Theses assays could be used in clinical reference labs and also in evaluation of candidate therapeutics in development at Pharmaceutical and Biotechnology…
From Becton Dickinson – 27 May 2015 13:04:56 GMT
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Halozyme, Ventana Enter Into Global Agreement To Collaboratively Develop Companion Diagnostic For Cancer Treatment
SAN DIEGO, May 27, 2015 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) and Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, announced today a global agreement to collaborate on the development of, and for Ventana to ultimately commercialize, a companion diagnostic assay for use with Halozyme’s investigational new drug, PEGPH20.
The Ventana assay will be used to identify high levels of hyaluronan (HA). HA is a glycosaminoglycan – a chain of natural sugars distributed throughout human tissue – that can accumulate around cancer cells. Halozyme has announced plans for rollout of a global phase 3 clinical study in 2016 targeting metastatic pancreatic cancer patients with high HA levels using its PEGPH20 in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine.
Under the agreement, Ventana will develop an in vitro diagnostic (IVD), under design control, using Halozyme’s proprietary HA binding protein, with the intent of submitting it for regulatory approval in the United States, Europe and other countries.
“Ventana brings a high level of development, regulatory and commercial expertise to our companion diagnostic strategy, which will help ensure we are well prepared for the initiation of our phase 3 study in pancreatic cancer,” said Dr. Helen Torley, president and CEO of Halozyme. “The agreement is an important milestone in our PEGPH20 program as we study the potential of PEGPH20 across multiple tumor types.”
“We are pleased to enter into this master collaboration agreement with Halozyme, which may produce the first diagnostic to target tumor-associated HA and possibly the first companion diagnostic assay in pancreatic cancer,” said Doug Ward, Vice President, Ventana Companion Diagnostics. “The PEGPH20 program, coupled with our global reach, has the potential to improve the standard of care in pancreatic cancer for patients around the world.”
The financial terms of the agreement were not disclosed.
This pharma collaboration is one of many at Ventana, where the Companion Diagnostics team is developing patient stratifying diagnostic tools that can help identify those individuals who are most likely to benefit from specific treatments.
Companion diagnostics (CDx) are tests designed to confirm the presence of a specific biomarker to assist physicians in selecting effective therapies for their patients, based on the individual characteristics of each person. Incorporating a companion diagnostic strategy into a drug development program may expedite the drug approval process and help generate more effective treatments with improved safety profiles for patients.
About Ventana Medical Systems, Inc.
Ventana Medical Systems, Inc. (“VMSI”) (SIX: RO, ROG; OTCQX: RHHBY), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. VENTANA products are used in clinical histology and drug development research laboratories worldwide. The company’s intuitive, integrated staining, workflow management platforms, and digital pathology solutions optimize laboratory efficiencies to help reduce errors, support diagnosis and enable informed treatment decisions by anatomic pathology professionals. Together with Roche, VMSI is driving Personalized Healthcare through accelerated drug discovery and the development of companion diagnostics to identify the patients most likely to respond favorably to specific therapies.
Visit www.ventana.com to learn more.
PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the systemic treatment of tumors that accumulate hyaluronan.
The FDA granted orphan drug designation to PEGPH20 for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.
Clinical trials are currently ongoing for development of PEGPH20 in pancreatic ductal adenocarcinoma and in non-small cell lung cancer. More information may be found at: http://oncologytrials.halozyme.com/
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme’s lead proprietary program, our investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor. PEGPH20 is currently in development for metastatic pancreatic cancer and non-small cell lung cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Pfizer, Janssen and Baxter for its drug delivery platform, ENHANZE™, which enables biologics and small molecule compounds that are currently administered intravenously to be delivered subcutaneously. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the possible activity, benefits and attributes of PEGPH20, the possible method of action of PEGPH20, its potential application to improve cancer therapies and statements concerning future actions relating to the development of PEGPH20) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 11, 2015.
Ventana Medical Systems
VMSI Media Relations
Vice President, Marketing &
Hyaluronic Acid expressed in pancreatic cancer tissue at 40x magnification
SOURCE Halozyme Therapeutics, Inc.; Ventana Medical Systems, Inc.
Company Adds Broad Financial, Operating and Business Experience with Bob Goeltz as Chief Financial Officer and Cynthia Ladd as Senior Vice President, General Counsel
SOUTH SAN FRANCISCO, Calif., May 27, 2015 /PRNewswire/ – CytomX, a biotechnology company developing Probody™ therapeutics for the treatment of cancer, today announced the appointments of Bob Goeltz as chief financial officer and Cynthia Ladd as senior vice president and general counsel. Prior to joining CytomX, Goeltz was chief financial officer of Onyx Pharmaceuticals, an Amgen subsidiary. Ms. Ladd previously served as an independent consultant and legal counsel to several leading biotech companies, including CytomX.
“CytomX continues to execute towards building a long-term, multi-product company, and I am thrilled to be further strengthening our senior team with the additions of Bob and Cynthia,” said Sean McCarthy, D.Phil, chief executive officer of CytomX. “Bob brings broad-based financial and operating experience to guide our future financing activities as we focus on long term value creation. Cynthia has been a trusted business advisor to the company through its growth and now will join us in a permanent position.”
During his 11 year tenure at Amgen, Mr. Goeltz held numerous positions in finance. He played an integral role in Amgen’s $10.4 billion acquisition of Onyx and worked with leadership to deliver financial performance across multiple oncology therapeutics, including recently launched Blincyto™. Earlier in his career, he served as director of finance for Tularik. In this position, he supported the raise of more than $100 million in follow-on offerings. Mr. Goeltz began his career as an audit manager for Ernst & Young where he supported a number of initial public offerings. He received his master’s in business administration from the University of California Los Angeles’ Anderson School of Management and his bachelor’s degree from Emory University’s Goizueta Business School.
Ms. Ladd most recently was an independent consultant to biotechnology companies, supporting corporate growth by advising on corporate strategy, negotiations around collaborations, and clinical and regulatory issues, as well as acting as general counsel. Before this, she was president and chief executive officer of AGY Therapeutics. During her tenure, she guided the company through a successful venture round and its transition to a clinical organization. Ms. Ladd previously served as senior vice president and general counsel at Pharmacyclics. In this role, she led various operating groups, including Regulatory Affairs, advised on corporate governance and compliance matters, structured negotiations for business development activities and led all of the legal activities at the company, including those related to the company’s intellectual property portfolio. Earlier in her career, Ms. Ladd held a number of positions at Genentech, including vice president of corporate law and chief corporate counsel. She began her career as an associate with Wilson, Sonsini, Goodrich & Rosati and Ware & Freidenrich (now DLA Piper). Ms. Ladd received her law degree from Stanford Law School, a master’s degree in animal nutrition and biochemistry from Cornell University and a bachelor’s degree in animal science from Pennsylvania State University.
About CytomX Therapeutics
CytomX Therapeutics develops Probody™ therapeutics for the treatment of cancer. Probodies are masked antibodies that remain inert in healthy tissue but are activated specifically in the disease microenvironment. The Probody approach is designed to blunt systemic toxicities associated with antibodies and expand the therapeutic window of these drugs, unlocking new therapeutic targets. The Company is initially focusing this highly innovative platform to discover and develop new immunotherapy and antibody drug conjugate therapies to treat areas of major unmet medical need in oncology. CytomX has attracted multiple strategic collaborations with industry-leading pharmaceutical companies including Pfizer Inc., ImmunoGen and Bristol-Myers Squibb. CytomX is led by a seasoned and proven management team and is financed by leading life science investors, including Third Rock Ventures, Canaan Partners, Roche Venture Fund and Pfizer Venture Investments. For more information, please visit www.cytomx.com.
SOURCE CytomX Therapeutics
Share, document and deliver user training as directed.. A growing biotech company in North County, San Diego is seeking a Helpdesk Specialist to join their…
From San Diego Pro Staffing – 27 May 2015 08:29:42 GMT
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Karthik Bodhinathan, Ph.D., is a 2014 Fishman Fund Awardee, who recently was featured in the March 2015 Portal’s Next Generation of Science profile.
A growing biotech company in North County, San Diego is seeking a Helpdesk Specialist to join their growing team. This position would be responsible for coordinating
Provides scientific input and oversees the design and execution of experiments, interpretation of primary experimental….
From Epic Sciences – 27 May 2015 06:00:38 GMT
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CA-Aliso Viejo, CyberCoders Matching Great People with Great Companies Learn more about CyberCoders PHP Developer Aliso Viejo, CA Full-Time $70,000 – $100,000 Apply Apply PHP Developer Aliso Viejo, CA Full-Time $70,000 – $100,000 Apply Job Details If y…
Our customers include a broad range of academic, government, pharmaceutical, biotechnology, and other leading institutions around the globe. All About Us….
From Illumina, Inc. – 27 May 2015 02:45:09 GMT
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Our customers include a broad range of academic, government, pharmaceutical, biotechnology, and other leading institutions around the globe….
From Illumina, Inc. – 27 May 2015 02:44:58 GMT
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