Cyclacel’s CYC065 CDK Inhibitor Demonstrates Synergy With Venetoclax By Dual Targeting Of Chronic Lymphocytic Leukemia
April 17 2018 - 9:00AM
Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP)
("Cyclacel" or the "Company"), a biopharmaceutical company
developing oral therapies that target various phases of cell cycle
control for the treatment of cancer and other serious disorders,
today announced the presentation by investigators led by William
Plunkett, PhD, Professor and Deputy Chair, Department of
Experimental Therapeutics, The University of Texas MD Anderson
Cancer Center, Houston, Texas, of preclinical data demonstrating
strong synergy between Cyclacel’s CDK2/9 inhibitor, CYC065,
and the Bcl-2 inhibitor, venetoclax (ABT-199, AbbVie) in
chronic lymphocytic leukemia (CLL) samples obtained from patients.
The data were presented at the American Association for Cancer
Research (AACR) Annual Meeting being held April 14-18, 2018 in
Chicago, Illinois.
“The MD Anderson data show that the combination
of CYC065 and venetoclax is strongly synergistic in primary CLL
cells from patients, including those with 17p deletions. In
addition, the combination was active in two CLL samples which were
resistant to either agent alone. These findings support the
hypothesis that dual targeting of the Mcl-1- and Bcl-2-dependent
mechanisms could induce synergistic cell death by apoptosis,” said
Spiro Rombotis, President and Chief Executive Officer of Cyclacel.
“Last weekend during the same AACR conference, we reported that
CYC065 durably suppresses Mcl-1, a member of the Bcl-2 family of
survival proteins, in patients with advanced solid tumors1. Taken
together the data highlight an exciting opportunity to rationally
disrupt the pathways promoting the survival of CLL cells. Cyclacel
plans to start soon a clinical study to evaluate CYC065 in
combination with venetoclax in patients with relapsed/refractory
CLL.”
Details of the poster presentation are as
follows:
|
|
Title: |
Strategic combination
of the cyclin-dependent kinase inhibitor CYC065 with venetoclax to
target anti-apoptotic proteins in chronic lymphocytic leukemia |
Presenter/Authors: |
Rong Chen, Yuling Chen,
Sheelagh Frame, David Blake, William G. Wierda, Daniella Zheleva
and William Plunkett. |
Category: |
Experimental and
Molecular Therapeutics |
Session: |
PO.ET07.03 - Receptor
Targeting and the Tumor Microenvironment |
Abstract
#: |
3905/ 5 |
Location: |
McCormick Place South,
Exhibit Hall A, Poster Section 38 |
Date and
Time: |
Tuesday, April 17,
2018, 8:00 AM - 12:00 PM |
|
|
About CYC065
CYC065, a second generation CDK2/9 inhibitor, is
being evaluated in a first-in-human, Phase 1 trial in patients with
advanced solid tumors. It is mechanistically similar but has higher
dose potency, in vitro and in vivo, and improved properties
compared to seliciclib, a first generation CDK inhibitor. Similarly
to FDA approved CDK4/6 inhibitors, CYC065 may be most useful in
combination with other anticancer drugs, including Bcl-2
inhibitors, such as venetoclax, or HER2 inhibitors, such as
trastuzumab. CYC065 durably suppresses Mcl-1, a member of the Bcl-2
family of survival proteins, in Phase 1 patients with advanced
solid tumors. Preclinical data show that CYC065 may benefit
patients with adult and pediatric hematological malignancies,
including acute myeloid leukemias (AML), acute lymphocytic
leukemias (ALL), and in particular those with MLL rearrangements,
chronic lymphocytic leukemias (CLL), B-cell lymphomas, multiple
myelomas, and certain solid tumors, including breast and uterine
cancers, and neuroblastomas.
About Cyclacel Pharmaceuticals,
Inc.
Cyclacel Pharmaceuticals is a clinical-stage
biopharmaceutical company using cell cycle, transcriptional
regulation and DNA damage response biology to develop innovative,
targeted medicines for cancer and other proliferative diseases.
Cyclacel's transcriptional regulation program is evaluating CYC065,
a CDK inhibitor, in patients with advanced cancers. The DNA damage
response program is evaluating a sequential regimen of sapacitabine
and seliciclib, a CDK inhibitor, in patients with BRCA positive,
advanced solid cancers. Cyclacel's strategy is to build a
diversified biopharmaceutical business focused in hematology and
oncology based on a pipeline of novel drug candidates. For
additional information, please visit www.cyclacel.com.
Forward-looking Statements
This news release contains certain
forward-looking statements that involve risks and uncertainties
that could cause actual results to be materially different from
historical results or from any future results expressed or implied
by such forward-looking statements. Such forward-looking statements
include statements regarding, among other things, the efficacy,
safety and intended utilization of Cyclacel's product candidates,
the conduct and results of future clinical trials, plans regarding
regulatory filings, future research and clinical trials and plans
regarding partnering activities. Factors that may cause actual
results to differ materially include the risk that product
candidates that appeared promising in early research and clinical
trials do not demonstrate safety and/or efficacy in larger-scale or
later clinical trials, trials may have difficulty enrolling,
Cyclacel may not obtain approval to market its product candidates,
the risks associated with reliance on outside financing to meet
capital requirements, and the risks associated with reliance on
collaborative partners for further clinical trials, development and
commercialization of product candidates. You are urged to consider
statements that include the words "may," "will," "would," "could,"
"should," "believes," "estimates," "projects," "potential,"
"expects," "plans," "anticipates," "intends," "continues,"
"forecast," "designed," "goal," or the negative of those words or
other comparable words to be uncertain and forward-looking. For a
further list and description of the risks and uncertainties the
Company faces, please refer to our most recent Annual Report on
Form 10-K and other periodic and other filings we file with the
Securities and Exchange Commission and are available at
www.sec.gov. Such forward-looking statements are current only as of
the date they are made, and we assume no obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contacts |
|
Company: |
Paul McBarron, (908)
517-7330, pmcbarron@cyclacel.com |
Investor
Relations: |
Russo Partners LLC,
Alexander Fudukidis, (646) 942-5632,
alex.fudukidis@russopartnersllc.com |
© Copyright 2018 Cyclacel Pharmaceuticals, Inc. All
Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of
Cyclacel Pharmaceuticals, Inc.
________________________1 Phase I safety, pharmacokinetic and
pharmacodynamic study of CYC065, a cyclin dependent kinase
inhibitor, in patients with advanced cancers
(NCT02552953); AACR 2018 Sunday, April 15, 2018,
3:35 PM (Abstract CT037).
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