Initiated Expansion Cohort of SY-5609 with
Chemotherapy in Pancreatic Cancer Patients
Expects to Report Data from Three Clinical
Trials Across Hematology and Selective CDK Inhibitor Programs in
2022
Now Expects to Initiate Phase 1 Single Agent
Trial of SY-5609 in Hematologic Malignancies in 2H 2022
Expects to Nominate Development Candidate from
CDK12 Program in 2H 2022
Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development
of medicines that control the expression of genes, today provided
an update on its clinical development programs and outlined its
strategic priorities and upcoming expected milestones.
“2022 promises to be a transformative year as we continue to
advance our studies of tamibarotene, SY-2101, and SY-5609. We are
looking forward to three clinical data readouts this year as well
as pivotal data from the SELECT-MDS-1 trial in late 2023 or early
2024,” said Nancy Simonian, M.D., Syros’ Chief Executive Officer.
“Additionally, in the second half of this year we expect to
nominate our new development candidate from our CDK12 program,
highlighting the productivity of our gene control discovery engine
and our expertise in CDK inhibition. Together, we believe these
upcoming milestones will provide insight into the clinical
potential of our development-stage assets and lay the foundation
for our long-term growth as we advance Syros into a fully
integrated biopharmaceutical company.”
Dr. Simonian continued, “We are pleased with our recent
interactions with the U.S. Food and Drug Administration on the
Phase 3 clinical trial design of SY-2101, which we now expect to
initiate in the first quarter of 2023. In addition, based on
preclinical data that supports CDK7 inhibition’s potential across a
range of hematologic malignancies, we expect to start in the second
half of this year a Phase 1 single agent study of SY-5609 in
patients with relapsed blood cancers, including B-cell lymphomas,
prior to moving into specific indications. We are excited to be the
first company to advance a CDK7 inhibitor into hematology clinical
development. The trial results have potential to benefit a broader
patient population as well as demonstrate CDK7 inhibition as a
novel approach for many difficult-to-treat hematologic
cancers.”
CLINICAL PROGRAM UPDATES AND UPCOMING MILESTONES
Targeted Hematology
Tamibarotene: Oral RARa agonist
Syros is evaluating tamibarotene in patients with RARA-positive
newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS). The
Company expects to report data from the ongoing SELECT-MDS-1 Phase
3 trial evaluating tamibarotene in combination with azacitidine in
HR-MDS in the fourth quarter of 2023 or first quarter of 2024, with
a potential NDA filing expected in 2024.
Syros is also evaluating tamibarotene for the treatment of
patients with RARA-positive newly diagnosed unfit acute myeloid
leukemia (AML). The Company expects to report data from the safety
lead-in portion of the ongoing SELECT-AML-1 Phase 2 trial
evaluating tamibarotene in combination with azacitidine and
venetoclax in the second half of 2022.
SY-2101: Oral arsenic trioxide (ATO)
Syros is evaluating SY-2101 in patients with newly diagnosed
acute promyelocytic leukemia (APL). The Company expects to report
PK and safety data from its ongoing dose confirmation trial in
mid-2022. The feedback from a Type C meeting with the U.S. Food and
Drug Administration (FDA) in November 2021 continues to support
molecular complete response rate as the primary endpoint for
accelerated approval and event free survival as the primary
endpoint for full approval, in each case compared to historic IV
ATO data. Additionally, based on the feedback, Syros now expects
the trial to enroll approximately 215 patients randomized two to
one to receive SY-2101 or intravenously administered (IV) ATO. The
IV ATO arm will allow safety and tolerability comparisons. Syros
now expects to initiate the Phase 3 trial in the first quarter of
2023 and to announce data in 2025.
Selective CDK Inhibition
SY-5609: Oral CDK7 inhibitor
In the fourth quarter of 2021, Syros initiated the expansion
cohort evaluating SY-5609 in combination with chemotherapy in
patients with second-line metastatic pancreatic cancer. The cohort
is expected to enroll approximately 50 pancreatic cancer patients
who have progressed following first-line treatment with FOLFIRINOX.
Patients will receive either SY-5609 in combination with
gemcitabine, or SY-5609 in combination with gemcitabine and
nab-paclitaxel, at the approved doses of the combination agents.
The study will evaluate safety and tolerability, as well as
efficacy measures such as disease control rate and progression free
survival. Syros expects to report safety lead-in data of SY-5609 in
combination with chemotherapy in the second half of 2022.
Syros also plans to evaluate the potential of SY-5609 in
hematologic tumors. Based on mechanistic rationale and preclinical
data, which support the potential of CDK7 inhibition in a broad
range of blood cancers, Syros will evaluate the maximum tolerated
dose of SY-5609 in patients with relapsed hematologic malignancies,
including B-cell lymphomas, such as mantle cell lymphoma, before
starting a focused expansion cohort. The Phase 1 trial is expected
to begin in the second half of 2022, with data expected mid-2023,
which will inform further development in specific hematologic
cancers.
In August 2021, Syros entered into an agreement with Roche to
explore SY-5609 in combination with atezolizumab in patients with
BRAF-mutant colorectal cancer (CRC), and Roche plans for this arm
of its ongoing Phase 1/1b INTRINSIC trial to be open for enrollment
in the first half of this year. Under the terms of this agreement,
Roche is the sponsor of the trial and Syros is supplying
SY-5609.
Gene Control Discovery Engine
Syros announced today that the next development candidate from
its gene control discovery engine will be a CDK12 inhibitor. Syros
plans to nominate this candidate in the second half of 2022.
Syros also announced today that small molecule inhibitors of
CDK11 and WRN are the focus of two additional oncology programs in
discovery.
Financial Guidance
Based on its current operating plans, Syros expects that its
existing cash, cash equivalents and marketable securities will be
sufficient to fund its anticipated operating expenses and capital
expenditure requirements into 2023.
About Syros Pharmaceuticals
Syros is redefining the power of small molecules to control the
expression of genes. Based on its unique ability to elucidate
regulatory regions of the genome, Syros aims to develop medicines
that provide a profound benefit for patients with diseases that
have eluded other genomics-based approaches. Syros is advancing a
robust clinical-stage pipeline, including: tamibarotene, a
first-in-class oral selective RARα agonist in RARA-positive
patients with higher-risk myelodysplastic syndrome and acute
myeloid leukemia; SY-2101, a novel oral form of arsenic trioxide in
patients with acute promyelocytic leukemia; and SY-5609, a highly
selective and potent oral CDK7 inhibitor in patients with select
solid tumors and blood cancers. Syros also has multiple preclinical
and discovery programs in oncology and monogenic diseases. 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 Syros’
clinical development plans, including with respect to tamibarotene,
SY-2101 and SY-5609, the potential for Syros’ clinical programs to
result in new standards of care, the potential of SY-5609 to
address a range of hematologic malignancies and patient
populations, the timing of anticipated data readouts from Syros’
clinical trials, the timing to initiate the Phase 3 clinical trial
of SY-2101 in APL and the trial of SY-5609 in hematologic
malignancies, the potential for Syros’s product candidates to
obtain regulatory approval, the timing of nomination of Syros’ next
development candidate, and the sufficiency of Syros’ capital
resources to fund its operating expenses and capital expenditure
requirements into 2023. 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: advance the development of
its programs, including tamibarotene, SY-2101 and SY-5609, under
the timelines it projects in current and future clinical trials;
demonstrate in any current and future clinical trials the requisite
safety, efficacy and combinability of its drug candidates; sustain
the response rates and durability of response seen to date with its
drug candidates; successfully develop a companion diagnostic test
to identify patients with the RARA biomarker; 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, 2020 and Quarterly Report on Form 10-Q for the quarter
ended September 30, 2021, 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. In addition, the extent to which the
COVID-19 pandemic continues to impact Syros’ workforce and its
clinical trial operations activities, and the operations of the
third parties on which Syros relies, will depend on future
developments, which are highly uncertain and cannot be predicted
with confidence, including the duration and severity of the
pandemic, additional or modified government actions, and the
actions that may be required to contain the virus or treat its
impact. Any forward-looking statements contained in this press
release speak only as of the date hereof, and Syros expressly
disclaims any obligation to update any forward-looking statements,
whether because of new information, future events or otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220110005268/en/
Media Contact Courtney Solberg Syros Pharmaceuticals
917-698-9253 csolberg@syros.com
Investor Contact Hannah Deresiewicz Stern Investor
Relations, Inc. 212-362-1200 hannah.deresiewicz@sternir.com
Syros Pharmaceuticals (NASDAQ:SYRS)
Historical Stock Chart
From Apr 2022 to May 2022
Syros Pharmaceuticals (NASDAQ:SYRS)
Historical Stock Chart
From May 2021 to May 2022