Cellular Biomedicine Group Announces Phase I Results From CAR-T Immuno-Oncology Clinical Development Programs
March 25 2015 - 9:00AM
Cellular Biomedicine Group Inc. (Nasdaq:CBMG) ("CBMG" or the
"Company"), a biomedicine firm engaged in the development of
effective treatments for degenerative and cancerous diseases, today
announced clinical data from its CAR-T immuno-oncology clinical
development programs. The data will be discussed by Dr. Wei
(William) Cao, PhD, BM, Chief Executive Officer of Cellular
Biomedicine Group, at the 2015 Annual Regen Med Investor Day on
March 25 in New York City.
Dr. Cao commented, "We are very pleased with the efficacy and
toxicity profile of our CAR-T technology, given the advanced stage
of the cancer patients in the trials. With over 3.5 million new
cancer patients diagnosed every year in China, developing safer and
more effective cancer immunotherapy programs with leading hospitals
will serve urgent unmet medical needs. We look forward to
additional progress in advancing our CAR-T cell pipeline with
further clinical development of our CD19, CD20, CD30 and EGFR-HER1
constructs."
About the Trials
The CAR-T trials were designed and conducted
by Chinese PLA General Hospital ("PLAGH", Beijing, also known
as "301 Hospital"), led by Principal Investigator Wei Dong
Han, MD, PhD, head of PLAGH's cancer immunotherapy
department. They studied genetically engineered lymphocyte
therapy in treating patients with B-cell leukemia or lymphoma that
is relapsed (after stem cell transplantation or intensive
chemotherapy) or refractory to available therapeutics. The studies
recruited male and female subjects with CD19+ and CD20+ B
cell malignancies with no available curative treatment options
(such as autologous or allogeneic SCT) that had limited prognosis
(several months to < 2 year survival) with currently available
therapies.
CAR-T CD19 for Acute Lymphocytic
Leukemia (B-cell ALL) Data Analysis
Nine adult patients with relapsed or chemotherapy-refractory
B-cell lineage acute lymphocytic leukemia (B-cell ALL) were
enrolled in this CAR-CD19 T cell therapy trial. Results showed a
complete response (CR) rate of 22.2% (two out of nine patients) and
a partial response (PR) rate of 44.4% (four out of nine patients)
for an overall response rate (ORR) of 66.7% (six out of nine
patients). Further subgroup analysis showed an overall response
rate (ORR) of 71.5% (five out of seven patients) in the six CD19
patients with extramedullary involvement and one patient with no
extramedullary lesions and treated with autologous CAR-CD19 T cell
therapy. In the six CD19 patients with extramedullary leukemia
involvement or bulky adenopathy, an overall response rate (ORR) of
66.7% (four out of six patients) was achieved. Two of the nine
patients with extramedullary lesions received allogeneic CAR-CD19 T
cell therapy (CBM-C19.a1) and had converted mixed to complete donor
chimerism at the onset of graft-versus-host disease (GVHD). One of
those patients eventually died of GVHD, but the other gradually
reached a complete hematologic remission and a partial regression
of her extramedullary leukemic lesions. There were two Grade 2-3
toxicities and GVHD Grade 4 toxicities.
This study is registered at www.clinicaltrials.gov as
NCT01864889.
CAR-T CD20 for Advanced Diffuse Large B Cell Lymphoma
(DLBCL) Data Analysis
The Company also summarized the results of a Phase I clinical
trial on CAR-CD20 T cell therapy (CBM-C20.1), which enrolled seven
patients with chemotherapy refractory advanced diffuse large B cell
lymphomas (DLBCL). One of the two patients with no bulky tumors
achieved a 14-month durable and ongoing complete remission by cell
infusion only, and another achieved a 6-month tumor regression
achieving a complete response (CR) rate of 50% (one out of two
patients) and an overall response rate (ORR) of 100% (two out of
two patients). Of those patients with bulky tumor burden, four of
five patients were evaluable for clinical efficacy. Of those four
patients, three achieved three to six month tumor regression for an
overall response rate (ORR) of 75% (three out of four
patients).
Delayed toxicities related to CAR-CD20 cell infusion are
directly correlated to tumor burden, and mainly included, but were
not limited to, curable cytokine release symptoms and tumor lysis
symptoms, and these results were achieved by combining debulking
conditioning regimens in advanced DLBCL patients with bulky tumors.
Overall there were three Grade 2-3 toxicities and one Grade 4
toxicity.
This study is registered at www.clinicaltrials.gov as
NCT01735604. Publication source: Effective response and delayed
toxicities of refractory advanced diffuse large B-cell lymphoma
treated by CD20-directed chimeric antigen receptor-modified T
cells. Clin Immunol. 2014 Dec;155(2):160-75. doi:
10.1016/j.clim.2014.10.002. Epub 2014 Oct 16.
Further details of the clinical data may be viewed in the
Company's most recent presentation filed on Form 8k with the SEC,
which can be found on the Company's website at the following link,
http://cellbiomedgroup.com/investor-relations/investment-overview/
under SEC filings or presentations.
The Company expects to release Phase I clinical data in the
third quarter of 2015 from its clinical studies of the CAR-T
constructs targeting CD30-positive Hodgkin's lymphoma and
EGFR-HER1-positive advanced lung cancer.
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell
therapies for the treatment of certain degenerative diseases and
cancers. Our developmental stem cell, progenitor cell, and
immune cell projects are the result of research and development by
scientists and doctors from China and the United
States. Our flagship GMP facility, consisting of eight 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, but are not
limited to, risk factors inherent in doing business.
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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