Immunitybio, Inc. · NASDAQ:IBRX
Immunitybio — Jefferies Healthcare Conference 2022
32 slides from Immunitybio's conference presentation, Jun 10, 2022
Slide 1: Overview Presentation
NASDAQ: IBRX Overview Presentation June 2022 6/10/2022 1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation and the accompanying verbal remarks contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not statements of historical fact are considered forward-looking statements, which are u
Slide 3: Mission: Innate and Adaptive Immune Memory
MISSION: Innate and Adaptive Immune Memory Goal: Durable Complete Remission & Prevention of Cancer and Infectious Diseases Induce Memory NK, T & B Cells PLATFORMS: NK, T and B Cells Activators DAMP Inducers DNA Vaccine RNA Vaccine Recombinant & Cytokines Toll Receptor Activators NK Cell Therapy • Al
Slide 4: Select Active Clinical Trials in Oncology
Select Active Clinical Trials in Oncology June 2022 Solid Tumors Phase Target Indication Preclinical Phase I Phase II Phase III BCG Unresponsive NMIBC CIS (Cohort A) BLA Submitted 2 May 23, 2022 Single Arm, NMIBC - Breakthrough & Fast Track NCT03022825 QUILT 3.032 BCG Unresponsive NMIBC Papillary (C
Slide 5: Select Clinical Trials in Infectious Diseases
Select Clinical Trials in Infectious Diseases June 2022 Infectious Phase Target Indication Preclinical Phase I Phase II Phase III 1 ACTG / NIAID: HIV Broadly Neutralizing Antibodies Single Arm, Phase 1, HIV NCT04340596 Thai Red Cross & Walter Reed Army Institute of Research HIV 2 Randomized, Phase 2
Slide 6: ImmunityBio: A Leading Immunotherapy Company
ImmunityBio: A Leading Immunotherapy Company June 2022 > 5 Trillion Over 5 Trillion Natural Killer NASDAQ: IBRX (NK) Cells Manufactured to Date DAMP DNA RNA Recombinant & Toll Receptor NK Cell Inducers Vaccine Vaccine Cytokines Activators Therapy 6 Immune Enhancing • Aldoxorubicin • hAd5 Adenovirus
Slide 7: Orchestrating the Immune System
Orchestrating the Immune System First-in-Class Comprehensive Platforms Late-Stage U.S. Clinical Trial Updates: NK + T Cells • IL-15 Fusion Proteins • Bladder Cancer Anktiva • Pancreatic Cancer Natural Killer Cells • Head & Neck Cancer • NK-92 Off-the-Shelf • Autologous m-ceNK • iNKT Cells • Lung Can
Slide 8: Orchestrating the Immune System
Orchestrating the Immune System First-in-Class Comprehensive Platforms Late-Stage U.S. Clinical Trial Updates: NK + T Cells • IL-15 Fusion Proteins • Bladder Cancer Anktiva • Pancreatic Cancer Natural Killer Cells • Head & Neck Cancer • NK-92 Off-the-Shelf • Autologous m-ceNK • iNKT Cells • Lung Can
Slide 9: N-803, an IL-15 Superagonist, Proliferates and Activates NK & T Cells
N-803, an IL-15 Superagonist, Proliferates and Activates NK & T 9 Cells, Providing the Secondary Stimulus (The Boost) to Trained Innate Immune Memory of BCG (The Prime) BCG “Trained immunity or innate immune memory enables innate immune cells to mount a more robust response to secondary non-related
Slide 10: QUILT-3.032: NMIBC Trial Rationale
QUILT-3.032: NMIBC Trial Rationale N-803 Synergistic with BCG: Enhances Proliferation of NK and T Cells Prime: BCG Activates Natural Killer Cells Boost: N-803 IL-15 Proliferates Natural Killer Cells & T Cells BCG N-803 BCG + N-803 BCG Administered Administered BCG Intravesically Intravesically 2001
Slide 11: Phase 1: NMIBC – Complete Response in 9 of 9 Subjects
Phase 1: NMIBC – Complete Response in 9 of 9 Subjects 11 With Durable 24 Month Response When N-803 is Combined with BCG (Trained Innate Immune Memory) N-803 + BCG Inducing 24-Month Durable Response https://doi.org/10.1080/2162402X.2021.1912885 IC: Inconclusive Cystoscopy
Slide 12: Clinically Meaningful Efficacy Results in Responders Cohort A (CIS)
12 Clinically Meaningful Efficacy Results in Responders Cohort A (CIS) Responder Population (N = 58) QUILT-3.032 Complete Response (n) 58 / 82 Complete Response CR Rate (95% CI) 71% (59.6, 80.3) Median Duration of Response in Months (95% CI) 26.6 (9.9, NR) Duration of Response Duration of Response >
Slide 13: 26.6 Month Durable Complete Remission in CIS (Cohort A)
QUILT 3032 26.6 Month Durable Complete Remission in CIS (Cohort A) Median Duration of CR 26.6 Months Ongoing Response, Still on Study 21 / 58 (36%) Data Presented ASCO June 2022 by Dr. Karim Chamie 13
Slide 14: QUILT 3032 Compared to KEYNOTE-057 in NMIBC BCG Unresponsive CIS Disease
QUILT 3032 Compared to KEYNOTE-057 in NMIBC BCG Unresponsive CIS Disease Primary Endpoint: Efficacy Further evidence of a clinically meaningful difference in efficacy across multiple subgroups favoring N-803 plus BCG COHORT A (CIS +/- Ta T1) Primary Endpoint: 30% CR rate with the lower bound 95% con
Slide 15: QUILT 3032 Compared to KEYNOTE-057: Cystectomy Avoidance
QUILT 3032 Compared to KEYNOTE-057 in NMIBC BCG Unresponsive CIS Disease Cystectomy Avoidance 8 / 24 (33%) 29 / 57 (51%) 5 / 58 (9%) 11 / 39 (28%) Higher cystectomy rate in KEYNOTE-057 KEYNOTE-057: 42% subjects overall population and 28% subjects in responders VS QUILT 3032: 16% subjects overall pop
Slide 16: QUILT 3032 Compared to KEYNOTE-057: Safety
QUILT 3032 Compared to KEYNOTE-057 in NMIBC BCG Unresponsive CIS Disease Safety: Immune Related AEs • N-803 + BCG Well Tolerated with AEs Comparable to BCG Alone • Pembrolizumab with Systemic Immune-Related AEs Requiring Steroid Therapy Data Presented ASCO June 2022 by Dr. Karim Chamie 16
Slide 17: Orchestrating the Immune System
Orchestrating the Immune System First-in-Class Comprehensive Platforms Late-Stage U.S. Clinical Trial Updates: NK + T Cells • Bladder Cancer • IL-15 Fusion Proteins • Pancreatic Cancer Natural Killer Cells • Head & Neck Cancer • NK-92 Off-the-Shelf • Autologous m-ceNK • iNKT Cells • Lung Cancer • HI
Slide 18: Natural Killer Cells
Natural Killer Cells
Slide 19: Exploratory Trial of PD-L1 t-haNK and Anktiva in Metastatic Pancreatic Cancer
Exploratory Trial of PD-L1 t-haNK and Anktiva in Combination with Chemo Modulation in Metastatic Pancreatic Cancer Median Overall Survival: 13 months Patients (2nd Line or Greater) Historical >2L Survival Rate Weeks of Follow Up or Until Death (12 weeks) 6/10/20 19 22
Slide 20: Phase 2 QUILT 88 trial in advanced pancreatic cancer
Abstract # 4147 Phase 2 QUILT 88 trial of DAMP inducers combined with IL15 superagonist, N-803 and anti PDL1-t-haNK cell therapy more than doubles historical overall survival with 3rd to 6th line advanced Pancreatic Cancer Tara Seery1, Chaitali Nangia1, Heide McKean2 Leonard Sender3, Sandeep Reddy3,
Slide 21: Orchestrating the Immune System
Orchestrating the Immune System First-in-Class Comprehensive Platforms Late Stage USA Clinical Trial Updates: NK + T Cells • Bladder Cancer • IL-15 Fusion Proteins • Pancreatic Cancer Natural Killer Cells • Head & Neck Cancer • NK-92 Off-the-Shelf • Autologous m-ceNK • iNKT Cells • Lung Cancer • HIV
Slide 22: Complete Response: 5th Line Metastatic Head & Neck Cancer
Complete Response: 5th Line Metastatic Head & Neck Cancer NANT Cancer Vaccine Therapies Used: • haNK • N-803 • Ad5 CEA • Chemo Unpublished Data
Slide 23: Memory-Like Cytokine Enhanced Natural Killer (M-ceNK) Cells First-in-Human Trials
Memory-Like Cytokine Enhanced Natural Killer (M-ceNK) Cells from Peripheral Blood First-in-Human Clinical Trials Day 1 Day 1 Day 17 Day 17 Single Aliquot For Enrichment Autologous Cytokine Autologous Enhanced Natural Killer Cells Aliquot One Bag into Concentrate for Transfusion Apheresis 10 Lots for
Slide 24: Chordoma Cells Lines are Efficiently Killed by M-ceNK Cells
Chordoma Cells Lines are Efficiently Killed by M-ceNK Cells • Two chordoma tumor cell lines UM-Chor-1 CH22 (UM-Chor-1, CH22) were incubated with M-ceNK cells. • Tumor cell killing was assessed over 18h. MCENK Cells HD NK Cells • Depicted is 30 minute killing. • Timepoint after this showed 100% killi
Slide 25: Orchestrating the Immune System
Orchestrating the Immune System First-in-Class Comprehensive Platforms Late-Stage U.S. Clinical Trial Updates: NK + T Cells • Bladder Cancer • IL-15 Fusion Proteins • Pancreatic Cancer Natural Killer Cells • Head & Neck Cancer • NK-92 Off-the-Shelf • Autologous m-ceNK • iNKT Cells • Lung Cancer • HI
Slide 26: Median Overall Survival of Anktiva Compared to Any Therapy After Checkpoint Inhibitor
Median Overall Survival of Anktiva Compared to Any Therapy in Patients Who Progressed on Checkpoint Inhibitor Additional Therapy Following Checkpoint Anktiva IL-15 Therapy Following Inhibitor Progression Checkpoint Inhibitor Progression Median OS: 6.1 Months Median OS: 14.1 Months QUILT 3.055 doi: 1
Slide 27: Anktiva Selected by LUNG-MAP for 2nd Line Patients
Anktiva Selected by LUNG-MAP for 2nd Line Patients who Progressed on Checkpoint Therapy ImmunityBio Announces First Participants Have Been Enrolled in Lung-MAP Trial Studying Anktiva to Activate NK and T Cells in Non-Small Cell Lung Cancer April 25, 2022 • Novel combination therapy of Anktiva, an IL
Slide 28: Orchestrating the Immune System
Orchestrating the Immune System First-in-Class Comprehensive Platforms Late-Stage U.S. Clinical Trial Updates: NK + T Cells • Bladder Cancer • IL-15 Fusion Proteins • Pancreatic Cancer Natural Killer Cells • Head & Neck Cancer • NK-92 Off-the-Shelf • Autologous m-ceNK • iNKT Cells • Lung Cancer • HI
Slide 29: 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+ (ART) patients treatment, ART + N-803 Fully Enrolled Phase 1 ACTG 5386: N-803 +/- 2 bNABs in HIV+ subjects Principle Investiga
Slide 30: Orchestrating the Immune System
Orchestrating the Immune System First-in-Class Comprehensive Platforms Late Stage USA Clinical Trial Updates: NK + T Cells • Bladder Cancer • IL-15 Fusion Proteins • Pancreatic Cancer Natural Killer Cells • Head & Neck Cancer • NK-92 Off-the-Shelf • Autologous m-ceNK • iNKT Cells • Lung Cancer • HIV
Slide 31: ImmunityBio Vaccine Platforms Against COVID
ImmunityBio Vaccine Platforms Against COVID Adeno mRNA Nabisome* Yeast hAd5 saRNA EDV RBD Subunit Protein Human Adenovirus 5 DNA Based Self Amplifying RNA Endosome Delivery Vector RBD + 3M-052 Adjuvant • Spike & Nucleocapsid T Cells • Potent Antibodies • Potent Antibodies • Potent Antibodies • Memor
Slide 32: Orchestrating the Immune System
Orchestrating the Immune System First-in-Class Comprehensive Platforms Late-Stage U.S. Clinical Trial Updates: NK + T Cells • Bladder Cancer • IL-15 Fusion Proteins • Pancreatic Cancer Natural Killer Cells • Head & Neck Cancer • NK-92 Off-the-Shelf • Autologous m-ceNK • iNKT Cells • Lung Cancer • HI