On March 19, 2020 NantKwest, Inc. (Nasdaq: NK), a next-generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer and infectious diseases, reported dosing of the first patient in a Phase 2 trial for second- and third-line Merkel cell carcinoma (MCC) in patients who are refractory to immune checkpoint inhibitors (Press release, NantKwest, MAR 19, 2020, https://ir.nantkwest.com/news-releases/news-release-details/nantkwest-doses-first-patient-phase-2-single-arm-trial?field_nir_news_date_value[min]= [SID1234555710]). The trial will evaluate the Company’s first-in-class, off-the-shelf CD16-targeted natural killer (haNK) cells in combination with ImmunityBio’s IL-15 superagonist N-803 and Avelumab.
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MCC is a rare and aggressive skin cancer that arises from uncontrolled growth of cells in the skin. Increasing in incidence, approximately 2,500 new cases are reported in the U.S. each year. Patients with metastatic or locally advanced MCC have an extremely poor prognosis, with less than 20% of patients surviving longer than five years. Typically, these patients are treated with a range of drugs, including chemotherapy, which can result in significant side effects. Although new immune therapies have the potential to improve survival, Merkel cell carcinoma is still fatal for a majority of patients who have progressed on or after treatment with a checkpoint inhibitor and represents an unmet medical need.
"With over 70% of patients failing checkpoint inhibitors in solid tumors, it is vital to develop novel and effective therapeutic options," said Patrick Soon-Shiong, M.D., chairman and CEO of NantKwest and ImmunityBio. "Checkpoint and CAR-T therapies only target the T cell, which is a small portion of effector killer cells, and often result in substantial side effects. These side effects make those therapies unusable for many patients. Our combination therapy is designed to activate the innate immune system to create an immunological memory against tumors, resulting in immunogenic cell death."
"We have now established the first-in-class, cryopreserved CD16 NK-92 cell line, which can be manufactured under GMP conditions at scale. Having accomplished this development and manufacturing milestone in the field of NK cell therapy, we are actively pursuing pivotal trials for our CD16 NK-92 products haNK and PD-L1 t-haNK," continued Soon-Shiong.
The single-arm study will involve 43 patients who failed all standard of care treatments for MCC, including checkpoint therapy (QUILT-3.063; NCT03853317). Clinical trial sites are currently being activated.
"Single-arm studies allow us to offer patients who have no other approved treatment options the opportunity to participate in a potential treatment for this rare and deadly disease without fear of receiving a placebo drug," said John Lee, M.D., senior vice president of adult medical affairs at NantKwest. "Our past study using our non-targeted aNK cells showed clinical responses either alone or in combination with N-803. The current study builds on this approach using a PD-L1 antibody that will bind to the high affinity CD16 receptor on haNK cells to potentially help target PD-L1 tumor cells. The N-803 superagonist has been shown to enhance the body’s NK and T cells to also help attack the tumor cells. The goal of this work is to provide real hope for these patients using the power of our combination therapies."