Cellular Biomedicine Group Announces Positive Phase I Results From CAR-T CD30 Immuno-Oncology Clinical Development Program
May 22 2015 - 9:17AM
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 encouraging clinical data from its Chimeric Antigen
Receptor (CAR-T) CD30-positive Hodgkin's lymphoma immuno-oncology
clinical development program. The results of this trial to date
demonstrated that five out of seven patients responded to the
treatment. CD30-directed CAR-T cell therapy was demonstrated in
this trial to be safe, feasible and efficient.
The data was presented by Dr. William (Wei) Cao, PhD, BM, Chief
Executive Officer of Cellular Biomedicine Group, at the 10th Annual
World Stem Cells & Regenerative Medicine Congress in London, UK
on May 21, 2015.
Dr. Cao commented, "We are very encouraged by the efficacy and
toxicity profile of our CAR-T CD30 technology, given that the
cancer patients in the trials were diagnosed with Stage III and IV
Hodgkin's lymphoma. The patient selection criteria of our CAR-T
studies are very stringent, as the participants enrolled are
advanced, relapsed, and refractory to other standard-of-care
therapies. The results of this study has led us to move forward
with this protocol into the treatment of relapsed/refractory CD30
positive lymphoma patients."
"We previously announced positive clinical data from our Phase I
clinical trials for CD19 and CD20 constructs and expect to announce
clinical data from our EGFR-HER1-positive advanced lung cancer
trial in the third quarter of this year. We look forward to
additional progress in advancing our Immuno-Oncology platform with
further clinical developments of our CD19, CD20, CD30 and EGFR-HER1
constructs."
About the Trial
The CAR-T trial was 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. It
assessed the feasibility, safety and efficacy in subjects with
progressive relapsed/refractory Hodgkin's lymphoma following the
administration of CD30-targeting CAR-T cells. The study recruited
male and female subjects who had a heavy treatment history (16
previous treatments, ranging from 8-24) and/or multiple tumor
lesions 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.
This trial was a Phase I, open-label trial (NCT02259556) whereby
enrolled patients received escalating doses of autologous T cells
transduced with a CD30-directed chimeric antigen receptor moiety
for a consecutive 3-5 days. The level of CAR transgenes in
peripheral blood and biopsied tumor tissues were measured
periodically according to assigned protocol by Quantitative
PCR.
CAR-T CD30 for Hodgkin's
Lymphoma Data Analysis
Seven adult patients with relapsed/refractory Hodgkin's lymphoma
were enrolled in this CAR-CD30 T cell therapy trial. Results showed
that 2 out of 7 patients achieved partial response (PR) and 3 out
of the 7 patients obtained stable disease (SD), therefore the
therapy resulted in an overall disease control rate of 71.4%
(5/7) and an objective response rate of 28.6% (2/7) in
the patients with relapsed/refractory Hodgkin's lymphoma.
Neither conditioning chemotherapy nor subsequent
allogeneic-HSCT (hematopoietic stem cell transplant) was
applied. Only one out of seven patients experienced an adverse
effect with a 5-day self-limiting arthralgias, myalgias and dual
knee swelling 2 weeks after cell infusion.
This study is registered at
https://clinicaltrials.gov/ct2/show/NCT02259556.
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://www.cellbiomedgroup.com/investor-relations/investment-overview/ under
SEC filings or presentations.
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 in China, 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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