Syros Announces First Patient Dosed in SELECT-AML-1 Trial of Tamibarotene in Combination with Venetoclax and Azacitidine in Newly Diagnosed Unfit AML
September 09 2021 - 8:00AM
Business Wire
Initial Data from the Phase 2 Trial Expected in
2022
Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development
of medicines that control the expression of genes, today announced
that the first patient has been dosed in the SELECT-AML-1 clinical
trial of tamibarotene, its first-in-class selective retinoic acid
receptor alpha (RARα) agonist, in combination with venetoclax and
azacitidine. The randomized Phase 2 trial is enrolling
RARA-positive newly diagnosed unfit patients with acute myeloid
leukemia (AML).
“Despite recent advances, one third of newly diagnosed unfit AML
patients still don’t respond to front-line treatment and many more
relapse,” said Eytan M. Stein, M.D., Assistant Professor of
Medicine and Director of the Program for Drug Development in
Leukemia at Memorial Sloan Kettering Cancer Center. “These patients
need new therapies that can deliver durable remissions with minimal
or manageable toxicities. I am encouraged by tamibarotene’s
distinct safety profile, as well as the compelling clinical and
translational data that has emerged, suggesting it may benefit
patients in the greatest need of new treatment options. I look
forward to further exploring its potential in this clinical trial
as part of a triplet regimen with venetoclax and azacitidine.”
Tamibarotene has demonstrated promising results in combination
with azacitidine in RARA-positive newly diagnosed AML patients who
are not suitable candidates for standard chemotherapy. At the 62nd
American Society of Hematology (ASH) Annual Meeting in December
2020, Syros presented data from a Phase 2 clinical trial,
demonstrating a 67% overall response rate and a 61% composite
complete response (CR/CRi) rate. The data also showed that
tamibarotene in combination with azacitidine was generally
well-tolerated, with no evidence of increased myelosuppression
compared to single-agent azacitidine.
Also at ASH, Syros presented translational data demonstrating
that most RARA-positive newly diagnosed unfit AML patients in the
Phase 2 trial of tamibarotene had a monocytic disease phenotype
associated with resistance to venetoclax, which, in combination
with azacitidine, is the standard of care for newly diagnosed unfit
patients. These data suggest that the RARA biomarker selects for
patients who are more likely to benefit from tamibarotene and who
may be less likely to benefit from venetoclax.
“AML is a complex, heterogenous disease, and many patients may
present upfront with both monocytic and non-monocytic leukemia
cells,” said David A. Roth, M.D., Chief Medical Officer at Syros.
“By employing a triplet strategy that combines tamibarotene with
venetoclax and azacitidine, we believe we can simultaneously target
both cell types, reducing the emergence of resistant disease and
increasing the likelihood of deeper and more durable responses. We
are excited to be actively enrolling patients in this study, as we
advance our portfolio of targeted hematology therapies with the aim
of setting new standards of care for people with acute leukemias
and myelodysplastic syndrome.”
The SELECT-AML-1 trial is designed with a single-arm safety
lead-in, followed by the randomized portion of the trial, which
will evaluate the safety and efficacy of tamibarotene in
combination with venetoclax and azacitidine compared to venetoclax
and azacitidine in approximately 80 patients randomized 1:1. The
trial will also evaluate the triplet regimen as a salvage strategy
in patients in the control arm who do not respond to venetoclax and
azacitidine. The primary endpoint of the trial will be composite CR
rate.
Syros is also evaluating tamibarotene in combination with
azacitidine in the SELECT-MDS-1 Phase 3 clinical trial in
RARA-positive patients with newly diagnosed higher-risk
myelodysplastic syndrome.
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.
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’s clinical
development plans, including with respect to tamibarotene, the
timing of anticipated data readouts from the SELECT-AML-1 trial,
and the ability of tamibarotene to have a benefit for patients. 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 tamibarotene 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 tamibarotene; sustain the response rates and
durability of response seen to date with tamibarotene; 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210909005159/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
Syros Pharmaceuticals (NASDAQ:SYRS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Syros Pharmaceuticals (NASDAQ:SYRS)
Historical Stock Chart
From Apr 2023 to Apr 2024