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Billionaire Controlled Biotech IND Approved For NK Cell Therapy to Enter Clinical Trials

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NantKwest launches the first engineered, GMP-grade, cryopreserved, off-the-shelf, bi-specific NK cell therapy to enter human clinical trials targeting PD-L1 and CD16 in patients with solid tumors.

As reported in its press release, NantKwest established a leading portfolio of off-the-shelf NK cells at the clinical stage of development with three engineered KN92 cells in trials: CD16 targeted hank, CD19/CD16 targeted t-haNK and now PD-L1/CD16 targeted t-haNK.

The Summary

Nk reports itself as a pioneering, next generation, a clinical-stage immunotherapy company focused on harnessing the unique power of the human immune system using national killer (NK) cells to treat cancer, infectious diseases, and other diseases. Today they announced that the company’s PD-L1 t-haNK investigational new drug application (IND) has cleared FDA review and the program has now transitioned to a first-in-human clinical trial in patients with locally advanced metastatic solid tumors.

PD-L1

Programmed death-ligand 1 (PD-L1) is a transmembrane protein that plays a major role in suppressing the immune system in many cancer patients. The binding of PD-L1 to the inhibitory checkpoint molecule PD-1 establishes an inhibitory signal that reduces the proliferation of antigen-specific T-cells while also reducing apoptosis in suppressive regulatory T cells (Tregs) that further inhibits immune responses.

t-haNK Cell Therapy

NantKwest’s PD-L1 t-haNK cell therapy is a novel, NK cell-based immune-oncology therapy that includes a PD-L1 based Chimeric Antigen Receptor (CAR) engineered into the company’s proprietary hank NK cell, which also includes the high-affinity variant of the CD16 receptor (V158 FcyIIIa) to mediate antibody-dependent cellular cytotoxicity (ADCC). Together, the use of this targeted, bi-specific, next-generation PD-L1 t-haNK therapy has been shown in preclinical studies to significantly enhance cancer cell killing and improve overall response rates.

Dr. Patrick Soon-Shiong Speaks

Dr. Patrick Soon-Shiong is a well known Southern California-based billionaire biotech entrepreneur. He noted “In just a few short weeks since announcing the FDA clearance of our first bi-specific engineered NK cell therapy clinical trial using a CD19 t-haNK targeting patients in lymphoma, we are now pleased to announce that the FDA has authorized the company to go forward with our second bi-specific NK cell therapy clinical trial using a PD-L1 t-haNK targeting patients with solid tumors.” Dr. Soon-Shiong continued “We plan to synergistically combine a wide range of immunotherapy molecules with our proprietary, multi-targeted, off-the-shelf NK cell therapy, in this case, a PD-L1 t-haNK to explore the unique therapeutic potential of interesting both the innate and adaptive immune systems to achieve durable complete remissions. Based on the FDA clearance, we look to rapidly transition this program to a Phase I human clinical trial designed to assess the safety, tolerability, and efficacy of PD-L1 t-haNK cell therapy in patients with solid tumors. Upon completion of this safety phase, NanKwest intends to combine this PD-L1 t-haNK cell therapy with other immunomodulatory agents including NabFc-N802, a IL 15 cytokine superagonist and Adenovirus/yeast vectors delivering tumor-associated and neoantigens, as part of an integrative, combination therapy designed to further enhance the therapeutic effectiveness of this novel NK cell-based therapeutic intervention, which we describe as our NANT Cancer Memory Vaccine.”

PD-L1 t-haNK

NantKwest’s PD-L1 t-haNK cell therapy is designed to provide precise tumor-cell specificity through the use of a CAR construct that utilizes a PD-L1-specific scFv (single chain antibody fragment) engineered into the company’s proprietary haNK NK cell that includes the high affinity variant of the CD16 receptor (V158 FcγRIIIa) to mediate antibody-dependent cellular cytotoxicity (ADCC). In preclinical studies, cytotoxicity of these GMP-grade cryopreserved PD-L1 t-haNK cells was comprehensively evaluated against a panel of cancer cell lines with different levels of PD-L1 expression in vitro and in vivo, with these studies showing increased activity and selective cytotoxicity toward a wide range of PD-L1-expressing tumor cells.

About NantKwest

A publicly traded venture, NantKwest positions itself as an innovative clinical-stage immunotherapy company focused on harnessing the power of the innate immune system by using the natural killer cell to treat cancer, infectious diseases, and inflammatory diseases.

NantKwest states it is uniquely positioned to implement precision cancer medicine, with the potential to change the current paradigm of cancer care. Natural Killer cells are ancient cells in the human body designed to recognize and detect cells under stress or infected. The NantKwest “off-the-shelf” activated Natural Killer (NK) platform is designed to destroy cancer and virally infected cells from the body. The safety of their NK cells, as well as their activity against a broad range of cancers, have been tested in multiple phases 1 clinical trial in the United States, Canada, and Europe. In addition to their NK cells capability to be administered in the outpatient setting as an “off-the-shelf” living drug, it serves as a universal cell-based therapy without the need for individualized patient matching. Moreover, our NK cell-based platform has been bioengineered to incorporate chimeric antigen receptors (CARs) and antibody receptors to potentially further optimize targeting and potency in the therapeutic disease.

Finances a Challenge but a Billionaire Backer

A publicly traded concern since 2015, the finances do not look great. With a market capitalization of $103.1 million, revenues are minuscule and losses total about $86 million The company has about $98 million cash and a stock price of $1.05 per share. Although publicly traded, it is a thinly traded company and the majority (64.8%) of the stock is controlled by Dr. Soon-Shiong.

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