Bad News for Bay Area's Five Prime as GlaxoSmithKline Walks Away from Cancer Drug Pact

March 11, 2016
By Alex Keown, BioSpace.com Breaking News Staff

SOUTH SAN FRANCISCO – GlaxoSmithKline is terminating its five-year developmental partnership with California-based Five Prime Therapeutics for the early-stage cancer drug FP-1039, which was being studied for non-small cell lung cancer and mesothelioma, Five Prime announced Thursday.

On March 10, Five Prime said London-based GlaxoSmithKline notified the company that it was providing its 180-day notice of termination of the FP-1039 license and collaboration agreement for convenience. In January, GlaxoSmithKline and Five Prime abandoned its squamous non-small cell lung cancer trial with FP-1039, but continued to focus on a trial for mesothelioma. Five Prime said it plans to work with GSK to “ensure completion of enrollment in the ongoing mesothelioma arm of the Phase 1b study and to transfer the asset and program back to Five Prime.” Five Prime said it will base decisions on future development of FP-1039 for mesothelioma on “whether the quality and durability of responses in this population is maintained in this trial.”

GlaxoSmithKline has submitted the mesothelioma data for presentation at the ASCO 2016 annual meeting, Five Prime said.

Although GSK terminated its relationship, Five Prime’s stock is up more than 6 percent this morning, trading at $32.95 per share. The stock increase followed Five Prime’s 2015 fourth quarter financial report showing revenue of $363.3, beating analysts’ estimates of $354.8 million, the Associated Press reported. For the full year Five Prime posted net income of $249.6 million.

Since the start of 2016, Five Prime’s stock is down about 20 percent. The stock started the year trading at $41.50 per share. In February, the stock hit a low of $29.04 per share.

Lewis T. “Rusty” Williams, president and chief executive officer of Five Prime, called 2015 a transformational year for the company. Although the GSK agreement is coming to an end, Williams touted its ongoing partnership with Bristol-Myers Squibb for the development and commercialization of its experimental FPA008 therapy. He said the agreement “maximizes the clinical and commercial potential of FPA008” and the “exceptional terms have strengthened our financial position.”

In October, Five Prime secured an immuno-oncology deal with Bristol-Myers Squibb worth $1.74 billion. The deal is for the development and commercialization of Five Prime’s colony stimulating factor 1 receptor (CSF1R) antibody program, including FPA008 which is in Phase 1 development for immunology and oncology indications. That deal replaced a previous one between the two companies to combine Opdivo (nivolumab), Bristol-Myers Squibb’s programmed-death 1 (PD-1) immune checkpoint inhibitor, with FPA008 in six tumor types. FPA008 is an investigational antibody that inhibits CSF1R and has been shown in preclinical models to block the activation and survival of monocytes and macrophages.

In addition to the Bristol-Myers deal, Williams said the company is encouraged by early data from its experimental gastric cancer treatment FPA144. FPA144 is an anti-FGF receptor 2b (FGFR2b) monoclonal antibody that is engineered to recruit NK cells into the tumor microenvironment. In January, Five Prime presented clinical data for FPA144 that showed two partial responses in six gastric cancer patients with IHC 3+ FGFR2b-positive gastric cancer, as well as a partial response in a patient whose bladder cancer overexpressed FGFR2b.

"Beyond our clinical programs, we also made progress in our internal immuno-oncology research programs, and continue to be on track to file an IND application in 2017,” Williams said in a statement.