In recent years, Korean biopharmaceutical companies have been actively licensing out drug technology in the global market. Therefore, industry watchers are now paying attention to which companies will show notable achievements this year.

The domestic drugmakers showed remarkable results last year, concluding 33 license-out agreements worth 13 trillion won ($10.8 billion), three times higher than in 2020.

Adding on to the optimism, three companies have already licensed out their treatment in January.

A case in point is Neoimunetech.

Among many companies aiming to license out their drug pipelines, Neoimmunetech has drawn the attention of big global pharmaceutical companies by making a presentation at the Biotech Showcase 2022 and receiving an invitation to the 2022 JP Morgan Healthcare Conference.

The company is currently developing NT-I7, a T cell amplifier that increases the response rate of immune checkpoint inhibitors, and is conducting clinical research for various indications, some with multinational pharmaceutical companies.

Korea Biomedical Review met with Neoimmunetech CEO Yang Se-hwan to learn about the company's main pipeline, NT-I7, and the company’s other plans.

Question: Could you please introduce Neoimmunetech?

Answer: We founded the company in the U.S. Although many companies are developing new drugs in Korea, most of the results of new drug development come from the U.S. and Europe. Therefore, we decided to start a business in the U.S., going directly to the center of the global competition.

Having a headquarter in the U.S. is very beneficial as the company is in Maryland, a 30-minute drive from Washington D.C., home to major institutions engaged in drug research and approval, such as the Food and Drug Administration, National Institutes of Health, National Cancer Institute, and Centers for Disease Control and Prevention.

Accordingly, it is a place where key personnel related to drug development and approval gather, a good area for hiring and retaining the talents needed by the company.

However, this does not mean Korea is nonessential, as Korea has excellent manufacturing and basic science fields.

As we wanted to utilize the benefits of both sides, the company is conducting manufacturing and basic science research in Korea and clinical and business development in the U.S.

Q: What is the competitiveness of your company's main pipeline, NT-I7?

A: Neoimmunetech's NT-I7 is a T cell amplifier.

The most important cells in immunotherapy are T cells. Of course, there are various other cells, including natural killer cells, currently discussed, but most of the treatments still sold in the market are T cell-related and programmed cell death protein 1 (PD-1) type treatments.

T-cell amplification is necessary for cancer patients and immunocompromised patients with insufficient T-cell numbers.

Therefore, we believe that NT-I7 helps cancer patients who do not have enough T-cell counts and show insufficient efficacy from existing immune checkpoint inhibitors.

While some express concerns that NT-I7 is our only pipeline, but the substance has a wider usable range than other partially used new drug candidates.

NT-I7, like PD-1 immune checkpoint inhibitors, has wide applications in various cancer patients and has a long-lasting effect.

Q: Is the wide application of NT-I7 its only strength compared to other candidates?

A: No. One of the most noticeable characteristics of the drug is it is relatively free from side effects.

Hospitals often treat patients with combination therapy using two or more drugs in chemotherapy. There are also combination therapies that use three or more treatments. However, if the side effects of the newly added drug are serious, it is not easy to apply the treatment.

However, NT-I7 is less burdensome than combination therapy because the risk of side effects is not high, giving it wide tolerability.

NT-I7's role is to increase the number of memory T cells and have fewer side effects while helping the anticancer effect last longer.

Q: Could you explain some of the clinical trials the company is conducting concerning NT-I7?

A: Broadly speaking, there are cancer and infectious diseases, and in detail, the company has divided the entire process into five programs.

The first program is for cold tumors, which are difficult to treat with immune chemotherapy among chemotherapy. Typical examples include pancreatic cancer and microsatellite stable (MSS) colorectal cancer.

The program's primary goal is not to replace the existing market shared by multinational pharmaceutical companies but to create a new market.

The company is conducting pancreatic cancer and MSS colorectal cancer combined with a PD-1 immune checkpoint inhibitor.

We are also conducting clinical trials for four types of cancers -- small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and high-risk skin cancer -- that proceed and decline when using immune checkpoint inhibitors first.

Recently, the company is also trying to use NT-I7 as a first-line treatment for NSCLC combined with an immune checkpoint inhibitor.

The second program is a combination clinical trial of CAR-T and NT-I7 in hematologic malignancies. Clinical trials are underway to administer NT-I7 to those who have lost effectiveness after CAR-T treatment. Currently, the protocol of administering NT-I7 21 days (3 weeks) after CAR-T administration is in progress.

Other programs include clinical trials targeting glioblastoma (GBM) using a combination therapy of NT-I7 and chemo and radiotherapy, infectious diseases using vaccine and NT-I7, and NT-I7 as a monotherapy to treat rare and infectious diseases.

Q: It seems the company has gained confidence after attaining positive results in fields with unmet demand. What is the reaction of other partners abroad?

A: We receive good responses at renowned academic conferences even before entering the market.

Last year, we announced clinical results at major societies, such as the American Association for Cancer Research (AACR), the American Society of Clinical Oncology (ASCO), and the Society for Immunotherapy of Cancer (SITC).

Notably, the company's presentation at SITC confirmed an unknown area for interleukin-7 among cytokines and that NT-I7 increases Tscm, which increases T cells and plays the most important role in cancer in the human body by 50 times -- received a lot of attention.

After seeing the SITC results, the person in charge of the Cytokine-Based Immuno-Oncology Society urgently invited us two weeks before their meeting and requested a new session presented by the company.

Such progress seems to have helped change how multinational companies view Neoimmunetech.

Q: What is Neoimmunetech's vision for this year?

A: This year, Neoimmunetech has two goals. The first is to prepare a roadmap for business development, such as license out, and the second is to establish a product approval roadmap.

Since the head office is located in the U.S., we can meet closely with potential partners after the two conferences in January – Biotech Showcase and JP Morgan Healthcare Conference --, and I expect that the discussion will continue through various conferences.

Therefore, Neoimmunetech's slogan this year is "New Drug Development 2.0."

If the "New Drug Development 1.0" was a process centered on substance development and clinical trials to initial public offer (IPO), this year's goal is to set up a business development and regulatory affairs road map to find an appropriate partner with a lot of resources, experience, and network for the development of anticancer drugs.

And if the partnership is successful, we expect to launch a new drug in the future.