirus (hAd5) Antibody Cytokine Fusion Proteins Activating NK & T Cells Albumin-Bound Immuno-Modulators Tumoricidal Macrophages Vaccine Technologies Memory T Cells Mechanism of Action Core Modaliti
Slide 6: Immunotherapy Platform: Antibody Cytokine Fusion Proteins
ImmunityBio’s Immunotherapy Platform: Antibody Cytokine Fusion Proteins Anktiva (N-803) Antibody Cytokine Fusion Proteins Activating NK & T Cells Mechanism of Action Core Modalities Lead Cytokine Cytokine Fusion Antibody (IgG1)
Slide 7: Immunotherapy Platform: Albumin-Bound Immuno-Modulators
ImmunityBio’s Immunotherapy Platform: Albumin-Bound Immuno-Modulators Aldoxorubicin Albumin-Bound Immuno-Modulators Tumoricidal Macrophages Mechanism of Action Core Modalities Lead pH- Sensitive Hydrazine Linker Albumin-binding site
Slide 8: Immunotherapy Platform: Vaccine Technologies
ImmunityBio’s Immunotherapy Platform: Vaccine Technologies Adenovirus (hAd5) Vaccine Technologies Memory T Cells Mechanism of Action Core Modalities Lead hAd5
Slide 9: Immunotherapy Platform: Natural Killer Cell Therapy
ImmunityBio’s Immunotherapy Platform: Natural Killer Cell Therapy Mechanism of Action Core Modalities Lead Natural Killer (NK) Natural Killer Off-the-Shelf NK Cells Autologous Memory ceNK 1 2 3
Slide 10: A Leading Immunotherapy Platform in: I. Solid Tumors
A Leading Immunotherapy Platform in: I. Solid Tumors
Slide 11: A Leading Immunotherapy Platform in: I. Solid Tumors (Continued)
A Leading Immunotherapy Platform in: I. Solid Tumors (Continued)
Slide 12: A Leading Immunotherapy Platform in: II. Liquid Tumors (Oncology)
A Leading Immunotherapy Platform in: II. Liquid Tumors (Oncology) NCT02384954 NCT02989844 NCT02099539 NCT00990717 NCT01885897 NCT03050216 NCT02782546 NCT01898793 NCT02890758 NCT04052061
Slide 13: A Leading Immunotherapy Platform in: III. Infectious Diseases
A Leading Immunotherapy Platform in: III. Infectious Diseases
Slide 14: IV. Pre-Clinical & Pre-IND Pipeline Platforms
A Leading Immunotherapy Platform in: IV. Pre-Clinical & Pre-IND Pipeline Platforms Phase Product Description Preclinical Pre-IND IND Filed IND Auth Fusion Proteins Adenovirus Natural Killer Antibody Cytokine Fusion Proteins Pre-IND IL-15 Superagonist + Anti CD20 Fusion Protein N-820: IL-15 / CD20 Pr
Slide 15: A Leading Immunotherapy Platform in: I. Solid Tumors
A Leading Immunotherapy Platform in: I. Solid Tumors
Slide 16: Bladder Cancer
Bladder Cancer Updated March 2021
Slide 17: Overview of Non-Muscle Invasive Bladder Cancer (NMIBC)
Overview of Non-Muscle Invasive Bladder Cancer (NMIBC) High rates of progression and recurrence for NMIBC make it one of the most expensive cancer to treat Current standard of treatment is Transurethral resection of bladder tumor (TURBT), with or without intravesical therapy Intravesical BCG is comm
Slide 18: Phase I Results in NMIBC
Phase I Results in NMIBC Dose (intravesicular instillation) Patient Stage Response Assessments W12 6M 9M 12M 15M 18M 21M 24M 100 μg 1 Pap T1 CR* CR CR CR CR CR CR CR 2 Pap Ta CR* CR CR CR CR CR CR CR 3 Pap T1 CR* CR CR CR CR CR CR CR 200 μg 4 Pap T1 IC CR* CR CR CR CR CR CR 5 CIS IC IC IC CR CR CR C
Slide 19: Phase II / III Data in BCG-Unresponsive NMIBC CIS
Phase II / III Data in BCG-Unresponsive NMIBC CIS Ongoing Study 80 patients accrued to date (fully accrued) Results: 51 CRs at any time have been reached CR Rate at Any Time of 71% (95% CI: 59%, 81%) Overall SAE rate of 11%, no treatment-related SAEs Individual SAE events were all ≤ 1% Primary Endpo
Slide 20: Historical Comparison of CR Rates in BCG-Unresponsive NMIBC
Drug N CR Rate at Anytime Median Duration of CR in responders Median follow up (months) Cystectomy Free Rate to date % with Extra Vesical Disease Anktiva (N-803) 80 71% 19.2 Months* 10.7 88% 1 Pembrolizumab1 97 41% 16.2 Months 24.1 63% 3 Nadofaragene2 103 53% 9.7 Months 19.7 71% 1 1. ODAC: https://w
Slide 21: Efficacy & Safety in BCG-Unresponsive NMIBC CIS and 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%) 71% (59%, 81%) Duration of Response in Responding Patients Medi
Slide 22: Pancreatic Cancer
Pancreatic Cancer Updated March 2021
Slide 23: Phase 1/2 Trial of haNK + PD-L1 in 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 24: 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 Weeks of Follow Up or Until Death Patient alive at last follow-up Patients (2nd Line or Greater) 2nd Line or Greater Metastatic Pancreatic Cancer Median Overall Survival = Not Reache
Slide 25: Phase 2 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 This is a Phase 2, three-cohort (2 randomized and 1 single-arm), open-label study to evaluate the comparative efficacy and overall safety
Slide 26: Lung Cancer
Lung Cancer Updated March 2021
Slide 27: Phase IIb Data in Lung Cancer 2nd and 3rd Line NSCLC
Phase IIb Data in Lung Cancer 2nd and 3rd Line NSCLC (QUILT 3.055) In Discussions with Lung-MAP As of December 2020 Shows preliminary evidence of long-term stable disease in 2L/3L NSCLC patients who previously progressed Patients Receiving Checkpoint + Anktiva Tumor Response Over Time - NSCLC Subjec
Slide 28: Anktiva as the Backbone to Checkpoint Therapy
Anktiva as the Backbone to Checkpoint Therapy Registrational Trial: Anktiva + Checkpoint in First Line Lung Cancer (QUILT 2.023) 1L Squamous & Non-Squamous Non-Small Cell Lung Cancer CPI Alone 1L Non-Small Cell Lung Cancer CPI + Concurrent Chemo 1L Non-Small Cell Lung Cancer CPI + Concurrent Chemo A
Slide 29: Checkpoint Failure Basket Trial – Patients Enrolled
Checkpoint Failure Basket Trial – 135 Patients Enrolled Phase IIb: Multi-Cohort Basket Trial of CPI Failures Enrolled Patients
Slide 30: Triple Negative Breast Cancer (TNBC)
Triple Negative Breast Cancer (TNBC) Updated March 2021
Slide 31: Triple Negative Breast Cancer Phase Ib/II
Triple Negative Breast Cancer Phase Ib/II IND Filing by Q1 2021 for Randomized Phase 3 in TNBC Q1 2021: Protocol completed for Phase 3 TNBC Q3 2021: Confirm registrational protocol design Anticipated Next Steps ORR:67% Median PFS: 14.3 months Median OS: 20.2 months 89% (8/9) Subjects with Disease Co
Slide 32: Metastatic Colon Cancer
Metastatic Colon Cancer Updated March 2021
Slide 33: Adenovirus Experience in Colon Cancer
Adenovirus Experience in Colon Cancer Solid Tumors Phase Target Indication Preclinical Ph I Ph II Ph III Anktiva Adenovirus Colon I CEA Expressing Tumors ✓Anktiva ✓ hAd5-CEA II 3L Metastatic Colon Cancer ✓ hAd5-CEA II Metastatic or Unresectable Colon Cancer ✓ hAd5-CEA Single Arm, Phase 2, 3L Colon R
Slide 34: Liquid Tumors
Liquid Tumors Updated March 2021
Slide 35: A Leading Immunotherapy Platform in: II. Liquid Tumors (Oncology)
A Leading Immunotherapy Platform in: II. Liquid Tumors (Oncology) NCT02384954 NCT02989844 NCT02099539 NCT00990717 NCT01885897 NCT03050216 NCT02782546 NCT01898793 NCT02890758 NCT04052061
Slide 36: Liquid Tumor Experience: Non-Hodgkin's Lymphoma
Liquid Tumor Experience: Non-Hodgkin’s Lymphoma NCT02384954 In the SQ dose finding, overall response rate (ORR) was 67% (8 of 12) in the SQ cohort. The majority of patients experienced reductions in the size of their lymph nodes. In the highest dose of SQ cohort, for patients with anti-CD20 mAb sens
Slide 37: A Leading Immunotherapy Platform in: III. Infectious Diseases
A Leading Immunotherapy Platform in: III. Infectious Diseases
Slide 38: COVID-19
Seve COVID-19 Updated March 2021 ImmunityBio - N
Slide 39: 2nd Generation COVID-19 Vaccine Addressing Limitations of First Generation Vaccines
Oral delivery Self-administration No healthcare worker required. No needles No plastics, vials. Repeat dosing Reuse of vector Oral dosing means no treatment limiting anti-vector immune response unlike injected administration. E2b- deletion ImmunityBio, A Leading 2nd Generation COVID-19 Vaccine Addre
Slide 40: One Vaccine, Three Routes of Protection
One Vaccine, Three Routes of Protection Second Generation Universal Boost to S-Based Vaccines hAd5 S+N Subcutaneous hAd5 S+N Oral Capsule hAd5 S+N Oral Sublingual In-House Large Scale hAd5 GMP Manufacturing Capacity
Slide 41: Positive Interim Phase 1 Safety Data of hAd5 T-Cell COVID-19 Vaccine Candidate
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 . first 12 reported; trials expected to be fully enrolled in Q2 + First COVID-19 vaccine trials designed to deliver both S and N SARS-C
Slide 42: hAd5 S+N: NHP Challenge Study – Operation Warp Speed
hAd5 S+N: NHP Challenge Study – Operation Warp Speed Anti-Spike IgG levels rise sharply after oral dosing Antibodies Rapid clearance of SARS-CoV-2 from nasal and airway tissue Protection T cells Induction of memory T cell (CD4+) response to both antigens Gabitzsch E, et al., (2020) https://doi.org/1
Slide 43: 2009-2020 Clinical Experience with Second Generation E2b-Deleted Human Ad5
2009-2020 Clinical Experience with Second Generation E2b-Deleted Human Ad5 (hAd5) Humoral and Cell Mediated Immunity Even in the Presence of Previous Adeno Immunity H1N1 Pandemic - 2009 H1N1 Pandemic - 2009 SIV - 2011 Lassa Fever - 2019 Non-Replicating Viral Vector Second Generation (E2b-Deleted) Hu
Slide 44: Summary
Svanyees Summary Updated March 2021
Slide 45: Combined Immunotherapy Platforms Better Positioned to Treat Patients
Combined Immunotherapy Platforms Better Positioned to Treat Patients Expansive clinical-stage pipeline. 17 first-in-human molecules in 25 Phase II to III clinical trials across solid tumors, liquid tumors and infectious diseases. Breakthrough Therapy and Fast Track Designations for Anktiva for BCG-u