Forma Therapeutics Highlights Etavopivat Development Expansion and Introduces New Oncology Program from Research Pipeline at Inaugural Research and Development (R&D) Day
May 26 2022 - 7:05AM
Business Wire
Expanding etavopivat development in 2022
with Phase II trial exploring transfusion burden across sickle cell
disease (SCD), thalassemia and myelodysplastic syndromes (MDS)
Phase 1 trial of FT-7051 in mCRPC proceeding
with predicted efficacious dose range under evaluation and
exploring alternative dosing schedule
FT-3171 (USP1 inhibitor) introduced targeting
BRCA mutant tumors with investigational new drug (IND) filing
expected in the first half of 2023
Early stage research pipeline focusing on red
blood cell (RBC) health and novel mechanisms in rare hematology and
targeted oncology indications
Forma well-positioned with $441 million in cash
to progress programs in rare hematologic diseases and cancers
Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a
clinical-stage biopharmaceutical company focused on sickle cell
disease (SCD), prostate cancer and other rare hematologic diseases
and cancers, will hold a virtual R&D Day today to provide a
comprehensive update on its pipeline and strategic vision.
The R&D event is taking place today at 8:00 a.m. ET. A live
webcast will be available in the “News & Investors” section of
Forma’s website.
“We are pleased to share insights into Forma’s unique commitment
to patients and expansion of etavopivat development into
transfusion-dependent populations that have tremendous unmet need
across sickle cell disease, thalassemia and MDS,” said Frank Lee,
president and chief executive officer of Forma.
“In our early stage research pipeline, we are excited to
introduce a USP1 program that targets a novel DNA damage repair
pathway relevant to a broad range of tumor types,” said David Cook,
chief scientific officer of Forma. “We are also capitalizing on our
knowledge of the emerging science of red blood cell health by
exploring areas beyond hematologic disease.”
Etavopivat (oral PKR activator) Program in SCD, thalassemia
and MDS:
In addition to ongoing enrollment in the Phase II/III Hibiscus
Study in SCD, Forma will outline ongoing and anticipated future
development plans:
- A Phase II trial is enrolling patients in three cohorts: SCD
with chronic transfusion, and both transfusion-dependent and
non-transfusion-dependent thalassemia. Etavopivat has the potential
to address RBC health, hemolytic anemia and/or ineffective
erythropoiesis in these populations, leading to reduction of
transfusion burden and associated iron overload and improvement of
anemia.
- A Phase II trial in lower-risk MDS is planned to commence in
the second half of 2022. Dr. Michael Savona of Vanderbilt
University will review the significant unmet need in lower-risk MDS
and the potential for etavopivat to provide a well-tolerated oral
treatment that may be able to improve the ability of bone marrow to
produce healthier RBCs.
- Analyses from the completed Phase I trial in SCD show benefit
in both pain events reported in the trial and vaso-occlusive crises
(VOC’s) occurring during treatment.
- Enrollment in the Phase II/III Hibiscus Study in SCD is on
track for the first interim analysis (IA1) in late 2022.
FT-7051 (oral CBP/p300 inhibitor) in prostate cancer:
Forma’s Phase I trial continues to enroll men with metastatic
castration-resistant prostate cancer (mCRPC).
- As of May 12, 2022, 25 patients have enrolled in the Phase I
dose escalation trial, assessing the predicted efficacious exposure
range supported by target engagement.
- The trial population is heavily pre-treated, with a high AR-v7
positivity rate and mutation burden.
- Future trial enrollment to include less heavily pre-treated
patients and alternative dosing schedules to address adverse
events, with updated results expected in the first half of
2023.
Research Pipeline/RBC Health:
Forma’s ongoing research efforts are focused on novel mechanisms
of action in oncology and expansion in red blood cell health and
hematologic diseases:
- Forma’s research pipeline is led by the USP1 program (FT-3171),
targeting a novel DNA damage repair pathway with the potential to
address multiple tumor types in both poly ADP ribose polymerase
inhibitor (PARPi)-sensitive and resistant settings.
- FT-3171 IND filing is expected in the first half of 2023.
- Ongoing pre-clinical research is targeting areas of expansion
for RBC health, novel mechanisms that may be complementary to
etavopivat in rare hematology, and targeted oncology.
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 the company’s beliefs and expectations
regarding its: business plans and objectives; future plans for
etavopivat, FT-7051 and FT-3171, including expectations regarding
potential development expansion plans as well as regulatory
filings, enrollment, timing, success and data announcements of
planned and ongoing clinical and pre-clinical trials; therapeutic
potential, clinical benefits, mechanisms of action and safety of
our product candidates; plans for the USP1 program (FT-3171) and
other research pipeline expansion efforts; upcoming milestones and
planned additional trials for the company’s product candidates;
growth as a company; upcoming presentations of our R&D
programs, including the introduction of a new molecule and related
studies; uses and need of capital, expenses and other financial
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related data analyses; positive results from a clinical study may
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clinical studies; any one or more of our product candidates may not
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version on businesswire.com: https://www.businesswire.com/news/home/20220526005218/en/
Media Contact: Caitlin Hunt, +1 781-985-5967 Porter
Novelli caitlin.hunt@porternovelli.com Investor Contact:
Mario Corso, +1 781-366-5726 Forma Therapeutics
mcorso@formatherapeutics.com
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