Five Prime Presents Data from FPA144 in Urothelial Cancer at 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Th...
December 01 2016 - 4:05PM
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage
biotechnology company focused on discovering and developing
innovative immuno-oncology protein therapeutics, announced that a
poster featuring data related to FPA144 in urothelial cancer (UC),
also known as bladder cancer, was presented today at 28th
EORTC-NCI-AACR Symposium on Molecular Targets and Cancer
Therapeutics in Munich, Germany. The Poster titled “FGFR2b
Represents a Novel Target for Treatment of Urothelial Cancer,” is
available at
http://www.fiveprime.com/news-media/publications-presentations.
"This translational data suggest that FGFR2b protein is
expressed in a subset of bladder cancers," said Robert Sikorski,
M.D., Ph.D., senior vice president and chief medical officer of
Five Prime. "In our Phase 1 clinical trial, a patient with bladder
cancer that expressed FGFR2b achieved a complete response after
treatment with FPA144. We are actively investigating FPA144 as a
treatment for gastric cancer and are now exploring its clinical
potential in bladder cancer.”
FPA144 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.
As reported at the 2016 American Society of Clinical Oncology
(ASCO) Annual Meeting, in the dose escalation phase of the Phase 1
clinical trial, a 76-year-old patient diagnosed with stage 4
bladder cancer received FPA144 at the 3 mg/kg dose level. That
patient achieved a durable complete response, suggesting potential
efficacy for FPA144 in bladder cancer. As of the November 4,
2016 cutoff, the patient has remained on treatment with FPA144 for
571 days.
The poster presented today includes data showing positive FGFR2b
immunohistochemistry (IHC) staining in 11.6% of 387 archival
primary bladder cancer tumor samples tested. Five Prime believes
bladder cancer patients could be selected for treatment with FPA144
using an IHC molecular diagnostic test, similar to what is being
used to identify gastric cancer patients for treatment with
FPA144.
FivePrime has completed dose escalation testing in the ongoing
Phase 1 study of single-agent FPA144 in patients with solid tumors
including gastric cancer, and the drug was well tolerated with no
dose limiting toxicities, and no maximum tolerated dose was
reached. Enrollment continues in the expansion portion of the trial
evaluating the safety, pharmacokinetics (PK) and efficacy of
biweekly 15 mg/kg infusions of FPA144 in patients with gastric
cancer whose tumors overexpress FGFR2b as well as in a new cohort
to evaluate FPA144 in patients with bladder cancer whose tumors
overexpress FGFR2b.
About FPA144FPA144 is an anti-FGF receptor 2b
(FGFR2b) humanized monoclonal antibody in clinical development as a
targeted immune therapy for tumors that over-express FGFR2b, as
determined by a proprietary immunohistochemistry (IHC) diagnostic
assay. FGFR2 gene over-expression is found in a number of tumors,
including in approximately 5% of gastric cancer patients, and is
associated with poor prognosis.
FPA144 is designed to block tumor growth through two distinct
mechanisms. First, it has been engineered to drive immune-based
killing of tumor cells by antibody-dependent cell-mediated
cytotoxicity (ADCC) and the recruitment of natural killer (NK)
cells and T cells. Second, it binds specifically to FGFR2b and
prevents the binding of certain fibroblast growth factors that
promote tumor growth. When combined with PD-1 blockade, FPA144 has
shown an additive effect in tumor growth inhibition in preclinical
models. 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 regarding Five Prime's
potential receipt of upfront and milestone payments and royalties.
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
Amy Kendall
Corporate Communications
415-365-5776
amy.kendall@fiveprime.com
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