NeoImmuneTech 'NT-I7', Starting Commercialization as Radiation Therapy?

Contract Signed with US National Institute of Allergy and Infectious Diseases
Direct Sales of Therapeutics to Government Planned

Ongoing Cancer Drug Clinical Trials
Results for CAR-T and Others Expected in Second Half

Yang Se-hwan, CEO of NeoImmuneTech, is speaking at a corporate briefing held on the 3rd in Yeouido, Yeongdeungpo-gu, Seoul. / Photo by Lee Chun-hee

[Asia Economy Reporter Lee Chun-hee] NeoImmuneTech, which is developing the first-in-class next-generation immuno-oncology drug that induces T cell expansion, announced on the 3rd that it has signed a primary collaboration agreement with the National Institute of Allergy and Infectious Diseases (NIAID), under the U.S. National Institutes of Health (NIH), for the research and development of a treatment for Acute Radiation Syndrome (ARS).

Yang Se-hwan, CEO of NeoImmuneTech, disclosed this information at a corporate briefing held in Yeouido, Yeongdeungpo-gu, Seoul, emphasizing, "Because this contract is directly with the U.S. government, it could become a case that generates direct sales." Lee Ha-young, Executive Director of NeoImmuneTech's IR Business Division, also described it as "the first achievement toward clinical commercialization."

ARS is a syndrome caused by exposure to a large amount of radiation in a short time, resulting in organ damage and a decrease in neutrophils and lymphocytes, including bone marrow, increasing the risk of death due to infections. NIAID directly supports the research and development of candidate substances by biotech companies to develop treatments for public health emergencies such as ARS. During the COVID-19 pandemic, it signed licenses with Moderna to support the rapid commercialization of vaccines. Notably, treatments for neutropenia such as Amgen's 'Neulasta' and Sanofi's 'Leukine' have been developed, and treatments for thrombocytopenia like Amgen's 'Nplate' are listed on the Biomedical Advanced Research and Development Authority (BARDA) list; however, there are currently no treatments for lymphopenia.

NeoImmuneTech CI (Photo by NeoImmuneTech)

Through this contract, which is part of the Radiation Nuclear Countermeasures Program (RNCP), NeoImmuneTech will provide its drug candidate NT-I7 (substance name: Epinepakin alfa) for NIAID's ARS treatment development research. Due to the nature of the disease, clinical trials on patients exposed to radiation are impossible, so two animal experiments will be conducted. First, rodent experiments will be conducted by NIAID, followed by primate experiments, such as on monkeys, by BARDA. After this process, if recognized as a national strategic item by the U.S. federal government, emergency use authorization (EUA) could lead to NeoImmuneTech's first product sales.

NeoImmuneTech expressed confidence in commercialization, citing preclinical studies presented by Duke University researchers and the U.S. Radiation Injury Treatment Network (RITN) and the Radiation Research Society (RRS), which showed that experimental groups administered NT-I7 after radiation exposure rapidly restored total T cell counts to normal levels compared to control groups. CEO Yang also mentioned, "Last October, the U.S. Department of Health and Human Services purchased Nplate for $290 million (approximately 370 billion KRW)," indicating significant sales expectations.

Regarding overseas expansion beyond the U.S., he said, "We plan to discuss with the European Health Emergency Preparedness and Response Authority (HERA)." He added, "Since Europe operates nuclear power plants and demand for stockpiling ARS treatments has increased since last year due to issues like the Russia-Ukraine conflict, we intend to engage in close discussions."

Yang Se-hwan, CEO of NeoImmuneTech, is speaking at a corporate briefing held on the 3rd in Yeouido, Yeongdeungpo-gu, Seoul. / Photo by Lee Chun-hee

At the briefing, CEO Yang also introduced the current status of immuno-oncology or chimeric antigen receptor (CAR)-T cell therapy combination clinical trials targeting pancreatic cancer, MSS colorectal cancer, brain cancer (glioblastoma), and diffuse large B-cell lymphoma. He explained, "In the first half of this year, we will present the remaining results of the 'NIT-110' clinical trial (phase 2a combination trial with 'Keytruda' for solid tumors) at the American Society of Clinical Oncology (ASCO), and in the second half, we plan to announce related results for NIT-110, 106, 119, 107, and 109." 'NIT-106' and 'NIT-119' are combination trials with 'Tecentriq' targeting skin cancer and non-small cell lung cancer, respectively, with phase 2 interim results expected in the second half of the year. 'NIT-107' is a combination trial with temozolomide for glioblastoma, a type of brain cancer, with phase 1/2 interim results expected in the second half. 'NIT-109' is a combination trial with Opdivo for gastrointestinal cancers, with phase 1 interim results expected in the second half.

NeoImmuneTech is also conducting combination trials with the CAR-T cell therapy 'Kymriah.' CEO Yang explained, "CAR-T therapies have the limitation of being administered only once," and added, "NT-I7 can enhance the effect of CAR-T, so it is receiving a lot of attention." This clinical trial, named 'NIT-112,' is expected to have final phase 1b results in the second half of this year.

CEO Yang presented a vision, stating, "Through these clinical trials, we expect NT-I7 to be recognized this year as a 'hot' therapeutic agent as a T cell amplifier in combination with radiation, immune checkpoint inhibitors, and CAR-T therapies," and added, "By breaking ground in non-oncology areas through ARS treatment, we anticipate securing funding and gaining momentum in developing new oncology drugs."