CBMG Responds to Inquiries From Investors and the Scientific Community About the Phase IIa Results From CAR-T CD20 Immuno-Onc...
November 03 2015 - 9:20AM
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
responded to inquiries from investors and the scientific community
about the announced results from an ongoing Phase IIa clinical
trial evaluating the safety, feasibility and anti-tumor activity of
its acquired Chimeric Antigen Receptor-Modified T-Cells (CAR-T)
immunotherapy (CBM-CD20.1) targeting CD20 for the treatment of
patients with advanced B-cell Non-Hodgkin lymphoma (NHL).
What are the significant treatment
differences between the Phase I and Phase IIa studies?The
Phase IIa study excluded patients with uncontrolled bulky lymphoma
(maximum diameter ≥5 cm or lesion number >3) after salvage
treatments. The object of the early Phase IIa study is to
evaluate the clinical activity of CBM-CD20.1 in NHL patients
refractory or relapsed after chemotherapy. We also want to evaluate
whether CBM-CD20.1 might improve the clinical outcome of advanced
NHL patients that respond partially to chemotherapy. There
will be a more detailed discussion in an upcoming manuscript in a
peer-reviewed journal.
Please clarify how many patients
actually enrolled in this Phase IIa NHL trial?Fifteen
patients were screened and twelve patients were enrolled. Of
the twelve patients enrolled, two patients did not proceed with
cell infusion. One withdrew consent and the other had disease
progression and did not meet the inclusion criteria. Nine of the
ten patients were refractory or relapsed after chemotherapy. The
tenth patient showed partial response to most recent
chemotherapy.
The abstract published by the 4th International
Conference on Translational Medicine held in Baltimore on October
26-28th discussed an 11th patient from the Phase I trial. This
patient remained in complete remission for over 25 months since the
initial treatment of CBM-CD20.1, and the response is still on
going. This patient was given a second treatment of
CBM-CD20.1 infusions at 16 months post initial treatment based
on the significant decrease of CD20 CAR-T cells in the peripheral
blood (“Patient X”). In congruence with study
protocol, we did not include Patient X in our presentation. The
presented data of the 10 patients (seven patients with diffuse
large B-cell lymphoma (DLBCL) and three patients with other types
of NHL) from the Phase IIa trial can be viewed on the Company
website under Investor Relations/Presentations.
How many of the patients who
participated in the original Phase I trial enrolled in the Phase
IIa study?None of the ten patients reported in the
Company’s October 28th press release had participated in the
original Phase I trial.
Please provide rationale on why the
Phase II study result is substantially better than that of the
Phase I study.Besides excluding patients with uncontrolled
bulky lymphoma, there were improvements in the conditioning regimen
and treatment protocol, as well as the CBM-CD20.1 CART production
process. Together these contributed to the improved clinical
outcome in the phase IIa results.
What is the Company’s next step on
targeting CD20 for the treatment of NHL?The company
intends to seek an opportunity to confirm the safety and clinical
efficacy of CBM-CD20.1 in advanced NHL in a multicenter, single
arm, Phase IIb trial. We plan to also explore other
opportunities such as repeated treatment of CBM-CD20.1 or
combination with other immuno-oncology therapies in advanced
NHL.
About Cellular Biomedicine
GroupCellular 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
nine 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
StatementsStatements 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.
Contacts:
Sarah Kelly
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com
Vivian Chen
Managing Director Investor Relations, Grayling
+1 347 481-3711
vivian.chen@grayling.com
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