SOUTH SAN FRANCISCO, Calif., Aug. 24, 2015 (GLOBE NEWSWIRE) -- Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that initial data from GlaxoSmithKline (GSK)'s ongoing Phase 1b trial of FP-1039/GSK3052230, an FGF ligand trap, in patients with squamous non small cell lung cancer (sqNSCLC) and mesothelioma will be featured in an oral presentation by study investigators during the upcoming World Conference on Lung Cancer 2015 in Denver (September 6-9, 2015).
Abstract #2879 entitled, "FP1039/GSK3052230 with Chemotherapy in Patients with Fibroblast Growth Factor (FGF) pathway deregulated squamous NSCLC or MPM," published today at http://wclc2015.iaslc.org/ and includes data through the time of submission in April 2015. The oral presentation is scheduled on Wednesday, September 9, 2015 in the "Mini 38: Biology and Prognosis" session [6:30-8:00 pm] and is expected to include study data up to August 2015, which will be detailed in a press release at that time.
The Phase 1B trial being conducted by GSK is evaluating the safety and efficacy of FP-1039/GSK3052230 weekly infusion in combination with paclitaxel + carboplatin in previously untreated FGFR1 gene amplified metastatic squamous NSCLC (Arm A), in combination with docetaxel in FGFR1 gene amplified metastatic squamous NSCLC that has progressed after at least 1 line of chemotherapy (Arm B), or in combination with pemetrexed + cisplatin in patients with untreated and unresectable malignant pleural mesothelioma (Arm C). GSK continues to enroll patients in the study. Arm A and Arm C have advanced into the expansion phase and dose escalation is ongoing for Arm B.
Five Prime licensed development and commercialization rights for FP-1039/GSK3052230 in the U.S., Europe and Canada to GSK, which funds clinical development. Five Prime retains rights outside of these regions as well as an option to co-promote FP-1039/GSK3052230 in the U.S.
About FP-1039/GSK3052230
FP-1039/GSK3052230 is a protein drug designed to intervene in FGF signaling. As a ligand trap, FP-1039/GSK3052230 binds to FGF ligands circulating in the extracellular space, preventing these signaling proteins from reaching FGFR1 on the surface of tumor cells where they would otherwise stimulate cancer cell division and/or angiogenesis. However, FP-1039/GSK3052230 does not bind to certain "hormonal" FGFs, including FGF23, which regulates phosphate levels in the blood. As a result, treatment with FP-1039/GSK3052230 treatment has not been shown to cause hyperphosphatemia, a side effect seen with small molecule inhibitors of FGF receptors, which block the activity of both cancer-associated FGFs and FGF23.
Five Prime licensed development and commercialization rights for FP-1039/GSK3052230 in the U.S., Europe, and Canada to GSK, which funds clinical development. The Phase 1B clinical trial is investigating treatment with FP-1039/GSK3052230 combined with standard doses of chemotherapy in patients with newly-diagnosed or recurrent FGFR1 amplified metastatic squamous non-small cell lung cancer as well as patients with malignant pleural mesothelioma, a tumor in which the FGF2 ligand is overexpressed.
About Five Prime
Five 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 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. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during the clinical study, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of GSK, Five Prime's licensee, to support or advance the clinical study of FP-1039 and unexpected litigation or other disputes. 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.