Biodesix announced that it has closed a $7.1M Series C round. The round was led by existing investors, who provided $5.1M of the total, and joined by five new investors. The proceeds of the the round will be used to fund commercialization activities for VeriStrat, a test designed to help guide treatment decisions for patients with non small cell lung cancer. The VeriStrat test evaluates a large number of markers from a blood sample and classifies patients as VeriStrat Good or VeriStrat Poor based on expected outcomes from treatment with erlotinib (Tarceva). The funds will also support additional clinical validation programs for VeriStrat, including confirming its clinical utility with additional targeted oncology therapies and for other tumor types. Biodesix, based in Broomfield, Colorado, also reported it received $1.4 in grants from the Qualified Therapeutic Discovery Program.
Many companies have reported awards from the Qualifying Therapeutic Discovery Project Program this week and several Colorado companies are included.
- Inviragen (Fort Collins) received two grants totaling $488,958 for ongoing programs to develop vaccines against dengue and chikungunya viruses.
- GlobeImmune (Louisville) has been awarded three grants totaling $733,438 for three development programs: GI-5005 the company’s lead product candidate for Hepatitis C, and GI-4004 and GI-6207 both for the treatment of different cancers.
- Microphage (Longmont) received two grants totaling $977,916 for continued development of its rapid MRSA/MSSA Blood Culture Test currently under review by the FDA.
Only companies with less than 250 employees were eligible for the program. Additionally, projects had to show significant potential to produce new therapies to address areas of unmet medical needs, prevent, detect or treat chronic or acute disease and conditions, reduce the long-term growth of health care costs and advance the goal of curing cancer within the next 30 years.
GlobeImmune Inc. announced additional data from a Phase 2b study of GI-5005 used in the treatment of patients with genotype 1 chronic hepatitis C virus (HCV). The addition of GI-5005 to standard of care improved sustained virologic response 12% compared to standard of care (SOC, , pegylated-interferon alpha 2a plus ribavirin) alone in patients who had failed prior treatment with standard of care . In the group treated with SOC + GI-5005 the rate of sustained virologic response, defined as undetectable virus in the blood 6 months after finishing treatment, was 17% compared to only 5% in the SOC alone group. These results suggest GI-5005 holds significant promise for patients chronically infected with HCV. GI-5005, Globeimmune’s lead product candidate, is a tarmogen that generates activated killer T cells that are designed to locate and eliminate virally-infected cells. Based in Louisville, Colorado, GlobeImmune is developing tarmogens for the treatment of viruses and cancer.
Inviragen and Pharmajet announced that they received a five-year $15.5M contract from National Institute of Allergy and Infectious Diseases, part of the NIH, to advance development of a needle free dengue vaccine. The development will focus on combining Inviragen’s DENVax with Pharmajet’s needle-free delivery system. The funding is earmarked for pre-clinical testing, regulatory filings, manufacturing, and clinical studies. DENVax was developed by scientists at the CDC’s Division of Vector-Borne Diseases and should offer immunity against all four strains of the dengue virus, a mosquito borne disease estimated to affect 30 to 50 million people annually worldwide. Phase 1 testing of DENVax delivered by traditional needle and syringe began earlier this year. Inviragen is based in Fort Collins, Colorado. Pharmajet, headquartered in Golden, Colorado, manufactures and markets vaccine and drug delivery products based on its proprietary needle free jet injection technology.
The second day of BioWest began with Chris Nolet of Ernst and Young discussing his company’s global biotechnology report. Nolet highlighted many of the figures, which can be found in the report that will be available for download here. Although biotechnology did not fare as badly in 2009 as anticipated in 2008 and on the whole was profitable, Notel noted that the industry was moving towards a new normal focused on capital efficiency. This paradigm reaches across early stage companies considering virtual R&D and creative fund raising to larger companies trying increase their shots on goal through partnerships and more focused internal R&D. Also of note to healthcare companies is the increased government focus on doing more with fewer healthcare dollars potentially leading to more use of comparative effectiveness and outcomes based pricing.
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The first day of CBSA’s BioWest included a wide variety of perspectives from presentations by emerging companies in Colorado to a panel focusing on international opportunities
The first presentation of the morning was offered by Thomas Warick, Director of the FDA’s Denver District. Warick discussed the challenges faced by the FDA when staffing and funding levels fell substantially around 2008 putting offices in the position that they only had time to “chase emergencies.” With staffing levels starting to come back somewhat, the FDA is now seeing the chance to be somewhat more proactive. Among the continuing challenges faced by the FDA, Warick noted the increasing need for overseas operations because FDA regulated products are imported from 150 countries. Specific to the Denver region, Warick commented on efforts and plans to improve laboratory throughput to enable the testing of more samples. Warick also encouraged young companies to approach the FDA early on (the CDER for drugs and the CDRH for devices) so there are fewer surprises as they move towards regulatory submissions.
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The first day of CBSA’s annual BioWest Conference brought the always-popular venture showcase in which the four finalists, selected from 21 entrants, presented their technologies to a panel of investors. Brief descriptions of the four finalists follow.
AmideBio, presented by CEO Misha Plam, has a process to manufacture peptides more efficiently and economically. The proprietary process, invented by Dr, Michael Stowell, has potential application in both the research and reagent market and in the manufacture of drugs. The process creates ultrapure bioactive peptides free of biologic contaminants while simultaneously boosting yields. Early revenues are coming from research markets, but the company has a particular interest in insulin as it moves towards products intended for human use.
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The Colorado Institute for Drug, Device and Diagnostic Development (CID4) announced the two companies that received funding based on its initial solicitation. Sophono, Inc, based in Boulder, is receiving $600K to further the development of its Alpha 1 Magnetic Bone Anchored Hearing System. The system, which has received its CE mark signifying European approval, is the world’s first and only non‐percutaneous, osseointegrated hearing solution designed to treat conductive and mixed hearing loss and single sided deafness. The company plans to use funds to support its efforts for FDA approval and to move manufacturing from Germany to Boulder. PeptiVir, Inc, based in Aurora, will receive $300K to support development of its universal flu vaccine. Unlike current flu vaccines, PeptiVir’s lead product PVI‐1000 has the potential to be effective against multiple seasonal and pandemic strains based on only one or two administrations. PeptiVir will be one of the presenters at tomorrow’s 2010 BioWest Venture Showcase.
CID4 was created to help bridge the gap between research and commercialization for promising life science technologies in the Colorado. CID4 is accepting proposals for its second solicitation until October 15.
The Colorado Institute for Drug, Device and Diagnostic Development (CID4) has issued its second call for proposals from “Colorado life science technologies in need of funding and active management”. CID4, a private, not-for-profit entity launched in February, aims to help bridge the gap between research and commercialization for promising life science technologies in the state. Proposals are due on October 15th and may be submitted via the institute’s website. CID4 selected two technologies based on its initial solicitation for proposals in February. These two technologies – one a biopharmaceutical and one a medical device – will begin receiving CID4 support and funding. Announcement of the specifics of these two projects is pending completion of legal documentation.
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.
