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 responded to inquiries from
investors and the scientific community about its Immuno-Oncology
cell therapy platform as it relates to information surrounding
CD19, CD20 and CD30.
Dr. William (Wei) Cao, Chief Executive Officer of Cellular
Biomedicine Group, commented, "We are taking a proactive approach
to addressing inquiries from the investment and scientific
community on the Company's Immuno-Oncology cell therapy platform on
a more real-time basis. This area has been well followed and we
would like to take this opportunity to expand on frequently asked
questions and dispel misinformation in the marketplace. We will
continue to keep our stakeholders apprised of ongoing business and
pipeline developments."
Can CBMG clarify what constructs were a part of the
acquisition from PLA General Hospital's ("PLAGH") Chimeric Antigen
Receptor T cell (CAR-T) therapy and was CART-33 a part of this
acquisition?
As the Company had previously announced on February 9, 2015, the
recombinant expression vectors CD-19, CD-20, CD-30 and Human
Epidermal Growth Factor Receptor's (EGFR or HER1) were the only
constructs acquired in addition to its respective patent
applications and Phase I clinical data. At no time has CBMG
acquired CART-33, which is a classification of which the Company is
unaware. Details related to the acquisition and the respective
constructs can be found in the Company's Form 8-Ks filed February
9, 2015, March 25, 2015, May 26, 2015; the Form 10-K filed March
31, 2015; and the Form 10-Qs filed on May 15 and August 13,
2015. Any statement made otherwise is simply false.
In order for the community to better benchmark CBMG's
data relative to its competitors, can the Company clarify CBMG's
lead drug as it relates to patients enrolled with chemotherapy
refractory advanced diffuse large B cell lymphomas (DLBCL) and the
respective indications of each construct?
Different from other clinical trials that have been published,
CBMG's lead drug candidate is CD-20 CART and not CD-19 CART for
DLBCL. At this time we would like to reiterate that the
clinical trial data presented for CD-19 CART was for B-cell Lineage
Acute Lymphoblastic Leukemia (B-cell ALL); CD20 CART was for
Advanced Diffuse Large B Cell Lymphoma (DLBCL) and CD30 CART was
for Hodgkin's lymphoma. It is important to note here that
comparing clinical outcomes from two different drugs that target
two different tumor antigens could be misleading if the detailed
background of the trials are not provided. Clinical trial data
for all three constructs can be found registered with the U.S.
National Institute of Health (NIH) at the following links:
NCT01864889, NCT01735604, NCT02259556.
What is the accurate overall response rate (ORR) for
CD-19 CART?
As we had previously announced on March 25, 2015, nine adult
patients with relapsed or chemotherapy-refractory B-cell lineage
acute lymphoblastic leukemia (B-ALL) were enrolled in this CAR-CD19
T cell therapy trial. Different from other competitive trials,
pediatric patients were not enrolled as part of this
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 71.4% (five out
of seven patients) in the six CD-19 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. It should be noted that 2 out of
the 9 patients were infused with allogeneic CD-19 CART. When
comparing clinical trial results that were carried out with
autologous CART only, the patients infused
with allogeneic CART should be excluded to allow meaningful
comparison.
Can the Company clarify the overall response rate (ORR)
for its CD-20 CART and CD-30 CART?
As the Company had previously reported on March 25, 2015, the
results for CAR-CD20 T cell therapy trial showed an overall
response rate (ORR) of 83% with five of six patients with evaluable
clinical efficacy achieving complete response (CR) or partial
response (PR). The Company had also previously reported on May
22, 2015, the results for CAR-CD30 T cell therapy trial showed
overall response rate (ORR) of 71% with five of seven patients
achieving CR or partial response PR.
Can the Company explain which vector was used in the
genetic modification of patients' T cells with anti-CD19 CAR and
anti-CD20 CAR?
The transduction method utilized in the genetic modification of
patients' T cells is in fact the lentiviral vector transduction
method. The Company made an error in the filing with
clinicaltrials.gov and will rectify the situation immediately.
What is the next major clinical milestone for
CBMG?
The Company will present CAR-T Phase I/II clinical trial data
for Non Small Cell Lung Cancer (NSCLC) and Cholangiocarcinoma (CC
or CCA) at the 5th World Congress on Cancer Therapy on September 28
in Atlanta, Georgia.
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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