BOTHELL, WA and AUSTIN, TX--(Marketwire - December 23, 2011) - Marina Biotech, Inc. (NASDAQ: MRNA), a leading oligonucleotide-based drug discovery and development company, and Mirna Therapeutics, Inc. (Mirna), a privately-held biotechnology company pioneering microRNA (miRNA) replacement therapy for cancer, announced today that they have entered into a license agreement regarding the development and commercialization of microRNA-based therapeutics utilizing Mirna's proprietary microRNAs and Marina Biotech's novel SMARTICLES liposomal delivery technology. Mirna will have full responsibility for the development and commercialization of any products arising under the Agreement and Marina Biotech will support pre-clinical and process development efforts. Under terms of the Agreement, Marina Biotech could receive up to $63 million in total upfront, clinical and commercialization milestone payments, as well as royalties on sales, based on the successful outcome of the collaboration. Further terms of the Agreement were not disclosed.
Marina Biotech, Inc. (Formerly Known as MDRNA, Inc.) and Mirna Therapeutics, Inc. Announce License Agreement for Up to $63 Million for the Development
Nanotechnology firm Liquidia partners with PATH on new pneumonia vaccine
December 13, 2011
North Carolina nanotechnology company Liquidia Technologies is partnering with nonprofit organization PATH to develop a new pneumonia vaccine that could be deployed globally.
Research Triangle Park-based Liquidia is working with PATH to conduct preclinical studies on a “next generation” pneumococcal vaccine that could be more effective than existing vaccines and more efficient to produce. Financial terms of the partnership were not disclosed. But it’s not the first time the two entities have worked together. Liquidia has also partnered with PATH’s Malaria Vaccine Initiative to develop a new malaria vaccine.
Plexxikon Inc. Advances Novel Targeted Treatment PLX3397 in Blood Cancer
Berkeley, CA, December 12, 2011 -- Plexxikon Inc., a member of Daiichi Sankyo Group, today announced scientific findings from preclinical studies showing that treatment with a novel oral agent, PLX3397, selectively inhibited key cancer-driving Flt3 mutations that occur in 20-30 percent of acute myeloid leukemia (AML) patients. In a preclinical model of AML, PLX3397 showed significant tumor regression. This preclinical work also showed that PLX3397 retained activity against certain drug-resistant forms of mutated Flt3 that can occur with other treatments. These scientific findings were presented during the American Society of Hematology (ASH) Conference, taking place December 10-13, 2011 in San Diego (Abstracts #764 and #3632). Plexxikon recently initiated a Phase 1/2 study in AML patients, further described at www.clinicaltrials.gov.
CeNeRx, expecting trial results and drug partner in 2012, raises $4.8M
December 9, 2011
Central nervous system drug development company CeNeRx BioPharma is developing an antidepressant whose novel mechanism causes fewer side effects, and the company is now in active talks with large pharmaceutical companies who could take the candidate, called TriRima, into phase 3 studies.
Finding satisfaction in stratification
CAMBRIDGE, Mass., December 8, 2011 — Selventa, a personalized healthcare company focused on stratification of patients and development of predictive biomarker panels based on disease-driving mechanisms, recently formed a strategic scientific alliance with Linguamatics, a software solutions company that provides knowledge extraction through its I2E natural language processing (NLP) text-mining platform.
The idea is to combine the analytical capabilities of both companies to efficiently extract complex life science knowledge in a computable, structured, biological expression language format that can be used to interpret large-scale experimental data in the context of published literature.
Anthera Pharmaceuticals Completes Interim B-Cell Analysis of PEARL-SC Study
HAYWARD, Calif., Dec. 1, 2011 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced positive interim biomarker data from the PEARL-SC phase 2b clinical study in patients with systemic lupus erythematosus.
After analysis by an independent statistician, data from the on-going PEARL-SC study indicate that weekly and monthly subcutaneous doses of blisibimod resulted in statistically significant reductions of B-cells. Elevations in these B-cells have been associated with an increased risk of disease activity in lupus patients. These findings are consistent with data from previous clinical studies of blisibimod. The company remains blinded to primary efficacy data.
More Big Foundations Are Investing in For-Profits
November 29, 2011
Major foundations are increasingly relying on program-related investing to achieve their goals, putting money into for-profit firms whose work meshes with the donors’ causes, according to The New York Times.
The Bill & Melinda Gates Foundation has increased its pool for such investments, known as PRI’s, from $400-million to $1-billion since 2009, and earlier this year it bought a $10-million stake in Liquidia Technologies, a commercial firm working on vaccine delivery. The Omidyar Network, the David & Lucile Packard Foundation, and other funding entities have also stepped up PRI’s.
FierceBiotech's 2011 Women in Biotech - Plexxikon President and Tesaro Co-founder Honored
November 29, 2011
Female biotech executives have been key players in many of the biggest events in the industry this year--Takeda Pharmaceutical's buyout of Nycomed, the merger of Alkermes ($ALKS) and Elan Drug Technologies and the sale of Plexxikon to Daiichi Sankyo. Should we be surprised? No, women in this industry defy the odds when they rise to key positions in the male-dominated biotech game. Of course we're seeing them accomplish big things. But they deserve recognition.
So, we're excited to bring our readers FierceBiotech's much-awaited-and belated-Women in Biotech feature. We had an overwhelming response to our call for nominations this year, with more than 130 great submissions and an amazing slate of candidates. True to our mission of providing readers the top news in biotech, many of the honorees here are women who drove some of the big stories we covered this year. We also wanted the women featured this year to represent the best of the global biotech industry, and you'll find women here who are making an impact for organizations based in Asia, Europe and here in the U.S.These women are inspiring, not just to women, but (at least speaking for the males on our team) men involved in the industry, too. Our profiles will bring you up to date with what each of these female movers in biotech are working on these days. Some are rallying scientists at young startups, gearing up for important late-stage trials or leading research of serious health concerns such as HIV. For each of the honorees, there are unique stories about how impressive women have gotten ahead in the competitive biotech field."
I think that the potential interesting little extra that you get from speaking to some of the women in biotech is we've probably been challenged with thinking a little bit more about how to cultivate our careers," said Abbie Celniker, chief executive of Eleven Biotherapeutics and one of this year's Women in Biotech. "As a result, we can be a tiny bit more self-reflective because we've had to do lots of course correction to make sure we could compete in the days when it was more predominately male."
Kathleen Sereda Glaub
President, Plexxikon
In the biotech business and at her home garden, Kathy Glaub likes to plant seeds and watch them grow. Of course, the seeds of biotech involve investments in R&D and carefully crafted financing strategies. In those regards, there's been a bumper crop this year at the drug discovery firm Plexxikon, and Glaub has been able to savor the fruits of her 10 years spent helping to shape the business strategy and firming up lucrative partnership deals.
Mary Lynne Hedley
President, CSO, Co-founder, Tesaro
Mary Lynne Hedley's latest biotech adventure has her exploring multiple paths to find and develop new therapies and supportive care drugs for cancer patients. Hedley, the president and chief scientist at Lexington, MA-based Tesaro, is now leading the company's excursion to gain FDA approval of its lead compound, rolapitant, which aims to prevent nausea and vomiting from chemotherapy and is ready for late-stage trials. At the same time, she's responsible for hunting for other drugs for cancer patients that fit the company's in-licensing strategy.
Personalized medicine’s opportunities and challenges for clinicians, business
Perhaps the biggest personalized medicine breakthrough of 2011 was the progress of melanoma drug Zelboraf and its companion diagnostic, both of which sped through regulatory approval.
Clinical trials demonstrated that Roche‘s (OTC:RHHBY) Zelboraf was extremely effective in treating skin cancer. But the drug doesn’t work for everyone. Only patients whose tumors express a particular gene mutation respond to the drug. The companion diagnostic also developed by Roche identifies the appropriate patients for Zelboraf. Under priority review by the U.S. Food and Drug Administration, approval of that diagnostic was expected this November. The agency beat that target by nearly three months.
Not all personalized medicine drugs and diagnostics will have such a speedy path through the FDA. But the companies, academics and investors who have a stake in personalized medicine are working to smooth the path for future personalized medicine breakthroughs.
The Personalized Medicine Coalition has released a report “The Case for Personalized Medicine,” choosing Research Triangle Park, North Carolina, where the group has a large cluster of members, to formally announce the document. In addition to supporting personalized medicine education and innovation, the group is also pushing for new legislation that would go further than the Genomics and Personalized Medicine Act of 2007. Among the group’s goals are forging a more predictable regulatory path for personalized medicine products and getting Medicare coverage of personalized medicine diagnostics. PMC President Edward Abrahams discusses some of the group’s legislative goals here.
The coalition hosted a panel discussion at the North Carolina Biotechnology Center on the opportunities and challenges facing personalized medicine. Here are some highlights.
Personalized medicine’s promise: In the last quarter, Burlington, North Carolina laboratory services and diagnostics company LabCorp (NYSE:LH) has released two personalized medicine tests, one of them a companion diagnostic for Zelboraf. The other, an Abbott companion diagnostic for lung cancer patients, predicts patient response to the Pfizer (NYSE:PFE) drug Xalkori. LabCorp CEO David King said that at one time, personalized medicine was thought of primarily in terms of reproductive testing such as pre-natal and neo-natal testing. But the technology today has come far and it promises to go even further.
Dr. Amy Abernethy, director of the Duke Cancer Care Research Program, sees many of those tools in the clinic. The kinds of tests that are available for her to use to make diagnostic and treatment decisions are vast and they grow each year. “The way we’ve practiced medicine in the clinic has rocketed forward in the last decade,” Abernethy said.
The challenges: While Abernethy embraces the new diagnostic tools, she said she’s not sure when a new test will show up in an electronic system with a reimbursement code. Jonathan Roy, director of commercial diagnostics for GlaxoSmithKline Biologicals (NYSE:GSK), offered a different perspective on reimbursement. In the United States, a company might get reimbursed, but not at a level they’d like. “In the European market, you might not get reimbursed at all,” he said. Roy said the global regulatory environment is wildly inconsistent from one market to another. But in finding partners for companion diagnostics, GSK must think globally because its goal is to make a test and a treatment available to the largest number of people. LabCorp’s King also sees regulatory as well as cost challenges for companion diagnostics. But as these tests become more common, he also sees challenges for clinicians. Personalized medicine will mean the generation of an enormous amount of data and it will be a challenge to process it and manage it. King likened the challenge to standing on the beach staring at an approaching 60 foot tidal wave. “And there will be one every minute,” he said.
Solutions. There is no shortage of companies angling for financial backing of new therapies and diagnostics in personalized medicine. Durham venture capital firm Pappas Ventures, which focuses on life science investments exclusively, receives more than 1,000 proposals a year. The firm has made several investments in companies developing personalized medicine products. One of them, California biotechnology company Plexxikon, developed the drug that is now Zelboraf. Plexxikon was acquired by Japanese pharma company Daiichi Sankyo earlier this year in a deal valued at more than $935 million. Pappas Ventures saw a return greater than 10 times its original investment in the firm.
Pappas Ventures Managing Partner Eric Linsley said he’s an optimist who believes in personalized medicine. But he added that he’s paid by the firm’s limited partners to be a skeptic. Linsley said he believes solutions will come from innovation. But for that to happen, the FDA must encourage that innovation and payers must modernize how they reimburse new technologies.
CardioDx Passes Trial, Determining When Chest Pain Is No Big Deal
November 15, 2011
Chest pain is one of the big reasons people go to the ER or to see their primary care doc. Often when people get there, it’s hard to tell who has serious heart disease or something less serious. Now Palo Alto, CA-based CardioDx is presenting study results that say its new blood test, in certain situations, can help doctors tell the difference.
CardioDx said today that its test, called Corus CAD, was more effective than standard imaging techniques in a study of 537 patients. The study found that the gene expression test, which relies on a blood sample, was better than standard myocardial perfusion imaging (MPI) at ruling out the patients who don’t have coronary artery disease. The results, from a study called Compass, are being presented today at the American Heart Association’s scientific sessions in Orlando, FL.
