On January 16, 2020 NantKwest, Inc. and ImmunityBio, Inc. reported an update of the Cancer Breakthrough 2020 Initiative (the "Initiative") and findings on the preliminary safety and early signals of efficacy in Phase 1 and 2 trials for multiple tumor types at the 2020 J.P. Morgan Healthcare Conference on January 14, 2020 in San Francisco (Press release, NantKwest, JAN 16, 2020, View Source [SID1234553289]).

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"We hypothesized that a common treatment protocol that harnesses both the natural-killer cell and T cells could be effective in inducing immunogenic cell death leading to durable responses across multiple tumor types. We are grateful for the support of the FDA and over 200 investigators in 41 states who have been involved in testing this hypothesis in cancer patients with advanced disease," said Soon-Shiong. "The number of patients who experienced a complete remission in this advanced setting is encouraging and further validates our premise that high-dose chemo is harmful and that a paradigm change of exposing the tumor to a carefully orchestrated ‘triple triangle offense’ of NK cell, Dendritic cell and T-cell activation, is a safe cellular and immunotherapy regimen and can be administered in the outpatient setting with promising activity across multiple tumor types. Testing this hypothesis has been the basis of the QUILT trials since 2017."

Dr. Soon-Shiong first announced the Initiative, whose goal is to create a new standard of care for a wide range of cancers, at the 2016 J.P. Morgan Healthcare Conference. The Initiative has made significant progress based on research and clinical trials in the following areas:

Obtained 39 Investigational New Drugs (IND) authorizations from the FDA from 2017 to 2019 to undertake Phase 1 and 2 trials across multiple tumor types to assess safety and efficacy with 10 first-in-human immunotherapy agents as single agents and in novel combinations;
Activated 206 clinical trial sites and over 200 investigators in 41 states since 2016, with 20 clinical trials actively enrolling;
Tested combination immunotherapy of Natural Killer (NK) cells, checkpoint inhibitors, and fusion proteins, with over 700 doses of off-the-shelf NK cells (representing over a trillion NK cells) safely administered as outpatient therapy to 53 patients since 2017;
Chemotherapy-free responses noted in patients with bladder cancer, lung cancer, Merkel cell cancer, and Non-Hodgkin’s Lymphoma;
Phase 2 studies ongoing with over 100 patients with non-small lung cancer and over 200 patients with Bladder Cancer studied to date;
Reported novel, first-in-human immunotherapy agents and genomic tumor-normal tests in 94 peer reviewed scientific publications including The Lancet, Cancer Immunology Research, Nature Communications and Blood;
Phase 1 clinical trials were completed for more than ten first-in-human, first-in-class immunotherapy agents. These trials were designed to activate both the innate (NK) and adaptive (T cell) immune systems and were expanded through compassionate use access across 36 different tumor types in over 350 patients;
FDA authorized NantHealth’s Omics Core℠, the first custom targeted whole exome sequencing platform, utilizing solution-phase exon capture and sequencing, to report somatic alterations (point mutations, small insertions and deletions) in 468 genes and sequencing of 19,396 protein-coding genes (whole exome) to determine overall tumor mutation burden (TMB) in tumor specimens, TMB is an important test for immunotherapy treatment;
Breakthrough Therapy Designation awarded by the FDA in December, 2019 for N-803, IL-15 superagonist that is designed to activate NK and memory T cells for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer; and
Based on the safety and efficacy data of the Phase 1 trial in 11 patients with metastatic pancreatic cancer who had received haNK and N-803, an expanded access regime trial incorporating N-803 with PD-L1.t-haNK was authorized to study a patient with metastatic pancreatic cancer who had failed standard of care. After five infusions of PD-L1.t-haNK and N-803, the patient’s tumor metastasis resolved completely per CT/PET scan and the complete response has been confirmed by a repeat CT/PET scan. NantKwest expects to report this patient’s progress, as well as report data from the full 11 metastatic pancreatic patients enrolled in Quilt 3.064 in 2020.
Interim results of initial signals of safety and efficacy in these Phase 1 and 2 studies in advanced cancers were reported at multiple scientific conferences, including The Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 2018 and 2019 conferences, with complete responses noted in third-line Merkel cell carcinoma and fourth-line head and neck cancer patients who received combination immunotherapy, including NantKwest’s haNK CD-16 NK cells combined with Pfizer’s PD-L1 antibody, Avelumab, and with ImmunityBio’s N-803, IL-15 superagonist. In addition, the company reported complete responses using the same combination in Triple Negative Breast Cancer and observed durable complete responses in these patients who had failed all standards of care for breast cancer. The results were presented at the 2019 San Antonio Breast Cancer Symposium (SABCS) in December 2019. Most recently, exciting data of long duration response was presented at a plenary session at the AACR (Free AACR Whitepaper) meeting on January 2020. In this Phase 2 trial patients with lung cancer who had relapsed on checkpoint therapy were then administered the same checkpoint but with the addition of N-803. In the patients with high PDL1 non-small lung cancer who had relapsed on checkpoint therapy, 38 percent responded to the combination of N-803 plus the same checkpoint, with the duration of response still ongoing as long as 3 years to date.

A recording of the presentation and slides from the 2020 J.P. Morgan Healthcare Conference can be viewed on the NantKwest and ImmunityBio websites, www.NantKwest.com and www.Immunitybio.com

About Cancer Breakthrough 2020

The Cancer Breakthroughs 2020 program, which is one of the most comprehensive cancer initiatives launched to date, seeks to accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients by inducing immunogenic cell death and thereby avoiding the adverse effects of high dose chemotherapy. This national collaborative initiative aims to explore a new paradigm in cancer care by initiating single-arm and randomized Phase 2 trials in patients at all stages of disease in multiple tumor types by 2020. The findings from these initial studies will inform the pursuit of registration trials for FDA approval and provide the scientific underpinnings to develop an effective immunotherapy using the tumor itself as a source of vaccine antigens to combat cancer by 2025.