CBT101 / CHA Bio & Diostech - LARVOL DELTA

CHA Biotech’s NK cell therapy receives KDDF support for drug development (Korea Biomedical Review) - "CHA Biotech announced on Monday that its natural killer (NK) cell-based immunotherapy, CBT101, has been chosen for funding by Korea Drug Develpment Fund (KDDF). KDDF, a government-funded organization overseeing drug development projects in Korea's pharmaceutical and biotech industries, will support CBT101 with research and development funding for two years. CHA Biotech aims to develop large-scale production processes for CBT101, secure data and evidence for phase 2 clinical trials, and obtain investigational new drug (IND) approval to proceed with the trial."

Financing • Oncology

CHA Bio Group to showcase cell and gene tech at BIO 2024 in US (Korea Biomedical Review) - "CHA Bio Group said it would attend the 2024 BIO International Convention, the world's largest bio exhibition, from June 3 to 6 in San Diego, California...CHA Biotech will actively promote the development status of cell therapy drugs, including 'CBT101,' an anticancer immune cell therapy drug based on NK cells, and 'CordSTEM-DD,' a stem cell therapy drug. To maximize the effectiveness and characteristics of NK cell therapies, it is developing CAR-NK cell therapies that apply chimeric antigen receptor (CAR) and various combination therapies such as immuno-oncology drugs and antibodies, according to CHA Bio Group."

Clinical • CNS Disorders • Oncology • Solid Tumor

Challenge to commercialize world’s first ‘NK cell therapy’ [Google translation] (Chosun Biz) - P1 | N=6 | NCT04557306 | Sponsor: CHABiotech CO., Ltd | "CHA Biotech said, 'In a clinical trial conducted by researchers who administered CBT101 to patients with recurrent glioblastoma (a type of malignant tumor), the median survival time of patients was found to be 22.5 months,' adding, 'This is a survival period of more than 12 months compared to existing anticancer treatment.' 'This has been extended, and there are patients who have survived for more than 8 years.'....CBT101 has been designated as an orphan drug for malignant glioma by the U.S. Food and Drug Administration (FDA). CHA Biotech announced that it conducted phase 1 clinical trials for full-scale commercialization of CBT101 and confirmed its safety and tolerability."

Orphan drug • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Evaluationn of Tolerability and Safety of CBT101, an Autologous Natural Killer Cell, in Patients With Solid Cancer (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: CHABiotech CO., Ltd | Not yet recruiting ➔ Completed

Trial completion • Oncology • Solid Tumor

Professor Lee Joo-ho of Bundangcha Hospital received awards for his research on transarterial chemoembolization and combined immune cell treatment for liver cancer [Google translation] (Health Biz) - "Prof. Lee Joo-ho administered three doses of CBT101, an NK immune cell therapy cultured from the patient's blood, after transarterial chemoembolization to five patients whose tumors are confined to the liver but are too large or too large to undergo surgery. At six months, the interim assessment showed an Objective Response Rate (ORR) of 100%. Prof. Lee Joo-ho was highly praised for confirming the possibility of combining transarterial chemoembolization and NK immune cell therapy in the treatment of liver cancer."

Clinical data • Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor

Exploration of Immune Cell and Cytokine Biomarkers after Multiple Administrations of Autologous Natural Killer Cells in Patients with Solid Tumor (ASGCT 2023) - P1 | "Thus, we aimed to explore the biomarkers including various types of immune cells (NK cell, T cells, and myeloid-derived suppressor cells) and cytokines (tumor suppressor and protumoral cytokines) and their relationships after multiple administration of CBT101 (autologous NK cells) in patients who underwent curative surgery and adjuvant therapy for solid cancer. This research was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI19C0790, HI16C1559). The authors declare no conflict of interests to disclose."

Biomarker • Clinical • Immune cell • IO biomarker • Oncology • Solid Tumor • CCL2 • CXCL10 • IFNG • IL10 • IL4 • IL6 • NKG2D • TNFA

CHA Biotech releases topline results of phase 1 NK cell therapy trial (Korea Biomedical Review) - P1 | N=12 | NCT04557306 | Sponsor: CHABiotech CO., Ltd | "CHA Biotech investigated adverse events in six patients, and three showed adverse reactions. However, the company said they were all mild and unrelated to CBT101. The company said it planned to submit the final report of the trial to the Ministry of Food and Drug Safety on March 29. Based on the phase 1 trial outcome, the company will conduct a phase 2 study in patients with recurrent glioblastoma in Korea."

New P2 trial • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

SPARTA: APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=201; Recruiting; Sponsor: Apollomics Inc.; Trial primary completion date: Sep 2021 ➔ Dec 2022

Clinical • Trial primary completion date • Brain Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Glioblastoma • Kidney Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

CHA Bundang Hospital proves CBT101's efficacy in treating recurrent glioblastoma (Korea Biomedical Review) - “Researchers at CHA Bundang Hospital have confirmed the efficacy of CBT101, a natural killer (NK) immune cell therapy cultivated from a patient's blood, in treating recurrent glioblastoma. CBT101 prolonged the average survival time in patients with recurrent glioblastoma after administering the treatment to 14 patients suffering from recurrent glioblastoma. After the therapy administration, six patients survived for more than two years, and the treatment maintained its efficacy even after treatment. The team confirmed five out of 14 patients had progression-free survival (PFS) of two to seven years.”

Clinical data • Brain Cancer • Glioblastoma • Oncology

Evaluationn of Tolerability and Safety of CBT101, an Autologous Natural Killer Cell, in Patients With Solid Cancer (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: CHABiotech CO., Ltd

Clinical • New P1 trial • Oncology • Solid Tumor

APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=201; Recruiting; Sponsor: Apollomics Inc.; Trial completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial completion date • Brain Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Glioblastoma • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Cha Biotech, the Ministry of Food and Drug Safety 'Immune Cell Therapeutics' clinical phase 1 approval application [Google translation] (Medical News) - "Chabiotech announced on the 27th that it has applied for approval for the first phase of domestic clinical trials of autoimmune cell therapy (CBT101) based on autologous NK cells (natural killer cells) to the Ministry of Food and Drug Safety. In Phase 1 of the study, the safety and tolerability of CBT101 will be evaluated in patients with solid cancer, and the maximum dose and the recommended phase 2 dose will be determined."

New P1 trial • Non-US regulatory • Oncology • Solid Tumor