A photo taken through a microscope of NK (natural killer) cells. NK-T cells are immune cells that possess characteristics of both NK cells and T cells./Courtesy of National Institute of Allergy and Infectious Diseases (NIAID)

The possibility of domestic immuno-oncology drugs conquering rare blood cancers, which occur frequently in Korea and China, is increasing. Global pharmaceutical companies have overlooked this due to the low number of patients, but recently, domestic bio corporations have begun to develop new drugs and have achieved results.

According to the industry on the 14th, domestic bio corporations are accelerating the development of treatments for 'NK (natural killer) -T cell lymphoma,' a rare blood cancer. There is currently no standard treatment for this disease, and the recurrence rate reaches 80% within two years, making treatment challenging.

Domestic corporations believe the market entry barriers are relatively low and the first-mover advantage is significant. A viral infection common among East Asians is identified as a major cause, making it favorable to recruit patients for clinical trials domestically. Major regulatory agencies in the U.S., Europe, and Korea have designated this disease as a rare disease, so developing new drugs can lead to expedited approval with just the results of Phase 2 clinical trials.

Comparison of normal lymph nodes and lymph nodes with lymphoma./Courtesy of National Cancer Center

NK-T cells are immune cells that possess the characteristics of both natural killer cells that directly destroy targets and T cells that bind to targets. In other words, they are elite warriors equipped with reconnaissance and combat capabilities, comprising 1% of T cells.

NK-T cell lymphoma, a blood cancer that occurs in NK-T cells, is classified as a rare disease occurring at a rate of 1 in 100,000 people worldwide, and is considered a fast-progressing and lethal cancer. Generally, blood cancers occur primarily in lymph nodes, but NK-T cell lymphoma appears in various tissues, including the nasal cavity, orbit (around the eyes), skin, and intestines.

The biggest cause of NK-T cell lymphoma is infection with the Epstein-Barr virus (EBV). EBV is a member of the herpes virus family, with over 90% of the population in East Asia, including Korea, infected with this virus. Most become infected at a young age, but in some cases, the virus modifies immune cells and induces cancer. The International Agency for Research on Cancer (IARC) classifies EBV as a Group 1 carcinogen.

The only drug developed so far is 'Cejemli (ingredient name, sugemalimab),' approved by the Chinese corporation CStone at the end of October 2023. However, the efficacy of Cejemli is limited, making new treatment options necessary. Even Merck Sharp & Dohme (MSD), which has the most treatment targets in the U.S., has not received approval for this cancer type. This indicates that it is regarded as a niche market that global pharmaceutical companies have not yet ventured into.

Graphic=Jeong Seo-hee

Korea is advantageous in developing NK-T cell lymphoma treatments due to the high number of EBV infection patients. While NK-T cell lymphoma occurs at a rate of 1 in 100,000 globally, domestic EBV infection rates are high, with about 100 new cases each year. This makes it easier to secure patients, allowing for sufficient data collection through domestic clinical trials while reducing expenses compared to global clinical trials.

The leading corporation in drug development domestically is ViGenCell. The immune cell therapy candidate 'VT-EBV-N' from ViGenCell received orphan drug designation from the Korea Food and Drug Administration (KFDA) in 2019, and subsequently from the European Medicines Agency (EMA) in 2023.

ViGenCell completed dosing with VT-EBV-N for 48 patients in Phase 2 clinical trials as of September 2023 and is currently monitoring patients' progress over a two-year period. The company stated it would apply for conditional approval from the KFDA once the Phase 2 results are released in September.

ImmuneOncia, a subsidiary of Yuhan Corporation, is also developing a new immune-oncology drug called 'IMC-001.' In their recently disclosed Phase 2 interim results, the objective response rate (ORR), which indicates the percentage of patients whose cancer reduced, was 79%, outperforming Cejemli in China (46.2%), and has drawn attention. ImmuneOncia plans to apply for orphan drug designation with the KFDA in the second half of this year. The ongoing Phase 2 dosing is expected to be completed next year.

In addition, Eutilex has initiated Phase 2 trials for 'ABVNT,' while GC Biopharma's subsidiary GC Cell began administering Phase 1 doses for its immune-oncology drug 'GCC2005' in March last year.

If a domestic corporation receives orphan drug approval for NK-cell lymphoma immunotherapy, it could gain a monopolistic position in the market. This is because they would have the opportunity to enter the market relatively quickly through conditional approval after Phase 2 trials and enjoy market dominance.

Additionally, there is great potential for technology transfer. NK-cell lymphoma has a particularly high patient incidence in East Asia, attracting significant interest from Chinese corporations.

In the long term, the scope of applicable diseases can be expanded to solid tumors, thereby growing the market. In fact, ImmuneOncia has announced that after entering the NK-T cell lymphoma treatment market with IMC-001, it plans to widen its scope to solid tumors affecting general organs.

A company official noted, 'We are currently conducting Phase 2 trials for solid tumors' and added, 'Our goal is to expand the immune-oncology market to solid tumors after obtaining approval for NK-T cell lymphoma treatment.'