MBC Pharma announced that it received a $1,795,054 SBIR grant from the NIH. The two year grant will be used to expand the company’s pipeline of bone-targeted chemotherapeutics for the treatment of cancer induced bone disease. The grant money will be used to demonstrate if a new platform technology can produce effective compounds for cancer induced bone disease. Efficacy of the compounds, conjugates of agents with known activity against prostate cancer, will be tested in several animal models. MBC Pharma, based in Aurora, Colorado, is a pre-clinical stage company that plans to submit is first IND application to the FDA to begin trials in humans in the first quarter of 2011.
CBSA’s July Biobreakfast featured a panel discussion from three Colorado bioscience legends. The panel, moderated by new CBSA CEO Holli Baumunk, discussed a wide variety of issues including past mistakes and successes and recommendations to those in early stage companies. The panelists were:
- Dr. William Freytag who was Chairman and CEO of Myogen when it was acquired by Gilead.
- Dr. Larry Gold who is CEO and Chairman at SomaLogic and has found two other companies including NeXstar, which merged with Gilead
- Patrick Mahaffy who is CEO of Clovis Oncology and previously served in the same role at Pharmion (sold to Celgene) and NeXstar
All panelists agreed that successful companies are founded on great science and that ideas should be thoroughly tested and thought through before setting down a particular path. Gold acknowledged that it is “really hard [for scientists] to give up on ideas” that they believe in and have put much effort into. He also said that it takes the right person to really evaluate “the difference between strong and week science” upfront. Freytag noted a common mistake as “breaking the fundamental tenant of science – not believing the data.” Mahaffy cited several instances where companies should have given up on a compound after Phase I testing but instead pushed on to Phase II despite a questionable rationale for doing so.
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Yesterday, the Boettcher Foundation presented grants to the inaugural class of the Webb-Waring Biomedical research program. The six investigators from Colorado institutions will receive between $200,000 and $300,000 each spread over the next three years to support their research efforts. According to Governor Bill Ritter, who was on hand to announce these awards represent “the Boettcher Foundation’s newest endeavor to improve quality of life in Colorado and around the country.”
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Biodesix announced recently that the United States Patent and Trademark Office (USPTO) has awarded to the company patent number 7,736,905. The patent relates to the company’s first product Veristrat, which is used to identify non-small cell lung cancer patients likely to respond to therapy with erlotinib (Tarceva). Specifically, the patent is for the serum based identification of patients likely to benefit from epidermal growth factor targeted therapy. Instead of focusing on a single biomarker as many diagnostics do, Veristrat evaluates expected response based on many biomarkers measured via mass spectrometry and evaluated with proprietary algorithms. The patent additionally covers key aspects of the company’s ProTS platform, which has the potential to apply the same methods used in Veristrat to other types of medications and disease states. Biodesix is based in Broomfield, Colorado. RockyRadar recently reported on the company when Paul Beresford, the VP of business development, presented at a CBSA event.
CBSA’s May BioBreakfast allowed two of Colorado’s 2009 Bioscience success stories to share their stories. First up was Paul Beresford of Biodesix, a company playing in the diagnostic space. Instead of focusing on evaluating a single analyte to diagnose disease, Biodesix seeks to predict treatment response through the evaluation of many analytes run through an algorithm. The company’s ProTS platform uses mass spectrometry. The first test developed from this platform, VeriStrat was launched in May of 2009. Veristrat helps to identify patients expected to have more favorable outcomes from second line treatment on lung cancer with erlotinib (Tarceva). The test, which is run in Biodesix’ CLIA certified lab in Aurora, requires only a blood sample and not a tumor sample. The company is working to simplify sample collection even further such that blood can be spotted directly on a card for shipment to the lab. Biodesix also continues to strengthen its data package and is currently conducting a prospective study in Italy to supplement the information from previous retrospective studies. Beresford commented on the need to build a sales force to communicate with oncologists that looks more like that of a pharmaceutical company than that of a traditional diagnostic company. Along with commercializing Veristrat, Biodesix continues to develop additional tests from its platform independently and as companion diagnostics.
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HepQuant LLC and The University of Colorado have completed a licensing agreement that allows HepQuant to continue development of a CU diagnostic technology for evaluating liver disease. The Colorado-based company originally licensed the technology in 2008 when it also received a $100,000 seed grant from the CU Technology Transfer Office. The underlying technology for the diagnostic was invented by Gregory Everson, Professor and Director of Hepatology at the UC Denver School of Medicine. The first product in development based on this technology is HepQuant-Dual, which is a non-invasive test to measure the liver’s portal circulation using natural compounds labeled with stable isotopes. Information on portal circulation will help physicians detect liver disease and assess its severity and the risk of future complications. The company expects to begin clinical trials of its first product late this year.
CBSA’s BioBreakfast on Wednesday discussed the FDA approval process from a Medical Device Perspective. The panel discussion focused on the changing rules and attitudes that could affect medical device approval moving forward. Panelists at the event were:
- Mark Holmes, CaridianBCT, VP of Regulatory and Government Affairs
- Keith Martin, Medtronic Navigation, Senior Director Quality Systems and Regulatory Affairs
- Deborah Arthur, Cochlear Americas, Vice-President Regulatory and Quality
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The Colorado Institute for Drug, Device and Diagnostic Development (CID4) announced its official launch yesterday. The goal of CID4, a not-for-profit entity formed in 2009, is to bridge the gap between basic research, which is usually grant funded, and product commercialization in the life science industry. CID4 was formed through a collaboration of much of Colorado’s bioscience community including CU, CSU, the Colorado Bioscience Association, and the Fitzsimons Redevelopment Authority. The institute is currently soliciting proposals from Colorado based life science companies in need of funding and active management. The institute hopes to support three to four companies each year. First round proposals are due February 15.
CBSA held its second annual day at the Capitol, which featured brief remarks from several state legislators affirming their support for the industry along with a presentation from Patrick Kelly of BIO and a panel discussion on state legislative priorities.
Kelly rehashed some points from last year’s presentation on the key state attributes to create a strong bioscience industry and then focused on the possibilities for healthcare reform. Kelly first focused on some key factors that were included in the reform bill likely to be passed up until the election of Senator Brown from Massachusetts. Among the points that were generally favorable to the bioscience industry were the establishment of an approval path for follow-on biologics following a 12 year exclusivity period, Medicare Part D donut hole coverage, and a tax credit for small companies that brought a human therapeutic to market. Other key measures included an excise tax of drug manufacturers, a “sunshine provision” for information transparency, and comparative effectiveness provisions. To the final point, Kelly noted concern that this type of regulation could turn into cost-effectiveness analysis.
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AmideBio, LLC announced that it has closed a round of seed funding. The source and the amount of funding were not disclosed by the company. The proceeds of the round will be used to complete initial product optimization using its recombinant hydrid manufacturing technology. AmideBio has an exclusive license, announced two week ago, with CU to commercialize a method to manufacture recombinant proteins and peptides developed by Associate Professor Michael Stowell, who also serves as the Chief Scientific Officer for AmideBio. The new manufacturing technique has the potential both to reduce costs and to make it feasible to manufacture drugs that were difficult to produce with conventional methods. AmideBio is based in Boulder, Colorado.
