HONG KONG –Nkmax America Inc., of Santa Ana, Calif., a natural killer (NK) cell-based therapy developer, has secured $11 million in a seed funding round. It is the company’s first funding round in the U.S. capital market. The company is owned by South Korean biotech firm Nkmax Co. Ltd. based in Seongnam.

The company plans to choose the lead underwriters this month, begin series A funding and go for an IPO next year. In July, the U.S. biotech chose U.S. law firm Cooley LLP to handle the IPO.

Nkmax America manages the entire process of SuperNK (SNK)’s global clinical trials, except for trials in Asia. SNK, a lead candidate of Nkmax, is an NK cell immunotherapy that involves the infusion of a person’s own activated NK cells into the body to improve immune system function and eliminate infected or abnormal cells. 

According to the U.S. firm, SNK stands out from other available therapies as it is autologous, not genetically modified and has fewer side effects than other therapies such as chimeric antigen receptor T cell (CAR T) treatments. Nkmax America is conducting SNK’s two clinical trials in oncology and one trial in autoimmune diseases.

The company also has a cell therapy manufacturing facility based in Santa Ana, which completed good manufacturing practice (GMP) in September. The facility will start operation to manufacture clinical and commercial products next year.

“We are using the Nasdaq listing of the U.S. subsidiary to accelerate our global clinical trials and foreign investment. After the IPO next year, it will be much easier to attract global funds and speed up SNK’s R&D worldwide,” a spokeswoman at Nkmax Korea told BioWorld.

“Using the seed fund, we will conduct SNK’s clinical trials for various indications. Our goal is to develop various therapies for cancer and autoimmune diseases,” Paul Song, vice chairman and chief medical officer at Nkmax America, noted in a statement.

Song told BioWorld, however, that the U.S. company and its investors are not able to make any further comments on public offering plans at this time.

SNK is undergoing three global clinical trials. SNK01-N12a, therapeutic candidate for stage IV non-small-cell lung cancer (NSCLC), is a combination administration of SNK and pembrolizumab (Keytruda, Merck & Co. Inc.). The drug candidate is under a phase II clinical trial in Korea. Another oncology therapeutic candidate, SNK01-US01, is a single agent to treat refractory solid tumors. It is under a phase I trial in the U.S., which will be completed by the first quarter of 2020.

SNK01-MX03, an autoimmune diseases treatment, is a single agent SNK targeting moderate to severe psoriasis. The U.S. company has recently completed the final administration of the drug candidate to patients in a phase I trial in Mexico. The company will announce the study’s result in the first half of next year.

Also, the company plans to expand SNK’s indications for oncology including advanced/metastatic HER2 and solid tumors, osteosarcoma, stage I-IV triple-negative breast cancer, advanced epidermal growth factor receptor (EGFR) and solid tumors, and non-Hodgkin lymphoma, autoimmune diseases such as rheumatoid arthritis and multiple sclerosis, and neurodegenerative conditions like Alzheimer’s disease. A phase I clinical trial for Alzheimer’s disease treatment is planned to begin in Mexico early next year.  

In November, the company announced its new executive advisory board to strengthen key areas of strategic corporate development. The board members were medical professionals with years of experience, including Helen Kim, who is the managing director of U.S. life sciences investment firm VIDA Ventures LLC, and was formerly the executive vice president of business development at Kite Pharma Inc. She led the acquisition of Kite Pharma by Gilead Sciences Inc. of the U.S. 

According to a report from Allied Market Research, the global NK cells therapeutics market was valued at $1.4 billion in 2018. It is expected to reach $5.1 billion by 2026, with a compound annual growth rate of 17.4% from 2019 to 2026.  

The report said the key factors driving the market growth are the rise in adoption of NK cells for cancer treatment, infections and liver diseases. NK cells play a pivotal role in tumor immune-surveillance, which is boosting the adoption of NK therapeutics worldwide. Increase in the R&D of bispecific antibody development for engaging NK cells to eliminate tumor cells is also propelling market growth.  

However, lack of specificity and poor in vivo survival of the cells limit the NK cells’ therapeutics market growth. In addition, higher costs associated with the therapies and adverse side effects are expected to hamper market growth. On the other hand, a surge in R&D toward immunotherapy development in some developing economies is expected to offer lucrative opportunities, the report said.

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