Clinical Trial Cohort to Evaluate SY-5609 in
Combination with Atezolizumab, a PD-L1 Checkpoint Inhibitor
Marks First Clinical Investigation of Selective
CDK7 Inhibitor with Immunotherapy
Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development
of medicines that control the expression of genes, today announced
that it has entered into a clinical supply agreement with Roche.
Under the agreement, Syros will supply SY-5609, its highly
selective and potent oral inhibitor of cyclin-dependent kinase 7
(CDK7), for a combination dosing cohort in Roche’s ongoing Phase
1/1b INTRINSIC trial, which is evaluating multiple targeted
therapies or immunotherapy, including atezolizumab, as single
agents or in rational specified combinations in molecularly defined
subsets of colorectal cancer (CRC) patients.
“We are pleased that Roche has chosen to study SY-5609 as part
of its broader strategy to explore atezolizumab in combination with
other targeted agents in defined colorectal cancer patient
populations,” said Nancy Simonian, M.D., Chief Executive Officer of
Syros, “We believe SY-5609 is a potentially transformative targeted
approach for difficult-to-treat cancers. Preclinical data has shown
that CDK7 inhibition enhances the anti-tumor activity of PD-L1
inhibition, providing a strong rationale for combining SY-5609 and
atezolizumab. Notably, this trial marks the first clinical
investigation of a CDK7 inhibitor with an immunotherapy, and we
look forward to working with Roche to evaluate the potential of
this novel combination in patients with BRAF-mutant colorectal
cancer.”
Under the terms of the agreement, Roche will sponsor and conduct
the Phase 1/1b study to evaluate the safety, tolerability and
preliminary efficacy of the combination and will assume all costs
associated with the study. In exchange for providing SY-5609, Syros
will receive access to the data on SY-5609 in combination with
atezolizumab. Syros retains all rights to SY-5609.
Selective CDK7 inhibition has been shown to target two
fundamental processes in cancer: transcription and cell cycle
control. Additionally, published peer-reviewed research has shown
that CDK7 inhibition induces DNA replication stress and genome
instability in preclinical cancer models, triggering
immune-response signaling, which is further enhanced by the
addition of immune-checkpoint blockade.1
In May 2020, Syros presented preclinical data at the American
Society of Clinical Oncology Virtual Scientific Program
demonstrating that SY-5609 inhibited tumor growth, including
inducing sustained regressions at well-tolerated doses in CRC
models. In preclinical studies, SY-5609 resulted in ≥ 50 percent
tumor growth inhibition in 67 percent (20/30) of patient-derived
xenograft models of CRC, and ≥ 90 percent tumor growth inhibition
in 23 percent (7/30) of models. Deeper responses were observed more
frequently in models with BRAF mutations (50 percent, 5/10)
relative to wild-type models (10 percent, 1/10).
Syros is evaluating SY-5609 in an ongoing, multi-center,
open-label Phase 1 dose-escalation study in patients with advanced
breast, colorectal, lung, ovarian or pancreatic cancers, or with
solid tumors of any histology that harbor Rb pathway alterations.
Initial data from the dose escalation showed proof of mechanism at
tolerable doses. Syros expects to report additional dose-escalation
data, including clinical activity data, at the ESMO Congress in
September and initiate the expansion portion of the trial in the
second half of 2021.
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. 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.
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’s
clinical development plans and collaborations with respect to
SY-5609, the evaluation of SY-5609 in combination with other
therapies, the ability of SY-5609 to have a benefit for patients,
the plans for reporting additional dose-escalation data, including
clinical activity data, from Syros’ Phase 1 clinical trial of
SY-5609, and the future expansion of such trial. 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
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 SY-5609;
sustain the response rates seen to date with SY-5609; replicate
scientific and non-clinical data in clinical trials; successfully
establish a patient selection strategy and develop a companion
diagnostic test 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, 2020 and Quarterly Report on
Form 10-Q for the quarter ended June 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.
1 Zhang et al., 2020, Cancer Cell 37, 1-18
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version on businesswire.com: https://www.businesswire.com/news/home/20210805005216/en/
Media Contact: Naomi Aoki Syros Pharmaceuticals
617-283-4298 naoki@syros.com
Investor Contact: Hannah Deresiewicz Stern Investor
Relations, Inc. 212-362-1200 hannah.deresiewicz@sternir.com
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