Derived from FLAG’s FR-α/GARFTase Inhibitor platform technology, FLAG-094, an investigational candidate for the treatment of Epithelial Ovarian Cancer (EOC), is a multi-acting, water-soluable small molecule therapeutic designed to target, bind and kill cancer cells through multiple well-established mechanisms of action (MoAs). Specifically, FLAG-094 is designed to:

• Target cells that express Folate receptor-⍺, a cell surface receptor that is over expressed solely on certain cancer types, including epithelial ovarian cancer (EOC) and mesothelioma;       

• Inhibit  production of GARFTase (Glycinamide Ribonucleotide Formyltransferase),  an enzyme required for purine synthesis and cellular replication, thus disrupting cancer cell replication;

• Bypass efflux pumps (as it is not a P-gp substrate) thereby reducing drug resistance.

Need for New Treatment Options

Epithelial ovarian cancer, the most common of the three types of ovarian cancer, is a cancer found on the epithelial cells located on the outer surface of the ovary. Often times women with EOC are asymptotic and therefore not diagnosed until late-stage disease progression. In the United States, each year approximately 20,000 women are diagnosed with new cases of EOC and approximately 13,000 women die from the disease. The five-year survival rate of women diagnosed with EOC varies greatly depending upon when they were diagnosed:

•       5-year survival with late-stage EOC:   29%

•       5-year survival with early-stage EOC:  92%

While there is currently an established standard of care (SoC) for the treatment of EOC, there are limitations which underscore the need for new treatment options, namely:

• Current SoC drugs (Carboplatin with Paclitaxel) are subject to resistance with use

• Unfavorable safety profiles with PARP (poly-ADP ribose polymerase) inhibitors (lower overall survival rates)

• Significant need for alternative treatments for patients where SoC is ineffective

FLAG-094 holds the potential to provide a new treatment option to patients in need.

100 Percent Response Rate Seen in Preclinical Studies of FLAG-094 for EOC

Data from preclinical studies of FLAG-094 for EOC and mesothelioma are encouraging, demonstrating demonstrating a 100 percent response rate in animal models administered FLAG-094.