Two oral presentations on etavopivat include
data from Forma’s Phase 1 open label extension trial in sickle cell
disease demonstrating a favorable tolerability profile consistent
with previously-reported results
Additional data supports improvement in markers
of red blood cell health for people living with sickle cell
disease
One oral and one poster presentation include
data from ongoing Phase 2 trial of olutasidenib as a single agent
and in combination with azacitidine supporting a favorable
tolerability profile, clinical activity and induction of a durable
composite complete remission (CR) or CR plus CR with partial
hematologic recovery (CRh) in high-risk patients with mIDH1 AML
Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a
clinical-stage biopharmaceutical company focused on sickle cell
disease, prostate cancer and other rare hematologic diseases and
cancers, today announced that four abstracts have been accepted for
presentation – including three oral presentations and one poster
presentation – at the 63rd American Society of Hematology (ASH)
Annual Meeting taking place Dec. 11-14, 2021.
Two oral presentations will feature clinical data on a Phase 1
trial of etavopivat, the company’s oral, once-daily, selective
pyruvate kinase-R (PKR) activator for the treatment of sickle cell
disease (SCD). One abstract evaluates the ability of etavopivat to
improve anemia and decrease intravascular hemolysis. A second
abstract shows the effects of etavopivat on improving red blood
cell health and lifespan, as well as reduction in systemic markers
of inflammation and hypercoagulability. A third abstract highlights
clinical data from the Phase 2 trial of olutasidenib, the company’s
selective inhibitor for cancers with mutations in isocitrate
dehydrogenase 1 (IDH1m) being evaluated in patients with
relapsed/refractory acute myeloid leukemia (R/R AML).
“We’re pleased that these abstracts were selected for oral and
poster presentation at the ASH annual meeting,” said Patrick Kelly,
M.D., chief medical officer of Forma Therapeutics. “We look forward
to sharing updated data at the meeting on the profile of etavopivat
in sickle cell patients to not only increase hemoglobin but also to
improve markers of hemolysis, as well as red blood cell health and
red blood cell lifespan. In addition, the new olutasidenib results
indicate potential for use as a single agent and in combination
therapy with azacytidine to provide benefit in patients with
relapsed/refractory AML.”
The abstracts are currently available on the ASH website:
https://www.hematology.org/meetings/annual-meeting/abstracts
Oral Presentations: Title:
FT-4202, Activation of Pyruvate Kinase-R with Etavopivat (FT-4202)
Is Well Tolerated, Improves Anemia, and Decreases Intravascular
Hemolysis in Patients with Sickle Cell Disease Treated for up to 12
Weeks Date/Time: Saturday, Dec. 11, at 9:45 AM ET
Session: 114 Abstract: 147091 Presenter: R.
Clark Brown, MD, PhD
Title: FT-4202, Etavopivat, an Allosteric Activator of
Pyruvate Kinase-R, Improves Sickle RBC Functional Health and
Survival and Reduces Systemic Markers of Inflammation and
Hypercoagulability in Patients with Sickle Cell Disease: An
Analysis of Exploratory Studies in a Phase 1 Study
Date/Time: Saturday, Dec. 11, at 10:00 AM ET Session:
114 Abstract: 147078 Presenter: Theodosia A. Kalfa,
MD, PhD
Title: FT-2102, Olutasidenib (FT-2102) in Combination
with Azacitidine Induces Durable Complete Remissions in Patients
with mIDH1 Acute Myeloid Leukemia Date/Time: Monday, Dec.
13, at 3:00 PM ET Session: 616 Abstract: 144905
Presenter: Jorge E. Cortes, MD
Poster Presentation: Title:
FT-2102, Molecular Characteristics of Response to Olutasidenib
(FT-2102) in Patients with Relapsed/Refractory mIDH1 Acute Myeloid
Leukemia Date/Time: Sunday, December 12th at 6:00-8:00 PM ET
Session: 616 Abstract: 144912 Presenter:
Stéphane de Botton, MD, PhD
About Etavopivat Etavopivat is an investigational,
once-daily, selective red blood cell (RBC) pyruvate kinase-R (PKR)
activator designed to be a disease-modifying therapy for the
treatment of sickle cell disease (SCD). Employing a multimodal
approach, etavopivat is designed to work by activating the RBCs’
natural PKR activity to decrease 2,3-DPG levels, which leads
hemoglobin to hold on to oxygen molecules longer to reduce
polymerization and RBC sickling. Etavopivat-mediated PKR activation
also increases ATP levels, the fuel that provides energy to cells,
to improve RBC health and survival. Together, these effects are
anticipated to increase hemoglobin levels and decrease painful
vaso-occlusive crises. In preclinical safety studies, etavopivat
did not inhibit aromatase activity or affect steroidogenesis,
important biological processes responsible for sexual development.
Etavopivat has been granted Fast Track, Rare Pediatric Disease and
Orphan Drug designations from the U.S. Food and Drug Administration
(FDA), and Orphan Drug Designation from the European Commission
based on a positive opinion from the Committee for Orphan Medicinal
Products of the European Medicines Agency for the treatment of
patients with SCD.
About Olutasidenib Olutasidenib is an oral, potent,
small-molecule investigational agent designed to selectively bind
to and inhibit mutated IDH1 enzymes. This targeted treatment has
the potential to provide therapeutic benefit by reducing 2-HG
levels and restoring normal cellular differentiation. With the
conclusion of the Phase 2 R/R AML trial, Forma has begun preparing
a new drug application (NDA) for submission to the U.S. Food and
Drug Administration (FDA).
IDH1 is a natural enzyme that is part of the normal metabolism
of all cells; when mutated, its activity can promote blood
malignancies and solid tumors. IDH1 mutations are present in 6-8%
of patients with AML and as many as 70 to 80% of patients with
grade II/III gliomas and secondary glioblastoma. In gliomas, IDH1
mutations occur early in the tumor pathogenesis and persist
throughout progression from a neural stem or progenitor cell.
Gliomas are the most common, aggressive and difficult-to-treat
primary brain tumors, and high-grade gliomas are associated with
poor long-term prognosis. Treatment options for relapsed glioma are
limited.
About Forma Therapeutics Forma Therapeutics is a
clinical-stage biopharmaceutical company focused on the research,
development and commercialization of novel therapeutics to
transform the lives of patients with rare hematologic diseases and
cancers. Our R&D engine combines deep biology insight,
chemistry expertise and clinical development capabilities to create
drug candidates with differentiated mechanisms of action focused on
indications with high unmet need. Our work has generated a broad
proprietary portfolio of programs with the potential to provide
profound patient benefit. For more information, please visit
www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and
LinkedIn.
Forward-looking Statements This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including,
without limitation, express or implied statements regarding future
plans for etavopivat and olutasidenib, including expectations
regarding timing, success and data announcements of our current
ongoing clinical trials; therapeutic potential, clinical benefits,
mechanisms of action and safety of our product candidates; planned
regulatory submissions, including an NDA for olutasidenib; and our
planned presentation of data at the ASH annual meeting. The words
“may,” “will,” “could,” “would,” “should,” “expect,” “plan,”
“anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words.
Any forward-looking statements in this press release are based
on management’s current expectations and beliefs and are subject to
a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation, those risks and
uncertainties related to the advancement of our clinical programs
and other risks identified in our SEC filings, including those
risks discussed under the heading “Risk Factors” in our Quarterly
Report on Form 10-Q for the quarter ended June 30, 2021, as well as
other risks detailed in our subsequent filings with the SEC. We
caution you not to place undue reliance on any forward-looking
statements, which speak only as of the date they are made. We
disclaim any obligation to publicly update or revise any such
statements to reflect any change in expectations or in events,
conditions or circumstances on which any such statements may be
based, or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking statements. Any
forward-looking statements contained in this press release
represent our views only as of the date hereof and should not be
relied upon as representing its views as of any subsequent date. We
explicitly disclaim any obligation to update any forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20211104005291/en/
Media Adam Silverstein, +1
917-697-9313 Porter Novelli adam.silverstein@porternovelli.com
Investor Mario Corso, +1
781-366-5726 Forma Therapeutics mcorso@formatherapeutics.com
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