NEW YORK and SHANGHAI, Dec. 7,
2019 /PRNewswire/ -- Cellular Biomedicine Group Inc.
(NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm
engaged in the drug development of immunotherapies for cancer and
stem cell therapies, announced early data from its ongoing
investigator initiated trial ("IIT") at an oral presentation titled
"Novel Anti-BCMA CAR-T for Relapsed or Refractory Multiple Myeloma"
at the 61st American Society of Hematology ("ASH")
annual meeting on December 7, 2019 in
Orlando, Florida.
ABSTRACT DETAILS
C-CAR088 is a novel anti-B-cell
maturation antigen ("BCMA") chimeric antigen receptor T-cell
("CAR-T") product designed to improve efficacy through increasing
the specificity and reducing immunogenicity by fusing a
single-chain variable fragment ("scFv") from high-affinity
human monoclonal antibody to a CD3ζ/4-1BB signaling
domain. It can effectively eradicate BCMA positive tumor
cells both in vitro and in vivo.
A Phase 1, dose escalation trial is being conducted in patients
with relapsed or refractory Multiple Myeloma ("r/r MM") to assess
the safety and efficacy of C-CAR088. As of the end of
November the Company has enrolled eleven patients, of which eight
were infused with C-CAR088, and five patients were evaluable for
clinical response. Three of the five patients were
treated with C-CAR088 at the dose of 1.0 x 106 CAR-T cells/kg,
and the other two patients treated at 3.0x106 CAR-T cells/kg. All
five patients showed clinical improvement as early as two weeks
post treatment. By 4 weeks, one patient achieved a complete
response ("CR"), three patients reached a very good partial
response ("VGPR"), and one patient reached a partial response
("PR") post C-CAR088 infusion. Furthermore, the Company observed
that C-CAR088 proliferation & expansion in the peripheral blood
correlated with the decrease of tumor burden in all patients.
C-CAR088 treatment showed to be well tolerated. There were no
dose-limiting toxicities ("DLTs"). Reversible Grade 1 and
Grade 2 Cytokine release syndrome ("CRS") were observed in
four and one patient respectively.
"The early IIT clinical trial results in patients with relapsed
and refractory multiple myeloma for C-CAR088 support preclinical
findings that C-CAR088 shows promising efficacy and has a
manageable safety profile," stated Dr. Yihong Yao, Chief Scientific Officer of CBMG.
Dr. Yao added, "The very early clinical efficacy signal at low and
suboptimal dosing is encouraging and needs to be confirmed by the
ongoing clinical trial. We will continue to monitor and
evaluate the duration of response ("DOR") and to further pursue DOR
improvement alternatives."
The complete text of the abstract can be found at
https://ash.confex.com/ash/2019/webprogram/Paper125372.html
The full presentation can be found on the company's website.
About Multiple Myeloma
Multiple Myeloma, a
cancer derived from plasma cells, accounts for 1% of all cancers
and approximately 10% of all hematological malignancies[1]. It is
estimated that there are 27,800 new cases of MM diagnosed
in China each year. With the acceleration of the
aging process in China, it is predicted that MM, with a rapid
growth in incidence, will become one of the more significant
diseases that affect people's health in the country[2]. The
American Cancer Society estimates that in the United States, approximately 32,110 new
cases of MM (18,130 in men and 13,980 in women) will be diagnosed
in 2019[3].
[1] Moreau P et al., Annals of Oncology 24 (Supplement 6):
vi133–vi137, 2013
[2] Blood Cancer J. 2014 Aug 15;4:e239. doi:
10.1038/bcj.2014.55
[3]
https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html
About Cellular Biomedicine Group
Cellular Biomedicine
Group, Inc. (NASDAQ: CBMG) develops proprietary cell therapies for
the treatment of cancer and degenerative diseases. It conducts
immuno-oncology and stem cell clinical trials in China using products from its integrated GMP
laboratory. The Company's GMP facilities in China, consisting of twelve independent cell
production lines, are designed and managed according to both
China and U.S. GMP standards. Its
Shanghai facility includes a
"Joint Laboratory of Cell Therapy" with GE Healthcare and a "Joint
Cell Therapy Technology Innovation and Application Center" with
Thermo Fisher Scientific, which partnerships focus on improving
manufacturing processes for cell therapies. CBMG currently has
ongoing CAR-T Phase I clinical trials in China. The China NMPA (formerly CFDA) accepted
the Company's IND application for a Phase II trial for
AlloJoin®, CBMG's "Off-the-Shelf" allogenic haMPC
therapy for the treatment of Knee Osteoarthritis (KOA), and the
Company's IND application for a Phase II trial for
ReJoin® autologous haMPC therapy for the treatment of
KOA. CBMG is included in the broad-market Russell 3000®
Index and the small-cap Russell 2000® Index, and the
Loncar China BioPharma index. 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 and 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 those regarding CBMG's ability to implement its plans,
strategies and objectives for future operations, including
regulatory approval of its IND applications, its ability to execute
on proposed new products, services or development thereof, results
of its clinical research and development, regulatory infrastructure
governing cell therapy and cellular biopharmaceuticals, its ability
to enter into agreements with any necessary manufacturing,
marketing and/or distribution partners for purposes of
commercialization, its ability to seek intellectual property rights
for its product candidates, competition in the industry in which it
operates, overall market conditions, any statements or assumptions
underlying any of the foregoing and other risks detailed from time
to time in CBMG's reports filed with the Securities and Exchange
Commission, Annual Reports on Form 10-K, Quarterly Reports on Form
10-Q, and Current Reports on Form 8-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.
For more information, please contact:
Company Contact:
Derrick C. Li
Head of Strategy and Investor Relations, CBMG
Phone: 917-717-0994
Email: derrick.li@cellbiomedgroup.com
Investor Contact:
Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: 212-896-1254 / 212-896-1267
Email: cellbiomed@kcsa.com
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SOURCE Cellular Biomedicine Group