Cellular Biomedicine Group Announces Positive Results from CAR-T EGFR Immunotherapy Phase I Clinical Trial for Non-Small Cell Lung Cancer

SHANGHAI, China and PALO ALTO, Calif., September 28, 2015 /GlobeNewswire/ -- Cellular Biomedicine Group Inc. (NASDAQ: CBMG) (“CBMG” or the “Company”), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, today announced encouraging phase I clinical data from its Chimeric Antigen Receptor-Modified T-Cells (CAR-T) immunotherapy (CBM-EGFR.1)for the treatment of patients with EGFR expressing advanced relapsed/refractory Non-Small Cell Lung Cancer (NSCLC). Most of these patients received CBM-EGFR.1 therapy after failure with EGFR-TKI treatment. The early results showed that CBM-EGFR.1 immunotherapy was safe, well tolerated, and produced positive signal of clinical activity in NSCLC.The data was selected for a poster presentation entitled Chimeric Antigen Receptor-Modified T-Cells for the immunotherapy of Patients with HER-1 Expressing Advanced Relapsed/Refractory Non-Small Cell Lung Cancer at the 2015 European Cancer Congress’ (ECCO) annual meeting held in Vienna, Austria from September 25-29, 2015. The abstract can be viewed online here.

Yihong Yao, PhD, Chief Scientific Officer of the Company commented, “We are very encouraged by the safety, efficacy and tolerability profile of our CBM-EGFR.1 asset observed in early clinical development of advanced, refractory/relapsing, and EGFR positive NSCLC patients. To our knowledge this is the first report of positive safety and efficacy profile of EGFR CAR-T in solid tumors in humans.  It is important to note that many of these patients treated with CBM-EGFR.1 previously failed EGFR-TKI therapy.  We think that CBM-EGFR.1 may provide late stage NSCLC patients with another option and we will actively explore more alternatives in our continued clinical development of this asset.  CBMG is committed to integrating the state-of-the-art translational medicine strategy to identify the right patient population that might benefit the most from CBM-EGFR.1 therapeutic intervention in NSCLC and other solid tumors.”

About the Trial

The CBM-EGFR.1 phase I trial was designed and conducted by Chinese PLA General Hospital (“PLAGH”, Beijing, also known as “301 Hospital”), led by Principal Investigator Wei Dong Han, M.D., Ph.D., head of the cancer immunotherapy department and director of molecular immunology department of the life science institute of PLAGH.   The Phase I trial initially enrolled 11 EGFR positive patients with advanced relapsed/refractory NSCLC. The EGFR status was determined based on immunohistochemistry (IHC) where 50% or higher of the tumor cells expressed EGFR. All patients provided written informed consent before enrollment, and received dose escalating infusions of CBM-EGFR.1 cells with or without conditioning chemotherapy. Autologous CBM-EGFR.1 cells were generated from 50 to 80 ml peripheral blood after a 10 to 12-day in vitro expansion, and the total CAR-expressing T cell number of 1×10⁶/kg was set as an output control. The presence of EGFR positive cells in tumor tissues was evaluated by means of IHC.  Serum cytokines such as IL-6, IL-2, TNF-a, copy numbers of CAR-EGFR.1 transgene in peripheral blood and biopsied tissues, were monitored periodically according to assigned protocol. Clinical responses were evaluated using RECIST 1.1 and adverse events were graded by CTCAE 4.0.

This study is registered at https://www.clinicaltrials.gov/ct2/show/record/NCT01869166.

Highlight of Phase I clinical trial for CBM in advanced, refractory/relapsing NSCLC

• First known report of positive safety data of EGFR CAR-T in solid tumor
• First report of positive signal of clinical activity of EGFR CAR-T in solid tumor
• Most NSCLC patients treated with CBM-EGRF.1 failed EGFR-TKI therapy
• Disease control rate (DCR) of 63.6%
• 2 partial responders (PR) from 11 patients with evaluable clinical outcome

Of the eleven patients with evaluable clinical outcome, the disease control rate (DCR) was 63.6% (7 of 11). Two patients achieved partial response (PR) and 5 had stable disease (SD) for two to eight months. The pathological eradication of EGFR positive tumor cells after CBM-EGFR.1 treatment was observed in biopsied tumor mass from 2 of the 7 cases that achieved disease control. Patient #6 was biopsied at the same lesion in right lung one month after CBM-EGFR.1 CAR-T cell infusion with a result of disappearance of EGFR-expressing tumor cells. Patient #8 was sampled 1 month and 3.5 months after the infusion of CBM-EGFR.1 CAR-T cells and the IHC examination of the biopsied tumor tissue showed a continuous reduction of EGFR positive tumor cells. Currently, CBM-EGFR.1 is being actively evaluated in other EGFR expressing solid tumors. 

The Company previously announced positive clinical data results its Phase I clinical trials for CBM-CD19.1, CBM-CD20.1 and CBM-CD30.1 CAR-T assets targeting late-stage hematological cancer, and is scheduled to present more clinical data of CBM-EGFR.1 immunotherapy for the treatment of patients with EGFR expressing solid tumors besides NSCLC at the 5th World Congress on Cancer Therapy in Atlanta, Georgia on September 28, 2015.