EL SEGUNDO, Calif.--(BUSINESS WIRE)--NantKwest, Inc. (Nasdaq: NK), a clinical-stage, natural killer cell-based therapeutics company, and ImmunityBio, a privately-held immunotherapy company, today announced plans for a Phase 2, randomized, open-label study to evaluate the efficacy and safety of their combination immunotherapy: NantKwest’s PD-L1 t-haNK, ImmunityBio’s N-803, and aldoxorubicin HCI plus standard of care, versus standard-of-care chemotherapy for first- and second-line treatment of locally advanced or metastatic pancreatic cancer.
Four metastatic pancreatic cancer patients have been treated with PD-L1 t-haNK and N-803 under single patient INDs, with two patients on treatment for an evaluable period. One patient reported ongoing, durable, complete response six months after treatment, and one observed response of stable disease. The Investigational New Drug (IND) application has received authorization from the U.S. Food and Drug Administration (FDA) with the study anticipated to begin in June 2020.
“Our results from expanded access use of PD-L1 t-haNK in combination with N-803 offer proof-of-concept that, together with these agents, the immune system may play a role to activate robust and durable responses in metastatic cancer patients who have failed all standard-of-care therapies,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. “Based on these encouraging data, we are moving forward with a randomized Phase 2 program that will evaluate our immunotherapy combination on top of standard of care, compared to standard of care alone, in first- and second-line treatment settings. This unique approach to orchestrating the innate and adaptive immune systems to induce immunogenic cell death may be an important new approach for pancreatic cancer patients—these being among the most challenging to treat with poor prognoses.”
“Abraxane, a protein-based nanoparticle that activates macrophages, was our first evolution in making an impact on pancreatic cancer. With this addition of PD-L1 t-haNK and N-803, we are hopeful that we can proceed to the next step of long-term remission in this difficult to treat disease. Adding a natural killer cell with a checkpoint via PD-L1 t-haNK and activating memory T cells via N-803 will complete the ‘triangle offense’ we are orchestrating. The early results of complete response in one patient using the therapy on a compassionate use basis is encouraging and we are excited to initiate this trial involving other patients who suffer from pancreatic cancer,” he said.
This Phase 2, randomized, two-cohort, open-label study will evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with PD-L1 t-haNK, N-803, and aldoxorubicin HCl in subjects with locally advanced or metastatic pancreatic cancer (QUILT-88). Each treatment setting, and first- and second-line or later maintenance, will be evaluated independently as Cohort A and Cohort B, respectively, with each Cohort having independent experimental and control arms. The study will initially enroll 268 subjects across both cohorts with the primary objective of comparative efficacy by progression free survival (PFS) per RECIST V1.1. Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS).
Pancreatic cancer kills an estimated 47,000 people annually; it is the fourth leading cause of cancer-related death in the U.S., and 57,600 new cases are expected in 2020. Less than 5% of these patients will live for more than five years after diagnosis, and the median survival prognosis is 5 to 8 months.
NantKwest (NASDAQ: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally-induced infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized activated NK cells—as well as their activity against a broad range of cancers—has been tested in Phase I clinical trials in Canada and Europe, as well as in multiple Phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwest’s goal is to transform medicine by delivering off-the-shelf living drugs-in-a-bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit www.nantkwest.com
haNK is a registered trademark of NantKwest, Inc.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that NantKwest will be successful in improving the treatment of cancer. Risks and uncertainties related to this endeavor include, but are not limited to, obtaining FDA approval of NantKwest’s NK cells, as well as other therapeutics, as part of the NANT Cancer Vaccine platform as a cancer treatment.
Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.
These and other risks regarding NantKwest’s business are described in detail in its Securities and Exchange Commission filings, including in NantKwest’s Quarterly Report on Form 10-Q for the Quarter ended March 31, 2020. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.
ImmunityBio, Inc. is a privately held immunotherapy company with a broad portfolio of biological molecules at clinical stages of development. The Company’s goals are to employ this portfolio to activate endogenous Natural Killer (NK) and CD8+ T cells in the fields of cancer and infectious disease. Specifically, in regards to cancer, ImmunityBio’s goal is to develop a memory T-cell cancer vaccine to combat multiple tumor types—without the use of high-dose chemotherapy. Regarding infectious disease, the Company is addressing HIV, influenza, and the coronavirus SARS-CoV-2.
The Company’s first-in-human platform of technologies has enabled it to achieve one of the most comprehensive, late-stage clinical pipelines, activating both the innate (natural killer cell) and the adaptive immune systems. The product pipeline includes an albumin-linked chemotherapeutic (Aldoxorubicin), a novel IL-15 cytokine superagonist (N-803), checkpoint inhibitors, macrophage polarizing peptides, bi-specific fusion proteins targeting TGFb and IL-12, adenovirus, and yeast vaccine therapies targeting tumor-associated antigens and neoepitopes.
In December 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to N-803 for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC). Other indications currently at registration-stage trials include BCG-unresponsive papillary bladder cancer, first- and second-line lung cancer, and metastatic pancreatic cancer.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that ImmunityBio will be successful in improving the treatment of cancer, the novel coronavirus, and other diseases. Risks and uncertainties related to this endeavor include, but are not limited to, the company’s beliefs regarding the success, cost, and timing of its development activities, clinical trials and obtaining regulatory approval.
Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.