New haNK and T-haNK Based Natural Killer Cell Therapy Programs to Transition to Human Clinical Trials in 2019
CULVER CITY, CA – April 1, 2019 – NantKwest (Nasdaq:NK), a leading clinical-stage, natural killer cell based therapeutics company, today announced that the Company has been issued a new patent that further expands the Company’s foundational natural killer cell-therapeutics platform intellectual property estate. This new patent builds upon NantKwest’s extensive existing patent estate and broadens the Company’s established intellectual property combining haNK natural killer cell therapy together with antibody therapy.
This novel engineered haNK cell product represents the core foundational element of the Company’s haNK therapeutics program.
The patent, EP2801583, issued by the European Patent Office, “Genetically Modified Human Natural Killer Cell,” includes a key composition claim directed to NantKwest’s proprietary haNK cells that have been engineered to express a high affinity Fc receptor (FcyRlll-A), also described as CD16, in combination with an antibody that specifically binds to an antigen expressed by a cancer or infected cell.
The engineering of CD16 into an aNK cell forms the basis of a haNK natural killer cell and cements the ability of haNK cells to mediate antibody dependent cellular cytotoxicity (ADCC). ADCC is an important and highly desirable therapeutic capability, as the therapeutic effectiveness of five of the most widely used antibody drugs in clinical use have shown dependence on ADCC which can be potentially enhanced when used in combination with the Company’s haNK cell therapy. These five antibody therapies include: Avelumab, targeting the PD-L1 checkpoint in solid tumors; cetuximab, targeting EGFR in solid tumors; rituximab, targeting CD20 in hematological malignancies; and trastuzumab and pertuzumab targeting HER2 in breast cancer.
Having completed initial human clinical safety testing and safely administering over 300 infusions as a cryopreserved, “off-the-shelf” ready-to-use therapy, clinical programs that incorporate haNK cell therapy including our Merkel cell carcinoma trial, recently authorized by the FDA, which is a novel combination study that incorporates three synergistic therapeutic agents consisting of (1) avelumab, an antibody therapy targeting PD-L1 that is a well validated therapeutic target, expressed in a large percentage of cancer cells; (2) N-803, a novel, superagonist, IL-15 cytokine-based immune stimulating agent that the Company has co-exclusive worldwide rights to under the terms of a co-development agreement; and (3) haNK natural killer cells, which are intended to enhance the existing cancer cell killing activities of avelumab, while also contributing to the direct cancer cell killing effects of haNK natural killer cell therapy. These three agents are intended to synergistically enhance the targeting and elimination of cancer cells.
In addition, currently in advanced development utilizing the haNK technology platform include two clinical candidates transitioning from the Company’s t-haNK program. A t-haNK is a haNK natural killer cell additionally engineered to include an antigen-targeting, single chain antibody fragment (sc-Fv). These two t-haNK clinical candidates include a PD-L1 t-haNK therapy targeting solid tumors such as lung cancers and a CD19 t-haNK therapy targeting hematological malignancies. Both of these programs are anticipated to transition to human clinical trials in 2019.
Commenting on this landmark patent award, Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest stated, “We are pleased to announce the issuance of this important new patent covering our haNK natural killer cell technology platform in the European Union, further expanding our worldwide natural killer cell therapy intellectual patent estate. We continue to focus on enhancing our intellectual property rights associated with the Company’s natural killer cell based therapeutics platform while also seeking to innovate in order to maintain and expand our strong proprietary position in the field of NK cell based immunotherapies. Our haNK cell therapy program represents a core foundational program and we are committed to bringing this innovation in next generation cell therapy to cancer patients as rapidly as possible.”
In addition to clinical applications of our haNK and t-haNK cell products, this newly issued patent furthers NantKwest’s exclusive rights for the use of these CD16 expressing haNK cells in ADCC based laboratory testing of monoclonal antibodies that are intended for commercial applications. These cells are made available for non-clinical applications through its affiliate and exclusive licensee, Brink Biologics.
For more information regarding NantKwest, please visit www.nantkwest.com.
About NantKwest Inc.
NantKwest, a member of the NantWorks ecosystem of companies, is 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 and virally induced infectious diseases.
NantKwest is uniquely positioned to implement precision cancer medicine, with the potential to change the current paradigm of cancer care. Natural Killer (NK) cells are a safeguard in the human body designed to recognize and detect cells under stress due to cancer or viral infection. NantKwest’s “off-the-shelf” activated NK cell platform is designed to destroy cancer and virally infected cells from the body. The safety of our NK cells as well as their activity against a broad range of cancers have 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. In addition to being a universal cell-based therapy that does not require individualized patient sourcing or matching, our NK cell products have been largely administered in the outpatient setting as an “off-the-shelf” living drug.
With the capacity to grow active killer cells as a living cancer therapy, our NK cells have been designed to induce cell death against cancers and virally infected cells by several mechanisms, including: (i) innate killing, whereby all of our NK platforms recognize the stress proteins typically found on cancer cells, which, upon binding, release toxic granules to immediately kill their targets; (ii) antibody-mediated killing with our haNK® platform, which are NK cells engineered to express antibody receptors that can bind to therapeutic antibody products, thereby enhancing the cancer cell killing effect of that antibody; and (iii) Chimeric Antigen Receptor directed killing using the taNK® platform, which includes NK cells engineered to incorporate chimeric antigen receptors (CARs) to target tumor-specific antigens found on the surface of cancer cells. All three modes of killing (innate, antibody-mediated, and CAR directed killing) are employed by our t-haNK™ platform, which is an innovative combination of our aNK, haNK® and taNK® platforms in a single product.
Our haNK®, and t-haNK™ platforms have been designed to address certain limitations of CAR T-cell therapy including the capability to infuse cell therapy in an outpatient setting which allows for potential reduction of risk for serious cytokine storms and protracted serious adverse events. In Phase I and II clinical trials in patients with late stage cancer, our NK cells have been administered as an investigational outpatient infusion safely with greater than 300 infusions to date at a dose of 2 billion cells per infusion.
By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, we believe NantKwest is uniquely positioned to be the premier immunotherapy company and transform medicine by delivering living drugs in a bag and bringing novel NK cell-based therapies to routine clinical care.
NK-92, aNK, haNK, taNK, and t-haNK are trademarks 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 the Company 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 our 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 our business are described in detail in our Securities and Exchange Commission filings, including in our Annual Report on Form 10-K for the year ended December 31, 2018. 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.