The second Rocky Mountain Life Science Investor and Partnering Conference brought together a diverse group of 31 companies and investors at the Brown Palace hotel on Friday. The program included discussion of the Barbara Davis Center for Childhood Diabetes and The Center for Regenerative Medicine and Stem Cell Biology at the University of Colorado along with a lunchtime presentation from Roy Davis of Johnson & Johnson, who urged new companies to stay focused on value creation. The focus of the day, however, was on the presenting companies who each presented for 15 minutes and answered 10 minutes of questions. The companies, 23 of whom hailed from Colorado, spanned the life science spectrum including drugs, devices and diagnostics. The companies also represented a wide variety of stages of development from companies with currently marketed to products to those just getting of the ground.
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Sophono announced that it has received FDA clearance for its implantable Otomag Alpha 1(M) Bone Conduction Hearing System. The Alpha 1(M) can treat several hearing disorders including conductive and mixed hearing loss, as well as single sided deafness. The offers distinct advantages from current implanted bone conduction hearing devices that require an abutment (a titanium screw sticking out of the side of the head). The use of an abutment also necessitates permanent hair removal and the daily hygiene routines. The Alpha 1(M) instead uses magnetic coupling between internal (implanted) and external magnets to secure the device. The device is approved for use in adults and children as young as 5. Sophono, based in Boulder, Colorado, received startup funding from the Colorado Institute for Drug, Device and Diagnostic Development.
The Boettcher Foundation announced its second class of investigators in the Webb-Waring Biomedical Research Program. This program provides grants of between $200,000 and $300,000 to assist early-career investigators (ECIs) engaged in biomedical science research in Colorado. These grants provide ECIs, defined as those who are four years or less from their first academic appointment at a research institution, funds to get research at their own labs underway, as NIH funding can be difficult to attract for those early in their careers. This year’s recipients hail from three different campuses around the state. A list of the recipients and their research topics follows.
- Zhe Chen, Ph.D. , Assistant Research Professor of Molecular, Cellular and Developmental Biology, University of Colorado Boulder, “Axon Guidance During Neural Development”
- Robert C. Doebele, M.D., Ph.D., Assistant Professor of Medical Oncology, University of Colorado Anschutz Medical Campus, “Resistance Mechanisms In Oncogene-Driven Lung Cancer”
- John D. (Nick) Fisk, Ph.D., Assistant Professor of Chemical and Biological Engineering, Colorado State University, “Bacteriophage Biomedical Devices and Engineering”
- Jing H. Wang, M.D., Ph.D., Assistant Professor of Immunology, University of Colorado Anschutz Medical Campus, “Antibody Production and Genomic Instability in B Lymphocytes”
- Tingting Yao, Ph.D., Assistant Professor of Biochemistry and Molecular Biology, Colorado State University, “Ubiquitin-Dependent Signaling”
The Second Annual GoldLab Symposium brought together a diverse group of presenters for a two day event. According to Larry Gold, the leader of the event and founder and CEO of Somalogic, this year’s event had a dual focus on the various “omics” – genomics, proteomics, transcriptionomics, etc – and on medical infrastructure and healthcare delivery. An early presentation in the seminar was provided by Kevin Davies, author of The $1,000 Genome. Davies discussed the decreasing cost of whole genome sequencing, now available for less than $10,000. As more people may have genetic information in hand, the question becomes how this information can be interpreted and used. As Gold noted in his opening remarks to an increasing degree, there is a belief that “genomics is not the game.” There is wide recognition that few diseases are actually caused by a single, simple mutation but rather many more layers and complexities are involved.
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AmideBio announced that it has closed a $575,000 preferred equity financing round. The source of the funds was not disclosed. AmideBio uses proprietary “Cap-Clip” technology, exclusively licensed from the University of Colorado, to produce and commercialize technically challenging peptides. This technology has the potential to both lower costs and improve purity in peptide manufacturing. This new manufacturing process has applicability in both the research and therapeutics market. To date, AmideBio has produced research grade peptides with its technology, and the company has biosimilars and therapeutic peptides in development. The funds will be used to continue optimization of multiple peptide products. AmideBio is based in Boulder, Colorado.
The FDA announced the approval of the KeyPath MRSA/MSSA Blood Culture Test, manufactured by MicroPhage, Inc. The test can identify whether the bacteria in a patient’s blood culture sample is methicillin resistant (MRSA) or methicillin susceptible (MSSA) Staphylococcus aureus within five hours after the first bacterial growth in the sample – compared to the 48 to 72 hours required for traditional techniques. This improved speed will allow for patient’s to begin effective antibiotic treatment more quickly. The test does not require any special equipment, beyond blood culture equipment, to get results. MicroPhage’s technology relies on bacteriaphages, viruses that infect bacteria. Each phage is specific to and will only infect and multiply in one certain type of bacteria. These phages multiply at rates 50 to 200 times that of bacteria, meaning they will reach detectable levels long before the bacteria themselves. MicroPhage is based in Longmont, Colorado.
Cerapedics, Inc announced results of a prospective, randomized, controlled trial of its i-FACTOR™ biologic bone graft for patients undergoing posterior lumbar interbody fusion (PLIF) spine procedures. The trial, which was conducted in Europe, was designed to evaluate the safety and efficacy of Cerapedics’ novel i-FACTOR biologic bone graft compared to autologous bone graft. At both 6 and 12 months, i-FACTOR showed superior outcomes to autologous both graft. At 6 months, the radiological fusion rate was 97.7% for patients treated with i-FACTOR compared to 59.1% for patients treated with autograft (p < 0.01). At 12 months, the radiological fusion rate was 97.8% for patients treated with i-FACTOR compared to 82.2% for patients treated with autograft (p < 0.01). i-FACTOR received its CE Mark (European regulatory approval) in 2008 and has been used in more than 3500 surgeries worldwide since that time. Currently, iFACTOR is being evaluated in the United States (FDA) as part of an Investigational Device Exemption (IDE) Clinical Study in the cervical spine. Cerapedics is a medical device company focused on bone repair and based in Westminster, Colorado.
The full press release is available here.
Array BioPharma announced the achievement of a $10 million clinical research milestone in its development collaboration with Novartis. This milestone was reached after Novartis reported the first patient visit in a Phase 2 clinical trial of MEK162. The open-label study will evaluate the safety and efficacy of MEK162 in patients with malignant cutaneous melanoma, harboring BRAFV600E or NRAS mutations. The study is designed to measure objective response rate and will also evaluate progression free survival, safety, and tolerability in patients receiving MEK162 orally. The agreement between Array and Novartis for joint development of MEK162 and other MEK inhibitors was announced in April 2010. Array, based in Boulder, Colorado, received an initial payment of $45M and is eligible for additional payments of more than $400M if additional clinical, regulatory, and commercial milestones are reached. The full press release is available here.
BiOptix Diagnosics, Inc announced the closing of a $9M Series B round. The round was led by The Russian Corporation for Nanotechnologies (“RUSNANO”) and joined by Boulder Ventures, which led the company’s series A financing, and several private investors. The funds will be used to expand marketing and establish a subsidiary in Russia (BiOptix Nanoprom LLC) to produce the company’s disposable bionanosensors ‐ glass substrates covered with precision metallic and biofunctional nanofilms. The company also plans to enter into R&D partnerships with academic institutions in Russia. Based in Boulder, Colorado, BiOptix markets the ACCOLADE™ system for label free detection for the biomedical and research markets.
December’s BioBreakfast featured two of CBSA’s 2010 award winning companies. The companies – Amgen, which won Company of the Year honors, and Sharklet Technologies, which was named the Rising Star – showcase the spectrum of bioscience activity going on within the state. Amgen has been in business for 30 years and employs about 17,000 worldwide. The company has had a presence in Colorado almost since its inception through the research labs of CU professor Marvin Caruthers. The presence in the state grew in 1995 when Amgen acquired Boulder based Synergen, including a facility where manufacturing still takes place. The company later opened an additional manufacturing location in Longmont and now employs about 900 people in Colorado. The Longmont facility manufactures Epogen and is also involved in manufacture of several clinical stage products. Prolia, a recently approved drug for osteoperosis, Nplate, as well as several clinical stage products are manufactured in Amgen’s Boulder facility.
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