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Development-stage pharmaceutical company with a platform technology to deliver novel therapeutics to the urinary bladder lumen for the treatment of inflammatory bladder conditions such as overactive bladder and interstitial cystitis. Our portfolio includes prodcuts in pase-I and phase-II clinical trials in the United States and overseas, as well as pre-clinical programs. We also have one program designated as orphan. In addition to therapeutics, Lipella also develops diagnostic agents to be used in connection with medical imaging.

Antibody Solutions is a premier developer of therapeutic, diagnostic and critical reagent antibodies. Our platforms include human antibodies from transgenic OmniRats™, Hybridoma Libraries™, and high-throughput flow-cytometry screening of cell-associated targets. We provide full technical support and project management with all services performed in the USA. 

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.

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.

Arcus Ventures was founded in 2007 and is based in New York City. Arcus Ventures is currently investing from its second fund, which had a first close of $36m in 2014 and is targeting a raise of $100m. The firm typically invests $2-5 million. Arcus invests primarily in the USA but is also open to considering opportunities in Canada.

We are focused on Valley Fever, an orphan disease that kills 150 people a year. Thousands are taking drugs for life, and many others have no effective drug therapy options. Nikkomycin-Z is a new, first in class antifungal ready for Phase II testing. Teliable animal models suggest NikZ will be effective. 

With our guidance, the NIH is funding two Phase II trials starting about late 2015. We would like to run a third, sweet-spot-of-market trial as soon as we secure funding. Our Chief Medical Officer is lead author on an NIH study on standard of care drugs for this disease. We plan to try NikZ under a simlar protocol as soon as we secure support. 

Valley Fever Solutions has made our API at pilot scale. The process is robust and repeatable. We are ready to make a large batch as soon as we secure funding. We expect the proof of concept trial can reach at least early readout within 18 months of funding. This can be achieved for less than $10M.

Amorphex Therapeutics is an early clinical stage company that was founded to develop products for sustained ophthalmic drug delivery using patented TODDD™ technology. Topical ophthalmic pharmaceuticals are a $5+Billion market, but inaccurate and inefficient delivery systems, poor compliance and excessive side effects undermine their clinical benefits and true sales potential. TODDD™ is a soft, non-invasive device that is completely concealed under the eyelid and continuously delivers therapeutic levels of drug 24/7 over several months. While TODDD™ is soft and flexible, unlike soft contact lenses, it doesn’t contain appreciable water and avoids the surface drying and resulting deposits that irritate and deter many contact lens wearers. In recognition of the potential benefits and their developmental progress, the company’s founders have been awarded three National Institutes of Health (NIH-SBIR) grants for the TODDD™ technology totaling $2.5 million.

TODDD™ has issued patents in major markets and has been successfully tested in safety studies, animal trials with drugs and without drug in humans.

Amorphex is seeking to fund small, 30 - 40 subject, human clinical trials of TODDD™ delivering timolol, prostaglandin and both drugs simultaneously. This funding will also support pre-clinical development of TODDD™ for ocular allergy and inflammation applications.  These milestones will drive dramatic increases in valuation and corporate partner interest.