New haNK and T-haNK Based Natural Killer Cell Therapy Programs to Transition to Human Clinical Trials in 2019
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
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.
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.
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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
NK-92, aNK, haNK, taNK, and t-haNK are trademarks of
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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
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