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 results from an
expanded Phase I/II clinical trial evaluating the safety,
feasibility and anti-tumor activity of its Chimeric Antigen
Receptor-Modified T-Cells (CAR-T) immunotherapy (CBM-EGFR.1)
targeting wild type EGFR (Epidermal Growth Factor Receptor) for the
treatment of patients with EGFR expressing advanced
relapsed/refractory solid tumors. Based on the results from 24
patients treated with CBM-EGFR.1 (17 patients with non-small cell
lung cancer (NSCLC), 5 patients with cholangiocarcinoma, 1 patient
with pancreatic cancer and 1 patient with renal cell carcinoma
(RCC)), the early results showed that CBM-EGFR.1 immunotherapy was
safe, well tolerated, and had positive signal of clinical activity
in several indications. The data was selected for a late-breaking
oral presentation entitled EGFR-Targeted Chimeric Antigen
Receptor-Modified T Cells Immunotherapy for Patients With
EGFR-Expressing Advanced or Relapsed/Refractory Solid Tumors at the
5th World Congress on Cancer Therapy in Atlanta, Georgia on
September 28, 2015. The abstract can be viewed online here. The
results from the first 11 NSCLC patients in the trial outlined in
the abstract, entitled Chimeric Antigen Receptor-Modified T-Cells
for the Immunotherapy of Patients with HER-1 Expressing Advanced
Relapsed/Refractory Non-Small Cell Lung Cancer was presented 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.
About the Trial
The CBM-EGFR.1 phase I/II 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 trial enrolled 24 EGFR positive (defined as at
least 50% membrane staining of EGFR based on immunohistochemistry),
advanced, relapsed/refractory patients with NSCLC,
cholangiocarcinoma, RCC or pancreatic cancer. Most of the NSCLC
patients failed EGFR-TKI therapy prior to CBM-EGFR.1 treatment. 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
immunohistochemistry (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 with the U.S. National Institute of
Health (NIH) here.
Highlight of Phase I/II clinical trial for CBMG CAR-T
products in multiple advanced, refractory/relapsing
solid tumors
- First known report of positive safety and signal of clinical
activity of EGFR CAR-T in multiple solid tumor indications
- Most NSCLC patients treated with CBM-EGFR.1 failed EGFR-TKI
therapy prior to CBM-EGFR.1 treatment
- Overall disease control rate (DCR) is 79% (19 of 24). 100%
DCR in cholangiocarcinoma (5/5), 71% DCR in NSCLC (12/17)
- Objective response rate (ORR) of 25% in combined indications: 2
complete response (CR) and 1 partial response (PR) in
cholangiocarcinoma, 2 PR in NSCLC and 1 PR in pancreatic
cancer
The clinical responses were evaluated with RECIST1.1 and
immune-related response criteria by a team of experts, and adverse
events were graded with CTCAE 4.0. Of the 24 patients with
evaluable clinical outcome, the overall DCR was 79% (19 of 24).
Under standard protocol, an independent review of the
clinical data by a separate team of experts will commence at the
end of the trial. Of the 5 cholangiocarcinoma patients
reported here, 2 achieved CR, 1 achieved PR, and 2 had stable
disease (SD). The single pancreatic cancer patient had a PR and a
single RCC patient achieved SD. Of the 17 NSCLC patients
treated, 2 had PR, 10 had SD, and 5 had progressive disease. Of the
26 adverse events experienced by patients, only 1 was grade 3-4
where the patient experienced serum lipase increase. No patients
experienced drug related deaths. Grade 1-2 pruritus was the most
frequent adverse event experienced by patients (9/26; 35%).
Desquamation and constipation are the other two frequently observed
adverse events in the trial (4/26 each; 15%). Only 3 out of 24
patients exhibited Grade 2 cytokine release syndrome within one
week post infusions. The median dose of transfused CBM-EGFR.1 cells
was 1.18×107 cells/kg (IQR, 0.76 to 1.43×107 cells/kg). The
transgene copies measured by PCR in both blood and biopsy tissues
post CBM-EGFR.1 infusions indicated the trafficking of CART cells
into the tumor tissues. Pathological eradication of EGFR positive
tumor cells after CBM-EGFR.1 treatment was observed in tumor
biopsies, along with clear evidence of the CBM-EGFR.1 cells
detected in tumor-infiltrating T cells in all patients with
available tumor biopsies post treatment.
Yihong Yao, Ph.D., Chief Scientific Officer of the Company
commented, "The early signal of clinical activity, especially those
observed in patients with late stage cholangiocarcinoma, and those
with late stage NSCLC that failed prior EGFR-TKI therapy, are very
encouraging. To our knowledge this is the first report of positive
safety and tolerability data of EGFR CAR-T in multiple solid tumor
indications. We are moving forward to confirm the safety and
tolerability profile of CBM-EGFR.1 in cholangiocarcinoma and NSCLC,
and will actively explore the opportunities in other solid tumor
indications by implementing state-of-the-art translational medicine
strategy in the clinical development. We are determined to
look for early possibilities of conducting multi-center Phase IIb
trials to validate the clinical activity from early
observations. We have also begun to evaluate potential
partners to develop an immunohistochemistry based diagnostic assay
to aid in the patient selection whenever needed. We are optimistic
that CBM-EGFR.1 will be able to provide late stage cancer patients
with another option to extend their lives."
The Company also previously announced positive clinical data
results for its Phase I clinical trials for CBM-CD19.1, CBM-CD20.1
and CBM-CD30.1 CAR-T assets targeting late-stage hematological
cancer. Clinical trial data for all three constructs can be found
registered with the U.S. National Institute of Health
(NIH) here: NCT01864889, NCT01735604, NCT02259556.
"We are extremely excited by the recent developments resulting
from the collaboration between CBMG and PLA General Hospital.
These two reports on CBM-EGFR.1 therapy for late stage solid tumors
have clearly demonstrated our ability to innovate, advance
boundaries between basic research and translational medicine and
streamline the manufacture of CAR-T and clinical treatment.
We are confident and determined to be at the forefront of
clinical development of these breakthrough CAR-T therapies for late
stage cancer patients with solid tumors," concluded Dr. William
(Wei) Cao, Chief Executive Officer of Cellular Biomedicine
Group.
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell
therapies for the treatment of certain degenerative and cancerous
diseases. Our developmental stem cell and Immuno-Oncology
projects are the result of research and development by scientists
and doctors from China and the United States. Our
flagship GMP facility in China, consisting of six independent cell
production lines, is designed, certified and managed according to
U.S. standards. To learn more about CBMG, please visit:
www.cellbiomedgroup.com.
Forward-Looking Statements
Statements in this press release relating to plans, strategies,
trends, specific activities or investments, and other statements
that are not descriptions of historical facts may be
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Forward-looking
information is inherently subject to risks and uncertainties, and
actual results could differ materially from those currently
anticipated due to a number of factors, which include risks
inherent in doing business, trends affecting the global economy,
including the devaluation of the RMB by China in August 2015 and
other risks detailed from time to time in CBMG's reports filed with
the Securities and Exchange Commission, quarterly reports on form
10-Q, current reports on form 8-K and annual reports on form 10-K.
Forward-looking statements may be identified by terms such as
"may," "will," "expects," "plans," "intends," "estimates,"
"potential," or "continue," or similar terms or the negative of
these terms. Although CBMG believes the expectations reflected in
the forward-looking statements are reasonable, they cannot
guarantee that future results, levels of activity, performance or
achievements will be obtained. CBMG does not have any obligation to
update these forward-looking statements other than as required by
law.
CONTACT: Sarah Kelly
Director of Corporate Communications, CBMG
+1 650 566-5064
sarah.kelly@cellbiomedgroup.com
Vivian Chen
Managing Director Investor Relations, Grayling
+1 347 481-3711
vivian.chen@grayling.com
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