BACKGROUND: Optimized new therapies for HCV are needed that have pan genotypic activity and a high barrier to viral resistance. To meet these challenges, 3-V Biosciences has developed a small molecule inhibitor of HCV that targets the host’s fatty acid synthase (FASN) enzyme (Abstract 88). HCV infection increases the expression of FASN, the host enzyme responsible for the production of palmitate, and down regulation of FASN inhibits critical viral processes including entry into cells, RNA replication, and particle assembly. FASN inhibitors are expected to have pan- genotypic activity and pose a high barrier to viral resistance due to interference with multiple stages of the HCV lifecycle.

OBJECTIVE: The objective of this study is to characterize the pharmaceutical properties of a novel, small molecule inhibitor of FASN as a treatment for chronic HCV infection.

RESULTS: 3-V Bioscience’s FASN small molecule inhibits the human FASN enzyme in biochemical and cell based assays with an IC50 of 0.049 ?M and 0.025 ?M, respectively. Activity against the HCV Gt1b replicon parallels FASN inhibition with an EC50 of 0.060 ?M and no observed cytotoxicity. A 10 mpk oral dose of this compound is rapidly absorbed and highly bioavailable (~60%) in rats and dogs with an apparent half-life of 3.2 h and 3.9 h, respectively.

Pharmacodynamic activity in rats is exposure-dependent: a 60 mpk dose causes complete inhibition of palmitate synthesis 12h after administration while a single 30 mpk oral dose causes >50 % inhibition at 12h. Palmitate synthesis remains suppressed by ~60% at 24 hours following a 60 mpk dose, consistent with a once-daily oral dosing regimen. The results of this current work demonstrate that 3-V Bioscience’s FASN inhibitor can inhibit de novo fatty acid synthesis in vivo and has pharmaceutical properties necessary for clinical development.

3­V Biosciences presented two publications at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting®) held November 9-13 in Boston, Massachusetts. AASLD: Potent HCV Antiviral Activity by Inhibiting Fatty Acid Synthase.

BACKGROUND: Optimized new therapies for HCV are needed that have pan genotypic activity and a high barrier to viral resistance. To meet these challenges, 3-V Biosciences has developed a small molecule inhibitor of HCV that targets the host’s fatty acid synthase (FASN) enzyme (Abstract 88). HCV infection increases the expression of FASN, the host enzyme responsible for the production of palmitate, and down regulation of FASN inhibits critical viral processes including entry into cells, RNA replication, and particle assembly. FASN inhibitors are expected to have pan- genotypic activity and pose a high barrier to viral resistance due to interference with multiple stages of the HCV lifecycle.

OBJECTIVE: The objective of this study is to characterize the pharmaceutical properties of a novel, small molecule inhibitor of FASN as a treatment for chronic HCV infection.

RESULTS: 3-V Bioscience’s FASN small molecule inhibits the human FASN enzyme in biochemical and cell based assays with an IC50 of 0.049 ?M and 0.025 ?M, respectively. Activity against the HCV Gt1b replicon parallels FASN inhibition with an EC50 of 0.060 ?M and no observed cytotoxicity. A 10 mpk oral dose of this compound is rapidly absorbed and highly bioavailable (~60%) in rats and dogs with an apparent half-life of 3.2 h and 3.9 h, respectively.

Pharmacodynamic activity in rats is exposure-dependent: a 60 mpk dose causes complete inhibition of palmitate synthesis 12h after administration while a single 30 mpk oral dose causes >50 % inhibition at 12h. Palmitate synthesis remains suppressed by ~60% at 24 hours following a 60 mpk dose, consistent with a once-daily oral dosing regimen. The results of this current work demonstrate that 3-V Bioscience’s FASN inhibitor can inhibit de novo fatty acid synthesis in vivo and has pharmaceutical properties necessary for clinical development.

Menlo Park, California, November 10, 2012. 3–V Biosciences, Inc., announced today that preclinical data for its novel fatty acid synthase (FASN) inhibitors for the treatment of chronic hepatitis C virus (HCV) infection will be presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting®) being held November 9–13 in Boston, Massachusetts.

“New, potent therapeutics that combine with and improve on the evolving standard of care for the treatment of hepatitis C infection are needed to ensure that we can reach the broadest population of patients with appropriate, curative regimens,” said George Kemble, Chief Scientific Officer of 3– V Biosciences. “3–V’s FASN inhibitors represent an entirely new class of therapy. With a novel mechanism of action, and broad–spectrum, potent antiviral activity demonstrated across multiple preclinical studies, we believe that our FASN inhibitors will bring substantial benefits to patients as a key component in emerging multi–drug treatment regimens. We look forward to initiating clinical studies early next year.”

Novel FASN Inhibitors
3–V’s FASN inhibitors for the treatment of HCV are designed to have broad–spectrum activity, a high barrier to resistance and the ability to combine with direct–acting antivirals, such as nucleotide/nucleoside inhibitors, protease inhibitors, NS5a inhibitors and other mechanisms of action currently in development. Data characterizing the preclinical antiviral activity of 3–V’s FASN inhibitors will be featured in oral and poster presentations during The Liver Meeting. Highlights of these data include:

• Orally bioavailable representative molecules are potent and specific, with IC50s in the 5– 50nM range;
• Inhibitors have demonstrated excellent exposure and low toxicity in rodents associated with prolonged in vivo suppression of FASN;
• Antiviral activity against wild–type Genotype 1a, 1b and 2a replicons; and
• Antiviral activity against mutant HCV replicons resistant to NS3, NS4b, NS5a and NS5b inhibitors.

3–V’s FASN inhibitors are a chemically diverse set of potent, specific, reversible molecules with an excellent range of pharmaceutical properties. The company has filed multiple worldwide patent applications covering these inhibitors. 3–V’s HCV program is on track for an IND in the first quarter of 2013 and the company anticipates clinical proof–of–concept data by year–end 2013.

Data describing 3–V’s FASN inhibitor preclinical activity will be presented by Dr. Kemble during Sunday’s HCV Therapy: Preclinical and Early Clinical Development parallel session at 5:30 pm in a talk titled: “Potent Hepatitis C Antiviral Activity By Inhibiting Fatty Acid Synthase” (Abstract #88). A poster, “TVB–2640, a Novel Anti–HCV Agent, Safely Causes Sustained Host–Target Inhibition in Vivo” (Abstract #1876), describing mechanism and activity for one of 3–V’s compounds will be presented on Tuesday, November 13 during the HCV Therapy: Preclinical and Early Clinical Development poster session from 8:00 am to 12:00 pm.

About FASN
FASN is a cellular enzyme implicated in HCV replication and several cancers. First–generation FASN inhibitors have shown preclinical benefits in a variety of viral infections, including HCV, as well as in models of pancreatic, prostatic, breast and colorectal tumors, but their development has been hindered by poor bioavailability and systemic tolerability. 3–V has discovered and is advancing proprietary FASN inhibitors with pharmaceutical properties that overcome the shortcomings of earlier generations of inhibitors, and have the potential to become significant new approaches to the treatment of chronic HCV and other indications.

About 3–V Biosciences
3–V Biosciences, Inc. is a privately held biopharmaceutical company that discovers and develops antiviral therapeutics designed to have broad–spectrum 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 with internal expertise in virology, biology, 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 Stephen R. Brady Chief Business 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

Contact information
Stephen R. Brady
Chief Business 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

Menlo Park, California, October 1, 2012. 3­‐V Biosciences, Inc., announced today that two abstracts have been accepted for presentation at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting®) being held November 9‐13 in Boston, Massachusetts.

3‐V Biosciences is discovering and developing oral antiviral therapeutics designed to have broad-spectrum activity and a high barrier to resistance. Data characterizing the preclinical antiviral activity of the company’s novel small molecules targeting the fatty acid synthase (FASN) pathway for the potential treatment of chronic hepatitis C virus (HCV) infection will be featured in oral and poster presentations.

Oral Presentation
Sunday, November 11, 2012 at 5:30pm ET:
HCV Therapy: Preclinical and Early Clinical Development
“Potent Hepatitis C Antiviral Activity By Inhibiting Fatty Acid Synthase” (Parallel 13, Hynes: Room 21)

Poster Presentation (Presidential Poster of Distinction award)
Tuesday, November 13, 2012 from 8:00am ‐ 12:00pm ET:
HCV Therapy: Preclinical and Early Clinical Development
“TV­‐2640, a Novel Anti‐HCV Agent, Safely Causes Sustained Host‐Target Inhibition in Vivo” (Poster Hall, #1876)

About FASN
FASN is a cellular enzyme implicated in HCV replication and several cancers. First‐generation FASN inhibitors have shown preclinical benefits in a variety of viral infections, including HCV, as well as in models of pancreatic, prostatic, breast and colorectal tumors, but their development has been hindered by poor bioavailability and systemic tolerability. 3‐V has discovered and is advancing proprietary FASN inhibitors with pharmaceutical properties that overcome the shortcomings of earlier generations of inhibitors, and have the potential to become potent therapeutics for chronic HCV and other indications.

About 3-­V Biosciences

3‐V Biosciences, Inc. is a privately held biopharmaceutical company that discovers and develops antiviral therapeutics designed to have broad-­spectrum 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 with internal expertise in virology, biology, 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

Stephen R. Brady Chief Business 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 ]]> http://www.3vbio.com/2012/10/3-v-biosciences-to-present-data-on-hcv-product-candidates/feed/ 0 http://www.3vbio.com/2012/07/3%e2%80%90v-biosciences-to-present-at-the-seventh-annual-jmp-securities-healthcare-conference/ http://www.3vbio.com/2012/07/3%e2%80%90v-biosciences-to-present-at-the-seventh-annual-jmp-securities-healthcare-conference/#comments Tue, 10 Jul 2012 13:15:44 +0000 admin http://www.3vbio.com/?p=512

Menlo Park, California, July 10, 2012. 3-­V Biosciences, Inc., announced today that George Kemble, PhD, Chief Scientific Officer, will present at the upcoming JMP Securities Healthcare Conference at the Peninsula Hotel in New York City. Dr. Kemble will provide an overview of 3‐V, including a discussion of both its lead program targeting the fatty acid synthase (FASN) pathway for the treatment of chronic hepatitis C virus (HCV) infection and the company’s discovery platform. Dr. Kemble’s presentation will take place on Friday, July 13 at 12:00pm.

FASN is a cellular enzyme with increased expression following infection with HCV and in several cancers. First‐generation FASN inhibitors have shown preclinical benefits in a variety of viral infections, including HCV, as well as in models of pancreatic, prostatic, breast and colorectal tumors, but their development has been hindered by poor bioavailability and systemic tolerability. 3‐V has discovered and is advancing proprietary FASN inhibitors with pharmaceutical properties that overcome the shortcomings of earlier generations of inhibitors, and have the potential to become potent therapeutics for chronic HCV and other indications.

About 3-­V Biosciences

3-­V Biosciences, Inc. is a privately held biopharmaceutical company that discovers and develops antiviral therapeutics designed to have broad-­spectrum 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 with internal expertise in virology, biology, 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

Stephen R. Brady Chief Business Officer 650‐561‐8600

“The continued support of the company’s investors for the host-factor vision reflects both the success of the team thus far and the potential for this program to play an import role improving the lives of patients with HCV,” said Merdad V. Parsey, MD, PhD, 3-V’s Chief Executive Officer.  “The company’s unique program stands out in its ability to combine with direct-acting antivirals as a potential backbone of HCV therapy.”

3-V closed a Preferred Stock financing providing the company with a minimum of $20 million. Existing investors Kleiner Perkins Caufield & Byers and New Enterprise Associates participated equally in the financing.  3-V plans to use the proceeds to advance the HCV program, earlier-stage pipeline opportunities and the company’s screening platform.

Both the target and proprietary molecules in the novel HCV program are the products of 3-V’s internal screening platform and drug discovery team. The company is developing the program to be the foundation of a next-generation, all-oral, well-tolerated HCV regimen.

About 3-V Biosciences

3-V Biosciences, Inc. is a privately-held biopharmaceutical company dedicated to discovering, developing and ultimately commercializing novel antiviral therapeutics that target host cell factors required for viral infection, thereby avoiding many of the shortcomings of traditional pathogen-directed approaches.  The company is located in Menlo Park, California.

3-V Biosciences, Inc., announced today the appointment of Douglas Buckley, PhD, as Vice President of Biology.  Dr. Buckley brings more than 25 years of experience in the biopharmaceutical industry, and his discoveries and research leadership have resulted in several marketed products and many more in clinical development.

“With our lead antiviral program entering the clinic in the next year, we are committed to building a strong pipeline.  Doug’s extensive experience in target identification and prosecution and his track record of successful early-stage drug development will be instrumental to our continued growth,” said George Kemble, PhD, 3-V’s Chief Scientific Officer.

“I look forward to building upon the early successes of 3-V and developing the next generation of antiviral compounds with this team,” said Dr. Buckley.  “3-V has taken a novel approach to antiviral therapies that are less likely to allow viral resistance to develop.  In addition, this approach opens up the possibility of developing high-value therapeutics in other therapeutic areas, making 3-V a compelling story.”

Dr. Buckley joins 3-V from Exelixis, Inc., where he served most recently as Vice President of Biochemistry.  In that role, he led research and discovery teams responsible for delivering over thirty IND-ready compounds to Exelixis’ internal pipeline and to external partnerships.  Also during his tenure at Exelixis, Dr. Buckley contributed to the New Drug Application filing for cabozantinib (XL 184).   Prior to Exelixis, Dr. Buckley was the Department Head of Protein Chemistry and Process Development at Scios, Inc., where he was responsible for process and assay development for two marketed biotherapeutic products (Fiblast® (trafermin) and NATRECOR® (nesiritide)).  Doug received his AB in Chemistry and Economics from Bowdoin College, his PhD in Endocrinology from the Hormone Research Laboratory at the University of California, San Francisco, and his post-doctoral training in the Molecular Biology Department at Massachusetts General Hospital and the Department of Genetics at Harvard Medical School.  Doug serves on the Astia Life Sciences Board as an advisor to women entrepreneurs starting life sciences companies and as a scientific advisor to Woodside Capital Partners.

About 3-V Biosciences

3-V Biosciences, Inc. is a privately held biopharmaceutical company that discovers and develops antiviral therapeutics designed to have broad-spectrum activity, a high barrier to resistance and efficacy against emergent viral strains.  The 3-V team applies an integrated approach with internal expertise in virology, biology, drug discovery and development to drive programs forward.  The company is located in Menlo Park, California.

“We are very pleased to have George as the newest member of the 3-V senior management team,” said Merdad V. Parsey, MD, PhD, 3-V’s Chief Executive Officer. “George’s extensive experience in drug discovery and development, as well as virology and host cell biology, brings additional strength to the 3-V team and will further our efforts in this novel area.”

Prior to joining 3-V Biosciences, Dr. Kemble was with MedImmune, Inc., a subsidiary of Astra Zeneca PLC, where he most recently served as Senior Vice President of R&D and Head of Research. During his tenure, Dr. Kemble was responsible for the research and development of multiple products, including the successful launch of FluMist®, the first innovation in influenza vaccines in over 60 years. The research organization for which he was responsible included over 700 scientists in Maryland, California and Cambridge, England, with expertise in research biology, lead generation and translational science in the areas of infectious diseases, oncology, inflammatory, respiratory, autoimmune diseases, neuroscience, cardiovascular and gastrointestinal indications. Dr. Kemble began his research career as a staff scientist at Aviron, which was later acquired by MedImmune. Dr. Kemble received a BS from the University of Santa Clara and a PhD from Stanford University and did his post doctoral training at UCSF, where he worked on a number of different human viruses.

“I’m very excited by the important projects we have in front of us,” said Dr. Kemble. “Our approach to combating these pathogens is highly innovative, and I am looking forward to continuing to grow our organization’s expertise at developing these impactful medicines.”

About 3-V Biosciences
3-V Biosciences, Inc. is a privately held biopharmaceutical company dedicated to discovering, developing and ultimately commercializing novel antiviral therapeutics that target host cell factors required for viral infection, thereby avoiding many of the shortcomings of traditional pathogen directed approaches. The company is located in Menlo Park, California and is financed by The Column Group, Kleiner Perkins Caufield & Byers, and New Enterprise Associates. For additional information on 3-V Biosciences, please visit www.3vbio.com.

“Steve’s contributions have been pivotal as a member of the team during his tenure at 3-V,” said Merdad V. Parsey, MD, PhD, 3-V’s Chief Executive Officer. “I look forward to working with him as we continue to build the 3-V team and advance the company’s programs.”

Mr. Brady joined the 3-V team in 2010 as Vice President, Corporate Development, Strategy & Operations, with management responsibility for the company’s business functions, including strategy, finance and legal. Prior to joining the company, Mr. Brady was the Vice President of Corporate Development of Proteolix, Inc. where he had primary responsibility for Proteolix’s business development activities, resulting in the sale of the company to Onyx Pharmaceuticals, Inc. Previously, Mr. Brady served as Senior Corporate Counsel at Lexicon Pharmaceuticals, Inc., where he served in business development, communications and corporate legal capacities. Prior to his tenure with Lexicon Pharmaceuticals, Inc., Mr. Brady was a Vice President with Lazard Venture Advisors, a division of Lazard Freres & Co., LLC, and an associate in the New York and San Francisco offices of Morrison & Foerster LLP. Mr. Brady received a B.A. in English from the University of Oregon and a LL.M. from the New York University School of Law.

About 3-VBiosciences
3-V Biosciences, Inc. is a privately held biopharmaceutical company dedicated to discovering, developing and ultimately commercializing novel therapeutics that target host cell factors required for infection, thereby avoiding many of the shortcomings of traditional pathogen directed approaches. The company is located in Menlo Park, California and is financed by The Column Group, Kleiner Perkins Caufield Byers, and New Enterprise Associates. For additional information on 3-V Biosciences, please visit www.3vbio.com

We are very pleased to have Merdad as the new CEO of 3-V,” said David M. Mott, 3-V’s Executive Chairman, who is returning to his role as Chairman of the Board. “Merdad’s extensive drug development experiences in different therapeutic areas, including infectious disease, coupled with his experience in respiratory medicine, make him an excellent choice to lead the team.”

Prior to joining 3-V Biosciences, Dr. Parsey held positions of increasing responsibility at Genentech, Inc., a member of the Roche Group, most recently as Senior Group Medical Director in Genentech Research and Early Development, overseeing early clinical development in multiple therapeutic areas. Prior to his tenure with Genentech, Dr. Parsey worked at Sepracor, Regeneron and Merck, Inc. He has worked on multiple development and post-marketing programs from initial human trials to NDA/BLA submissions in Respiratory, Inflammation, Virology, Neurology, Ophthalmology and Gastrointestinal diseases. In addition to his work in the biotechnology and pharmaceutical industries, Dr. Parsey was the Director of Critical Care Medicine at the NYU School of Medicine. He completed his MD and PhD at the University of Maryland, his residency in Internal Medicine at Stanford University and his fellowship in Pulmonary and Critical Care Medicine at the University of Colorado.

3-V has the opportunity, via the modulation of host-factor targets, to fundamentally change anti-viral treatment, and the company’s founders, employees, and investors have created an environment to achieve this goal,” said Dr. Parsey. “I am excited to join the 3-V team and help turn this exciting science into therapies that have the potential to improve the lives of patients.”

About 3-V Biosciences
3-V Biosciences, Inc. is a privately-held biopharmaceutical company dedicated to discovering, developing and ultimately commercializing novel antiviral therapeutics that target host cell factors required for viral infection, thereby avoiding many of the shortcomings of traditional pathogen-directed approaches. The company is located in Menlo Park, California and is financed by The Column Group, Kleiner Perkins Caufield Byers, and New Enterprise Associates.

For additional information on 3-V Biosciences, please visit www.3vbio.com.

“We are very pleased to welcome Jim Young to the 3-V Board,” said David M. Mott, 3-V’s Executive Chairman. “Jim’s expertise as a virologist, immunologist, drug developer and company builder make him extraordinarily well suited to assist 3-V in its mission to build the leading host cell factor anti-infective company. Jim has a great nose for science and the experience and wisdom in drug development gained from having been head of R&D at MedImmune for 19 years, from its founding until 2008 following its sale to AstraZeneca for $15.6 billion. Uniquely suited to 3-V’s initial focus, Jim has particular expertise in discovering, developing and commercializing products targeting viruses including influenza, respiratory syncytial virus, human papillomavirus, and cytomegalovirus.”

Most recently, Dr. Young graduated first in his class with a Certificate de Cuisine from Le Cordon Bleu Academie d’Art Culinaire de Paris in Paris, France. He currently serves on the Board of Directors of Novavax, Inc. and on the Board of Trustees of The Phillips Collection Museum of Modern Art in Washington, D.C. Previously, Dr. Young was with MedImmune, Inc. from 1988 through 2008 following its sale to AstraZeneca PLC. During his entire tenure, Dr. Young led MedImmune’s research and development organization and was directly involved in the development of approximately twenty clinical programs and commercialization of Synagis®, RespiGam®, CytoGam®, Flumist®, and Ethyol®. At the time of his retirement from MedImmune, Dr. Young oversaw R&D functions including approximately 1,500 people and an annual budget in excess of -600 million. Prior to MedImmune, Dr. Young was a Director in the Department of Molecular Genetics at Smith Kline and French Laboratories. Dr. Young has served on the Boards of Directors of Xencor, Inc., Iomai, Inc. and Arriva Pharmaceuticals, Inc. He received his Ph.D. in Microbiology and Immunology from Baylor College of Medicine.

Synagis®, RespiGam®, CytoGam®, Flumist®, and Ethyol® are registered trademarks of MedImmune, LLC, an AstraZeneca PLC company.

About 3-V Biosciences
3-V Biosciences, Inc. is privately-held biopharmaceutical company dedicated to discovering and developing novel antiviral therapeutics that target host cell factors required for viral infection, thereby avoiding many of the shortcomings of traditional pathogen-directed approaches. The Company is located in Menlo Park, California and is backed by The Column Group, Kleiner Perkins Caufield Byers, and New Enterprise Associates.

In addition to Dr. Young, 3-V’s Board of Directors includes Ari Helenius, Ph.D., of the ETH Zurich, Gordon Ringold, Ph.D. of University of California Santa Cruz, Richard Klausner, M.D. of The Column Group, Beth Seideberg, M.D. of Kleiner Perkins Caulfield & Byers, and Robert Garland, M.D. and David Mott from New Enterprise Associates.

For additional information on 3-V Biosciences, please visit www.3vbio.com.