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Vigilant Biosciences, Inc. (“Vigilant”) is an oncology-focused company providing early intervention for better outcomes. Our initial products include a quantitative lab assay as well as an oral rinse and test strip kit for head and neck squamous cell carcinoma (HNSCC).  The products are scheduled for product launch in 2015 to compete in the $3.9B US and $10.2B global HNSCC markets.

Unmet Clinical Need

 It is estimated that some $3.9B will be spent treating the 50,000+ people in the U.S. that are diagnosed with oral cancer in 2014.  Currently, a visual and physical examination is the “gold standard” for oral screening followed up with biopsy, but 2/3 of cases are diagnosed at Stage III or Stage IV with this method.  However, early intervention yields 80% - 90% cure rate representing a potential savings of $2B if the oral cancer is diagnosed at Stage I/II or earlier.  What is missing is a simple, specific and cost-effective test that can screen and aid in detection for early stage oral cancers.

The Solution 

The Vigilant oral cancer risk assessment kit is formulated to detect proteins specific to oral cancer captured by an oral rinse. Competitively priced, the test kit’s ease-of-use will be championed by clinicians; its specificity to minimize false positives and to detect oral cancer early will be championed by patients and doctors, and its cost-effectiveness will be championed by all.

Technology  

U.S. Patent #8,088,591 issued in early 2012 for broad method claims to associate certain key biomarkers specific for oral cancer as part of the technology portfolio exclusively licensed to Vigilant from the University of Miami.  Additional U.S. and international patent applications subject to the licensed portfolio are pending.

Competitive Advantage

The current “gold standard” for screening is a visual/manual oral examination given by the dental professional as part of the annual checkup standard of care followed up with biopsy for suspicious lesions.  However, over 2/3 of all oral cancers are identified at Stage III or Stage IV.  Vigilant seeks to revolutionize the oral cancer screening market by providing an easy-to-use, HNSCC specific test that allows for detection even before visual symptoms present.

Currently, there are several light-based systems and limited lab tests attempting to address the need for earlier intervention.  Light based systems include spectroscopic and chemiluminescent-based (light-based aid requiring use of acid or dye) offerings.  Lab based systems include liquid cytology or HPV tests.  Insufficient and inconclusive clinical data exists to support widespread acceptance of current offerings as screening or diagnostic aids and tools for HNSCC.  With respect to the light-based systems additional drawbacks of these systems include that:  (1) They address “abnormalities” in general versus HNSCC specifically; (2) They can require a significant upfront capital investment; (3) They are labor intensive and disruptive to business operations for dental practices; (4) Some are invasive requiring tissue excision; and (5) Results can be subjective depending on the examiner.  Lab-based system drawbacks include lack of proven clinical utility with its results and the costs.

The Vigilant solution overcomes these drawbacks by:  (1) detecting protein markers specifically for oral cancer; (2) requiring no significant capital investment; and (3) providing “easy-to-use” and “low touch” instructions to provide immediate and objective results.

Founded in 1997, Tech Coast Angels is the largest angel investor group in the United States. Its members provide funding and guidance to more early-stage high-growth companies in Southern California than any other investment group. TCA members invest in companies in a wide range of industries including life sciences, biotech and health IT. TCA has more than 325 members including its venture capital affiliates in five networks in Los Angeles Orange County San Diego Westlake/Santa Barbara and the Inland Empire. The organization will finance on an opportunistic basis as long as substantial disruptive market opportunities exists. The firm has historically invested in Biotech Therapeutics & Diagnostics, Biotechnology R&D Services, Biotechnology Other, Medical Technology companies with sub sectors of Anti-Infectives, Bioinformatics, CRO (Contract Research Organization), Diagnostic Instrumentation, Diagnostic Services, Drug Delivery, Food, Industrial Biotechnology, Small Molecules, Small Molecule Therapeutics, Wound Care and indications including Diseases of the Nervous System, Infectious and Parasitic Diseases, Neoplasms/Cancer/Oncology, Respiratory.

Websites:
www.greenwingsbiomedical.com
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Sofinnova Ventures was founded in 1974 and is based in Menlo Park, CA. The firm has approximately $1b of assets under management, and makes life science investments from two fund families; the main Sofinnova Ventures fund and Sofinnova HealthQuest Capital. Sofinnova Venture Partners IX closed at $500 million in 2014, and the debut HealthQuest fund closed at $110 million in 2014. The firm makes investments in the form of equity (preferred stock) and is an activist investor; the firm prefers to lead investments, take a board seat at its portfolio companies and be actively involved in company management. Sofinnova Ventures plans to make 4-6 new investments in life science companies in 2014. 

The Sofinnova Ventures main fund invests in biopharmaceuticals and typically makes initial investments of $5-15m, with the potential for a total investment of $15-30m. The fund invests in companies based in North America or Europe. 

HealthQuest Capital invests in non-biopharmaceutical life science and medtech companies and typically makes initial investments of $2-3m, with the potential for total investments of $5-6m. HealthQuest Capital is a venture growth fund focused on commercial-stage technologies, and only invests in companies headquartered in North America (particularly the US Southeast or West Coast).

SENS Research Foundation is based in Mountain View, CA. The foundation provides grants for research into rejuvenation biotechnologies that prevent or reverse age-related tissue damage. Historically grants have ranged from $40,000 to $200,000 although this range may change in the future. Grants are available to researchers worldwide. SENS requests that grants not be used to cover overhead/facilities costs. At present, 15 projects are being supported.