The Leading Late Stage Immunotherapy Companies
Harnessing Immunogenic Cell Death
JP Morgan Healthcare Conference
January 14, 2020
1
GENERAL DISCLAIMER
Not all product candidates and/or services referenced in these slides are proprietary to NantKwest or ImmunityBio and may be owned or controlled by third parties, including their affiliates.
FORWARD-LOOKING STATEMENTS
These slides and the accompanying oral presentation contain forward-looking statements within the meaning of the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, that are based on
management's beliefs and assumptions and on information currently available to our management. Forward-looking statements include, but are not limited to:
- our ability to pioneer immunotherapy, harness the power of the innate immune system, implement precision cancer medicine and change the current paradigm of cancer care;
- our expectations regarding the potential benefits of our strategy and technology;
- our ability to utilize multiple modes to induce cell death;
- our beliefs regarding the benefits and perceived limitations of competing approaches, and the future of competing technologies and our industry;
- our beliefs regarding the success, cost and timing of our product candidate development activities and clinical trials;
- the timing or likelihood of regulatory filings or other actions and related regulatory authority responses, including any planned investigational new drug (IND) filings or pursuit of accelerated regulatory approval pathways or orphan drug status and breakthrough therapy designations;
- our ability to implement an integrated discovery ecosystem and the operation of that planned ecosystem;
- our expectations regarding our ability to utilize the Phase I aNK clinical trial data to support the development our other product candidates;
- our ability to produce an"off-the-shelf" therapy;
- our beliefs regarding the potential manufacturing and distribution benefits associated with our product candidates, and our ability to scale up the production of our product candidates;
- our ability to obtain and maintain intellectual property protection for our product candidate and not infringe upon the intellectual property of others;
- the ability and willingness of strategic collaborators, including certain of our affiliates, to share our vision and effectively work with us to achieve our goals;
- the ability and willingness of various third parties to engage in research and development activities involving our product candidates, and our ability to leverage those activities; and
- regulatory developments in the United States and foreign countries.
Factors that could cause our results to differ materially from those expressed in forward-looking statements include, without limitation:
- the fact that our business is based upon the success of aNK cells as a technology platform and the success ofN-803 and the other product candidates;
- our aNK platform and other product candidate families, including genetically modified taNK, haNK andt-haNK product candidates, will require significant additional clinical testing;
- even if we successfully develop and commercialize our aNK product candidates orN-803, we may not be successful in developing and commercializing our other product candidates either alone or in combination with other therapeutic agents;
- we may not be able to file INDs, to commence additional clinical trials on timelines we expect;
- we will need to obtain substantial additional financing to complete the development and any commercialization of our product candidates; and
- risks associated with our ability to enforce intellectual property rights.
Forward-looking statements include statements that are not historical facts and can be identified by terms such as "anticipates," "believes," "could," "seeks," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would," or similar expressions and the negatives of those terms.
Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other risks regarding our business are described in detail in NantKwest's Securities and Exchange Commission filings. We encourage you to review NantKwest's SEC filings in order to understand these risks. These forward-looking statements speak only as of the date thereof, and we disclaim any obligation to update these statements except as may be required by law. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date of this presentation.
Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. No representation or warranty, express or implied, is given as to the completeness or accuracy of the information or opinions contained in this document and we do not accept any liability for any direct, indirect or consequential loss or damage arising from reliance on such information or opinions. Past performance should not be taken as an indication or guarantee of future performance. You should read this presentation completely and with the understanding that our actual future results may be materially different from what we expect.
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 2 |
The Cross Talk of the Immune System in Cancer
Inducing Immunogenic Cell Death
Cancer
Cell
TregTumorMDSCs
Microenvironment
M2 Macrophages
Off-the-Shelf NK Cell
Natural Killer | Cross Talk | |
(NK) Cell | ||
NKG2D |
E2b Deleted Adenovirus
Dendritic Cell
IL-15 Fusion Protein
Cross Talk | Memory Killer | |
T Cell | ||
TCR |
NASDAQ: NK
NK Cell - Born to Kill:
Nature's Killer Cell
Innate Immune System
Dendritic Cell - The Trainer: | T Cell - Trained to Kill: |
Nature's Trainer Cell | Nature's Targeted Killer |
The Cross Talk Between | Adaptive Immune System |
ImmunityBio, Inc.Innate & Adaptive Immune SystemConference 2020 | 3 |
ASCO 2019: Seminal Discovery by NANT of Neoepitope Silencing
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 4 |
ASCO 2019: Seminal Discovery by NANT of Neoepitope Silencing
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 5 |
The NANT Discovery of the Tumors Ability to Evade & Silence the Immune System
Tumor's Defense
Hide
Suppress
Disable
Metastasize
Cancer
ASCO 2019
Treg | MDSCs |
M2 Macrophages
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 6 |
Next Generation Immunotherapy
The NANT Cancer Vaccine
The Path to Complete Remission:
Unleashing the Triangle Offense of Killer Cells
Cancer
TregTumorMDSCs
Microenvironment
Triangle Offense
Immunomodulate the Tumor Itself as a Vaccine (DAMPs) and Transform the Microenvironment to Overcome Suppression (Metronomic Therapy)
Expose | M2 | ||||||
Unleash | Triangle Offense: Simultaneous Activation of NK, Dendritic and T Cells | ||||||
Kill | |||||||
Temporal Spatial Orchestration | |||||||
Complete | of NK & T Cells Towards | ||||||
Remission | Crosstalk | Immunogenic Cell Death | |||||
Natural Killer | |||||||
Dendritic Cell | |||||||
Memory Killer | |||||||
(NK) Cell | |||||||
The Trainer: | T Cell | ||||||
Born to Kill: | |||||||
Trained to Kill: | |||||||
Nature's Trainer Cell | |||||||
Nature's Killer Cell | Nature's Targeted Killer | ||||||
The Cross Talk Between | |||||||
Innate Immune System | Adaptive Immune System | ||||||
Innate & Adaptive Immune System | |||||||
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 7 |
1990 - 2017:Identified and Developed Key
First-in-Class Agents Driving Immunogenic Cell Death
1990 | 1992 | 2015 | 2015 | 2017 | 2017 |
Abraxane (Nab-Paclitaxel) | NK-92:Off-The-Shelf NK | E2b Deleted Adenovirus | N-803IL-15 Fusion Protein | Aldoxorubicin | Nanatinostat |
Transcytosis to the | Activated NK Cell Line Without | Genomically Informed | Activation of NK & | Transcytosis to the | Epigenetic Activation |
Tumor Microenvironment | Inhibitory Receptors | Dendritic Cell | Memory T Cells | Tumor Microenvironment | of MHC1 |
Activation of M2 Macrophages | DAMP Activator |
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 8 |
1990 - 2017:Key First-in-Class Immunogenic Cell Death Agents
2016:Announce Cancer Breakthroughs 2020
2017:Obtain FDA Authorization to Test Novel-Novel Immunological Combinations - QUILT
The NANT Cancer Vaccine: The Triangle Offense
2017 - 2019: Demonstrate Early Signals of Durable Complete Remission
2020 - 2023: Forecast for FDA Approvals in Multiple Tumor Types
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 9 |
Cancer Breakthroughs 2020:
Phase I / II Trials to Test the Hypothesis of the "Triangle Offense"
in Multiple Tumor Types (2014 - 2019)
Eleven (11) I/O Agents
3 I/O Agents | |||||||||||||
Two (2) I/O Agents | haNK | PD-L1t-haNK | |||||||||||
N-803 | N-803 | N-803 | N-803 | N-803 | N-803 | N-803 | N-803 | ||||||
BCG | Rituxumab | aNK | BCG | Pembro/Nivo | Pembro | Avelumab | Aldoxorubicin | ||||||
1 | st | Line | 2nd& 3rdLine | nd | rd | nd | 3rdLine | st | nd | rd | 2ndLine | ||
2 | & 3 Line | 2 Line | Checkpoint | 1 Line | 2 | & 3 Line | Metastatic | ||||||
NMIBC | iNHL | Merkel Cell | NMIBC | Relapse | Metastatic | Merkel Cell | Pancreatic | ||||||
Bladder | Carcinoma | Bladder | NSCLC | Carcinoma | |||||||||
NSCLC | Cancer | ||||||||||||
QUILT-2.005 | QUILT-3.002 | QUILT-3.009 | QUILT-3.032 | QUILT-3.055 | QUILT-2.023 | QUILT-3.063 | spIND | ||||||
Fast Track | Phase 1 / 2 | Phase 2 | Breakthrough | Pivotal | Pivotal | Pivotal | spIND | ||||||
Phase 2* | Phase 2* | Phase 2* | Phase 2* | Phase 2* | |||||||||
NCT02138734 | NCT02384954 | NCT02465957 | NCT03022825 | NCT03228667 | NCT03520686 | NCT03853317 | spIND | ||||||
InitiationDateMay 2014 | Mar 2015 | Jun 2015 | Jan 2017 | Jul 2017 | May 2018 | Feb 2019 | Sep 2019 |
Five (5) I/O Agents
Ad-CEA | Ad-CEA |
Ye-Ras | Ye-Ras |
aNK | haNK |
N-803 | N-803 |
Avelumab | Avelumab |
2nd& 3rdLine | 2nd& 3rdLine |
Metastatic | Metastatic |
Pancreatic | Pancreatic |
Cancer | Cancer |
QUILT-3.039 | QUILT-3.060 |
Phase Ib / II | Phase Ib / II |
NCT03136406 | NCT03329248 |
May 2017 | Nov 2017 |
Six (6)
I/O Agents
Aldoxorubicin
Ad-CEA
Ye-Ras
aNK
N-803
Avelumab
2nd& 3rdLine
Metastatic
Pancreatic
Cancer
QUILT-3.070
Phase Ib / II
NCT03387098
Dec 2017
Ten (10)
I/O Agents
Ad-MUC1
Ad-Brachy
Ye-Brachy
Ye-CEA
Aldoxorubicin
Ad-CEA
Ye-Ras
haNK
N-803
Avelumab
3rdLine
Metastatic
TNBC
QUILT-3.067
Phase Ib / II
NCT03387085
Dec 2017
Ad-HER2 | Ad-HER2 | Ad-HER2 |
Ad-MUC1 | Ad-MUC1 | Ad-MUC1 |
Ad-Brachy | Ad-Brachy | Ad-Brachy |
Ye-Brachy | Ye-Brachy | Ye-Brachy |
Ye-CEA | Ye-CEA | Ye-CEA |
Aldoxorubicin | Aldoxorubicin | Aldoxorubicin |
Ad-CEA | Ad-CEA | Ad-CEA |
Ye-Ras | Ye-Ras | Ye-Ras |
haNK | haNK | haNK |
N-803 | N-803 | N-803 |
Avelumab | Avelumab | Avelumab |
3rd Line | 3rdLine | 2nd& 3rdLine |
Metastatic | Metastatic | |
Metastatic | ||
Randomized | Pancreatic | |
Head & Neck | ||
Colorectal | Cancer | |
QUILT-3.090 | QUILT-3.071 | QUILT-3.080 |
Phase Ib / II | Phase Ib / II | Phase Ib / II |
NCT03387111 | NCT03563157 | NCT03586869 |
Dec 2017 | Jun 2018 | Jul 2018 |
1/14/2020 | ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 10 |
Cancer Breakthroughs 2020:
Evidence of Early Signals of Durable Complete Remission in Multiple Tumor Types
59 out of 105 (56%) Complete Responses in 7 Tumor Types | ||||||||||||||||||||
69 out of 161 (41%) Overall Response Rate in 8 Tumor Types | ||||||||||||||||||||
Ten (10) | ||||||||||||||||||||
I/O Agents | ||||||||||||||||||||
Ad-MUC1 | ||||||||||||||||||||
Ad-Brachy | ||||||||||||||||||||
Ye-Brachy | ||||||||||||||||||||
Six (6) | Ye-CEA | |||||||||||||||||||
I/O Agents | ||||||||||||||||||||
Five (5) I/O Agents | Aldoxorubicin | Aldoxorubicin | ||||||||||||||||||
Ad-CEA | Ad-CEA | Ad-CEA | Ad-CEA | |||||||||||||||||
Ye-Ras | Ye-Ras | Ye-Ras | Ye-Ras | |||||||||||||||||
3 I/O Agents | ||||||||||||||||||||
Two (2) I/O Agents | aNK | haNK | aNK | |||||||||||||||||
haNK | PD-L1t-haNK | haNK | ||||||||||||||||||
N-803 | N-803 | N-803 | N-803 | N-803 | N-803 | N-803 | N-803 | N-803 | N-803 | N-803 | ||||||||||
N-803 | ||||||||||||||||||||
BCG | Rituxumab | aNK | BCG | Pembro/Nivo | Pembro | Avelumab | Aldoxorubicin | Avelumab | Avelumab | Avelumab | Avelumab | |||||||||
st | nd | rd | nd | 3rdLine | st | nd | rd | 2ndLine | 2nd& 3rdLine | 2nd& 3rdLine | 2nd& 3rdLine | |||||||||
1 | Line | 2nd& 3rdLine | rd | |||||||||||||||||
2 | & 3 Line | 2 Line | Checkpoint | 1 Line | 2 | & 3 Line | Metastatic | Metastatic | Metastatic | Metastatic | 3 Line | |||||||||
NMIBC | iNHL | Merkel Cell | NMIBC | Relapse | Metastatic | Merkel Cell | Pancreatic | Pancreatic | Pancreatic | Pancreatic | Metastatic | |||||||||
Bladder | Carcinoma | Bladder | NSCLC | Carcinoma | TNBC | |||||||||||||||
NSCLC | Cancer | Cancer | Cancer | Cancer | ||||||||||||||||
QUILT-2.005 | QUILT-3.002 | QUILT-3.009QUILT-3.032QUILT-3.055QUILT-2.023 | QUILT-3.063 | spIND | QUILT-3.039 | QUILT-3.060 | QUILT-3.070 | QUILT-3.067 | ||||||||||||
Pivotal | ||||||||||||||||||||
Fast Track | Phase 1 / 2 | Phase 2 | Breakthrough | Pivotal | Pivotal | spIND | Phase Ib / II | Phase Ib / II | Phase Ib / II | Phase Ib / II | ||||||||||
Phase 2* | Phase 2* | Phase 2* | Phase 2* | Phase 2* | ||||||||||||||||
NCT02138734 | NCT02384954 | NCT02465957 | NCT03022825 | NCT03228667 | NCT03520686 | NCT03853317 | spIND | NCT03136406 | NCT03329248 | NCT03387098 | NCT03387085 | |||||||||
Complete | Complete | Complete | Complete | Durable | Durable | Complete | Complete | |||||||||||||
Initiation | Response | Response | Response | Response | Response | Response | Feb 2019 | Response | May 2017 | Nov 2017 | Dec 2017 | Dec 2017 | ||||||||
Date | May 2014 | Mar 2015 | Jun 2015 | Jan 2017 | Jul 2017 | May 2018 | Sep 2019 | |||||||||||||
Response |
Eleven (11) I/O Agents
Ad-HER2 | Ad-HER2 | Ad-HER2 | |
Ad-MUC1 | Ad-MUC1 | Ad-MUC1 | |
Ad-Brachy | Ad-Brachy | Ad-Brachy | |
Ye-Brachy | Ye-Brachy | Ye-Brachy | |
Ye-CEA | Ye-CEA | Ye-CEA | |
Aldoxorubicin | Aldoxorubicin | Aldoxorubicin | |
Ad-CEA | Ad-CEA | Ad-CEA | |
Ye-Ras | Ye-Ras | Ye-Ras | |
haNK | haNK | haNK | |
N-803 | N-803 | N-803 | |
Avelumab | Avelumab | Avelumab | |
3rd Line | 3rdLine | 2nd& 3rdLine | |
Metastatic | Metastatic | ||
Metastatic | |||
Randomized | Pancreatic | ||
Head & Neck | |||
Colorectal | Cancer | ||
QUILT-3.090 | QUILT-3.071 | QUILT-3.080 | |
Phase Ib / II | Phase Ib / II | Phase Ib / II | |
NCT03387111 | NCT03563157 | NCT03586869 | |
Durable | |||
Complete | Jun 2018 | ||
DecResponse2017 | Jul 2018 | ||
Response |
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 11 |
Cancer Breakthroughs 2020:
Evidence of Early Signals of Durable Complete Remission in Multiple Tumor Types
NK & T Cell Activator
N-803
Complete & Durable Responses in
Advanced Metastatic Disease Across Multiple Tumor Types
59 out of 105 (56%) Complete Responses in 7 Tumor Types
Off-the-Shelf
Natural Killer Cell Line
haNK
PD-L1t-haNK
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 12 |
Cancer Breakthroughs 2020:
Evidence of Early Signals of Durable Complete Remission in Multiple Tumor Types
Complete & Durable Responses in | |||
Advanced Metastatic Disease Across Multiple Tumor Types | |||
Indication | Responses | Duration of Response Chemotherapy Free | |
NK & T Cell Activator | |||
BCG Naïve Bladder Cancer (Phase I) | 9 / 9 CR | > 24 Months | |
N-803 | |||
Off-the-Shelf
Natural Killer Cell Line
haNK
PD-L1t-haNK
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 13 |
Bladder Cancer - Complete Response in 9 of 9 Patients
Phase I | Phase I (N=9) |
NCT02138734 | A Study of Intravesical BCG in Combination With N-803 in |
QUILT 2.005 | Patients With Non-Muscle Invasive Bladder Cancer |
N-803 + BCG in High-Risk NMIBC - Phase IResults
Durable Complete Responses (CR) or No Recurrence (NR) in 9 out of 9 Patients
Dose | Patient | Stage | Response Assessments | |||||||
(intravesicular | W12 | 6M | 9M | 12M | 15M | 18M | 21M | 24M | ||
instillation) | ||||||||||
1 | Pap T1 | CR* | CR | CR | CR | CR | CR | CR | CR | |
100 μg | ||||||||||
2 | Pap Ta | CR* | CR | CR | CR | CR | CR | CR | CR | |
3 | Pap T1 | CR* | CR | CR | CR | CR | CR | CR | CR | |
4 | Pap T1 | IC | CR* | CR | CR | CR | CR | CR | CR | |
200 μg | ||||||||||
5 | CIS | IC | IC | IC | CR | CR | CR | CR | CR | |
6 | Pap T1 | CR* | CR | CR | CR | CR | CR | CR | CR | |
7 | Pap T1 | CR* | CR | CR | CR | CR | CR | CR | CR | |
400 μg | ||||||||||
8 | CIS | CR* | CR | CR | CR | CR | CR | CR | CR** | |
9 | Pap Ta | CR* | CR | CR | CR | CR | CR | CR | CR | |
9 of 9 (100%) Patients Disease-Free at 24 Months
BCG naïve alone (SoC): Historical response rate is 55-75% at 3-6 months post BCG alone
Based on this data, FDA granted Fast Track Designation to the Pivotal Trial
*CR termed as No Recurrence (NR) in Papillary Disease **Negative Cystoscopy Inconclusive Cytology
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 14 |
Cancer Breakthroughs 2020:
Evidence of Early Signals of Durable Complete Remission in Multiple Tumor Types
Complete & Durable Responses in
Advanced Metastatic Disease Across Multiple Tumor Types
Indication | Responses | Duration of Response Chemotherapy Free |
NK & T Cell Activator
N-803 | |||
BCG Unresponsive CIS Bladder Cancer (Phase II) | 34 / 46 CR | 3 - 29 Months | |
& Ongoing | |||
Off-the-Shelf
Natural Killer Cell Line
haNK
PD-L1t-haNK
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 15 |
Breakthrough Designation
Registrational Trial in BCG Unresponsive CISNMIBC
2ndLine N-803 + BCG
Indication and Tumor | Design | Patients | CR Rate | Cystectomy | Safety & |
Type | Enrolled | Avoidance | Tolerability | ||
2ndLine | Single Arm: | 55 / 80 | 73% | 89% | 1% |
BCG Unresponsive | BCG + N-803 | Complete | Cystectomy | with treatment | |
to Date | |||||
CIS | N = 80 | Response | Free | related SAEs | |
16
Breakthrough Designation
Registrational Trial in BCG Unresponsive CISNMIBC
2ndLine N-803 + BCG Compared to Pembro December Approval
Drug | Patients | CR any | CR 3 | CR 6 | CR 9 | CR 12 | ||||
time | months | months | months | months | ||||||
N-803 + BCG | 55 | 73% | Ongoing Study | |||||||
CI (57%, 85%) | ||||||||||
Dec 2019 | ||||||||||
Local Therapy - 1% Adverse Events
Pembro | 96 | NA | 41% | NA | NA | 20% |
Systemic Therapy | CI (25%, 51%) | CI (16%, 33%) | ||||
Systemic Therapy - >10% Adverse Events
Cancer Breakthroughs 2020:
Evidence of Early Signals of Durable Complete Remission in Multiple Tumor Types
Complete & Durable Responses in
Advanced Metastatic Disease Across Multiple Tumor Types
Indication | Responses | Duration of Response Chemotherapy Free |
NK & T Cell Activator
N-803
3rdLine Relapsed & Refectory Checkpoint
Non-Small Cell Lung Cancer
Off-the-Shelf
Natural Killer Cell Line
haNK
PD-L1t-haNK
10 / 56 ORR
2 - 45 Months
& Ongoing
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 18 |
Metastatic Non-Small Cell Lung Cancer (NSCLC)
N-803 in Combination with Nivolumab in 3rdLine or Greater Patients
Relapsed and Refractory to Nivo or Chemo
Efficacy | All Patients | PD-L1 ≥ 50% | |
Enrolled | |||
Endpoint | (n=16) | ||
(n=56) | |||
Median | 3.5 Months | 4.5 Months | |
Progression | |||
(2.7, 5.1) | (1.4, 8.5) | ||
Free Survival | |||
Median Overall | 13.4 Months | 17.1 Months | |
Survival | (9.6, 19.5) | (4.6, Ongoing) | |
Overall | 18% | 38% | |
Response Rate | |||
Stable Disease | 45% | 38% | |
Disease | 63% | 75% | |
Control Rate | |||
Jan 12, 2020: Presented, Plenary
Session: Sixth AACR-IASLC
International Joint Conference: Lung Cancer Translational Science from the Bench to the Clinic
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 19 |
N-803 When Combined with Nivo Appears to Reduce AE's
Associated with Checkpoint Inhibitors
Comparison of Immune Related AEs in 2ndLine Treatment of NSCLC
Agent | Trial | Immune Related AEs |
Grade 3 or higher | ||
Nivo + N-803 | NCT02523469 | 7% |
Nivo Alone | Checkmate 57 | ~14% |
Pembro Alone | Keynote 10 | ~15% |
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020
Cancer Breakthroughs 2020:
Evidence of Early Signals of Durable Complete Remission in Multiple Tumor Types
Complete & Durable Responses in
Advanced Metastatic Disease Across Multiple Tumor Types
Indication | Responses | Duration of Response Chemotherapy Free |
NK & T Cell Activator
N-803
3rdLine Merkel Cell Carcinoma | 2 / 7 CR |
31 - 46 Months
& Ongoing
Off-the-Shelf
Natural Killer Cell Line
haNK
PD-L1t-haNK
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 21 |
Phase I/II: Complete Response in Merkel Cell CarcinomaWho Failed Checkpoints & Previous Chemotherapy
10/2014 | 12/2014 | 01/2015 | 04/2015 | 06/2015 | ||||||
First consultation at UW, Seattle | After RT plus IFN plus Imiquimod | Recurrent MCC nodules on | anti-PD-1 after 12 weeks of | Enrolled on a clinical | ||||||
scalp in RT fields. Started anti- | pembrolizumab | trial of intralesional | ||||||||
PD-1 (pembrolizumab) for | Pembrolizumab discontinued | TLR-4 agonist plus RT | ||||||||
unresectable MCC | due to progressive disease | |||||||||
07/2015 | 12/2015 | 03/14/2016 | 03/30/2016 | 06/21/2016 | 09/01/2016 |
Received neutron RT to scalp | Recurrent MCC tumors on | Enrolled on aNK trial | Day 14 | Day 99 | Day 171 |
and B/L neck tumors. | scalp. | Baseline Day 01 | No New Lesions | No New Lesions | |
First Infusion on 03/15/2016 | Since 03/14/2016 | Since 03/14/2016 |
22
Durable Complete Response in Merkel Cell Carcinoma
aNK alone | Treatment Initiation - August 2016 |
No Treatment Since July 2019 | |
followed by | Durable Complete Response 42 Months and Ongoing |
Checkpoint | Patient alive and disease free to date |
(1,258 Days: 3.5 Years - As of Jan 11, 2020) |
Page 23
Cancer Breakthroughs 2020:
Evidence of Early Signals of Durable Complete Remission in Multiple Tumor Types
Complete & Durable Responses in
Advanced Metastatic Disease Across Multiple Tumor Types
Indication | Responses | Duration of Response Chemotherapy Free |
NK & T Cell Activator
N-803
Indolent Non-Hodgkin Lymphoma
Off-the-Shelf
Natural Killer Cell Line
haNK
PD-L1t-haNK
10 / 21 CR
10 - 26 Months
& Ongoing
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 24 |
Relapsed Indolent Non-Hodgkin's Lymphoma Phase 1/2 Clinical Trial of N-803 Plus Rituximab
IL15N72D | Best Response | SubQ (N=9) | ||
15Ra | Rel/ref | CR | 7 (78%) | |
+ | ||||
Indolent | PR | 0 (0%) | ||
IgG1Fc | Non-Hodgkin | |||
Lymphoma | ||||
N-803 | ORR | 7 (78%) | ||
rituximab | ||||
(IL-15 Super | ||||
Agonist Complex) | (anti-CD20 mAb) | SD | 2 (22%) | |
78% CR Rate | ||||
PD | 0 (0%) | |||
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020
Cancer Breakthroughs 2020:
Evidence of Early Signals of Durable Complete Remission in Multiple Tumor Types
Complete & Durable Responses in
Advanced Metastatic Disease Across Multiple Tumor Types
Indication | Responses | Duration of Response Chemotherapy Free |
NK & T Cell Activator
N-803
Off-the-Shelf | 4thLine Head & Neck Cancer | 1 / 4 CR | 7 Months | Metronomic Low Dose |
Natural Killer Cell Line | ||||
haNK
PD-L1t-haNK
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 26 |
5thLine Relapsed Head and Neck Cancer
Patient: 3090-001-002
Pre-Treatment
5thLine
Complete Response in 5th
Line Metastatic Head & Neck
Cancer After 2 Cycles
Complete Remission Post
Cancer Memory Vaccine
Treatment
After 2-Cycles
5 cm
Tumor Mass
Failed Radiation,
Chemo, Checkpoint
(5thLine)
Complete
Response
CT SCAN
Complete
Response
CT SCAN
PET SCAN
5 cm
Tumor Mass
Failed Radiation, Chemo,
Checkpoint
(5thLine)
Tumor Mass Completely
Resolved After 60 Days
(2 Cycles, July 15, 2018)
Unpublished Data | ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 27 |
Cancer Breakthroughs 2020:
Evidence of Early Signals of Durable Complete Remission in Multiple Tumor Types
Complete & Durable Responses in
Advanced Metastatic Disease Across Multiple Tumor Types
Indication | Responses | Duration of Response Chemotherapy Free |
NK & T Cell Activator
N-803
Off-the-Shelf
Natural Killer Cell Line
haNK | 3rdLine Triple Negative Breast Cancer | 2 / 9 CR |
PD-L1t-haNK
9 - 12 Months | Metronomic Low Dose |
& Ongoing | |
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 28 |
% Change from Baseline
Jan 11, 2020 | |
3rdLine Triple Negative Breast Cancer | |
Best Response by Resist 1.1 | |
20% | 20% Progression |
X002 | ORR: PR*+ CR: 5 / 9 (56%) |
X004 | |
0% | Complete Response: 2 / 9 (22%) |
X003 | |
Disease Control: 7 / 9 (78%) |
-20% | SD 006 | |
-30% Partial Response | ||
PR 003 | ||
-40% | X010 | X001 |
-60%
Legend | ||||||||||
Stable Disease | ||||||||||
-80% | Partial Response | |||||||||
CR 008 | Complete Response | |||||||||
Withdrew | ||||||||||
-100% | CR 009 | X = Off-Study | ||||||||
Baseline | Scan 1 | Scan 2 | Scan 3 | Scan 4 | Scan 5 | Scan 6 | Scan 7 | |||
2 Months | 4 Months | 6 Months | 8 Months | 10 Months | 12 Months | 14 Months |
Presented at 2019 San Antonio Breast Cancer Symposium
As of Jan 2020
Encouraging Efficacy Signals with Combination Therapy
KEYNOTE-086
QUILT-3.067
NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.
9 out of 170 patients responded | |||||||
(5.3% ORR) | 5 (2 CR + 3 PR) out of 9patients responded | (56% ORR) | |||||
2 out of 170 patients had complete response | (1.2% CR) | 2 out of 9 patients had complete response | (22% CR) | ||||
13 out of 170 patients had disease control | (7.6% DCR) | 7 out of 9 patients had disease control | (78% DCR) | ||||
ImmunityBio, Inc. & NantKwest Inc. | - JP Morgan Healthcare Conference 2020 | 30 | |||||
Cancer Breakthroughs 2020:
Evidence of Early Signals of Durable Complete Remission in Multiple Tumor Types
59 out of 105 (56%) Complete Responses in 7 Tumor Types 69 out of 161 (41%) Overall Response Rate in 8 Tumor Types
Complete & Durable Responses in
Advanced Metastatic Disease Across Multiple Tumor Types
Indication | Responses | Duration of Response Chemotherapy Free |
NK & T Cell Activator
N-803
Off-the-Shelf
Natural Killer Cell Line
haNK
PD-L1t-haNK
2ndLine Metastatic Pancreatic Cancer
1 / 9 CR
2 Months | Metronomic Low Dose |
& Ongoing | |
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 31 |
PD-L1t-haNK (Tumor Targeted High Affinity NK)
First In Human PD-L1Off-the-Shelf NK
- haNK cells engineered to incorporate CARs to target cancer cells displaying specific surface antigens
- Three modes of killing: via NK receptors, ADCC, and CAR directed killing
- ADCC andCAR-directed cytotoxicity are independent but synergistic
- Currently in Development:
o | PD-L1t-haNK | Phase I Complete |
o | CD19 t-haNK | IND Approved |
o | HER2 t-haNK | IND Ready |
1/14/2020 | HER2 taNK | 32 |
2ndLine Metastatic Pancreatic Cancer | |||
Complete Response After Five PD-L1t-haNK | |||
Liver Metastasis | Infusions with N-803 | ||
July 12, 2019 | |||
5000 | Positive PET CT | ||
Relapse FOLFIRI | |||
4500 | |||
9-CA19
4000 | CA19-9 Level decreases from 4584 to 50 |
3500 | |
3000
2500
2000
1500
November 14, 2019 | Dec 30, 2019 | ||||||||||||||||||||
1000 | Complete Response | ||||||||||||||||||||
PET CT | Confirmed Complete Response | ||||||||||||||||||||
500 | PD-L1t-haNK | N-803 | PET CT | ||||||||||||||||||
0 | |||||||||||||||||||||
8/12/19 | 8/19/19 | 8/26/19 | 9/2/19 | 9/9/19 | 9/16/19 | 9/23/19 | 9/30/19 | 10/7/19 | 10/14/19 | 10/21/19 | 10/28/19 | 11/4/19 | 11/11/19 | 11/18/19 | 11/25/19 | 12/2/19 | 12/9/19 | 12/16/19 | 12/23/19 | 12/30/19 | 1/6/20 |
Chemo Modulation | Chemo Modulation | Chemo Modulation |
N-803 | N-803 | |
PD-L1t-haNK | PD-L1t-haNK | |
Aldoxorubicin |
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 33 |
Cancer Breakthroughs 2020:
Evidence of Early Signals of Durable Complete Remission in Multiple Tumor Types
59 out of 105 (56%) Complete Responses in 7 Tumor Types 69 out of 161 (41%) Overall Response Rate in 8 Tumor Types
NK & T Cell Activator
N-803
Off-the-Shelf
Natural Killer Cell Line
haNK
PD-L1t-haNK
Complete & Durable Responses in
Advanced Metastatic Disease Across Multiple Tumor Types
Indication | Responses | Duration of Response | Chemotherapy Free | |
BCG Naïve Bladder Cancer (Phase I) | 9 | / 9 CR | > 24 Months | |
BCG Unresponsive CIS Bladder Cancer (Phase II) | 34 | / 46 CR | 3 - 29 Months | |
& Ongoing | ||||
3rdLine Relapsed & Refectory Checkpoint | 10 / 56 ORR | 2 - 45 Months | ||
Non-Small Cell Lung Cancer | & Ongoing | |||
3rdLine Merkel Cell Carcinoma | 2 | / 7 CR | 31 - 46 Months | |
& Ongoing | ||||
Indolent Non-Hodgkin Lymphoma | 10 | / 21 CR | 10 - 26 Months | |
& Ongoing | ||||
4thLine Head & Neck Cancer | 1 | / 4 CR | 7 Months | Metronomic Low Dose |
3rdLine Triple Negative Breast Cancer | 2 | / 9 CR | 9 - 12 Months | Metronomic Low Dose |
& Ongoing | ||||
2ndLine Metastatic Pancreatic Cancer | 1 | / 9 CR | 2 Months | Metronomic Low Dose |
& Ongoing | ||||
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 34 |
1990 - 2017:Key First-in-Class Immunogenic Cell Death Agents
2016:Announce Cancer Breakthroughs 2020
2017:Obtain FDA Authorization to Test Novel-Novel Immunological Combinations - QUILT
The NANT Cancer Vaccine: The Triangle Offense
2017 - 2019: Demonstrate Early Signals of Durable Complete Remission
2020 - 2023: Forecast for FDA Approvals in Multiple Tumor Types
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 35 |
Cancer Breakthroughs 2020:
Phase I / II Trials to Test the Hypothesis of the "Triangle Offense" in Multiple Tumor Types
Albumin Bound
Tumor DAMP Inducer
Epigenetic Tumor
Modifier
NK & T Cell Activator
Off-the-Shelf
Natural Killer Cell Line
Unique Adenovirus
Dendritic Cell Activator
FDA Interactions and Authorizations
2017 | 2018 | 2019 | 2017-2019 | |
Formal Interactions with FDA | 135 | 268 | 278 | 681 |
INDs Authorized by FDA | 13 | 2 | 3 | 18 |
Pivotal Studies with | 4 | 1 | 2 | 7 |
Registrational Intent | ||||
spINDs Issued | 11 | 26 | 38 | 75 |
Investigator-initiated(II)-INDs | 5 | 2 | 14 | 21 |
Issued | ||||
Fast Track Designations | 2 | 0 | 1 | 3 |
Breakthrough Therapy | 0 | 0 | 1 | 1 |
Designation | ||||
FDA Approval | 0 | 0 | 1 | 1 |
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 36 |
Tumor Types and Indications Treated
Tumor Type | Number of Indications |
Non-Small Cell Lung Cancer (NSCLC) | 4 |
Colon | 2 |
Head & Neck Squamous Cell Carcinoma | 2 |
Indolent Non-Hodgkin's Lymphoma | 2 |
Merkel Cell Carcinoma (MCC) | 2 |
Non-Muscle Invasive Bladder Cancer (NMIBC) | 2 |
Ovarian | 2 |
Pancreatic | 2 |
Prostate | 2 |
Albumin Bound
Tumor DAMP Inducer
Epigenetic Tumor
Modifier
NK & T Cell Activator
Off-the-Shelf
Natural Killer Cell Line
Tumor Types & Indications
Studied (2017 - 2020)
Number of Tumor Types | 36 | |
Number of Indications | 48 | |
Triple Negative Breast Cancer (TNBC) | 2 |
Acute Myeloid Leukemia (AML) | 1 |
Adenoid Cystic Carcinoma | 1 |
Burkitt Lymphoma | 1 |
Carcinosarcoma | 1 |
Cervical | 1 |
Cholangiocarcinoma | 1 |
Chordoma | 1 |
Clear Cell Sarcoma | 1 |
Esophageal | 1 |
Ewing Sarcoma | 1 |
Gastric | 1 |
Glioblastoma | 1 |
Inflammatory Breast Cancer | 1 |
Intravascular Angiosarcoma | 1 |
Laryngeal Squamous Cell Carcinoma | 1 |
Medullary Carcinoma | 1 |
Melanoma | 1 |
Mesothelioma | 1 |
Myelodysplastic Syndrome (MDS) | 1 |
Osteosarcoma | 1 |
Progressive Multifocal Leukoencephalopathy (PML) | 1 |
Rectal | 1 |
Renal Cell Carcinoma (RCC) | 1 |
Unique Adenovirus
Dendritic Cell Activator
Rhabdomyosarcoma | 1 |
Small Cell Lung Cancer (SCLC) | 1 |
Spindle Cell Sarcoma | 1 |
36 Total Tumor Types | 48 Total Indications |
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 37 |
Cancer Breakthroughs 2020:
Phase I / II Trials to Test the Hypothesis of the "Triangle Offense" in Multiple Tumor Types
Peer Review Publications 2017 - 2019
Albumin Bound
Tumor DAMP Inducer
Epigenetic Tumor
Modifier
NK & T Cell Activator
Off-the-Shelf
Natural Killer Cell Line
Unique Adenovirus
Dendritic Cell Activator
Publications | ||
Aldoxorubicin | 15 | |
Nanatinostat | 1 | |
N-803 | 23 | |
Natural Killer Cells | 15 | |
(aNK, haNK, PD-L1t-haNK) | ||
Adenovirus | 4 | |
GPS Cancer & Neoepitope | 39 | |
Total | 94 | |
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 38 |
Selected Key Publications
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 39 |
Cancer Breakthroughs 2020:
Phase I / II Trials to Test the Hypothesis of the "Triangle Offense" in Multiple Tumor Types
Albumin Bound
Tumor DAMP Inducer
Epigenetic Tumor
Modifier
Clinical Trial Sites & Investigators Activated (2016 - 2019)
- 206Clinical Trial Sites Activated
- 206Investigators
- 20Clinical Trials Actively Enrolling
- 41States
NK & T Cell Activator
Off-the-Shelf
Natural Killer Cell Line
Unique Adenovirus
Dendritic Cell Activator
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 40 |
Off the Shelf Natural Killer Cells as a Product:
World's Largest Production and Clinical Infusion of Natural Killer Cells
3.3 Trillion Cells Manufactured
Off-the-Shelf
Natural Killer Cell Line
1.6 Trillion Cells in Storage
Off-the-Shelf Natural Killer Cells
Linearly Scalable
By the Numbers:
aNK / haNK / PD-L1t-haNK | 2017 - 2019 |
Number of Cells Manufactured in | 3.3 Trillion Cells |
GMP Facility to Date | |
Number of Patients Dosed | 53 |
as Outpatient | |
Number of Doses Administered | 719 |
(>2 Billion Cells Per Dose) | |
Number of Cells Administered to 53 | 1.5 Trillion Cells |
Patients Since 2017 | |
Number of Cells in Storage | 1.6 Trillion Cells |
NK Treatment Related | Zero |
Cytokine Storm | |
Off-the-Shelf Engineered NK-92
aNK, haNK, PD-L1t-haNK
Ready for Transfusion
Cryopreserved Off-the-Shelf
NK Product
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare Conference 2020 | 41 |
Cancer Breakthroughs Forecast for Next Four Years
Anticipated BLA Registration Filings 2020 - 2024
Tumor Types & Indications | Filing Date | NANT Agents | # of | # of Patients | |||||||||
Forecast | Sites | Accrued to Date | |||||||||||
ImmunityBio | ImmunityBio | NantKwest | |||||||||||
Bladder Cancer: BCG Unresponsive | 2020 | 35 Active Sites | FDA Breakthrough | ||||||||||
Complete | NMIBC CIS | N-803 | 55 / 80 | ||||||||||
Bladder | Response | ||||||||||||
Bladder Cancer: BCG Unresponsive | 2021 | 35 Active Sites | FDA Fast Track | ||||||||||
NMIBC Papillary | N-803 | 40 / 80 | |||||||||||
Bladder Cancer: BCG Naive | 2023 | 32 Active Sites | FDA Fast Track | ||||||||||
NMIBC CIS | N-803 | 49 / 366 | |||||||||||
Non-Small Cell Lung Cancer: | 2021 | 25 Active Sites | 19 / 55 | ||||||||||
Durable | Checkpoint Relapsed 2 | nd | Line | N-803 | |||||||||
Response | Non-Small Cell Lung Cancer: | 2021 | 25 Active Sites | 8 / 43 | |||||||||
Lung | Checkpoint Relapsed 3rdLine | N-803 | |||||||||||
Non-Small Cell Lung Cancer: | 2021 | To Be Opened | 0 / 55 | ||||||||||
Durable | PD-L1 Expression Second Line | N-803 | PD-L1t-haNK | ||||||||||
Response | Non-Small Cell Lung Cancer: | 2023 | 28 Active Sites | 11 / 388 | |||||||||
PD-L1 Expression 1st | Line | N-803 | |||||||||||
TNBC | Triple Negative Breast Cancer | ||||||||||||
2022 | To Be Opened | 0 / 43 | |||||||||||
Complete | rd | Line | N-803 | Aldox | PD-L1t-haNK | ||||||||
Response | 3 | ||||||||||||
MCC | Merkel Cell Carcinoma: | ||||||||||||
2023 | 3 Active Sites | 1 / 43 | |||||||||||
Complete | Checkpoint Relapsed, 2ndLine | N-803 | haNK | ||||||||||
Response | |||||||||||||
Panc | Response | Metastatic Pancreatic Cancer | 2024 | N-803 | Aldox | PD-L1t-haNK | To Be Opened | 0 / 188 | |||||
2 | Line | ||||||||||||
Complete | nd | ||||||||||||
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan | Total Patients Accrued To Date = 183 / 1341 | 42 |
1990 - 2017:Key First-in-Class Immunogenic Cell Death Agents Identified
2016:Announced Cancer Breakthroughs 2020 | |
2017:Obtained FDA Authorization to Test Novel-Novel-Novel Immunological Combinations | |
2017 - 2019:39 INDs Authorized with >200 Investigator Sites in 41 States | |
94 Peer Reviewed Scientific Publications | |
The Triangle Offense, QUILT Trials Completed with Over 1 Trillion NK Cells Infused | |
Combination Therapy Tested in 36 Tumor Types in 48 Indications | |
Tumor Mutation Burden for Tumor-Normal Tissue: First FDA Approval in US - Omics Core | |
Demonstrated Early Signals of Durable 59 Complete Remissions out of 105 Solid Tumors in Multiple Diseases | |
2020 - 2023: Forecast for FDA Approvals in Multiple Tumor Types | |
Breakthrough Status Achieved for Bladder Cancer | |
7 Active Registration Trials in Bladder, Lung, and Merkel Cell Cancer | |
NantKwest & ImmunityBio to Integrate Platforms of NK Cells, N-803 and Aldoxorubicin | 43 |
ImmunityBio, Inc. & NantKwest Inc. - JP Morgan Healthcare onference 2020 |
The Cross Talk of the Immune System in Cancer
Inducing Immunogenic Cell Death
Cancer
Cell
TregTumorMDSCs
Microenvironment
M2 Macrophages
Off-the-Shelf NK Cell
Natural Killer
(NK) Cell
E2b Deleted Adenovirus
Cross Talk | Dendritic Cell |
IL-15 Fusion Protein
Cross Talk | Memory Killer |
T Cell | |
PD-L1t-haNK | N-803 |
NASDAQ: NK
NK Cell - Born to Kill:
Nature's Killer Cell
Innate Immune System
Dendritic Cell - The Trainer: | T Cell - Trained to Kill: |
Nature's Trainer Cell | Nature's Targeted Killer |
The Cross Talk Between | Adaptive Immune System |
ImmunityBio, Inc.Innate & Adaptive Immune SystemConference 2020 | 44 |
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NantKwest Inc. published this content on 14 January 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 January 2020 20:52:02 UTC