ImmunityBio, Inc 8-K, filed Mar 17, 2021
ImmunityBio, Inc. (IBRX)
About this 8-K
ImmunityBio, Inc filed this 8-K on March 17, 2021.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
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| Item 7.01 |
Upon the closing of the merger transaction on March 9, 2021 as previously disclosed, the number of shares of common stock outstanding of ImmunityBio, Inc. (the “Company”) was 383,179,376.
A copy of a slide presentation that the Company intends to present to investors is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein solely for purposes of this Item 7.01 disclosure.
The information referenced under Item 7.01 (including Exhibit 99.1 referenced in Item 9.01 below) of this Current Report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report. This Current Report shall not be deemed an admission as to the materiality of any information in the Current Report that is required to be disclosed solely by Regulation FD.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | ImmunityBio, Inc. Presentation | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| IMMUNITYBIO, INC. | ||||||
| Date: March 17, 2021 |
By: | /s/ David Sachs | ||||
| Chief Financial Officer | ||||||
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
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 such as “anticipates,” “believes,” “continues”, “could”, “estimates,” “expects,” “intends,” “may,” “plans,” “potential”, “predicts”, “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. These forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) potential adverse effects or changes to relationships with employees, suppliers or other parties resulting from the completion of the merger , (ii) the outcome of any legal proceedings that may be instituted against the parties and others related to the merger, (iii) unexpected costs, charges or expenses resulting from the merger, (iv) uncertainty of the expected financial performance of the combined company following completion of the merger, including the possibility that the expected synergies and value creation from the merger will not be realized or will not be realized within the expected time period, (v) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs, and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, (vi) inability to retain and hire key personnel, and (vii) the unknown future impact of the COVID-19 pandemic delay on certain clinical trial milestones and/or ImmunityBio’s operations or operating expenses. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 8-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 10, 2021 and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov. ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. Forward Looking Statements
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 Manufactured to Date > Antibody Cytokine Fusion Proteins A Leading Immunotherapy Platform in Oncology & Infectious Diseases Chemo Immuno Modulators Vaccine Technologies Natural Killer Cells NASDAQ: IBRX 2035+ Worldwide Patents Extending to 2035 and Beyond
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 Officer Shahrooz Rabizadeh, PhD Chief Scientific Officer Fusion Protein & Neoepitope Kayvan Niazi, PhD Chief Science Officer Immunology and Vaccinology Elizabeth Gabitzsch Vice President, Vaccines Sarah Singleton Chief Communications Officer Hans Klingemann, MD, PhD Chief Scientific Officer Cellular Therapy Manju Saxena, PhD Vice President, Product Dev Cell Therapy Program Sylvain Roy Vice President, Manufacturing Barry Simon, MD Chief Corporate Affairs Officer
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 Modalities Lead pH- Sensitive Hydrazine Linker Albumin-binding site Cytokine Cytokine Fusion Antibody (IgG1) Natural Killer (NK) Natural Killer Off-the-Shelf NK Cells Autologous Memory ceNK hAd5
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)
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
ImmunityBio’s Immunotherapy Platform: Vaccine Technologies Adenovirus (hAd5) Vaccine Technologies Memory T Cells Mechanism of Action Core Modalities Lead hAd5
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
A Leading Immunotherapy Platform in: I. Solid Tumors
A Leading Immunotherapy Platform in: I. Solid Tumors (Continued)
A Leading Immunotherapy Platform in: II. Liquid Tumors (Oncology) NCT02384954 NCT02989844 NCT02099539 NCT00990717 NCT01885897 NCT03050216 NCT02782546 NCT01898793 NCT02890758 NCT04052061
A Leading Immunotherapy Platform in: III. Infectious Diseases
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 Pre-IND IL-15 Superagonist + Anti PD-L1 Fusion Protein N-809: IL-15 / PD-L1 Pre-IND Tumor Necrosis Targeting (TNT) TNT + TGFb Trap Fusion Protein N-830: TNT / TGFb Pre-IND Tumor Necrosis Targeting (TNT) TNT + IL-12 Fusion Protein N-812: TNT / IL-12 NK Platform Pre-IND HER2 t-haNK HER2 t-haNK Pre-IND EGFR t-haNK EGFR t-haNK Pre-IND TxM Induced M-ceNK TxM IL-12 / IL-18 / IL-15 M-ceNK Pre-IND Nanatinostat – Epigenetic Modifier Peptides Pre-IND M2 Macrophage Polarizer to M1 RP-182 Adenovirus Pre-IND hAd5 Human Papillomavirus (HPV) hAd5 E6/E7 Pre-IND hAd5 to N-803 hAd5 N-803 Pre-Clin hAd5 Influenza hAd5 HA / M Pre-Clin hAd5 COVID-19 ACE2 Decoy hAd5 ACE2 Decoy MSC Phase 1 Mesenchymal Stem Cell w/ GMP-in-a-Box Mesenchymal Stem Cells (MSC) N-820 N-809 N-830 N-812 HER2 t-haNK EGFR t-haNK M-ceNK RP-182 hAd5 E6/E7 hAd5 N-803 hAd5 HA/M hAd5 ACE2 MSCs w/ GMP-in-a-Box Nanatinostat
A Leading Immunotherapy Platform in: I. Solid Tumors
Bladder Cancer Updated March 2021
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 commonly used as an adjuvant treatment after TURBT for intermediate-high-risk NMIBC – side effects are common Patients who have failed BCG therapy require radical cystectomy with urinary diversion or chemotherapy and radiation Only 50% of patients undergoing radical cystectomy will survive at 5 years BCG Administered Intravesically Intravesical BCG BCG + Anktiva Administered Intravesically Intravesical BCG Anktiva Bladder Catheter Medication Bladder Catheter Medication Current Standard of Care ImmunityBio’s Approach BREAKTHROUGH THERAPY DESIGNATION for BCG-Unresponsive NMIBC CIS 80k Annual New Cases 18k Annual Deaths
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 CR CR 6 Pap T1 CR* CR CR CR CR CR CR CR 400 μg 7 Pap T1 CR* CR CR CR CR CR CR CR 8 CIS CR* CR CR CR CR CR CR CR** 9 Pap Ta CR* CR CR CR CR CR CR CR Anktiva + BCG in High-Risk NMIBC – Phase I Results FDA granted Fast Track Designation to the pivotal trial based on this Phase I data. 9 of 9 (100%) Patients Disease-Free at 24 Months Data as of Feb 2018 Standard of Care historical response rate is 58-81% at 3-6 months post BCG alone CR – Complete Response CR* -- No Recurrence (NR) in Papillary Disease CR** -- Negative Cystoscopy Inconclusive Cytology
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 Endpoint | Complete Response at Any Time Secondary Endpoint | Duration of Complete Response Updated Jan 2021 Primary Endpoint: CR at any time, with lower bound of 95% CI ≥ 20% To meet the primary endpoint, 24 out of 80 patients must have had a CR at any time 1H 2021: Initial FDA Readout Ph II / III BCG Unresponsive NMIBC Carcinoma In-Situ CIS 2nd Line 2H 2021: CIS BLA Filing Ph II / III BCG Unresponsive NMIBC Anticipated Next Steps Duration of CR at 12 months 56% (95% CI: 38.8%, 70.3%) probability of patients maintaining CR for 12 months Duration of Complete Response Safety Population – Cohort A (CIS) 12 Months 56% 95% CI (38.8%, 70.3%)
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://www.fda.gov/media/133542/download, ASCO 2020 2. Boorjian et al. Lancet 2020 Late-Breaking Presentation ASCO GU 2021 (Feb 12) *Kaplan-Meier estimate Presented by Dr. Karim Chamie (UCLA) https://meetinglibrary.asco.org/record/195299/abstract A historical comparison. Not a head to head comparison
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 Median Duration of CR in Months (range) 16.2 (0.0+ – 26.8) 19.2 (0.0+ – 26.4) Cystectomy Free Rate % Cystectomy Free 63% 89% Immune-Mediated Adverse Event KEYNOTE-057 Keytruda QUILT-3.032 Anktiva + BCG Any Immune-Mediated AE 21% 0 Grade 3-5 Immune-Mediated AEs 3% 0 Any Immune-Mediated SAE 5% 0 Discontinuation due to Immune-Mediated AEs 4% 0 Discontinuation due to Immune-Mediated SAEs 2% 0 Approved Jan 2020 A historical comparison. Not a head to head comparison
Pancreatic Cancer Updated March 2021
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 12 2nd Line or Greater Metastatic Pancreatic Cancer Historical >2L Survival Rate (12 weeks)1 haNK + PD-L1 Inhibitor (Avelumab) Median Overall Survival = 8.0 months (95% CI: 5.0, 12.3) haNK + PD-L1 inhibitor (Avelumab) in Metastatic Pancreatic Cancer Median Overall Survival 8.0 Months
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 Reached to Date (Jan 2020) PD-L1 t-haNK PD-L1 t-haNK Favorable to haNK + PD-L1 inhibitor (Avelumab) in Metastatic Pancreatic Cancer Median Overall Survival to Date (As of Jan 2020) Not Reached Historical >2L Survival Rate (12 weeks)
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 of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with Aldoxorubicin, N-803, and PD-L1 t-haNK in subjects with locally advanced or metastatic pancreatic cancer. Each treatment setting (ie, first line maintenance, second line, or third line or greater) will be evaluated independently as a separate cohort. Cohort A1st Line therapy (Randomized) Cohort B2nd Line therapy (Randomized) Cohort C3rd Line or greater therapy (Single-Arm) Status: Enrolling Enrolling Enrolling Days of Follow Up or Until Death W Patients (2nd Line or Greater) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Patient alive at last follow-up Death of patient Patient withdrew from study W Data as of Jan 2021: 18 accrued to date in 3rd Line or Greater (Single Arm) – Cohort C 15 Alive to Date PD-L1 t-haNK + Chemo Immunomodulation in Locally Advanced or Metastatic Pancreatic Cancer (QUILT-88) PD-L1 t-haNK NCT04390399 (QUILT-88) N=248 15 out of 18 Patients Alive to Date (as of Jan 2021)
Lung Cancer Updated March 2021
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 Subjects QUILT 3.055 is an ongoing Phase IIb, basket trial of 11 anatomical tumor types of combination Anktiva + checkpoint 131 patients have been enrolled to date 81 / 131 of these have lung cancer (78 NSCLC and 3 SCLC) 1H 2021: Data lock anticipated for the QUILT 3.055 lung cancer cohorts In Discussions with Lung-MAP Anticipated Next Steps Multi-Cohort Basket and Status Change in Target Lesion From Baseline Point of Progression (%) 0 point baseline represents patients who were actively progressing on CPI prior to enrollment of study with Anktiva + CPI
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 Actively Enrolling N = 726 N = 404 N = 408 Phase Target Indication Pre-clinical Ph I Ph II Ph III Fusion Proteins Aldoxorubicin Adenovirus Natural Killer Lung III 1L Squamous & Non-Squamous Non-Small Cell Lung Cancer CPI Alone ✓ Anktiva III 1L Non-Small Cell Lung Cancer CPI + Concurrent Chemo ✓ Anktiva IIb 2L or Greater Checkpoint Relapsed Non-Small Cell Lung Cancer ✓ Anktiva ✓ PD-L1 t-haNK
Checkpoint Failure Basket Trial – 135 Patients Enrolled Phase IIb: Multi-Cohort Basket Trial of CPI Failures Enrolled Patients
Triple Negative Breast Cancer (TNBC) Updated March 2021
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 Control NantKwest Phase 1b / 2 TNBC Data (2nd Line or Greater) Phase 3: Open-label, randomized, controlled, phase 3 trial of sacituzumab versus sacituzumab plus Anktiva and PD-L1 t-haNK for the treatment of subjects with advanced triple-negative breast cancer after prior therapy. Planned N=374 (N=187 per Arm), Randomized 1:1, TNBC >2 Prior Treatments for Metastatic Disease 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. Not a head to head comparison
Metastatic Colon Cancer Updated March 2021
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 Randomized, Phase 2, 2L or Greater Colon, NCI Single Arm, Phase 1, CEA Kaplan-Meier survival plot on long-term overall survival of metastatic colorectal cancer patients immunized 3 times with the highest doses of our vaccine candidate, demonstrating a median survival of 13 months, with 19% of patients surviving 28-months. Cytolytic T cell responses increased after immunizations and cell-mediated immune (CMI) responses were induced Preliminary results revealed that activated CD4+ and CD8+ T cells were detected in a post-immunization sample exhibiting high CMI activity. While no head-to-head studies have been performed, this data compares favorably to historical controls of patients with late-stage metastatic colorectal cancer. In light of these favorable results, we are exploring a trial in late-stage colorectal cancer patients
Liquid Tumors Updated March 2021
A Leading Immunotherapy Platform in: II. Liquid Tumors (Oncology) NCT02384954 NCT02989844 NCT02099539 NCT00990717 NCT01885897 NCT03050216 NCT02782546 NCT01898793 NCT02890758 NCT04052061
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 sensitive disease, the ORR in the SQ cohort was 78% (7 of 9). In the SQ cohort of the 7 who responded, 7 of 7 (100%) responses were complete remissions (CR).
A Leading Immunotherapy Platform in: III. Infectious Diseases
COVID-19 Updated March 2021
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 Addressing the Limitations of First Generation Vaccines hAd5 S + N as the Universal T Cell Boost Antigenic drift Broader protection Protection from Covid-19 mutations. Dual construct approach S+N Quad immunity Enhanced protection Antibody and T cell. Mucosal and systemic immunity Thermally stable Global distribution Distribution by mail. Cold-chain free distribution means global market can be addressed
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
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/10.1101/2020.12.08.416297 Placebo SC + Oral SC Oral Oral Study Day Prime & Boost Vaccination SC + Oral Placebo SC + Oral Placebo Viral Challenge (Day 0) TCID50 1E6 Intratracheal Complete Inhibition of Viral Replication In collaboration with:
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) Human Adenovirus Type 5 (hAd5) Coronavirus Vaccine Candidate: hAd5 S-Fusion + N-ETSD TCELLVACCINE Trial Cancer – 2009-2013 hAd5: Cell Mediated Immunity Focus Cancer CEA - 2010 Multiple Antigens - 2019 Neoepitope - 2019 hAd5 CEA hAd5 CEA hAd5 CEA hAd5 MUC1 hAd5 Brachyury hAd5 Neoepitope hAd5 PSA hAd5 CEA hAd5 MUC1 QUILT Immunotherapy Trials - 2020 hAd5: Cell Mediated Immunity Focus HIV - 2009 SARS-CoV-2 - 2020 INFECTIOUS hAd5 EXPERIENCE CANCER hAd5 EXPERIENCE
Summary Updated March 2021
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-unresponsive NMIBC CIS. Differentiated technology and assets. Best-in-class combined discovery and development platforms for novel therapies and next-generation early-stage candidates across immunotherapy, neoepitopes and molecules enhancing allogenic and autologous NK and T-cell therapies. Cutting-edge cell manufacturing expertise and ready-to-scale facilities. GMP large scale adeno, protein and cell therapy manufacturing capacity. Extensive and seasoned R&D, clinical trial, and regulatory operations and development teams, will together occupy over 400,000 square feet of facilities. Completed merger between ImmunityBio and NantKwest. ImmunityBio has the scale that will allow us to advance development of more novel therapies in oncology and infectious diseases, and accelerate work on ImmunityBio’s unique COVID-19 vaccine.