-- New data support further evaluation of
SY-5609 for PDAC and HR+ breast cancer and demonstrate significant
potential for SY-5609 in a wide range of tumor types and
combinations --
-- Consistent with prior guidance, exploring
partnership opportunities to advance development of SY-5609 --
Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company
committed to advancing new standards of care for the frontline
treatment of hematologic malignancies, today announced new clinical
data from the Phase 1/1b clinical trial evaluating SY-5609, its
highly selective and potent inhibitor of CDK7, in patients with
relapsed/refractory pancreatic ductal adenocarcinoma (PDAC), HR+
breast cancer and other solid tumors. The data will be presented in
two posters at the 2023 American Society for Clinical Oncology
(ASCO) Annual Meeting, taking place June 2-6, in Chicago,
Illinois.
“We are pleased to share data from our Phase 1/1b clinical trial
of SY-5609, which further reinforce the potential of selective CDK7
inhibition as a potentially transformative approach for
difficult-to-treat solid tumors,” said David A. Roth, M.D., Chief
Medical Officer of Syros. “SY-5609's best in class selectivity and
potency produce a predictable, well-managed tolerability profile,
and we have optimized an intermittent dosing schedule that we
believe enables broad combination potential. Data from both
combination cohorts – evaluating SY-5609 in combination with
chemotherapy in PDAC and SY-5609 with fulvestrant in HR+ breast
cancer – demonstrate an acceptable tolerability profile, as well as
promising clinical activity in heavily pre-treated populations that
are unlikely to respond to standard of care. Based on these
results, we continue to believe that SY-5609 could play a
meaningful role in the evolving treatment landscape and are
continuing to explore partnership opportunities to maximize the
potential of this program.”
Syros’ Phase 1/1b trial of SY-5609 is a multi-center, open-label
study, consisting of two parts: Part 1 is a dose escalation study,
evaluating single agent SY-5609 in patients with select advanced
solid tumors and in combination with fulvestrant in HR+ breast
cancer. Part 2 included a combination safety lead-in designed to
inform a dose expansion study, evaluating the doublet regimen of
SY-5609 and gemcitabine and the triplet regimen of SY-5609,
gemcitabine and nab-paclitaxel in patients with PDAC in their
second or third line of treatment.
Data Demonstrate Encouraging Clinical Activity in Patients
with PDAC
Syros will present updated data from the single agent dose
escalation portion and the gemcitabine/nab-paclitaxel combination
safety lead-in portion of the Phase 1/1b trial. The maximum
tolerated dose (MTD) of SY-5609 as a single-agent was 10 mg using a
7 day on/7 day off dosing schedule. For the doublet, the MTD was 5
mg SY-5609 plus 1000 mg gemcitabine. A MTD was not established
using the triplet cohort of SY-5609, gemcitabine and
nab-paclitaxel. Each of the single-agent, doublet and the triplet
regimens were generally well-tolerated with mostly low-grade
events.
Encouraging clinical activity was observed at the MTDs with
SY-5609 both as a single-agent (10 mg) and in combination (4 or 5
mg plus gemcitabine). Among the three response evaluable patients
with select solid tumors, which included one patient with PDAC,
data demonstrated a 100% disease control rate (DCR) with 10 mg
SY-5609 monotherapy, with the PDAC patient experiencing a 10% tumor
reduction. Of the nine PDAC patients treated with 4 or 5 mg of
SY-5609 in combination with gemcitabine, the data demonstrated a
44% DCR (four patients). The single-agent DCR of 100% is superior
to results observed with lower doses of SY-5609 on the 7 day on/7
day off schedule and the doublet DCR of 44% is comparable to
current second-line benchmarks.
These data will be presented in a poster titled, “Phase 1/1b
study of SY-5609, a selective and potent CDK7 inhibitor, in
advanced solid tumors and in 2L/3L pancreatic ductal adenocarcinoma
(PDAC) in combination with gemcitabine +/- nab-paclitaxel,” on June
3, 2023, 8:00 – 11:00 am CT (9:00 am – noon ET) (Abstract#
3080).
Data Show Promising Early Activity in Patients with Advanced
HR+, HER2- Breast Cancer
Syros will present data from the fulvestrant combination cohort.
Patients enrolled in this cohort presented with advanced disease:
78.6% (11 of 14 patients) had liver metastases and were heavily
pre-treated: 78.6% (11 of 14 patients) had received ≥5 prior
therapies, 100% (14 of 14 patients) had progressed on CDK4/6
therapy, and 85.7% (12 of 14 patients) had received prior
fulvestrant. The data show that the combination of SY-5609 and
fulvestrant demonstrated an acceptable safety profile across a
variety of dosing schedules. The adverse event profile of the
combination was generally consistent with the safety profile of
single agent SY-5609 or fulvestrant, with no new safety signals
emerging from the combination at evaluated doses and dosing
schedules. An MTD was not established.
Twelve patients were evaluable for response across a range of
doses and dosing schedules. Five of 12 achieved stable disease for
a DCR of 42%; three of these five patients achieved target lesion
regression. Three patients remained on treatment with SD for
greater than six months, including patients with the TP53 mutation,
prior fulvestrant exposure and/or liver disease.
These data will be presented in a poster titled, “Tolerability
and preliminary activity of the potent, selective, oral CDK7
inhibitor SY-5609 in combination with fulvestrant in patients with
advanced hormone receptor-positive (HR+), HER2- breast cancer
(BC),” on June 3, 2023, 8:00 – 11:00 am CT (9:00 – noon ET)
(Abstract# 3081).
Both posters are now available on the Publications and Abstracts
section of the Syros website at www.syros.com.
About Syros Pharmaceuticals
Syros is committed to developing new standards of care for the
frontline treatment of patients with hematologic malignancies.
Driven by the motivation to help patients with blood disorders that
have largely eluded other targeted approaches, Syros is advancing a
robust late-stage clinical pipeline, including tamibarotene, an
oral selective RARα agonist in patients with higher-risk
myelodysplastic syndrome and acute myeloid leukemia with RARA gene
overexpression, and SY-2101, a novel oral form of arsenic trioxide
in patients with acute promyelocytic leukemia. Syros is also
seeking partnerships for SY-5609, a highly selective and potent
CDK7 inhibitor in clinical development for the treatment of select
solid tumors, and multiple preclinical programs in oncology. For
more information, visit www.syros.com and follow us on Twitter
(@SyrosPharma) and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995, including without limitation statements regarding the
commercial potential of SY-5609, its ability to benefit various
patient populations, and Syros’s partnership plans with respect to
the SY-5609 program. The words ‘‘anticipate,’’ ‘‘believe,’’
‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ “hope,”
‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’
‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Actual results or events could differ materially
from the plans, intentions and expectations disclosed in these
forward-looking statements as a result of various important
factors, including Syros’ ability to: secure a partnership to
support the further development of the SY-5609 program; demonstrate
in any future clinical trials the requisite safety, efficacy and
combinability of SY-5609; sustain the response rates and durability
of response seen to date with SY-5609; successfully establish a
patient selection strategy to identify patients most likely to
benefit from SY-5609; obtain and maintain patent protection for its
drug candidates and the freedom to operate under third party
intellectual property; obtain and maintain necessary regulatory
approvals; identify, enter into and maintain collaboration
agreements with third parties; manage competition; manage expenses;
raise the substantial additional capital needed to achieve its
business objectives; attract and retain qualified personnel; and
successfully execute on its business strategies; risks described
under the caption “Risk Factors” in Syros’ Annual Report on Form
10-K for the year ended December 31, 2022 and Quarterly Report on
Form 10-Q for the quarter ended March 31, 2023, each of which is on
file with the Securities and Exchange Commission; and risks
described in other filings that Syros makes with the Securities and
Exchange Commission in the future.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230525005247/en/
Syros Karen Hunady Director of Corporate Communications
& Investor Relations 1-857-327-7321 khunady@syros.com
Media Relations Brittany Leigh, Ph.D. LifeSci
Communications, LLC +1-813-767-7801 bleigh@lifescicomms.com
Investor Relations Hannah Deresiewicz Stern Investor
Relations, Inc. 212-362-1200 hannah.deresiewicz@sternir.com
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