- Third cohort added to independently evaluate the efficacy of NantKwest’s PD-L1 t-haNK natural killer cells plus ImmunityBio’s IL-15 superagonist AnktivaÔ (N-803) in third-line or greater therapy for patients with locally advanced or metastatic pancreatic cancer.
- Two other cohorts for first-line maintenance and second-line randomized against standards of care chemotherapy.
- 40 patients are currently enrolled in or being evaluated for the Phase 2 trial at three sites.
- Metastatic pancreatic cancer patients treated with PD-L1 t-haNK and Anktiva (N-803) through single-patient Expanded Access INDs continue to have ongoing stable disease and a durable complete response >11 months after initial treatment.
EL SEGUNDO and CULVER CITY, Calif., October 6, 2020 – NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, and ImmunityBio, a privately-held immunotherapy company, today announced they have added a third cohort to their ongoing Phase 2 trial of a novel immunotherapy for locally advanced or metastatic pancreatic cancer. The third cohort enables pancreatic cancer patients who have failed all approved standards of care to participate in the trial.
The randomized, open-label study is evaluating safety and efficacy of a combination immunotherapy comprising NantKwest’s PD-L1 t-haNK, ImmunityBio’s IL-15 superagonist Anktiva (N-803), and aldoxorubicin, plus standard of care. The results will be compared to standard-of-care chemotherapy for first- and second-line treatment; the third-line cohort is a single arm, with no comparator. Each cohort will be studied independently to provide more precise comparative data for each disease stage.
“Pancreatic cancer is one of the deadliest forms of cancer, with a five-year survival rate of just five percent, so new and more effective therapies are desperately needed,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. “By adding the third cohort to this important study, we’re able to enroll patients at all stages of the disease, even those who experience disease progression after the first- or second-line treatment.”
Trial Sites and Enrollment
Currently, three trial sites have been activated: Hoag Memorial Hospital Presbyterian in Orange County, Calif., The Chan Soon-Shiong Institute for Medicine in Los Angeles County, Calif., and Avera McKennan Hospital and University Health Center in Sioux Falls, South Dakota, which will serve patients in the tri-state area (Iowa, Nebraska and South Dakota). Forty patients are currently enrolled in or being evaluated for the trial.
NantKwest and ImmunityBio’s combination immunotherapy is designed to harness the body’s immune system to target, kill, and “remember” cancer cells. The agents in this trial are designed to find pancreatic cancer cells and initiate a large immune response against them. This may allow the body to develop its own antibodies to fight the cancer.
“Our research in pancreatic cancer, as well as many other forms of cancer, is focused on how we can recruit and amplify the power of the human body’s own immune system to target and destroy even the most difficult cancer cells,” said Dr. Soon-Shiong. “Our goal is to attack the disease aggressively so that we can provide more time and a higher quality of life to patients who today have a very poor prognosis.”
This Phase 2, randomized, three-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, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (QUILT-88, NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohort A, Cohort B, and Cohort C, respectively, with cohorts A and B having independent experimental and control arms. The study will initially enroll 298 subjects across all three cohorts. The primary objective of cohorts A and B is progression-free survival (PFS) and the objective of cohort C is overall survival (OS) 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 is the fourth leading cause of cancer-related death in the US, with an estimated 47,050 deaths and 57,600 new cases expected in 2020.1. It is the 12th most common cancer worldwide, with around 338,000 new cases diagnosed in 2012 (2% of all cancer diagnoses).
1.Siegel RL, Miller KD, and Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020;70:7-30
NantKwest (NASDAQ: NK) is an innovative, clinical-stage, immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and 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 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
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 or other critical illnesses, including COVID-19. Risks and uncertainties related to these endeavors include, but are not limited to, obtaining FDA approval of NantKwest’s NK cells and MSC as well as other therapeutics and manufacturing challenges.
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 June 30, 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 late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. The company’s immunotherapy platform activates both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.” This novel approach is designed to eliminate the need for high-dose chemotherapy, improve upon the outcomes of current CAR T-cell therapies, and extend beyond checkpoint inhibitors.
ImmunityBio’s platform is based on the foundation of three separate modalities: antibody cytokine fusion proteins, synthetic immunomodulators, and second-generation human adenovirus (hAd5) vaccine technologies.
AnktivaÔ (ImmunityBio’s lead cytokine infusion protein) is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC). The company is also in Phase 2 or 3 trials for indications such as first- and second-line lung cancer, triple-negative breast cancer, metastatic pancreatic cancer, recurrent glioblastoma, and soft tissue sarcoma in combination with the company’s synthetic immune modulator (aldoxorubicin).
ImmunityBio is also developing therapies, including vaccines, for the prevention and treatment of HIV, influenza, and the coronavirus SARS-CoV-2 with its second-generation human adenovirus (hAd5) vaccine technologies.
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 various diseases, including, but not limited to the novel coronavirus and cancer. 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 and clinical trials.
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.