Barcelona, Spain, November 19, 2014. 3-V Biosciences, Inc., (3-V), a clinical-stage biopharmaceutical company developing therapeutics that modulate key pathways in oncology and infectious diseases, today presented the first human clinical data for its first-in-class lead oncology candidate, TVB-2640, at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics currently taking place in Barcelona, Spain. Data from 3-V’s ongoing Phase 1 clinical trial of TVB-2640 were delivered in an oral presentation, entitled “Initial Report of a First-In- Human Study of the First-In-Class Fatty Acid Synthase (FASN) Inhibitor, TVB-2640,” by Jeffrey R. Infante, M.D., Director, Drug Development Program of the Sarah Cannon Research Institute in Nashville, Tennessee, and principal investigator for the 3-V clinical trial.
“FASN is a highly promising target that is specific to cancer cell survival and correlates to increasing disease severity and poor outcome in a number of tumor types,” said Dr. Infante. “The preliminary results we have seen from this TVB-2640 Phase 1 trial have demonstrated favorable safety, tolerability and pharmacokinetics. In addition, well-tolerated doses that exceed those predicted to be efficacious have been achieved. We look forward to analyzing additional data from this ongoing trial and the opportunity to observe indications of efficacy of TVB-2640 against a variety of solid tumor types.”
Dr. Infante’s oral presentation detailed data from the first fourteen patients enrolled in the trial. Patients were given 60 mg/m2, 120 mg/m2 and/or 240 mg/m2 oral doses of TVB-2640 once daily. Plasma levels of drug increased in a dose-proportionate manner, with steady state reached by day eight of treatment, on average. The mean half-life of TVB-2640 was observed to be approximately 18 hours. Dose-limiting toxicities were as predicted, with eye- and skin-related events that were manageable and fully reversible upon discontinuation of therapy. Other toxicities reported were generally mild and, notably, there were no signals of gastrointestinal or hematological toxicity, and no QTc prolongation noted.
“The first look at these data is a major milestone for TVB-2640 and 3-V and we are gratified to see initial positive clinical feedback,” said Merdad Parsey, M.D., Ph.D., Chief Executive Officer of 3-V Biosciences. “With favorable pharmacokinetics supporting once-daily oral dosing and these clinical findings support our belief that TVB-2640 could be an important new development in the treatment of cancer as a monotherapy and combination therapy. As we approach dose selection
for Phase 2 and initiate expansion cohorts, we expect to see early efficacy data from this TVB-2640 Phase 1 program in 2015.”
The Phase 1, multi-center, open-label, dose-escalation trial is expected to enroll up to 130 patients with advanced solid tumors whose cancer has become refractory to standard therapy and/or for whom no potentially beneficial treatment exists. The primary endpoint for the Phase 1 study is the identification of dose-limiting toxicities and the establishment of a maximum-tolerated dose (MTD) for oral TVB-2640. Secondary endpoints include safety, pharmacokinetics and initial signs of efficacy. The trial is intended to recommend a TVB-2640 dose for use in Phase 2 trials, both as a monotherapy and in possible combination with other chemotherapeutic agents, while also exploring and defining biomarkers of response.
In addition to the oral presentation at EORTC-NCI-AACR, Timothy Heuer, Ph.D., Senior Director, 3- V Biosciences, will present a poster, entitled “Mechanistic analysis of reversible FASN inhibition in preclinical tumor models identifies highly susceptible tumor types and enriches biomarker discovery for clinical applications,” on November 21, 2014. These data will further detail the multiple mechanisms of action of FASN inhibition and the rationale for biomarker candidates to support the ongoing clinical trials of TVB-2640, 3-V’s novel FASN inhibitor candidate.
TVB-2640 is an oral, proprietary fatty acid synthase (FASN) inhibitor being evaluated for the treatment of solid tumors. FASN, an enzyme responsible for the synthesis of palmitic acid (palmitate), plays a key role in tumor metabolism, lipid signaling and tumor cell survival. FASN over-expression is associated with aggressive disease and poor prognosis in a number of solid tumors. TVB-2640 is the first FASN inhibitor to enter human clinical trials.
About 3-V Biosciences
3-V Biosciences, Inc. is discovering and developing therapeutics that modulate key pathways in oncology and infectious diseases. In oncology, the company’s lead candidate is a fatty acid synthase (FASN) inhibitor that has been shown to block tumor cell signaling pathways and induce tumor cell apoptosis. 3-V’s antiviral therapeutics have demonstrated the ability to block host- pathogen interactions, resulting in robust and broad-spectrum in vitro and in vivo antiviral activity, including efficacy against viruses resistant to other classes of antiviral drugs, and a high barrier to resistance. The 3-V team applies an integrated approach, leveraging internal expertise in biology, medicinal chemistry, drug discovery and development to drive programs forward. The company is located in Menlo Park, California.
For additional information on 3-V Biosciences, please visit www.3vbio.com.com.
# # #
Merdad Parsey, M.D., Ph.D.
Chief Executive Officer
BCC Partners on behalf of 3-V Biosciences, Inc.
Karen L. Bergman