Immunotherapy

NK101: Supercharged NK Cell Therapy

NKore's Development

Relevant animal & human models demonstrate promising results regarding safety and efficacy when treating many  forms of cancer with NKore's non-toxic, supercharged natural killer cell theray, NK101.


Currently, the market is still largely dominated by traditional treatments such as chemotherapy and radiation, as well as costly, individualized (autologous) immuno -therapies.


Existing treatments struggle to target many forms of cancer, both solid and hematologic, due to the challenges posed by their complex cellular structures and metabolic activity. We believe NK101 has the ability to target both.


Manufacturing

NKore has engaged licensed, cell-based contract manufacturers in the US and abroad to collect and process allogeneic primary NK cells from healthy, qualified donors. Several patients have been treated outside the US with early, promising results.

Medical Advancement

NKore has developed a more effective approach to treating solid tumors and hematologic malignancies by targeting and killing the cancer stem and stem-like cells to stop or reverse disease progression in many forms of cancer. The novel activation and expansion method used to produce NK101 increases the cytotoxicity of the cells to make them more aggressive in targeting cancer stem cells and inducing the differentiation of those cancer cells that avoid cell death.

Why is this Important?

By inducing differentiation, NK101 reduces the potential for tumor regrowth or metastasis.

Off-the-Shelf

As a cryopreserved, allogeneic (from a healthy donor) therapy, NK101 will provide an "off-the-shelf" solution for patients to significantly lower treatment costs and expand access to therapy. 

Competitive Positioning

Preclinical mouse and human models have demonstrated the safety and efficacy of sNK cells to stop or reverse disease progression and act as a catalyst to restore immune function. Early clinical data confirms that NK101 has an excellent safety profile with the potential to translate the preclinical results into more patients.

The Future of Healthcare

NKore believes that NK101 will prove to be an effective monotherapy in the treatment of patients in the early stages of disease progression and a critical part of a combinational treatment approach when patients are diagnosed at later stages.


With advances in genomic sequencing to detect biomarkers indicating precursors of disease, NK101’s ability to restore immune function could lead to an effective preventive treatment option.   

NKore's Development

Relevant animal & human models demonstrate promising results regarding safety and efficacy when treating many  forms of cancer with NKore's non-toxic, supercharged natural killer cell theray, NK101.


Currently, the market is still largely dominated by traditional treatments such as chemotherapy and radiation, as well as costly, individualized (autologous) immuno -therapies.


Existing treatments struggle to target many forms of cancer, both solid and hematologic, due to the challenges posed by their complex cellular structures and metabolic activity. We believe NK101 has the ability to target both.


Manufacturing

NKore has engaged licensed, cell-based contract manufacturers in the US and abroad to collect and process allogeneic primary NK cells from healthy, qualified donors. Several patients have been treated outside the US with early, promising results.

Medical Advancement

NKore has developed a more effective approach to treating solid tumors and hematologic malignancies by targeting and killing the cancer stem and stem-like cells to stop or suppress disease progression in many forms of cancer. The novel activation and expansion method used to produce NK101 increases the cytotoxicity of the cells to make them more aggressive in targeting cancer stem cells and inducing the differentiation of those cancer cells that avoid cell death.

Why is this Important?

By inducing differentiation, NK101 reduces the potential for tumor regrowth or metastasis.

Off-the-Shelf

As a cryopreserved, allogeneic (from a healthy donor) therapy, NK101 will provide an "off-the-shelf" solution for patients to significantly lower treatment costs and expand access to therapy. 

Competitive Positioning

Preclinical mouse and human models have demonstrated the safety and efficacy of sNK cells to stop or suppress disease progression and act as a catalyst to restore immune function. Early clinical data confirms that NK101 has an excellent safety profile with the potential to translate the preclinical results into more patients.

The Future of Healthcare

NKore believes that NK101 will prove to be an effective monotherapy in the treatment of patients in the early stages of disease progression and a critical part of a combinational treatment approach when patients are diagnosed at later stages.


With advances in genomic sequencing to detect biomarkers indicating precursors of disease, NK101’s ability to restore immune function could lead to an effective preventive treatment option.   

Pathway to Market

At NKore BioTherapeutics, our pathway to market is strategically designed to accelerate access to our non-toxic immunotherapy. We are currently generating real-world data from a human study conducted in Cancun, Mexico, where patients are being treated under a controlled clinical framework. The promising outcomes from this study are informing our U.S. regulatory strategy and serving as a foundation for our pre-IND submission to the FDA. We are working closely with experienced regulatory advisors and intend to file our Investigational New Drug (IND) application by the end of 2025, with the goal of launching clinical trials in the United States shortly thereafter.


Supercharging The Innate Immune System

Just as T-cells are the core of the adaptive immune system, Natural Killer (NK) cells are the core of the innate immune system; the immune system you are born with. As such, NK cells are unique in their ability to identify and destroy cancer stem and stem-like cells and trigger the differentiation of aggressive undifferentiated tumors to make them more susceptible to other forms of cancer treatment, including chemotherapy, radiation therapy, check point inhibitor therapy, and CAR-T therapy. These characteristics are unique to NK cells and demonstrate why they are indispensable in the development of more effective, less toxic treatment options for patients.

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The Therapy

NK101 is an infusion of allogeneic, from a healthy adult, natural killer cells that have been supercharged using our proprietary method. The therapy is given using an intravenous drip that traditionally flows over approximately 3 hours. Patients that are currently enrolled in our study have been deemed terminal or incurable, and qualify under compassionate use for palliative care.


One of NKore's main focuses is to determine the amount of infusions each patient will need based on age, weight, cancer type, and stage of cancer. With a plan to file for FDA approval in late 2025, NKore expects to open up small scale safety trials in blood cancer first, followed by solid tumors in subsequent trials. It is our hope to continue administering our therapy to patients as one off treatments if they meet "compassionate use" qualifications while running larger trials in parallel.