Five Prime Therapeutics Presents Initial Safety Data from the Phase 1 Trial of FPT155 at the Society for Immunotherapy of Can...
November 09 2019 - 7:00AM
Business Wire
- Results Demonstrate FPT155 was Well Tolerated
in all Patients through Seven Cohorts, Allowing for Continuation of
Dose Escalation and Dose Finding -
Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage
biotechnology company focused on developing immune modulators and
precision therapies for solid tumor cancers, today presented
initial safety data from the Phase 1 clinical trial of FPT155 in
patients with advanced solid tumors in a poster presentation at the
Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting in
National Harbor, Maryland. The poster can be found on the
Publications Page of the Five Prime Therapeutics website.
“FPT155 is a first-in-class CD80 fusion protein with potential
dual mechanisms to activate T cells,” said Helen Collins, M.D.,
Executive Vice President and Chief Medical Officer of Five Prime
Therapeutics. “Importantly, the initial safety results for FPT155
suggest that it may not cause the same safety issues seen with a
prior molecule targeting CD28. This allows us to continue enrolling
patients to study additional dose escalation cohorts and identify a
dose for future studies.”
The FPT155 data presented at SITC included initial safety
results from the Phase 1a dose escalation portion of the trial,
which is designed to characterize the safety and pharmacokinetic
(PK)/pharmacodynamic (PD) profile of FPT155 and identify a
recommended dose for the Phase 1b portion of the trial. This
included data from 15 patients with solid tumors that were treated
with FPT155 at doses of 0.07 mg, 0.21 mg, 0.7 mg, 2.1 mg, 7 mg, 21
mg, and 42 mg. The key highlights from the presentation
include:
- FPT155 was well tolerated at all dose levels, with no
dose-limiting toxicities and no grade 4 or higher adverse
events.
- There is no evidence of clinical or laboratory cytokine release
syndrome, an adverse event associated with a prior therapy
targeting CD28.
- Dose escalation with FPT155 is ongoing with the study currently
enrolling patients at the 70 mg dose level.
The Phase 1a/1b open-label, multicenter, dose escalation, dose
exploration and dose expansion study will evaluate the safety and
tolerability of FPT155 in patients with advanced solid tumors. The
Phase 1a dose escalation portion of the trial will characterize the
safety and PK/PD profile of FPT155 and will identify a recommended
dose for the Phase 1b portion of the trial. The Phase 1b portion of
the trial is intended to further characterize the safety, PK/PD
profile, and preliminary efficacy of FPT155.
About FPT155
FPT155 is a first-in-class CD80 fusion protein that (i) directly
engages CD28 to enhance its co-stimulatory T-cell activation
activity without inducing super agonism, and (ii) blocks CTLA-4
from competing for endogenous CD80, allowing CD28 signaling to
prevail in T-cell activation in the tumor microenvironment. FPT155
has also demonstrated its ability to retain anti-tumor activity
independent of its engagement with CTLA-4, suggesting a
differentiated mechanism of action from CTLA-4-blocking antibodies.
Studies in preclinical models suggest FPT155 has the potential to
be a potent T-cell co-stimulator with strong monotherapy anti-tumor
activity.
About Five Prime Therapeutics
Five Prime Therapeutics, Inc. develops innovative protein
therapeutics to improve the lives of patients with cancer. The
company focuses on developing immune modulators and precision
therapies for solid tumor cancers paired with companion diagnostics
to identify patients who are most likely to benefit from treatment
with Five Prime’s product candidates. The company’s product
candidates have innovative mechanisms of action and address patient
populations in need of better therapies. Five Prime has entered
into strategic collaborations with leading global pharmaceutical
companies and has promising product candidates in clinical and
preclinical development. For more information, please visit
www.fiveprime.com.
Cautionary Note on Forward-looking Statements
This 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. 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.
Source: Five Prime Therapeutics, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20191109005015/en/
Media and Investor Contact Martin Forrest VP, Investor
Relations & Corporate Communications Five Prime Therapeutics,
Inc. 415-365-5625 martin.forrest@fiveprime.com
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