ImmunisBio Receives Approval for Phase 2 Clinical Trial in Gastric Cancer

Entering the Stage of Confirming the Efficacy of Solid Tumor Treatment

Immunis Bio, a specialized company in advanced biopharmaceuticals, announced on the 22nd that it will conduct a Phase 2 clinical trial of its autologous NK cell therapy (MYJ1633) for gastric cancer.

Gastric cancer ranks high in mortality rates following lung, liver, and colorectal cancers, and depending on clinical efficacy, the commercialization of NK cell therapies for solid tumors is expected to accelerate.

According to the Central Cancer Registry, South Korea has the highest incidence rate of gastric cancer worldwide. As of 2022, approximately 26,000 cases were reported, accounting for 10.8% of all cancer patients. Although the mortality rate of gastric cancer is decreasing, patients with advanced high-risk groups and those with postoperative recurrence are known to have limited treatment options.

Cancer treatment is conducted through surgery, radiation therapy, chemotherapy, and hormone therapy. Progression and recurrence after failure of second-line standard chemotherapy often indicate a severe stage of cancer.

The clinical trial targets patients with progressive and recurrent gastric cancer who have failed second-line standard chemotherapy. The therapy is administered via intravenous infusion (IV infusion) once a week for a total of six times, delivering more than 2 billion cells per session. The efficacy will be explored in 63 patients.

The trial is conducted at three institutions: Severance Hospital, Kyung Hee University Hospital, and Incheon St. Mary's Hospital, targeting patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2, which assesses daily living capabilities.

The investigational drug MYJ1633 is an activated autologous NK cell therapy that has received approval from the Ministry of Food and Drug Safety and is undergoing clinical trials for indications including gastric cancer, breast cancer, and gastrointestinal cancers.

Kang Jeong-hwa, CEO of Immunis Bio, stated, "Our MYJ1633 is leading the clinical trials of NK cell therapies targeting solid tumors," adding, "We expect this clinical trial to serve as an opportunity to further expand the scope of immune cell therapies." She also noted, "On the 1st of last month, the Advanced Regenerative Bio Act passed the National Assembly plenary session, opening the path for advanced regenerative medical treatments for domestic patients."

This content was produced with the assistance of AI translation services.