Investment Highlights for NKore Biotherapeutics, LLC

NKore Biotherapeutics, LLC
2309 Duntreath Road
Germantown, TN, 38139
https://www.nkore.com/
Contact: tryan@nkore.com

• NKore Biotherapeutics, LLC (“NKore” or “The Company”) is a biotherapeutics company focused on the early detection, prevention, and treatment of cancer. The Company’s technology platform is based on a proprietary method of activating allogeneic natural killer (NK) cells, creating Supercharged Natural Killer (sNK) cells used as a novel oncology immunotherapy technology platform.  

• The technology was developed by Dr. Anahid Jewett, NKore’s co-founder and Chief Scientific Advisor. Based on preclinical results, the Company believes that Dr. Jewett’s 30-plus years researching NK cell function has resulted in the development of a novel and effective cancer immunotherapy. NKore's current focus is to translate and replicate the positive preclinical results into human clinical trials to obtain marketing approval.  

• NK cell therapy has significant advantages against competing alternatives. Since NK cells do not need to be genetically engineered to recognize cancer cells, it simplifies the lengthy and costly manufacturing process normally associated with many other forms of immunotherapy. In addition, NK cell therapy provides a better safety profile compared to other forms of cancer treatment, such as chemotherapy and radiation, which are normally associated with severe toxicities and can reduce physical strength and impair immune response. 

• NK cells’ ability to identify and spontaneously kill cancer cells allows them to play a critical dual role in the prevention and treatment of cancer. NK cells cytotoxic activity not only attacks infected and cancerous cells in the tumor, but also helps to eliminate poorly differentiated cancer stem cells (CSCs), a subpopulation of tumor cells displaying self-renewal ability and resistance against conventional cancer therapies. CSCs presence is recognized as a crucial factor contributing to tumor progression, recurrence, and metastasis.  

• NK cells also play a dual role in the elimination of CSCs. NK cells have been shown to selectively kill CSCs as well as induce differentiation of these cells through the release of gamma interferon (IFN-y), eliminating their self-renewal ability and making them more susceptible to other cancer treatments, leading to their elimination. 

• However, despite NK cells’ key role in controlling cancer, the tumor microenvironment (TME) has been shown to suppress both the number and the function of NK cells, diminishing IFN-γ secretion, reducing cytotoxicity against cancer cells, and adversely influencing other anti-cancer processes. 

• Working with Dr. Jewett, NKore has developed NK101, a cellular-based immunotherapy that has proven effective in preclinical models in the treatment of both solid tumors and hematologic malignancies. The proprietary NK cell activation method generates more robust and effective NK cells that better withstand the suppressive TME, enhancing their cytotoxic function and increasing their secretion of functional IFN-y.  

• Preclinical studies have demonstrated NK101’s ability to stop or reverse disease progression as well as to reduce the metastatic potential of tumor cells in many forms of cancer, including glioblastoma, pancreatic, melanoma, oral, lung, and ovarian cancer, as well as hematologic malignancies.  

• NKore has commenced clinical use in Cancun, Mexico, using NK101 as a palliative treatment option for patients with metastatic or unresectable cancers that have failed conventional treatment options. Initial clinical use included two patients that were treated in an effort to reduce the pain and discomfort associated with their diseases and demonstrate the clinical safety of NK101. With the treatment of additional patients, the Company plans to use the data to support its IND submission with the FDA. 

• • • While only limited clinical data is available, NK101 appears to have a solid safety profile, with neither patient experiencing any adverse side effects or discomfort after receiving the therapy. Initial results look promising, demonstrating the ability of NK101 to target and spontaneously kill at least some tumor cells, reverse disease progression, and begin to restore immune function, similar to the preclinical results achieved by Dr. Jewett. 
      
      
      • At 60 days post-infusion, Patient 1 (a 64-year-old male diagnosed with a form of non-Hodgkin’s lymphoma and presenting with a genetic mutation which limits his ability to respond to conventional therapy) achieved a 75% reduction in tumor cell infiltration in his bone marrow, as well as a significant reduction in the size of enlarged lymph nodes in his abdominal cavity. The 90-day review of the post-infusion test results suggest early signs of partial remission after only one treatment.  
        
        
      • Early safety data for Patient 2, an 11-year-old girl diagnosed with an incurable Optic Pathway Glioma brain tumor, is also positive. Blood draws following therapy continue to show a positive immune response and a significant increase in cell activation, IFN-γ release, and cytotoxic activity. Given the location and nature of this tumor, the Company believes that it is too early to assess a clinical response to therapy.  

• • • To support its immunotherapy initiative, NKore also intends to commercialize a companion proprietary cell-based diagnostic screening platform to monitor the patient’s immune function to assess a patient's response to therapy and to assist clinicians in the development of better personalized treatment plans.  

• • • Since formation, NKore has completed funding activities totaling approximately $3.2 million.

* Updated on April 17, 2024.