FLAG Therapeutics’ two novel classes of investigational drugs, anti-angiogenic/anti-tubulin (AA/AT) and folate-targeted anti-cancer (FTAC) compounds, are designed to harness the power of multiple therapeutic actions into highly water-soluble small molecule compounds. 

Engineered to specifically overcome the shortcomings of conventional cancer therapies, namely efficacy, tolerability and drug resistance issues, FLAG’s investigational compounds hold the potential to treat multiple cancer types, including ovarian, breast, lung and pancreatic cancers.  

To date, over $13.5 million in grant funding has been used to synthesize, optimize and screen compounds in vitro and in vivo, resulting in a library of thousands of promising compounds.  The mechanisms of action for both classes of compounds have been fully elucidated and validated, thereby potentially minimizing development risks and facilitating clinical development. 

Strong Intellectual Property Portfolio
FLAG's AA/AT and FTAC product platforms are protected by a strong intellectual property portfolio.  Portfolio highlights include:

  • 53 issued patents (32 US, 21 International)
  • 44 pending applications (13 US, 31 International)
  • Patents cover composition of matter and uses
  • Patent coverage extends beyond 2035 (including 7-year orphan drug designation extension)

October 2014, FLAG granted Orphan Drug Designation for FLAG-003 for the treatment of Glioma in both the US and EU.

October 2016 - successful pre-IND meeting with US FDA.

September 2017 - Awarded $1.5 M 2 year SBIR to study FTAC molecules for the treatment of Mesothelioma

Late 2018 - Plan to file IND for a Phase I study of FLAG-003 for the treatment of glioma

FLAG's compounds have undergone:

Structural Activity Relationship (SAR) Analysis

Molecular modeling

In vitro activity screening (NCI 60 cell line panel)

Mechanism of action elucidation

In vivo efficacy studies with clinically relevant comparator