Five Prime Therapeutics Presents Updated Data From the Phase 1a/1b Trial of FPA150 at the European Society for Medical Oncolo...
September 30 2019 - 03:01AM
Business Wire
- Results Provide First Clinical Demonstration
of B7-H4 as a Potential Therapeutic Target and Continue to Support
FPA150’s Greatest Potential in Combination Therapy -
Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage
biotechnology company focused on discovering and developing immune
modulators and precision therapies for solid tumor cancers, today
presented updated data from the Phase 1a/1b clinical trial of
FPA150 in patients with advanced solid tumors in a poster
presentation at the European Society for Medical Oncology (ESMO)
2019 Congress in Barcelona, Spain. The poster can be found on the
Scientific Publications Page of the Five Prime Therapeutics
website.
The FPA150 data presented at ESMO included preliminary efficacy
results from the Phase 1b monotherapy expansion portion of the
study in patients preselected for B7-H4 tumor overexpression across
breast, endometrial and ovarian cancers, and early safety results
from the Phase 1a Keytruda® (pembrolizumab, a PD1 antibody)
combination portion of the study in patients preselected for B7-H4
tumor overexpression in ovarian cancer.
“B7-H4 is a novel T cell immune checkpoint and the early results
from the phase 1b monotherapy portion of our FPA150 study provide
the first clinical demonstration of B7-H4 as a potential
therapeutic target,” said Helen Collins, Executive Vice President
and Chief Medical Officer of Five Prime Therapeutics. “Based on the
study results to-date, we continue to believe that the most
promising opportunity for FPA150 is in combination with other
therapeutic agents.”
Key highlights from the presentation include:
Phase 1 FPA150 Monotherapy:
- Two patients with B7-H4 positive ovarian cancer experienced a
confirmed partial response (one in the dose escalation and one at
the recommended dose of 20mg/kg)
- 10 patients with stable disease remain on therapy as of August
9, 2019
- Increased tumor infiltration of T cells and NK cells observed
in patients with a partial response or stable disease
- Recommended dose of 20 mg/kg was well tolerated in all
patients
Phase 1 Safety Lead-in Combination of
FPA150 + Pembrolizumab :
- Combination was well tolerated in the first four patients
treated with FPA150 (20 mg/kg) and pembrolizumab (200 mg)
- Expansion initiated in August 2019 in a cohort of ovarian
cancer patients with B7-H4 overexpression
About FPA150
FPA150 is a novel, fully human, afucosylated monoclonal antibody
targeting B7-H4. B7-H4 overexpression is observed in multiple solid
tumors, including breast and gynecologic cancers. FPA150 is
designed with a dual mechanism of action: blocking the T cell
checkpoint activity of B7-H4 as well as promoting enhanced
antibody-dependent cell-mediated cytotoxicity (ADCC) against tumor
cells expressing B7-H4.
About Five Prime Therapeutics
Five Prime Therapeutics, Inc. discovers and develops innovative
protein therapeutics to improve the lives of patients with serious
diseases. Five Prime’s product candidates have innovative
mechanisms of action and address patient populations in need of
better therapies. Five Prime has five programs in various stages of
clinical development with two of these programs partnered with
Bristol-Myers Squibb. The company focuses on researching and
developing immuno-oncology and targeted cancer therapies paired
with companion diagnostics to identify patients who are most likely
to benefit from treatment with Five Prime’s product candidates.
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 or follow us on
LinkedIn, Twitter and Facebook.
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/20190930005202/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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