Five Prime Therapeutics Advances into Phase 1b Portion of Trial Evaluating the Immunotherapy Combination of Cabiralizumab (FP...
October 04 2016 - 9:00AM
Phase 1a/1b trial on track to enroll
approximately 280 patientsPhase 1b portion of the trial will assess
safety, tolerability and initial efficacy in multiple tumor
types
Five Prime Therapeutics, Inc. (Nasdaq:FPRX) a clinical-stage
biotechnology company focused on discovering and developing
innovative immuno-oncology protein therapeutics, today announced
that it has initiated the Phase 1b portion of the clinical trial
evaluating the immunotherapy combination of cabiralizumab (FPA008),
Five Prime's investigational monoclonal antibody that inhibits
colony stimulating factor-1 receptor (CSF1R), with OPDIVO®
(nivolumab), Bristol-Myers Squibb's PD-1 immune checkpoint
inhibitor, in multiple tumor types.
"We are very pleased to progress to the Phase 1b portion of this
trial evaluating cabiralizumab in combination with nivolumab as a
treatment for patients with multiple types of tumors, many of whom
currently have no effective treatment options," said Robert
Sikorski, M.D., Ph.D., Chief Medical Officer, at Five Prime. “Our
goal is to develop new therapeutics that unleash the immune
system’s natural anti-cancer activity. Based on the science, we
believe that targeting both the CSF1R and PD-1 pathways has the
potential to produce a synergistic treatment effect.”
Five Prime initiated the Phase 1a/1b trial, which is expected to
enroll approximately 280 patients, in September 2015. During Phase
1a, Five Prime evaluated the safety, pharmacokinetics and
biomarkers of escalating doses of cabiralizumab as a monotherapy,
as well as in combination with the approved 3 mg/kg dose of
nivolumab.
Five Prime will continue to run the Phase 1b portion of the
trial and will evaluate the safety, tolerability and preliminary
efficacy of the selected dose of cabiralizumab in combination with
nivolumab for the treatment of advanced solid tumors, including but
not limited to non-small cell lung cancer, squamous cell carcinoma
of the head and neck, pancreatic cancer, glioblastoma, renal cell
carcinoma and ovarian cancer.
About Cabiralizumab (FPA008)Cabiralizumab is an
investigational antibody that inhibits the CSF-1 receptor and has
been shown in preclinical models to block the activation and
survival of monocytes and macrophages. Inhibition of CSF1R in
preclinical models of several cancers reduces the number of
immunosuppressive tumor-associated macrophages (TAMs) in the tumor
microenvironment, thereby facilitating an immune response against
tumors. Cabiralizumab is currently in a Phase 2 clinical trial in
pigmented villonodular synovitis (PVNS) and a Phase 1 clinical
trial in oncology indications. Cabiralizumab is being developed
under an exclusive worldwide license and collaboration agreement
entered into with BMS in October 2015.
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 the planned
clinical development of cabiralizumab (FPA008), including in
combination with OPDIVO (nivolumab). Many factors may cause
differences between current expectations and actual results
including unexpected safety or efficacy data observed during
preclinical or clinical studies, clinical trial site activation or
enrollment rates that are lower than expected, changes in expected
or existing competition, changes in the regulatory environment,
BMS’s decision to not support or advance the development of
cabiralizumab, and unexpected litigation or other disputes. Other
factors that may cause Five Prime's 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" sections 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.
Heather Rowe
Investor Relations
415-365-5737
heather.rowe@fiveprime.com
Amy Kendall
Corporate Communications
415-365-5776
amy.kendall@fiveprime.com
Five Prime Therapeutics (NASDAQ:FPRX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Five Prime Therapeutics (NASDAQ:FPRX)
Historical Stock Chart
From Sep 2023 to Sep 2024