Menlo Park, California, June 9, 2015: 3-V Biosciences, Inc., a clinical-stage biopharmaceutical company developing therapeutics that modulate key pathways in oncology and infectious diseases, is pleased to announce that new data from its ongoing Phase 1 Study of its lead program (TVB-2640), a first-in-class Fatty Acid Synthase (FASN) inhibitor were presented at the AACR Metabolism and Cancer Conference held on June 7-10 in Bellevue, Washington in a poster titled “Translational Studies of a First-in-Class FASN Inhibitor, TVB-2640, Linking Preclinical Studies to Clinical Laboratory Observations in Solid Tumor Patients,” and is available at www.3vbio.com.com/news+events. With the reporting of these data, the maximal tolerated dose (MTD) and consequently the dose for expansion cohorts, which are now open, has been established as a once-daily, oral therapy.
The objectives of the study, an open label, multicenter international trial, are to evaluate the safety, pharmacokinetics and preliminary evidence of anti-tumor activity of TVB-2640 as monotherapy and in combination with paclitaxel.
At the end of April, 2015, 37 patients had been treated with TVB-2640 either as monotherapy or in combination with paclitaxel. During the dose-escalation phase of this study, heavily-pretreated patients with an average of more than 4 previous treatment regimens, regardless of tumor type, were enrolled. To date, the pharmacokinetic profile of TVB-2640 has been favorable, with predictable exposure and a half-life of approximately 15 hours. The tolerability of TVB-2640 has also been acceptable, with alopecia and no significant GI, hematologic, or serum chemistry adverse events. Dose-limiting toxicities are thought to be on-target and consist of manageable and reversible hand-foot dryness/scaling or manageable and reversible eye inflammation likely due to surface dryness. Importantly, no newly emergent toxicities or alterations in pharmacokinetics have been observed when TVB-2640 was combined with paclitaxel.
Changes in the peripheral blood and tumors of treated patients in response to TVB-2640, including decreased AKT phosphorylation in tumor biopsies, are expected as a result of target inhibition systemically and in the tumors of patients. Furthermore, initial signs of clinical benefit, including stable disease in three of five patients with NSCLC, have been observed.
“This new data set from our ongoing clinical phase 1 trial, especially seeing stable disease in advanced cancer patients with recalcitrant tumors, bolsters our confidence in TVB-2640 as we transition to expansion cohorts with specific tumor types that have been demonstrated pre-clinical sensitivity to FASN inhibition” commented Dr. Merdad Parsey, Chief Executive Officer of 3-V Biosciences.
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 FASN inhibitors have demonstrated in vitro and in vivo anti-tumor activity in cell-line and patient-derived xenografts as monotherapy and synergistically in combination with other anti-tumor agents. 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.
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