Forma Therapeutics Reviews 2020 Highlights and Outlines Key 2021 Milestones
11 January 2021 - 11:05PM
Business Wire
Strong pipeline progress in 2020 positions
company well for 2021
Established proof of concept in SCD for
FT-4202
Potential transformative treatment profile for
IDH1 inhibitor olutasidenib in R/R/ AML
Enrolling Phase 1 FT-7051 trial for prostate
cancer - including patient with AR-v7 splice variants
Completed successful IPO and follow-on equity
offering
Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a
clinical-stage biopharmaceutical company focused on rare
hematologic diseases and cancers, today provided a review of
corporate highlights from 2020 and outlined anticipated key
clinical program milestones for 2021.
“While 2020 was marked by tremendous challenges due to the
COVID-19 pandemic, Forma made important strides due to the courage
of patients and the dedication of our employees. We reported
promising results our from our clinical programs including FT-4202
in sickle cell disease, olutasidenib in both AML and glioma, and
FT-7051 in prostate cancer, and also raised approximately $695
million in public equity offerings,” said Frank Lee, president and
chief executive officer of Forma. “In this coming year, we
anticipate continued progress, and look forward to advancing drug
candidates that we believe have the potential to significantly
impact patients living with rare hematologic diseases and
cancers.”
Clinical Program Highlights and
Milestones
PKR Program in Sickle Cell Disease (SCD):
FT-4202 is a novel investigational selective red blood cell
pyruvate kinase R (PKR) activator Forma is actively evaluating in a
multi-center, placebo-controlled Phase 1 trial in individuals with
sickle cell disease ages 12 years and older.
- In June 2020, encouraging single dose cohort data were
reported at the 25th European Hematology Association (EHA) Annual
Congress. Initial findings from Forma’s Phase 1 trial of
FT-4202 in patients with SCD demonstrated a favorable tolerability
profile and biologic effects, with evidence of pharmacodynamic
activity.
- In December 2020, clinical proof-of-concept data were
presented at the 62nd American Society of Hematology (ASH) Annual
Meeting and Exposition. Forma presented data from a multi-dose
cohort of its Phase 1 trial of FT-4202 in patients with SCD,
showing that 86% of patients dosed with 300 mg of FT-4202 for 14
days achieved a hemoglobin increase of greater than 1 g/dL from
baseline. The observed reduction in hemolysis in conjunction with
the biomarker analysis showing improved deformability and hydration
of RBCs supports the hypothesis that pyruvate kinase activation may
have an impact on vaso-occlusive crises (VOCs).
- Additional clinical data anticipated from the ongoing Phase
1 randomized placebo-controlled trial in SCD patients. Data
from the MAD2 600 mg cohort of the Phase 1 trial is expected to be
reported in the first quarter of 2021, followed by results from the
12-week open-label extension in the second quarter of 2021.
- Expanding FT-4202 development program. Forma has
initiated a global pivotal Phase 2/3 trial of FT-4202 in SCD
patients, with plans to initiate a Phase 2 trial in thalassemia in
the second half of 2021, and a pediatric SCD trial in the first
half of 2022.
IDH1 Program in AML and Glioma:
Olutasidenib (FT-2102) is a selective inhibitor for cancers with
IDH1 mutations Forma is evaluating for the treatment of acute
myeloid leukemia (AML) and glioma. Olutasidenib is currently being
studied in a registrational Phase 2 trial for relapsed/refractory
(R/R) AML and an exploratory Phase 1 trial for glioma.
- In May 2020, positive data for olutasidenib in glioma was
announced at the American Society of Clinical Oncology (ASCO).
Forma announced positive preliminary Phase 1 data for olutasidenib
in refractory, enhancing glioma at ASCO 2020, suggesting the
potential for response and prolonged disease control in
relapsed/refractory IDH1-mutated glioma patients.
- In October 2020, positive data for olutasidenib in a
registrational trial for R/R AML was announced. Forma announced
positive results from the planned interim analysis of the Phase 2
registration trial of olutasidenib in R/R AML patients with IDH1
gene mutations. Olutasidenib as a monotherapy demonstrated a
favorable tolerability profile and achieved a composite complete
remission (CR/CRh) rate of 33.3% (30% CR and 3% CRh), the primary
efficacy endpoint. While a median duration of CR/CRh has not yet
been reached, a sensitivity analysis indicated the median duration
of CR/CRh to be 13.8 months. Further data analysis indicates an
estimated 87% survival rate at 18 months in patients who respond to
treatment with olutasidenib. Olutasidenib’s potential
transformative treatment profile is based upon three key
indicators: durability of response and increased survival for
responders, favorable tolerability suggesting ability to combine
with other therapies, and properties to support indication
expansion to other IDH1 mutated cancers.
- Forma has begun preparing for a new drug application for
olutasidenib in R/R AML.
CPB/p300 Program in Prostate Cancer:
FT-7051 is a potent and selective CBP/p300 inhibitor Forma is
evaluating for the treatment of metastatic prostate cancer
resistant to androgen receptor (AR) signaling inhibitor
therapy.
- In April 2020, preclinical data on FT-6876 (a research
compound related to FT-7051) in breast cancer was presented at the
American Association for Cancer Research (AACR). Forma
presented preclinical data that demonstrated antitumor activity of
FT-6876 in AR-dependent breast cancer cell lines, suggesting that
FT-6876 could serve as a treatment for patients with other
AR-dependent tumors, such as prostate cancer.
- Phase 1 underway in 2021. In December 2020, Forma
initiated recruitment in a Phase 1 trial of FT-7051 in men with
metastatic castration-resistant prostate cancer including those
with AR-v7 splice variants. Dosing in this trial is anticipated to
begin in early in the first quarter of 2021. Forma plans to
disclose initial safety, tolerability and preliminary response data
in the second half of 2021.
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 our beliefs and expectations regarding its:
our business plans and objectives; future plans for FT-4202,
FT-7051, and olutasidenib, including expectations regarding timing
and success of the current ongoing clinical trials as well as
planned future clinical trials, therapeutic potential and clinical
benefits thereof, and upcoming milestones for our other product
candidates; the planned timing and potential submission of new drug
applications for olutasidenib in R/R AML, growth as a company and
the anticipated contribution of our employees and the members of
our board of directors to our operations and progress; presentation
of additional data at upcoming scientific conferences, and other
preclinical data in 2021; the potential commercial and
collaboration opportunities, including potential future
collaborators and parties, as well as value and market, for our
product candidates; uses of capital, expenses and other 2021
financial results or in the future, and the potential impact of
COVID-19 on patient retention, strategy, future operations,
clinical trials or IND submissions. 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 September 30, 2020, 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/20210111005249/en/
Media Contact: Megan McGrath, +1 781-235-3060 MacDougall
mmcgrath@macbiocom.com
Investor Contact: Mario Corso, +1 781-366-5726 Forma
Therapeutics mcorso@formatherapeutics.com
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