Vaxcell-Bio Therapeutics said on Friday that its Vax-NK/HCC, immuno-oncologic drug for advanced liver cancer patients received compassionate use approval from the Ministry of Food and Drug Safety (MFDS) on Thursday.

The compassionate use approval system is designed to allow patients to access a therapeutic drug before it obtains marketing authorization, typically in critical or life-threatening situations where there are no other treatment options available. 

Vaxcell-Bio Therapeutics is currently conducting a phase 2a study of Vax-NK/HCC which is a patient-specific, autologous cell therapy for advanced liver cancer. 

The company has recently announced promising results regarding the therapy's safety and therapeutic efficacy, which have been presented in papers at both domestic and international conferences. 

The company has received 11 compassionate use approvals for nine cancer types, including liposarcoma and glioblastoma.

In 2019, one terminal liver cancer patient with multiple lung metastases failed conventional systemic chemotherapy. However, after an emergency clinical trial using Vax-NK/HCC, the patient was diagnosed with complete remission (CR) and has been cancer free for the past three years.

"Through the compassionate use approval system, we will provide treatment opportunities for more patients with terminal cancer," said Vaxcell-Bio CEO Lee Je-jung. "In addition to our flagship pipeline of Vax-NK/HCC therapeutics, new clinical trials for advanced pancreatic cancer and refractory small cell lung cancer are well underway, and we are committed to expanding the Vax-NK platform."