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| Item 7.01 | Regulation FD Disclosure. |
On June 4, 2021, at 8:30 a.m. PT, ImmunityBio, Inc., a Delaware corporation (the “Company”) will present at the Jefferies Virtual Healthcare Conference (the “Conference”). Dr. Patrick Soon-Shiong, the Company’s Founder and Executive Chairman, will deliver the presentation, and following the presentation, a replay of the live video webcast may be accessed through the “Investor Relations” section of the Company’s website. In addition to Dr. Soon-Shiong, senior management of the Company will be available to discuss the presentation with participants of the Conference after the presentation concludes.
A copy of the slide presentation the Company intends to present at the Conference 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 on Form 8-K is being furnished and 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 on Form 8-K. This Current Report on Form 8-K shall not be deemed an admission as to the materiality of any information in the Current Report on Form 8-K that is required to be disclosed solely by Regulation FD.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit |
Description | |
| 99.1 | ImmunityBio, Inc. Presentation on June 4, 2021 | |
| 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: June 4, 2021 |
By: | /s/ David Sachs | ||||
| Chief Financial Officer | ||||||
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
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 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. Statements of past performance, efforts, or results of our clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performances or results. 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) 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, (ii) whether interim, initial, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data, (iii) our ability to obtain additional financing to fund our operations and complete the development and commercialization of our various product candidates, (iv) uncertainty of the expected financial performance and successful integration 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 period, (v) inability to retain and hire key personnel, and (vi) the unknown future impact of the COVID-19 pandemic delay on certain clinical trials or their 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 presentation, 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 5 Trillion Over 5 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 600+ Worldwide Patents Extending to 2035 and Beyond 100+ Patients Dosed with Off-the-Shelf Natural Killer Cells NK Cells
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
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
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
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 Population – Cohort A (CIS) CR at 12 Months: 58% (95% CI: 42.9%, 71.1%) NCT03022825 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 56 out of 80 CR’s have been reached CR rate at any time 70% (95% CI: 59%, 80%) CR rate confirmed by central review
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 Median Duration of CR in Months (range) 16.2 (0.0+ – 26.8) 19.9 (0.0+ – 26.6) Cystectomy Free Rate % Cystectomy Free 63% 86% 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
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
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 (as of June 2021) Enrolled to Date 30 Alive to Date with Ongoing Follow-Up
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
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 (3 Months)1 haNK + PD-L1 Inhibitor (Avelumab) Median Overall Survival = 8.0 months (95% CI: 5.0, 12.3) NK Synergy in Pancreatic Cancer haNK + PD-L1 inhibitor (Avelumab) in Metastatic Pancreatic Cancer Median Overall Survival 8.0 Months, Doubling Historical Survival Rates 1. Accessed Jan 2020 - Taylor et al. Designing Clinical Trials in 3rd Line or Greater Pancreatic Cancer DOI: 10.1200/JCO.2019.37.4_suppl.226
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. Accessed Jan 2020 - Taylor et al. Designing Clinical Trials in 3rd Line or Greater Pancreatic Cancer DOI: 10.1200/JCO.2019.37.4_suppl.226 2nd Line or Greater Metastatic Pancreatic Cancer Patients (2nd Line or Greater) Ongoing Treatment Median Overall Survival = 13 months
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
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 Metastatic Pancreatic Cancer (QUILT-88) Last Updated June 2021 N = 42 to date 30 Alive to Date with Ongoing Follow-Up 1. Accessed Jan 2020 - Taylor et al. Designing Clinical Trials in 3rd Line or Greater Pancreatic Cancer DOI: 10.1200/JCO.2019.37.4_suppl.226
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 Abstract # 343497 BACKGROUND STUDY ENDPOINTS © 2021 ImmunityBio ASCO Annual Meeting June 2021 REFERENCES Tara Seery1, Chaitali Nangia1, Leonard Sender2, Sandeep Reddy2, Patrick Soon-Shiong2 1Hoag Cancer Center, Newport Beach, CA; 2, ImmunityBio Inc. Culver City, CA. CONTACT info@immunitybio.com 310-883-1300 Main 1. An Antibody Designed to Improve Adoptive NK-Cell Therapy Inhibits Pancreatic Cancer Progression in a Murine Model Jaemin Lee, Tae Heung Kang, Wonbeak Yoo, Hyunji Choi, Seongyea Jo, Kyungsu Kong, Sang-Rae Lee, Sun-Uk Kim, Ji-Su Kim, Duck Cho, Janghwan Kim, Jeong-Yoon Kim, Eun-Soo Kwon and Seokho Kim DOI: 10.1158/2326-6066.CIR-18-0317 Published February 2019 2. Oh E, Min B, Li Y, Lian C, Hong J, Park GM, Yang B, Cho SY, Hwang YK, Yun CO. Cryopreserved Human Natural Killer Cells Exhibit Potent Antitumor Efficacy against Orthotopic Pancreatic Cancer through Efficient Tumor-Homing and Cytolytic Ability (Running Title: Cryopreserved NK Cells Exhibit Antitumor Effect). Cancers (Basel). 2019 Jul 9;11(7):966. doi: 10.3390/cancers11070966. Pancreatic cancer will claim an estimated 47,050 lives in the USA in 2020, with an expected 5 year survival of 10%. Thus there is an urgent need for novel treatment options in this disease. We hypothesize that effective response against pancreatic cancer requires a coordinated approach that orchestrates both the innate and adaptive immune system. We further hypothesize that by orchestrating the activation of the entire immune system, we could accomplish immunogenic cell death with durable responses in this disease. We describe a novel combination immunotherapy protocol of low-dose chemoradiation, cytokine-induced NK and T cell activation via N-803 (Anktiva, IL-15 cytokine fusion protein), and off-the-shelf PDL1-targeted high-affinity NK cell (PDL1 t-haNK) infusion. MAJOR INCLUSION CRITERIA MAJOR EXCLUSION CRITERIA STUDY DESIGN For Cohort A, subjects must have initially received, or are currently receiving, continuous treatment with gemcitabine plus nab-paclitaxel for at least 16 weeks and have confirmed PR, CR, or SD prior to receiving first-line maintenance therapy on this study. Duration of actual initial treatment may be unlimited as long as no evidence of disease progression is noted by the Investigator at the time of randomization. b. For Cohort B, subjects must have PD after receiving initial treatment with FOLFOX, FOLFIRINOX, or a gemcitabine- or paclitaxel-based therapy for pancreatic cancer. Subjects who discontinued prior therapy due to toxicity, intolerance, or available therapy was clinically contraindicated are allowed. c. For Cohort C, subjects must have PD after receiving at least 2 lines of therapy for pancreatic cancer, including but not limited to neoadjuvant, adjuvant, and/or metastatic settings. a. Absolute neutrophil count (ANC) < 1000 cells/mm3. b. Platelet count < 100,000 cells/mm3. Aldoxorubicin HCl, N-803 and PD-L1 t-haNK ImmunityBio, Inc. Clinical Trial Protocol: QUILT-88 Amendment 5 Confidential and Proprietary 10 c. Hemoglobin < 9 g/dL. d. Total bilirubin greater than two times the upper limit of normal (ULN; unless the subject has documented Gilbert’s syndrome). e. Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases). f. Alkaline phosphatase (ALP) levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or > 10 × ULN in subjects with bone metastases). g. Serum creatinine > 2.0 mg/dL or 177 μmol/L. h. Serum anion gap > 16 mEq/L or arterial blood with pH < 7.3. i. Albumin < 3.0. j. Ascites requiring paracentesis. COHORT A COHORT B COHORT C Days 1 and 15, every 4 weeks: • Nab-paclitaxel • Gemcitabine Days 1–5 and 15–19, every 4 weeks: • Cyclophosphamide Days 1, 8, 15, and 22; for first cycle only: • SBRT (not to exceed 8 Gy, exact dose to be determined by the radiation oncologist) Day 8, every 4 weeks: • Aldoxorubicin HCl • N-803 (15 μg/kg SC) Days 1, 8, and 15; every 4 weeks: • PD-L1 t-haNK (~2 × 109 cells/dose IV) STUDY EXPERIMENTAL TREATMENT Primary Efficacy Endpoints: • PFS per RECIST V1.1 (Cohorts A and B). • OS (Cohort C). Secondary Efficacy Endpoints: • ORR, CR rate, DoR, and DCR (confirmed CR or PR, or SD for at least 2 months) by RECIST V1.1 • OS (Cohorts A and B). • PFS per RECIST V1.1 (Cohort C). • QoL by PROs. Safety Endpoints: • Incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. • Safety laboratory tests. • Vital signs. Exploratory Endpoints: • PFS, ORR, CR rate, DoR, and DCR per iRECIST. • CA 19-9 levels and correlations with subject outcomes. Presenting at ASCO 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
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. Not a head to head comparison Phase 1/2: Open-label, Phase 1/2 trial of sacituzumab plus Anktiva and PD-L1 t-haNK for the treatment of subjects with advanced triple-negative breast cancer after prior therapy. TNBC >2 Prior Treatments for Metastatic Disease
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
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
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) Diffuse Large Cell Lymphoma (Ph 1) GBM (Ph 1) Bladder Cancer (Ph 2/3) Pancreatic Cancer (Ph 2/3) TNBC (Ph 1) Lung Cancer (Ph 3) Indolent Non-Hodgkin Lymphoma (Ph 1) Solid Tumors (Ph 1) Liquid Tumors (Ph 1) Cytokine Cytokine Fusion Antibody (IgG1) haNK PD-L1 t-haNK CD19 t-haNK HER2 t-haNK EGFR t-haNK t-haNK Anktiva (N-803) M-ceNK
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) Diffuse Large Cell Lymphoma (Ph 1) GBM (Ph 1) Bladder Cancer (Ph 2/3) Pancreatic Cancer (Ph 2/3) TNBC (Ph 1) Lung Cancer (Ph 3) Indolent Non-Hodgkin Lymphoma (Ph 1) Solid Tumors (Ph 1) Liquid Tumors (Ph 1) Cytokine Cytokine Fusion Antibody (IgG1) haNK PD-L1 t-haNK CD19 t-haNK HER2 t-haNK EGFR t-haNK t-haNK Anktiva (N-803) M-ceNK
Most Clinically Developed Off-the-Shelf NK Cell Therapy: More Patients Dosed with Longer Follow-up in NK Cell Therapy
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 CD16 PD-L1 CD19 HER2 EGFR Clinical Indication Core Cell Line Registrational Merkel Cell* Pancreatic* NSCLC Lymphoma Breast Head & Neck Current Status Universal NK Cell Line Phase II Jan 2019 Phase II June 2020 IND Authorized IND Planned Q4 2021 IND Planned Q3 2021 *Registrational Intent *Registrational Intent NK-92 Universal NK Cell Line First-ever Cell Therapy Engineered with Four Active Anti-tumor Modalities Cleared for U.S. Clinical Investigation
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) Diffuse Large Cell Lymphoma (Ph 1) GBM (Ph 1) Bladder Cancer (Ph 2/3) Pancreatic Cancer (Ph 2/3) TNBC (Ph 1) Lung Cancer (Ph 3) Indolent Non-Hodgkin Lymphoma (Ph 1) Solid Tumors (Ph 1) Liquid Tumors (Ph 1) Cytokine Cytokine Fusion Antibody (IgG1) haNK PD-L1 t-haNK CD19 t-haNK HER2 t-haNK EGFR t-haNK t-haNK Anktiva (N-803) M-ceNK
Liquid Tumors: Indolent Non-Hodgkin Lymphoma (iNHL)
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 minimal toxicity potentially enhances Rituxan mAb therapy with potential for broad application across liquid tumor indications Prolonged duration of disease without progression ranging from 18 to 24 months
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) Diffuse Large Cell Lymphoma (Ph 1) GBM (Ph 1) Bladder Cancer (Ph 2/3) Pancreatic Cancer (Ph 2/3) TNBC (Ph 1) Lung Cancer (Ph 3) Indolent Non-Hodgkin Lymphoma (Ph 1) Solid Tumors (Ph 1) Liquid Tumors (Ph 1) Cytokine Cytokine Fusion Antibody (IgG1) haNK PD-L1 t-haNK CD19 t-haNK HER2 t-haNK EGFR t-haNK t-haNK Anktiva (N-803) M-ceNK
M-ceNK (N=20): 3,000% Cell Expansion with Potent Killing Across Multiple Cell Lines
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, CENK Expansion M-ceNK Drug Substance Production M-ceNK Cryopreservation Potential 2-4 Doses Per Aliquot Potential ~20 Doses of Potent M-ceNK Cells Per Single Apheresis
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 Proliferation NK Enrichment Day 1-16 CD56 CD3 Enhanced NK Cells Autologous Cytokine Enhanced Natural Killer Cells for Transfusion 0.3 – 1.0 x 109 NK Cells Day 17 CD56 CD3 Memory Cytokine Enhanced NK (M-ceNK) Day 1 Cryopreservation For Future Uses First in Human Autologous NK For Solid Tumors M-ceNK: Autologous and Allogeneic Proprietary Process Memory Cytokine Enhanced NK (M-ceNK) Potential ~20 Doses of Potent M-ceNK Cells Per Single Apheresis
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 Healthy Donor N = 15 8 - 27 Billion Cells Per Donor 11 - 16 % CD56+ cells ~3,000% ~20 doses Cancer Patient N = 5 1.4 - 9.9 Billion Cells Per Donor 13 - 49 % CD56+ cells ~300 to ~6,000% ~15 doses Apheresis, MNCs M-ceNK Cytokine Enhanced NK cells (CENK) CD56 IFN-g N-803 Cytokine cocktail including N-803 ~20 days 14 H M-ceNK Intracellular Staining for IFN-g in CD56+ cells CENK
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
M-ceNK a potent killer of cancer cells across multiple solid and liquid tumor types 5/6/2021
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)
M-ceNK Clinical Trial Authorized – NCT04898543 (QUILT 3.076) Phase 1 – First in Human M-ceNK Trial
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
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 & South Africa South Africa South Africa
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 & South Africa South Africa South Africa
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
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 & South Africa South Africa South Africa
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
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 & South Africa South Africa South Africa
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 & South Africa South Africa South Africa
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
Sisonke Universal Boost Trial in South Africa (Phase 1/2) Prime (Ad26) + Boost (hAd5 S-Fusion + N-ETSD)
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
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 antibodies in monkeys Drives immune cells into 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-specific Tetramer-positive CD8+ T cells HIV-Gag-specific Tetramer-positive CD8+ T cells F:EF = Follicular:Extra-Follicular Increased SIV-specific CD8+ T cells in B-cell follicle
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 1University of Minnesota, Minneapolis, MN, 2Altor BioScience, a Nantworks company, Miramar, FL, 3Case Western Reserve University, Cleveland, OH, 4Vaccine Research Center, National Institutes of Health, Bethesda, MD
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 latently infected cells reside
N-803 Decreased Detectable HIV Reservoir in Lymphocytes With ConA Stimulation Measure of the overall size of the inducible reservoir
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 Wilken, Weill Cornell Medicine NCT04340596 46 HIV+ patients randomized to Arm A or B Arm A: N-803 alone txt 8x N-803 Arm B: 2 bNAbs (2x) + N-803 (8x) Trial opened for enrollment (May, 2021) Phase II Thailand Trial: N-803 in Acute HIV Infection Study Chair: Denise C Hsu, MD PhD – Henry M. Jackson Foundation NCT04505501 15 patients: 10 N-803 txt 3x, 5 Placebo 2 enrolled to date
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