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McDermott Will & Emery is a premier international law firm with a unique focus in representing life sciences companies and investors in a wide variety of transactional, intellectual property and regulatory matters.  Through our Life Sciences Entrepreneurs Acceleration Program ("LEAP") we provide early stage medical device, pharmaceutical, biotechnology and diagnostic companies access to sophisticated legal services.  Learn more here: http://www.mwe.com/leap/

VC fund focusing on investments in Switzerland and surounding areas

We are a Hong Kong-based venture fund management company focusing on mid- to long-term advanced technology investments at early stage. Through our partnership with the top analytical companies utilizing machine learning and large panel of experts, we can construct complex decision trees showing risk and return at every stage of company evolution. We routinely invest in both private and public companies specializing in biotechnology, drug discovery, personalized medicine, Big Data analysis, industrial expert systems and artificial intelligence. 

Apple Tree Partners is a private equity fund that was established in 1999 and based in New York, NY, with satellite offices in Princeton, NJ, Cambridge, MA and Brussels, Belgium. The firm controls up to $1.75 billion in assets under management and makes equity investments ranging from $100,000 for academic spinouts to $150 million dollar in later stage deals. The firm seeks to make investments around the globe with a focus on creating and building companies located within the US and Europe.

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.