Cyclacel Pharmaceuticals Reviews 2020 Achievements and Announces Key Business Objectives for 2021
January 11 2021 - 7:46AM
Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP;
"Cyclacel" or the "Company"), a biopharmaceutical company
developing innovative medicines based on cancer cell biology, today
provided a business update reviewing 2020 achievements and
outlining the Company’s key business objectives for 2021. The
Company will present at Biotech Showcase™ Digital 2021 taking place
virtually from January 11 to 15 with a prerecorded session of the
company presentation. Spiro Rombotis, President & Chief
Executive Officer, will provide an overview of the Company and
progress in key programs. Cyclacel will host one-on-one meetings
with investors and industry stakeholders during the event.
Registered Biotech Showcase™ Digital 2021 attendees may request
one-on-one meetings with Cyclacel through the partneringONE®
system.
"With the recent appointment of Dr. Mark Kirschbaum
as our CMO and the December 2020 strategic investment from Acorn
Bioventures, we are well resourced to progress fadraciclib and
CYC140, our two internally discovered molecules,” said Spiro
Rombotis, President and Chief Executive Officer. “Fadraciclib, a
CDK2/9 inhibitor, has shown promising clinical activity and
tolerability in patients with advanced cancers and CYC140, a PLK1
inhibitor, is in a first-in-human study. As the next step in our
clinical development program we will evaluate both agents, dosed
orally, across a broad spectrum of solid tumors and hematological
malignancies as part of our strategy of identifying clinical
activity which may lead to registration-enabling studies.”
2020 Key Achievements
- Data from Phase 1 study of fadraciclib
as a single agent reported at the Plenary Session of the
32nd EORTC-NCI-AACR (ENA) Symposium• Radiographically
confirmed partial response (PR) after a month and a half on i.v.
fadraciclib: MCL1-amplified endometrial cancer; failed seven lines
of prior therapy; continuing treatment for more than 16 months with
96% reduction in target tumor lesions• High bioequivalence
observed in 5 patients treated with oral fadraciclib
- Enrolled 19 patients evaluating i.v.
fadraciclib in combination with venetoclax in patients with
relapsed or refractory AML/MDS and CLL with evidence of
antileukemic activity
- Enrolled five patients evaluating i.v.
CYC140 in patients with advanced leukemias
- Enrolled 12 patients in Phase 1/2
study evaluating an oral regimen of sapacitabine in combination
with venetoclax in patients with relapsed or refractory
AML/MDS
- Announced peer-reviewed publication of
a fadraciclib review in PLOS ONE. Authored by scientists from
Cyclacel and The Institute of Cancer Research, London, the
publication describes the discovery of fadraciclib and shows that
its targeting of CDK2 and CDK9 leads to broad therapeutic
potential
- Appointed Mark Kirschbaum, M.D. as
Senior Vice President and Chief Medical Officer. Dr. Kirschbaum is
a highly experienced hematologist/oncologist with over 30 years of
experience in molecular medicine, new drug development, clinical
trial design and patient care
- Appointed Brian Schwartz, M.D,
formerly CMO at ArQule, Inc., and Karin L. Walker, Chief Accounting
Officer of Prothena Corporation plc, to the Board of Directors
- Raised approximately $30 million in
net cash in two equity financings and related warrant exercises
providing estimated capital to early 2023
In 2021, Cyclacel will commence streamlined Phase
1/2 clinical studies, initially of oral fadraciclib and
subsequently of oral CYC140, in a broad range of solid tumors and
hematological malignancies. These studies are supported by
fadraciclib’s Phase 1 clinical data and its transcriptional
mechanism of action enabling apoptosis of cancer cells and the
extensive preclinical data of CYC140 demonstrating its antimitotic
mechanism and broad therapeutic potential in several solid tumors
and hematological malignancies.
The clinical development plan for these studies
calls for parallel evaluation of different schedules of the two
agents in multiple cohorts defined by cancer histology and
collection of biospecimens for translational analysis. The aim of
these studies is to identify clinical activity which may lead to
registration-enabling studies.
Key Business Objectives for
2021
- First patient dosed with oral
fadraciclib in Phase 1/2 advanced solid tumor study
- First patient dosed with oral CYC140
in Phase 1/2 advanced solid tumor study
- Manufacture clinical supplies of
fadraciclib and CYC140 for registration-enabling studies
- Data on safety and antileukemic
activity from the i.v. fadraciclib-venetoclax Phase 1 study in
relapsed/refractory AML and CLL
- Data from the sapacitabine-venetoclax
Phase 1/2 study in relapsed/refractory AML or MDS
- Initial data from the CYC140 Phase 1
First-in-Human study in patients with advanced leukemias
- Data from the Phase 1b/2 IST of
sapacitabine-olaparib combination in patients with BRCA mutant
metastatic breast cancer when reported by the investigators
About Cyclacel Pharmaceuticals,
Inc.
Cyclacel Pharmaceuticals is a clinical-stage
biopharmaceutical company developing innovative cancer medicines
based on cell cycle, transcriptional regulation and mitosis
biology. The transcriptional regulation program is evaluating
fadraciclib, a CDK2/9 inhibitor, in solid tumors and hematological
malignancies. The anti-mitotic program is evaluating CYC140, a PLK1
inhibitor, in advanced cancers. Cyclacel's strategy is to build a
diversified biopharmaceutical business based on a pipeline of novel
drug candidates addressing oncology and hematology indications. 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 |
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Company: |
Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com |
Investor Relations: |
Russo Partners LLC, Jason Assad, (678) 570-6791,
jason.assad@russopartnersllc.com |
© Copyright 2021 Cyclacel Pharmaceuticals, Inc. All
Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of
Cyclacel Pharmaceuticals, Inc.
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