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TVB-2640: first-in-class, once daily, oral inhibitor of FASN

In preclinical studies, our FASN inhibitors have shown

  • Good tolerability profiles
  • Potent anti-tumor properties in vitro and in vivo
  • Modulation of tumor signaling pathways, alteration of tumor membrane structure and impact on tumor metabolism
  • Strong synergy with paclitaxel

Results of our preclinical studies of TVB-2640 have been presented at several scientific conferences and these data may be viewed on our Posters/Publications Page.

We are currently conducting a Phase 1 trial of TVB-2640 in patients with solid tumors. The objectives if this trial are to:

  • Assess safety and tolerability
  • Measure pharmacokinetic properties
  • Define the maximally tolerated dose (MTD)
  • Identify any early signs of anti-tumor activity both as a single agent and in combination with paclitaxel

We have established the preliminary safety and pharmacokinetic profile, defined the MTD, demonstrated target engagement in patients and have seen early signs of clinical activity. We are now expanding the trial to enroll multiple cohorts of patients with specific tumor types. Additional details regarding our Phase 1 trial can be found on www.clinicaltrials.gov (NCT02223247).

Our emerging data support the potential of this agent in patients with non-small cell lung cancer (NSCLC), triple-negative breast cancer and ovarian cancer. Additional tumor types are being evaluated in our ongoing Phase 1 clinical trial. We are also investigating biomarkers that may predict which patients will be most sensitive to treatment with TVB-2640.

In 2016, we expect to initiate one or more Phase 2 trials of TVB-2640 in select tumor types, as a single agent or in combination with other agents.