Cyclacel Pharmaceuticals Reviews 2019 Achievements and Announces Key Business Objectives for 2020
January 13 2020 - 6:00AM
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 2019 achievements and
outlining the Company’s key business objectives for 2020.
Cyclacel’s clinical and business strategy will be highlighted at a
presentation during Biotech Showcase™ 2020 on Monday, January 13,
2019 at 9:30 a.m. PT in the Yosemite A Suite (Ballroom level) at
the Hilton San Francisco Union Square. "During 2019 we have been
excited to observe evidence of anticancer activity with CYC065, our
CDK2/9 inhibitor, in patients with both solid and liquid cancers,”
said Spiro Rombotis, President and Chief Executive Officer. “We
have previously reported that CYC065 durably suppresses MCL1 in
cancer patients. Based on recent data we believe that CYC065 is a
leader amongst MCL1 suppressing compounds in development. For
example, a heavily pretreated patient with MCL1 amplified
endometrial cancer achieved a partial response (PR) on CYC065
monotherapy and reduction in her tumor volume has now reached 63%.
During 2020 we plan to advance clinical investigation of our lead
program CYC065 both as monotherapy and in combinations. Our
innovative clinical stage pipeline, comprising of CYC065 together
with sapacitabine and CYC140, our PLK1 inhibitor, is a central
element of our strategy of addressing cancer resistance.”Initial
data from Cyclacel’s ongoing clinical evaluation of a combination
regimen of CYC065 and venetoclax in patients with advanced
leukemias (AML/MDs and CLL) were reported at a recent medical
conference. Preliminary evidence from these dose escalation studies
suggests that the combination is active and well tolerated. The
rationale behind these studies is to investigate a ‘dual hit’
strategy of simultaneously suppressing MCL1 and BCL2 proteins. In
2020 Cyclacel will advance its precision medicine strategy by
reporting data from ongoing studies addressing high value
indications. With estimated capital on hand to the end of the
first quarter of 2021 the Company’s ultimate goal is to realize
shareholder value from its targeted drug pipeline.
2019 Achievements
- Reported anticancer activity in part 2 of 065-01, the Phase 1
study of CYC065 as a single agent, including a patient with MCL1
amplified endometrial cancer who achieved a radiographically
confirmed partial response (PR) after 4 cycles of treatment at
213mg;
- Opened part 3 of 065-01 evaluating an oral form of CYC065 in
patients with advanced solid tumors;
- Presented the designs of three ongoing studies at the 61st
American Society of Hematology Annual Meeting: CYC065 in
combination with venetoclax in patients with relapsed or refractory
AML/MDS or in patients with CLL and sapacitabine in combination
with venetoclax in patients with relapsed or refractory
AML/MDS;
- Enrolled eight patients with relapsed or refractory AML/MDS in
the 065-03 Phase 1 dose escalation study evaluating CYC065 in
combination with venetoclax. A poster presentation at the 61st
American Society of Hematology Annual Meeting showed that the
combination is active and well tolerated. Preclinical data
confirmed synergy of CYC065 and venetoclax, suggesting that the
suppression of both BCL2 and MCL1 may be more beneficial than
inhibiting either protein alone;
- Opened two new sites in the 065-02 study of CYC065 in
combination with venetoclax in patients with relapsed/refractory
CLL;
- Enrolled five patients in part 2 of the 682-11 Phase 1/2 study
evaluating an oral regimen of sapacitabine in combination with
venetoclax in patients with relapsed or refractory AML/MDS.
Sapacitabine is a nucleoside analogue that is active in AML and MDS
relapsed or refractory to prior therapy such as cytarabine or
hypomethylating agents. Combining sapacitabine with venetoclax may
offer an effective, oral treatment regimen for patients who have
failed front-line therapy;
- Enrolled three patients in a Phase 1, first-in-human study
evaluating CYC140 in patients with advanced leukemias. CYC140 is a
small molecule, selective polo-like-kinase 1 (PLK1) inhibitor that
has demonstrated potent and selective target inhibition and high
activity in xenograft models of human cancers;
- Presented data at the 2019 AACR Annual Meeting from the
Company's DNA damage response program with an oral regimen of
sequential sapacitabine and seliciclib, a CDK2/9 inhibitor, from an
expansion cohort in patients with BRCA mutant metastatic breast
cancer demonstrating safety and a clinical benefit rate of
30%;
- Enrolled five patients in a Phase 1b/2 investigator sponsored
study (IST) with an oral regimen of concomitant sapacitabine and
olaparib in patients with BRCA mutant breast cancer. Dual targeting
of the DNA damage response pathway with sapacitabine and the PARP
inhibitor olaparib may improve on currently available options for
such patients; and
- Raised net proceeds of approximately $4.1 million from a Common
Stock Sales Agreement with H.C. Wainwright.
Key Business Objectives for 2020
- Report updated Phase 1 safety, pharmacokinetics and efficacy
data for CYC065 utilizing a frequent dosing schedule in patients
with advanced solid cancers;
- Report initial safety and PK data from the Phase 1 study of an
oral formulation of CYC065;
- Report initial safety and proof of concept data from the
CYC065-venetoclax Phase 1 study in relapsed/refractory AML and
MDS;
- Report initial safety and proof of concept data from the
CYC065-venetoclax Phase 1 study in relapsed/refractory CLL;
- Report initial data from the sapacitabine-venetoclax Phase 1/2
study in patients with relapsed or refractory AML or MDS;
- Report initial data from the CYC140 Phase 1 First-in-Human
study in relapsed or refractory leukemias; and
- Report 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 DNA damage response biology. The
transcriptional regulation program is evaluating CYC065 as a single
agent in solid tumors and in combination with venetoclax in
patients with relapsed or refractory AML/MDS and CLL. The DNA
damage response program is evaluating an oral combination of
sapacitabine and venetoclax in patients with relapsed or refractory
AML/MDS. An IST is evaluating an oral combination of sapacitabine
and olaparib in patients with BRCA mutant breast cancer. The
anti-mitotic program is evaluating CYC140, a PLK1 inhibitor, in
AML/MDS patients. 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 StatementsThis 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, Jan Medina, (646) 942-5632,
Jan.Medina@russopartnersllc.com |
© Copyright 2020 Cyclacel Pharmaceuticals, Inc. All Rights
Reserved. The Cyclacel logo and Cyclacel® are trademarks of
Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals (NASDAQ:CYCC)
Historical Stock Chart
From Apr 2024 to May 2024
Cyclacel Pharmaceuticals (NASDAQ:CYCC)
Historical Stock Chart
From May 2023 to May 2024