Initial eight patients treated in ongoing
first-in-human, open-label, dose-finding trial of CBP/p300
inhibitor in late-line mCRPC patients
Adaptive trial design intended to efficiently
explore safe and efficacious doses of FT-7051
First evaluable patient completing more than 90
days of treatment demonstrated an ongoing PSA50 response
Pharmacodynamic evidence of activity
demonstrated via skin biomarker; no discontinuations due to adverse
events
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 positive initial results from a Phase 1
trial of its novel CBP/p300 inhibitor, the oral small molecule
FT-7051, in men with metastatic castration-resistant prostate
cancer (mCRPC). Initial clinical data from the Courage Study, an
ongoing first-in-human Phase 1 trial presented at the
AACR-NCI-EORTC Virtual International Conference on Molecular
Targets and Cancer Therapeutics, showed an encouraging safety
profile of FT-7051, as well as high specificity to the CBP/p300
pathway.
“Preliminary data from the Courage Study are promising,” said
Andrew J. Armstrong, M.D., principal investigator of the Courage
Study, and Professor of Medicine, Pharmacology and Cancer Biology,
and Director of Research at the Duke Cancer Institute Center for
Prostate and Urologic Cancers. “Managing the balance between
safety, tolerability and efficacy is a key element of targeting
this pathway, and thus far the doses studied are achieving
pharmacodynamic target engagement with acceptable
tolerability.”
Preliminary results reported today include data as of Sept. 1,
2021, from eight men enrolled in the trial. FT-7051 was
administered in 28-day cycles, with 21 days of dosing followed by
seven days of no dosing. Three patients remain on study; five
patients left the study (four due to disease progression and one
withdrawal of consent). The adaptive trial design is intended to
efficiently explore safe and efficacious doses of FT-7051. Prior to
enrollment, all of the men had received diagnoses of mCRPC,
castration-levels of serum testosterone and rising levels of the
biomarker prostate specific antigen (PSA) after the failure of at
least two lines of therapy with an approved androgen-receptor
pathway inhibitor.
The initial pharmacokinetic (PK) analysis of FT-7051 documented
rapid absorption, which produced maximum blood concentrations
within two hours. The 150 mg dose achieved drug concentrations that
approached the predicted efficacious dose based on modeling with
preclinical results. Skin biopsies of the men participating in the
study demonstrated a reduction in H3K27AC, a marker of activity in
the CBP/p300 pathway, the target of FT-7051.
The majority of the treatment-emergent adverse events (TEAEs)
were mild or moderate, at Grade 2 or lower, with no events leading
to treatment discontinuation. One patient experienced Grade 3
hyperglycemia, which was medically managed. Following a dose
reduction, this patient remained on treatment and experienced an
ongoing PSA decline of greater than 50% at 12 weeks and greater
than 80% at 16 weeks. Based upon these safety results, dose
escalation is ongoing. The trial is continuing according to its
adaptive design to further understand the safety and tolerability
of FT-7051, gather data on clinical response including PSA and
radiographic tumor response, as well as the assessment of secondary
endpoints of clinical response.
“There is substantial need for new therapies to treat those with
mCRPC as they progress while on existing lines of anti-androgen or
chemotherapy,” said David N. Cook, Ph.D., senior vice president,
Forma Therapeutics’ chief scientific officer. “Thanks to the eight
patients who participated in the Courage Study to date, we have
made progress in understanding the potential of CBP/p300 inhibition
in prostate cancer and look forward to continuing our dose
escalation study.”
Presentation Details
- Abstract P202: Initial Findings from an Ongoing First-in-human
Phase 1 Study of the CBP/p300 Inhibitor FT-7051 in Men with
Metastatic Castration-Resistant Prostate Cancer (Link)
- Abstract P204: Targeting the p300/CBP Epigenetic Pathway to
Overcome Hormone Therapy Resistance in Advanced Prostate
Cancer
Forma continues to enroll men into the Courage Study. For more
information, please visit
https://www.formatherapeutics.com/clinical-trials/ or
https://clinicaltrials.gov/ct2/show/NCT04575766.
About CBP/p300
Tumor resistance to anti-androgen therapies can arise due to
mutations and other changes within the androgen receptor (AR).
Androgen binds to two paired proteins in ARs, CBP and p300, in a
location that is highly resistant to mutations known as the
bromodomain. FT-7051 is designed to attach to the CBP/p300
bromodomain potently and selectively, which then blocks androgen
binding and reduces AR activation. In preclinical studies, FT-7501
demonstrated activity in both prostate cancer models that were
sensitive or resistant to the approved androgen-inhibitor medicine
enzalutamide.
About Prostate Cancer
Prostate cancer is the second most frequent cancer in men
globally, accounting for more than 1.4 million new diagnoses and
6.8 percent of all male cancer deaths in 2020.1 In the United
States, more than 248,000 men will be diagnosed with prostate
cancer in 2021, and the disease will account for more than 34,000
deaths.2 When cancer has spread beyond the prostate and surgery or
radiation are not an option, first-line treatment suppresses the
male hormone androgen because it can stimulate prostate cancer cell
growth.3,4 This treatment, called medical castration, slows
progression for about two years, but most men will develop
resistance and their cancer will progress.5,6 The five-year
survival rate of men with metastatic prostate cancer is 30
percent.7
About Forma Therapeutics
Forma Therapeutics (Nasdaq: FMTX) 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. Our investigational medicine, etavopivat, is in a
Phase 2/3 trial for sickle cell disease. For more information,
please visit www.FormaTherapeutics.com or follow us on Twitter
@FORMAInc and LinkedIn. Forma Therapeutics’ is located in
Watertown, MA.
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:
initial results to date for the FT-7051 open label Phase 1 clinical
trial; the therapeutic potential, clinical benefits and anticipated
safety related to FT-7051; whether initial results from our
clinical trials are predictive of final trial results or future
clinical studies; our ability to enroll patients in a timely manner
and retain such patients throughout the course of our study; and
our planned presentation of data at the 2021 AACR-NCI-EORTC Virtual
Conference. 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 our ability to execute on our strategy; the
therapeutic potential and safety of FT-7051; the timing and
completion of our Phase 1 study of FT-7051 (the Courage Study) and
final audit and quality controlled verification of initial data and
related analyses; positive results from initial data analyses may
not be predictive of final results; risks related to patient
enrollment and retention in our clinical trials; risks related to
our planned regulatory submissions and developments; and other
risks identified in our filings with the Securities and Exchange
Commission (SEC), 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 our views
as of any subsequent date.
References
1 Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics
2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for
36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249.
doi:10.3322/caac.21660.
2 Prostate At a Glance. American Cancer Society. Cancer
Statistics Center. 2018.
https://cancerstatisticscenter.cancer.org/#!/cancer-site/Prostate.
Accessed September 18, 2021.
3 Hormone Therapy for Prostate Cancer. American Cancer Society.
May 27, 2021.
https://www.cancer.org/cancer/prostate-cancer/treating/hormone-therapy.html.
Accessed September 18, 2021.
4 Merseburger AS, Alcaraz A, von Klot CA. Androgen deprivation
therapy as backbone therapy in the management of prostate cancer.
Onco Targets Ther. 2016;9:7263-7274. Published 2016 Nov 29.
doi:10.2147/OTT.S117176.
5 Ibid.
6 Sternberg CN, Baskin-Bey ES, Watson M, Worsfold A, Rider A,
Tombal B. Treatment patterns and characteristics of European
patients with castration-resistant prostate cancer. BMC Urol.
2013;13:58.
7 Survival Rates for Prostate Cancer. American Cancer Society.
May 27, 2021.
https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed September 18, 2021.
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version on businesswire.com: https://www.businesswire.com/news/home/20211007005510/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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