Sangwoo Park, CEO of NKMAX, "NK Cell Therapy as the Next-Generation Growth Engine"

Accelerating World's First Approval of NK Cell Therapy for Solid Tumors
Improvement in Progression-Free Survival and Overall Survival in Terminal Cancer Patients

[Asia Economy Reporter Hyungsoo Park] "Natural killer (NK) cells can be utilized to treat various diseases such as cancer, autoimmune disorders, anti-aging, and dementia. NK cells, which are responsible for the primary immune defense in the human body, represent a field that can sustain South Korea's future. We expect 'SNK,' developed by NKMAX, to become the world's first NK cell therapy approved for solid tumors."

Park Sang-woo, CEO of NKMAX, said, "We will disclose interim results for sarcoma patients who received compassionate use approval at the upcoming European Society for Medical Oncology (ESMO) conference next month," adding, "The development process of SNK is progressing smoothly." Compassionate use approval is a system where medical authorities provide new drugs free of charge before market approval to terminal cancer patients who have no appropriate treatment options and are about to give up treatment.

NKMAX possesses the immune cell therapy platform technology 'SuperNK,' which utilizes NK cells, a type of immune cell. This cell therapy platform technology isolates NK cells from human peripheral blood with 99% purity, cultivates them into highly efficient NK cells for cancer cell killing, and mass-produces them. Using SuperNK technology, NKMAX is developing treatments for various intractable diseases, including cancer. Clinical trials are being conducted in the United States, South Korea, and Mexico.

At the NKMAX IR Center located in the Federation of Korean Industries building on Yeoui-daero, Yeongdeungpo-gu, Seoul, CEO Park expressed confidence in the success of the immune cell therapy 'SNK.' Below is a Q&A with CEO Park.

Park Sang-woo, CEO of NK Max, is being interviewed by Asia Economy on the 22nd. / Photo by Moon Ho-nam munonam@

- Can SNK become a new drug that overcomes the limitations of existing anticancer treatments?

▲ We expect SNK to become the world's first NK cell therapy approved for solid tumors. It is anticipated to provide new treatment options for cancer patients and medical professionals. Cell therapies must show positive clinical results, but there are no clinical results for NK cell therapies targeting solid tumors overseas. NKMAX can become a pioneer by securing the first results in the field of solid tumor treatment.

So far, immuno-oncology has been dominated by immune checkpoint inhibitors and adaptive immune cells (T cells). By introducing NK cells, which are innate immune cells, NKMAX believes it can contribute to treating intractable diseases. Following clinical trials on sarcoma and lung cancer using autologous NK cells, we plan to conduct trials for triple-negative breast cancer and head and neck cancer. We are already conducting Alzheimer's clinical trials and continuously expanding indications, including Parkinson's disease.

- Clinical trials are being conducted on terminal cancer patients, such as stage 4 non-small cell lung cancer patients and terminal sarcoma patients, who are generally unlikely to expect treatment effects. Does this reflect confidence in SNK's efficacy?

▲ To expedite SNK's approval and commercialization, we are conducting clinical trials on terminal cancer patients who have failed existing treatments or have no available therapies. When evaluating clinical results, it is important not only to check for cancer cell remission (elimination) but also to focus on improvements in progression-free survival (PFS) and overall survival (OS). Generally, patients with stage 1 or 2 progressive cancer aim for a cure, but terminal cancer patients aim to extend life.

NKMAX achieved complete remission by combining SNK with Keytruda and Bavencio in terminal sarcoma patients. We also confirmed progression-free survival extended up to 52 weeks. At the World Conference on Lung Cancer (WCLC), the two-year follow-up results for stage 4 non-small cell lung cancer showed improvements in progression-free survival and overall survival.

- What does it mean that no side effects were observed during the treatment process?

▲ Patients diagnosed with terminal cancer usually have cancer spread throughout their bodies and are in poor health. They find it difficult to tolerate strong chemotherapy, and even if used, severe side effects often cause treatment discontinuation. Since SNK administration causes no side effects, patients do not have to endure painful side effects. They can maintain daily activities without issues after administration, significantly improving their quality of life.

- I heard that SNK can provide treatment opportunities even for patients who cannot use Keytruda, an immuno-oncology drug that recorded sales exceeding 22 trillion won last year.

▲ Immune checkpoint inhibitors can only be used for PD-L1 positive tumors with PD-L1 expression rates of 50% or higher, which accounts for only 20-30% of all cancer patients. Existing immuno-oncology drugs are effective when PD-L1 expression is positive.

Most patients participating in NKMAX's clinical trials have very low or negative PD-L1 expression. We confirmed efficacy when SNK was combined with immuno-oncology drugs. A sarcoma patient who received SNK and Keytruda under compassionate use approval achieved complete remission. NKMAX will disclose data from a total of eight patients, including those with complete remission, at ESMO. Research is underway to identify the mechanism by which SNK induces efficacy in PD-L1 negative patients.

- Are there plans to disclose other pipelines within this year?

▲ This year is the period to demonstrate SNK's efficacy with data. We presented interim results for sarcoma at the American Society of Clinical Oncology (ASCO) in the first half of the year. We disclosed two-year follow-up results for stage 4 non-small cell lung cancer at the World Conference on Lung Cancer. In the second half of the year, we expect to reveal interim results for TKI-resistant non-small cell lung cancer and Alzheimer's clinical trials.

We treated five patients with Alzheimer's or Parkinson's disease alongside Dr. Ming Guo, a renowned Alzheimer's expert. We confirmed SNK's efficacy in brain diseases. Although the exact mechanism for treating neurodegenerative diseases such as Alzheimer's, Parkinson's, and autism is not fully understood,

neurodegenerative diseases are pathologically characterized by the accumulation of abnormal protein aggregates such as alpha-synuclein and beta-amyloid in the brain. SNK is presumed to be effective by removing abnormal proteins and damaged neurons that cause neurodegenerative diseases. Mechanism studies are ongoing separately from clinical trials, and interim clinical results are planned to be disclosed by the end of this year.

- Are there concerns about side effects when starting clinical trials for allogeneic NK cell therapy (SNK02) extracted from another person's blood?

▲ On the 22nd, we submitted an Investigational New Drug (IND) application for phase 1/2a clinical trials to the Ministry of Food and Drug Safety. Since meaningful clinical research results have been obtained for autologous SNK extracted from the patient's own blood, we expect allogeneic SNK to be effective as well. Allogeneic NK cells have the advantage of lower production costs compared to autologous NK cells, making them more commercially viable. However, there are concerns about side effects compared to autologous NK cells.

NKMAX has culturing technology that expands cells up to an average of 19 billion-fold and maintains 99% NK cell purity and over 90% activity even after freezing and thawing. High purity is associated with reduced side effects. Animal experiments using allogeneic SNK have been completed with no toxicity detected. Since efficacy data have also been secured, we expect to confirm both safety and efficacy in clinical trials.

Park Sang-woo, CEO of NK Max, is being interviewed by Asia Economy on the 22nd. / Photo by Moon Ho-nam munonam@