Five Prime Therapeutics Initiates Patient Dosing in Phase 1 Clinical Safety Trial Evaluating FPA144 in Gastric Cancer in Japa...
July 17 2017 - 4:11PM
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage
biotechnology company focused on discovering and developing
innovative immuno-oncology protein therapeutics, today announced
the company has initiated dosing in its Phase 1 clinical trial of
FPA144, an anti-FGF receptor 2b antibody, in patients with advanced
gastric and gastroesophageal cancer in Japan.
"Gastric cancer is the sixth most common cancer by incidence
globally and we estimate approximately 10% of gastric cancer
patients have tumors that have FGFR2 gene amplification or
overexpress FGFR2b, which are associated with significantly lower
survival rates than the gastric cancer patient population as a
whole,” said Helen Collins, M.D., Senior Vice President and Chief
Medical Officer of Five Prime. “Moreover, the observed incidence of
gastric cancer is higher in Asian populations than in other
populations. We believe FPA144 represents a potentially promising
treatment option for this targeted patient population with high
unmet need.”
The number of metastatic gastric and gastroesophageal junction
cancer patients eligible for front-line treatment in Japan is
approximately 73,000 patients per year. Five Prime estimates
approximately 7,300 patients per year could be biomarker-positive
and eligible for FPA144 treatment with front-line chemotherapy.
The Phase 1 open-label, dose-finding study will evaluate the
safety, tolerability, pharmacokinetics (PK) and recommended dose of
FPA144 in approximately 6 to 12 Japanese patients with advanced
gastric or gastroesophageal cancer.
Completion of this Phase 1 trial is intended to enable the
inclusion of Japanese patients in potential future Phase 3 trials
of FPA144 in gastric cancer. Internal non-clinical data
demonstrates additivity of FPA144 to standard-of-care chemotherapy
regimens. Five Prime plans to initiate a global pivotal trial
of FPA144 for front-line treatment of FGFR2b-overexpressing or
FGFR2 gene-amplified metastatic gastric and gastroesophageal
junction cancer in combination with chemotherapy in 2018.
About FPA144FPA144 is an isoform-selective
antibody in development as a targeted immuno-therapy for tumors
that overexpress FGFR2b, a splice variant of a receptor for some
members of the fibroblast growth factor (FGF) family. FPA144 has
been engineered for enhanced antibody-dependent cell-mediated
cytotoxicity (ADCC) to increase direct tumor cell killing by
recruiting natural killer (NK) cells. FPA144 is an anti-FGF
receptor 2b (FGFR2b) humanized monoclonal antibody in clinical
development as a targeted immune therapy for tumors that
over-express FGFR2b. FGFR2b overexpression and FGFR2 gene
amplification are associated with poor prognosis.
FPA144 is currently being studied in a Phase 1 monotherapy trial
evaluating the safety, PK and efficacy of biweekly 15 mg/kg
infusions of FPA144 in patients with advanced gastric cancer whose
tumors overexpress FGFR2b. Five Prime plans to initiate a
combination trial of FPA144 with chemotherapy to advance into
front-line therapy in the U.S. Five Prime retains global
development and commercialization rights to FPA144.
About Five PrimeFive Prime Therapeutics, Inc.
discovers and develops innovative therapeutics to improve the lives
of patients with serious diseases. Five Prime's comprehensive
discovery platform, which encompasses virtually every medically
relevant extracellular protein, positions it to explore pathways in
cancer, inflammation and their intersection in immuno-oncology, an
area with significant therapeutic potential and a growing focus of
the company's R&D activities. Five Prime has entered into
strategic collaborations with leading global pharmaceutical
companies and has promising product candidates in clinical and late
preclinical development. For more information, please visit
www.fiveprime.com.
Cautionary Note on Forward-looking
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as "may," "will," "expect," "plan,"
"anticipate," "estimate," "intend" and similar expressions (as well
as other words or expressions referencing future events, conditions
or circumstances) are intended to identify forward-looking
statements. These forward-looking statements are based on Five
Prime's expectations and assumptions as of the date of this press
release. Each of these forward-looking statements involves risks
and uncertainties. Actual results may differ materially from these
forward-looking statements. Forward-looking statements contained in
this press release include statements about (i) the timing of
initiation, progress and scope of clinical trials for FivePrime’s
FPA144 product candidate; (ii) the potential use of FPA144 to treat
cancer patients; (iii) the extent of FGFR2 gene amplification and
FGFR2b protein overexpression in gastric cancer patients; (iv) the
incidence of gastric cancer in Japan; and (v) the advancement of
FPA144 into Phase 3 clinical development. Many factors may
cause differences between current expectations and actual results,
including unexpected safety or efficacy data observed during
non-clinical or clinical studies, clinical site activation rates or
clinical trial enrollment rates that are lower than expected and
changes in expected or existing competition. Other factors
that may cause actual results to differ from those expressed or
implied in the forward-looking statements in this press release are
discussed in Five Prime's filings with the U.S. Securities and
Exchange Commission, including the "Risk Factors" contained
therein. Except as required by law, Five Prime assumes no
obligation to update any forward-looking statements contained
herein to reflect any change in expectations, even as new
information becomes available.
CONTACTS:
Heather Rowe
Investor Relations
415-365-5737
heather.rowe@fiveprime.com
Five Prime Therapeutics (NASDAQ:FPRX)
Historical Stock Chart
From Apr 2024 to May 2024
Five Prime Therapeutics (NASDAQ:FPRX)
Historical Stock Chart
From May 2023 to May 2024