FLX Bio Announces Initiation of Phase 1 Trial of FLX925

Initiation of Phase 1 Trial of FLX925, a Selective Inhibitor of FLT3 and CDK4/6 in Acute Myeloid Leukemia

South San Francisco, Calif., August 31, 2015

FLX Bio also announced today the initiation of a Phase 1 study in patients with relapsed or refractory acute myeloid leukemia (AML), under an Investigational New Drug (IND) application for FLX925 (previously known as AMG 925), a dual inhibitor of FLT3 and CDK4/6.

FLX925 is a selective inhibitor of fms-like tyrosine kinase 3 (FLT3) and cyclin-dependent kinases 4 and 6 (CDK4/6) that was licensed from Amgen. The preclinical data for FLX925 are consistent with a potential best-in-class profile in the treatment of certain cancers that are driven by abnormal levels of FLT3 and/or CDK4/6 activity.

“Acute myeloid leukemia remains a disease with great unmet medical need,” said Beth Seidenberg, M.D., of FLX Bio’s Board of Directors and General Partner at Kleiner Perkins Caufield & Byers. “We believe FLX925 has the potential to bring meaningful benefit not only to patients with AML, but also to patients with other malignancies driven by CDK4/6.”
For more information about the clinical trial, including enrolling centers, please visit www.clinicaltrials.gov under trial identification number NCT02335814.

About FLX Bio

Founded in 2015 following the acquisition of its predecessor company, Flexus Biosciences, Inc., by Bristol-Myers Squibb, FLX Bio, Inc. is a privately-held biopharmaceutical company focused on the discovery, development and commercialization of novel cancer immunotherapies. The company is leveraging unexploited insights in immunology to discover novel agents that combat cancer by reversing tumor immunosuppression. This disruptive approach to cancer therapy targets that which is common to all tumors: the host immune system.

Located in South San Francisco, Calif., and funded by leading investors, including Kleiner Perkins Caufield & Byers (KPCB), The Column Group (TCG) and Celgene, FLX Bio has assembled a management and R&D leadership team with a proven track record of success and an advisory group and team of scientists with substantial knowledge and expertise in drug discovery and translational areas essential to execute on this approach. For more information, please visit www.flxbio.com.

Contact: inquiries@flxbio.com

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