Search 

Tangen Biosciences is an early stage diagnostic instrument company that has developed a group of novel technologies that together enable rapid, portable, lab-free, and very low cost molecular diagnostics at the point of care.   

The Tangen platform will amplify and detect specific nucleic acid sequences obtained from a variety of source samples, including clinical specimens such as blood, tissue and sputum, as well as environmental samples obtained from water, soil or food, for example.  The first application of the Tangen platform is the detection and diagnosis of Tuberculosis using DNA extracted from sputum samples, using the Tangen Sputum Processing assay kit

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.

Advances in synthetic chemistry and drug screening techniques have flooded the pharmaceutical industry with potential new drugs. At the same time, industry consolidation and financial pressures on R&D budgets have reduced the ability of biotech and pharmaceutical companies to develop early stage drugs. As a result of these market forces, large pharmaceutical companies have restricted their drug development activities to "blockbuster" drugs ($1 billion revenues) with proven efficacy. Promising early-stage drugs developed in emerging biotech and pharmaceutical companies, and university research laboratories are being shelved. 
VDDI Pharmaceuticals has been formed to capitalize on these opportunities. The Company will license attractive product development opportunities from academic institutions, biotech firms and pharmaceutical companies. VDDI Pharmaceuticals will focus on pharmaceutical product opportunities where general proof-of-principle has already been established in pre-clinical or human testing, and where the products are novel and offer significant potential advantages to products currently in the market or in development. VDDI Pharmaceuticals will pursue early-stage products qualifying for fast track approval, primarily in the areas of cancer, cardiovascular disease and infectious disease and develop the products through Phase II of the required regulatory approval processes. The developed products will be licensed to existing pharmaceutical companies for product marketing, thereby generating license fees and ongoing royalties for VDDI Pharmaceuticals.

As its name suggests, VDDI Pharmaceuticals utilizes a virtual business model. Virtual drug development entails: (i) a small core group of employees responsible for strategic management, regulatory strategy, and financial control, (ii) outsourcing all non-core business functions, including preclinical and clinical drug development, and (iii) electronic data capture and data submission to regulatory authorities. By adopting this model, VDDI Pharmaceuticals believes it can reduce total drug development program costs by at least 25% and development times by up to 50%.

viDA is a preclinical biotechnology company pursuing the development of first-in-class drugs for the treatment of several inflammatory and age-related conditions of the skin, respiratory, musculoskeletal, cardiovascular, and neurological systems.Our platform is based on recently identified, specifically extracellular, pathological roles of a family of serine proteases called Granzymes. 

Currently, our focus is specifically on extracellular Granzyme B (GzmB) and its role in a range of disease states involving inflammation and tissue damage. GzmB actively participates in the degradation of key components of the body’s extracellular matrix, which acts as a scaffold for cell binding and provides essential structural integrity for proper function of tissues and organs.

Based on this new mechanism of action, these molecules have shown positive therapeutic outcomes in a number of disease-specific models. viDA has been reviewing MS and the orphan indication of Discoid Lupus specifically.

Our lead compound is in preclinical development and is intended to be a topical treatment for Discoid Lupus. The lead candidate exhibits a high degree of specificity and selectivity for extracellular GzmB. The compound has attractive drug-like properties for topical application and is being assessed for other possible routes of administration amenable to treatment of other diseases.

The Company has developed a library of additional proprietary first-in-class small molecule inhibitors to GzmB. These innovative molecules will have specific properties amenable to treatment of diseases requiring different routes of administration. 

Studies using inhibitors and knockout approaches have demonstrated that GzmB inhibition does not suppress immunity.

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.

Western Oncolytics is developing a novel immunotherapy to treat a wide range of solid tumors.  Our therapy is an oncolytic vector with multiple therapeutic transgenes that both stimulate the immune system and remove local tumor immune inhibition.  The vector is engineered to avoid the immune system itself, thus overcoming a major drawback in competing designs.  It is the only therapy in the world with these leading attributes.  Western Oncolytics' therapy works in combination with other treatments, e.g. checkpoint inhibitors, and is capable of systemic (intravenous) delivery. 

Our team comprises the leading scientists, clinicians, and regulatory experts within our field, including entrepreneurs who successfully exited companies with earlier technologies.  In comparison animal testing measuring tumor growth and survival, our therapy performed far better than earlier, clinically-proven oncolytic therapies.

Western Oncolytics is currently raising investment to complete preclinical development and a planned clinical trial. 

Xalud Therapeutics is developing novel, non-opioid therapies for the treatment of neuropathic pain and osteoarthritis. Our lead product, XT-101, has shown exceptional efficacy in the leading rodent models of pain and in canine patients with neuropathic pain and osteoarthritis. XT-101 has an excellent safety profile -- it does not cause sedation, dizziness, numbness, addiction or tolerance.  7 and 28 day GLP toxicology studies have been completed with excellent results.  Xalud intends to file an IND for a Phase I/IIa trial in mid-2015 and, pending funding, initiate clinical trials thereafter.

Xalud's approach to treating pain is fundamentally different than conventional approaches. XT-101 causes the body to produce the natural anti-inflammatory IL-10.  In neuropathic pain, the use of this broad spectrum anti-inflammatory reduces inflammation around the spinal cord and reduces aberant pain signaling.  In gold-standard rodent models, a single injection of XT-101 completely eliminates neuropathic pain for 12 weeks.  We have also tested XT-101 in canine patients with severe osteoarthritis that has been resistant to standard treatments.  In these patients, XT-101 has provided long lasting pain relief resulting in dramatically increased mobility and activity levels and increased joint flexibility.

To date, Xalud's efforts have been supported by over $6 million of grant funding from the NIH, the DOD, and disease foundations.  We seek to raise $6 to $10 Million to fund our initial clinical trial or trials.  These will be placebo controlled Phase I/IIa trials in actual patients.  Because XT-101 has an extended duration, we expect that these trials will provide the safety, efficacy and biomarker data necessary to support a robust Phase II program.