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NKORE'S UNIQUE, PATENTED NK CELL ACTIVATION METHOD RENDERS scNK CELLS MORE POTENT BY EXHANCING THE CYTOTOXIC FUNCTION OF PRIMARY NK CELLS

NKore BioTherapeutics LLC has licensed a portfolio of patents from UCLA that includes a proprietary method of activating or “supercharging” allogeneic or autologous Natural Killer cells (scNK cells).  Our activation method makes the scNK cells significantly more potent by enhancing the cytotoxic function of primary NK cells and increasing the secretion of functional gamma interferon to induce the differentiation of those cancer stem and stem-like cells in the tumor microenvironment that avoid cell death.  The novel mechanism of action of these cells combine to slow or reverse the progression of disease and reduce the metastatic potential of the remaining tumor cells.  In addition to being more potent, the scNK cells are significantly more robust to survive longer in the suppressive tumor microenvironment and have demonstrated the potential to restore normal immune function in vivo.

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Immunotherapy: Supercharged NK Cells™

 

Our therapeutic approach was developed by Anahid Jewett, Ph.D., Professor and Director of the Tumor Immunology Laboratory in the Division of Oral Biology and Medicine at UCLA.  In preclinical trials that have included over 350 humanized BLT (hu-BLT) mice, the scNK cells have proven to be very effective in treating numerous forms of cancer, including glioblastoma, melanoma, oral, and pancreatic.  In addition, through a clinical trial collaboration in China, the scNK cells were used to treat a patient with non-Hodgkin’s lymphoma.  Six months post-treatment the patient was reported to be healthy and in remission (Covid-19 precluded additional follow up).  The treatment was a single infusion of allogeneic Supercharged NK Cells™.

 

In addition, in in vitro studies, Dr. Jewett has found that OVCAR8 ovarian tumor cells, a non-serous cancer, will not differentiate (and, therefore, have high metastatic potential), but are highly susceptible to scNK cell mediated cytotoxicity.  OVCAR8 is a very aggressive form of ovarian cancer with low survival rates when diagnosed in later stages (as most are), and, to our knowledge, there are currently no effective treatment options.  While additional studies are necessary to confirm these findings, we believe that our Supercharged NK Cells™ may provide a highly effective new treatment option for patients with OVCAR8 ovarian cancer. 

 

Unique Safety Profile:

 

Unlike T cells, the use of NK cells in cancer treatment have shown:

  • No evidence of cytokine release syndrome (CRS);

  • No graft versus host disease (GvHD);

  • No adverse neurological symptoms;

  • No signs of toxicity or adverse side effects noted in mice injected with the scNK cells; and

  • No signs of toxicity or adverse side effects noted in Chinese patient injected with scNK cells.

 

Diagnostics:

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In addition to the activation method for the Supercharged NK Cells™, our IP portfolio includes a robust diagnostic testing platform to measure the cellular function of the immune system for the development of better personalized treatment plans.  These tests will determine the ability of peripheral blood mononuclear cells, NK cells, and CD8+ T cells to respond to the activation and signaling through different cytokines and receptor triggering.  Together, these tests will allow us to establish a baseline to evaluate immune response and quantify changes in metabolic function during treatment to assist the physician in tailoring the treatment protocols to the patient.  In addition to these tests, we will eventually incorporate proteomic analysis to identify biomarkers for the early detection of disease onset or progression, and genetic analysis of the tumor cells or tissue to further refine the treatment protocols for the patient. 

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Recent Cannabis Finding:

 

After studying the blood of 29 cancer patients that were using medical cannabis as an adjunct to conventional therapies, Dr. Jewett discovered that their NK cell function was not defective.  In fact, in many of these patients that had been using cannabis regularly, their immune function was similar to or better than that of healthy adults.  Using a synthetic cannabinoid that activates the endocannabinoid system, Dr. Jewett has demonstrated in preclinical models with hu-BLT mice and in in vitro killing assays that cannabinoids can increase NK cell function and kill large numbers of cancer stem and stem-like tumors that chemotherapy and radiation therapy were not able to kill.  These findings were recently published in a highly regarded medical journal.  Patents related to these findings have also been filed and are included in NKore’s patent portfolio.  While secondary to the commercialization of our Supercharged NK Cells™, this work could significantly advance the science associated with the medical use of cannabis and create future therapeutic options that could prove promising. 

 

Next Steps:

 

Our cGMP contract manufacturer is finalizing the manufacturing and quality SOPs for our cellular-based immunotherapy and we anticipate filing our pre-IND submission packet with the FDA in July 2022 in preparation for the commencement of clinical trials.  Our progress to date has been funded through a seed investment round and we are now seeking to commence a Series A offering to fund the IND process, clinical trials and the build out of our diagnostic facility. 

 

1.          Kaur, K., et al., Osteoclast-expanded super-charged NK-cells preferentially select and expand CD8+ T cells. Sci Rep, 2020. 10(1): p. 20363.

2.          Kaur, K., et al., Probiotic-Treated Super-Charged NK Cells Efficiently Clear Poorly Differentiated Pancreatic Tumors in Hu-BLT Mice. Cancers (Basel), 2019. 12(1).

3.          Kaur, K., et al., Super-charged NK cells inhibit growth and progression of stem-like/poorly differentiated oral tumors in vivo in humanized BLT mice; effect on tumor differentiation and response to chemotherapeutic drugs. Oncoimmunology, 2018. 7(5): p. e1426518.

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