Oncology Preclinical Data News: Calithera Biosciences' Anti-Cancer Therapeutic Candidate

Calithera Biosciences to Present Data at the 55th American Society for Hematology Annual Meeting and the 2013 San Antonio Breast Cancer Symposium

Preclinical Results for CB-839 Demonstrate Anti-Tumor Activity in Hematologic Malignancies and Triple-Negative Breast Cancer

Full Press Release Follows.

SOURCE Calithera Biosciences

SOUTH SAN FRANCISCO, Calif. , Nov. 26, 2013 /PRNewswire/ -- Calithera Biosciences, a biotechnology company focused on the development of novel cancer therapeutics, today announced the presentation of preclinical data for its lead anti-cancer therapeutic candidate, CB-839, at two upcoming scientific conferences.  CB-839 is a potent and selective orally bioavailable glutaminase inhibitor that blocks the growth and survival of many different types of cancer cells by interfering with their metabolism of glutamine.   Calithera plans to advance CB-839 into Phase 1 clinical trials in patients with advanced solid and hematological tumors in early 2014.   At the 55th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, being held December 7-10, 2013, Calithera will present data from in vitro and in vivo studies evaluating CB-839 against diverse hematologic malignancies. •   Poster Presentation: Antitumor Activity of the Glutaminase Inhibitor CB-839 in Hematological Malignancies •   Monday, December 9, 2013, 6:00 pm - 8:00 pm •   Session 802: Chemical Biology and Experimental Therapeutics •   Abstract #4226 During the 2013 San Antonio Breast Cancer Symposium, being held December 10-14, 2013, Calithera will present in vitro and in vivo data on the anti-tumor activity of CB-839 in triple-negative breast cancer models. •   Poster Presentation: Antitumor Activity of the Glutaminase Inhibitor, CB-839, in Triple-Negative Breast Cancer •   Thursday, December 12, 2013, 7:30 am – 9:00 am •   Poster Session 2: Tumor Cell and Molecular biology •   Abstract # P2-09-03 "The presentations at ASH and the SABC Symposium will allow us to share the promising preclinical evidence of antitumor activity for CB-839 in both liquid and solid tumor types where glutaminase expression is believed to be a driver of tumor growth," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera Biosciences.  "Based on these results, we are looking forward to initiating clinical studies for CB-839 early next year." About Calithera Biosciences Calithera is discovering and developing novel small molecule oncology therapeutics that inhibit pathways critical to tumor growth and survival.  The Calithera team has the experience and the ability needed to discover novel therapeutics and advance these discoveries through clinical development.  The company is applying this expertise to build a pipeline of anti-cancer compounds that are distinct from other oncology therapeutics.  Calithera's lead clinical candidate, CB-839, blocks glutaminase, an enzyme critical to tumor metabolism, and is poised to enter Phase 1 clinical testing.  Calithera Biosciences is a privately held company located in South San Francisco, CA.  For more information, please visit www.calithera.com . SOURCE Calithera Biosciences CONTACT: Susan M. Molineaux, PhD, President and CEO, Calithera Biosciences, info@calithera.com, BCC Partners, Karen L. Bergman or, Michelle Corral, 650.575.1509, 415.794.8662 Web Site: http://www.calithera.com

Coal for Christmas: Americans Say Cable TV Holiday Ads Impacts Their Shopping—But Most Admit They Would Like to See More Scrooge-Like Themes in Ads

Coal for Christmas: Americans Say Cable TV Holiday Ads Impacts Their Shopping—But Most Admit They Would Like to See More Scrooge-Like Themes in Ads, New Viamedia Study Finds. Americans ranked their favorite Scroogey scenarios—from naughty kids getting coal to ditching the in-laws.

Full Article Appears Below

SOURCE: Daily Dog, Bulldog Reporter, www.bulldogreporter.com

November 25, 2013 -- Viamedia, a cable industry-focused independent cable rep firm and provider of online advertising services, recently announced its 2013 Holiday Cable Advertising Study, which determined how advertisements on cable TV networks impacts the 89% of Americans who watch cable TV programming. The study examined the positive qualities that make holiday advertisements on cable TV networks most memorable and finally asked what "Scrooge-like" themes, if any, Americans would like to see in holiday advertisements.

A majority of Americans (54%) admitted advertisements on cable TV networks (e.g., ESPN, Lifetime, TNT, A&E, History Channel, CNN) impact their holiday shopping. The demographics most affected were students (75%), men 18–34 (66%) and women (69%) 18–34. The reasons included:  

•   38%—informs me about sales (which was particularly important to 60% students)

•   25%—gives me ideas on what to buy for hard to buy people

•   21%—prompts me to consider shopping at that store or buy products at that store

•   19%—makes me realize how many shopping days are left

•   15%—makes me realize what’s hot

•   8%—makes me shop for myself

An overwhelming majority of Americans (72%) agreed positive qualities make a holiday advertisement on cable TV networks most memorable—especially 82% of households with children. However when it came to what exactly Americans thought of as memorable, Americans were hard-pressed to agree with the number one choice being emotional appeal—with just 18% of Americans naming that trait. Emotional appeal was followed by portrayal of the family with 14%.  Only 13% of households with children said portrayal of family was important.  That was followed by holiday tie-in (14%), feature people like me (8%), play on words like “happy Holidays” (6%) and inclusion of veterans (5%).

A majority Americans (59%) admitted they wanted to see "Scrooge-like" themes in holiday advertisements on cable TV networks—which was especially popular with men (77%) 18-34 and women (75%) 18-34. Americans ranked their favorite Scroogey scenarios—from naughty kids getting coal to ditching the in-laws:

•   27%—how do you react to a present you don’t like

•   25%—the best way to return a bad gift

•   21%—the right way to re-gift

•   19%—naughty kids getting coal for Christmas (24% of households with children said yes – 17% said no)

•   16%—how to shop for people I don’t like

•   14%—what to do with carolers who can’t sing

•   14%—how to shop for myself guilt free

•   13%—how kids can be annoying

•   12%—how to ditch the in-laws

“Viamedia’s 2013 Holiday Cable Advertising Study proves how cable TV advertisements play a key role in how we celebrate the season,” said Becky Jones, vice president marketing and research at Viamedia, in a news release. “Cable TV advertising impacts a majority of Americans—giving gifts ideas and even alerting them to how many shopping days we have left. It’s a good feeling to know that consumers find holiday ads on cable TV to be a meaningful part of their holiday experience. And, just like with the cable TV programs themselves, their opinions of what makes a commercial’s magic ingredient are as broad as their own imaginations.

“We found it surprising that while Americans can’t agree on the magic ingredient that makes a good holiday commercial, they can agree on wanting to see Scrooge-like themes in advertisements.”

Oncology Clinical Trial News: Phase Ib clinical trial for new cancer therapy for solid tumors

A first-of-its-kind Phase Ib clinical trial -- with Weill Cornell Medical College, Palo Alto Medical Foundation, and MD Anderson Cancer Center -- will study Berg's investigational compound, BPM 31510 (IV Continuous Infusion), as a new cancer therapy for solid tumors. Unlike other clinical trials, this is the first program to focus on the metabolism, or processes, of cancer rather than a specific mutation or target. Full press release follows. SOURCE: Berg Berg Launches First-Ever Stratified Medicine Clinical Trial To Investigate Cancer Metabolism Of Solid Tumors -- Patients at Cornell, the Palo Alto Medical Foundation, MD Anderson Participate in First Clinical Program to Comprehensively Use Artificial Intelligence -- FRAMINGHAM, Mass., Nov. 21, 2013 /PRNewswire/ -- Berg, a biopharmaceutical company committed to uncovering health solutions through a data-driven, biological research approach, today announced  a first-of-its-kind Phase Ib clinical trial with Weill Cornell Medical College, Palo Alto Medical Foundation, and MD Anderson Cancer Center to study its investigational compound, BPM 31510 (IV Continuous Infusion), as a new cancer therapy for solid tumors. "Unlike other clinical trials, this is the first program to focus on the metabolism, or processes, of cancer rather than a specific mutation or target," said Niven R. Narain, Co-Founder, President and CTO of Berg. "By using big data analytics, we're also able to identify the right type of patients who will respond to the BPM 31510 treatment. Stratifying patients by phenotype is the future of medicine and we want to boldly develop a cancer treatment using this approach" Peter Yu, MD, Director of Cancer Research at Palo Alto Medical Foundation and incoming president of The American Society of Clinical Oncology (ASCO), will serve as a primary investigator on this trial together with Ralph Zinner, MD at MD Anderson and lead PI, Manish Shah, MD at Weill Cornell Medical College, which is expected to enroll between 300 - 400 oncology patients affected by solid tumors, including those with highly aggressive cancers like pancreatic, triple-negative breast, liver or brain. BPM 31510 targets the cellular machinery that governs metabolism of cancer cells to alter those cells to behave like normal, healthy cells. The treatment is the first in Berg's pipeline endogenously occurring candidates discovered and developed by the Berg Interrogative BiologyTM platform, an artificial intelligence-based system that uses network biology methodologies to study biological systems. Through Berg's proprietary Interrogative Biology™ Drug Discovery Platform, this clinical program will establish each patient's molecular and metabolic fingerprint by analyzing multi-omic tissue samples (blood, urine, bone marrow, etc) in real time. This step will allow trial investigators to understand how patients' cells are responding to the treatment to assess the unique characteristics in patients who are responding to the therapy or combinations with BPM 31510.  One very interesting arm of the trial will also assess the effect of "mitochondrial priming" where BPM 31510 will be given for 1 cycle followed by chemotherapy to assess for increased efficacy and potential reduction in chemo-induced side effects. "It is both a privilege and honor to work with Berg - a forward thinking broad reaching company that is interested in truly moving the bar in medicine in a comprehensive and revolutionary way," said Dr. Manish A. Shah, Associate Professor of Medicine at the Weill Cornell Medical College of Cornell University.  "The goal of this comprehensive and unprecedented evaluation of clinical data, molecular profiles, and patient characteristics - a virtual clinical 'big data' evaluation - is to develop safer, more effective drugs in half the time. Drug development is an arduous process, but with Berg as a partner, it feels like we are on the fast track." More information about the clinical trials evaluating BPM 31510 also can be found at www.ClinicalTrials.gov. About BPM 31510 Berg's lead molecular candidate, BPM 31510, is a proprietary formulation of ubidecarenone, an endogenous small molecule responsible for generating cell energy. Preclinical trials indicate that BPM 31510 normalizes the BCL2 protein, which is a key feature in the regulation of cell death and is over-expressed in 60-70% of tumors. BPM 31510 is being investigated in clinical trials as both a monotherapy and in combination with chemotherapies like gemcitabine, 5FU and docetaxel for its potential to treat numerous cancers, including squamous cell carcinoma and solid tumors.  About the Berg Interrogative Biology™ Platform Berg's application of machine-learning (Artificial Intelligence) in biology and medicine allows for a combination of systems biology and systems engineering leading to well defined answers on human health. The Berg Interrogative Biology™ platform integrates molecular data directly from a patient with clinical and demographic information to learn predictive patterns. The platform has the potential to provide the physician with actionable information to recommend efficient and safe treatment pathways, insurance companies with health economics analyses to develop more relevant formulary and governments with a data ecosystem for financial modeling of healthcare needs of the population. Using the Interrogative Biology platform, the company has successfully harnessed the ability of its lead oncology candidate, BPM 31510, in development with gemcitabine, to create an anti-cancer effect. Phase 1 and 2 clinical trials of a topical formulation of BPM 31510 for the treatment of skin cancers have completed, as has a Phase 1 dose escalation clinical trial of an intravenous formulation of BPM 31510 for the treatment of solid tumors. About Berg                            Berg, the namesake of Carl Berg, is a biopharmaceutical company and parent company to Berg Pharma, Berg Biosystems and Berg Diagnostics. Our research focus seeks to understand how alterations in metabolism relate to disease onset. We have uncovered key insight into metabolic control factors and namely into underlying elements in the Warburg Hypothesis. The company has a deep pipeline of early-stage technologies in CNS diseases and metabolic diseases that complement its late-stage clinical trial activity in cancer and prevention of chemotoxicity. Armed with use of the discovery platform that translates biological output into viable therapeutics and a robust biomarker library, Berg is poised to realize its pursuit of a healthier tomorrow. For additional information, visit http://www.bergpharma.com/. Media Contact: Alisha Tischler Ogilvy Public Relations 212-880-5218 alisha.tischler@ogilvy.com Investor Contact: Tom Smith Ogilvy Public Relations 212-880-5269 tom.smith@ogilvy.com SOURCE Berg Web Site: http://www.bergpharma.com