3-V Biosciences Commences Patient Dosing In Phase 1 Clinical Study Of FASN Inhibitor TVB-2640 In Patients With Advanced Solid Tumors

MENLO PARK, Calif., Dec. 4, 2013 /PRNewswire/ -- 3-V Biosciences, Inc., a clinical-stage biopharmaceutical company developing therapeutics that modulate key pathways in oncology and infectious disease, today announced the recent initiation of a Phase 1 clinical study of TVB-2640 in patients with advanced solid tumors. TVB-2640 is an oral, proprietary fatty acid synthase (FASN) inhibitor being evaluated for the treatment of solid tumors. FASN is an enzyme responsible for the synthesis of palmitic acid and has a key role in tumor metabolism, lipid signaling and tumor cell survival.

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"For tumors to grow, cancer cells need to process more fuel than normal cells. The ability to interfere in tumor cell metabolism is an extremely compelling avenue for oncology drug development," said Jeffrey Infante, M.D., Sarah Cannon Research Institute in Nashville, TN and lead investigator for the 3-V clinical trial. "TVB-2640 is the first inhibitor of FASN to enter the clinic. Our center is excited to be leading the Phase 1 clinical study for this emerging and promising anti-cancer therapy."

The Phase 1 open-label, dose-escalation trial will enroll patients with advanced solid tumors whose cancer has become refractory to standard therapy, and for whom no useful treatment exists. Patients will receive TVB-2640 once daily for 21 days. The primary endpoint for the Phase 1 study is the identification of any dose-limiting toxicities and the establishment of a maximum-tolerated dose (MTD) for oral TVB-2640. Secondary and exploratory endpoints include safety, pharmacokinetics, and initial signs of efficacy and evidence of FASN biomarker activity.

"With the initiation of this Phase 1 clinical trial, we look forward to testing our hypothesis that blocking FASN could provide a significant benefit in patients with solid tumors," said Merdad Parsey, M.D., Ph.D., Chief Executive Officer of 3-V Biosciences. Data from this trial will provide further information on the safety profile, dosing and selection of cancer types in anticipation of future studies for TVB-2640."

FASN over-expression is associated with aggressive disease and poor prognosis in a number of cancers. In a series of preclinical studies, 3-V's FASN inhibitors demonstrated potent activity against multiple tumor types, including breast, lung, pancreatic, ovarian and colon cancers. FASN inhibition reduced cell proliferation and induced apoptosis (cell death) in a dose-dependent manner and single-agent FASN inhibition both blocked tumor growth and resulted in significant tumor regression in patient-derived xenografts. In addition, 3-V has demonstrated potential synergy of its FASN inhibitors with cytotoxic agents.

About 3-V Biosciences
3-V Biosciences, Inc. is a privately held biopharmaceutical company discovering and developing therapeutics that modulate key pathways in oncology and infectious disease. In oncology, the company's lead candidate is a fatty acid synthase (FASN) inhibitor that blocks tumor cell signaling pathways and induces tumor cell apoptosis. 3-V's antiviral therapeutics block host-pathogen interactions, resulting in robust and broad-spectrum 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.

Contact Information

Merdad Parsey, M.D., Ph.D.
Chief Executive Officer
650-561-8600

Media Inquiries

BCC Partners on behalf of 3-V Biosciences, Inc.
Karen L. Bergman
650-575-1509
kbergman@bccpartners.com
Michelle Corral
415-794-8662
mcorral@bccpartners.com

SOURCE 3-V Biosciences, Inc.