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BLADDER CANCER IN THE UNITED STATES
In 2013, The American Cancer Society estimated 65,000 new cases of bladder cancer were expected to be diagnosed among US, as well as an estimated more than 1 million patients with history of bladder cancer, who need monitoring at least 2 times a year.
In 2013, approximately 100 million people with CURRENT SMOKING (more than 44 million) and PRIOR HISTORY OF SMOKING (more than 50 million) or chemical carcinogen exposure were expected to be presented with microscopic hematuria from their regular health checkups (CDC report).
While hematuria needs to be screened with urine cytology for the people with smoking history (always screened with urine dip stick test), there are no appropriate screening methods available at this point.
Bladder cancer has become the most expensive cancer in US, costing more than 16 billion USD/year due to the lack of an efficient early detection method and likewise, due to lack of cost efficient screening methods for the groups of people with prior history of bladder cancer. In fact, due to the lack of an efficient screening and monitoring method for recurrent bladder cancer, this disease becomes the most expensive cancer in the U.S.
The JSY Cancer Research and world-wide license agreement from Johns Hopkins
JSY Cancer Research Foundation (JSY), founded in 2013 by Chul So Moon, M.D., Ph.D., has identified and patented a variety of genetic mutations from various oral cavity DNA and DNA from Blood samples.
These discoveries are based on a fundamentally different interpretation of human genomes. Dr. Moon has identified more than 29,000 new protein encoding genes, which were previously thought a junk DNA. Based on this discovery and an extensive bioinformatics analysis, Dr. Moon has discovered many “unique protein structure changing mutations” leading into development of various early detection markers for cancers including lung, breast, colon, brain, and pancreas and bladder cancer.
Additionally, in partnership with Affymetrix, JSY is in the process of designing a Gene-Chip based unique bladder cancer screening test which, when combined with urine dip stick test (standard of care), can significantly improve the accuracy of bladder cancer detection.
Finally, Dr. Moon’s research has been based on MSA (microsatellite assay) based bladder cancer detection (developed by his colleague, Dr. David Sidransky in Johns Hopkins). While the original technology from landmark discovery by Dr. Sidransky is offered based on 15 to 20 markers and needs blood sampling, Dr Moon has developed a new MSA tested based on different combinations of markers (4 to 8 markers), which does not need blood sampling. More importantly, Dr. Moon has been clearly demonstrating that there are 100% concordances between PY-1 Test and Vysis test (from Abbott), based on an initial validation study done in AI Biotechnology.
The Product “licensed-in” from JSY and Marketing Strategy
Basically, BCD has licensed three different technologies licensed from JSY; namely PY-1, PY-2 and PY-3 tests. At the inception of the test, BCD and Genetworx will launch PY-1 Test after completion of a mini validation study (50 sample based concordance study with prospective sample collections).
A) PY-1 Test : A novel “microsatellite based recurrent bladder cancer detection test , which will be marketed with IVD based FDA Approval.”
B) PY-2 Test: “Next generation- high through output DNA sequencing” as a tool of predicting the high risk group for bladder cancer: This will be offered as an adjunct to urine dip stick test for the detection of bladder cancer patient with a positive urine dip stick test.
C) PY-3: AFFYMETRIX DNA Chip based screening as an adjunct to urine dip stick test, which will be marketed with Affymetrix MOU with Genetworx. Genetworx will be the non-exclusive PY-1 test facility, the first test facility in the U.S. mostly covering tests done on the eastern side of United States. The professional expertise from Genetworx will guide BCD to set up additional test facilities in the rest of the U.S. territory. The primary role of Genetworx will guide BCD to obtain FDA Approval based on IVD track and subsequent marketing.
BOARD OF DIRECTORS
Mario Gobbo, MBA, PhD serves as Chairman of the Board of Directors for BCD Innovations, Inc. He has over 30 years of banking and corporate finance experience spanning healthcare, telecoms and energy. His expertise encompasses M&A, equity capital markets and venture capital/private equity. He holds a BA with a major in Organic Chemistry from Harvard College, a Master of Science in Biochemistry from the University of Colorado and a MBA, Master of Business Economics and a Ph.D. (Management) from the Wharton School of the University of Pennsylvania.
SCIENTIFIC ADVISORY BOARD
Dr. David Sidransky M.D., serves as Chairman of the Scientific Advisory Board for BCD Innovations, Inc. He is the President, (inventor of MSA assay), of The Head and Neck Cancer Research Institute, Johns Hopkins Medical Institute.
Dr. Shaji George Ph.D., serves as Vice Chairman of the Scientific Advisory Board for BCD Innovations, Inc. He is a former member of the Rockefeller University Faculty.
Dr. Matthew J. Beckman (VP, Genetworx), member of Scientific advisory Board for BCD and he will also serve as a Senior Technology Advisor for microsatellite test, maintenance of CLIA test facility.
Dr. Sarah Helber (Manager, Genetworx), member of Scientific advisory Board for BCD and she will also serve as a Senior Technology Advisor for microsatellite test for BCD. She has 10 years of experience in MSA based bladder cancer detection.
Mr. William L. Miller (CEO, Genetworx), member of Scientific advisory Board for BCD and he will also serve as a Senior Business Advisor for next-generation DNA sequencing and diagnostic kit design for BCD.
Dr. Thomas Reynolds (SVP, AI Biotechnology), member of Scientific advisory Board for BCD and he will also serve as a Senior Business Advisor for next-generation DNA sequencing and DNA Chip analysis for BCD.
MEDICAL ADVISORY BOARD
Dr. Chul So Moon, M.D., Ph.D., serves as Chairman of the Medical Advisory Board for BCD Innovations, Inc. He is an experienced principal investigator, attending physician, and member of multiple multidisciplinary treatment programs. He served as co-principal investigator of ONXY-015 gene therapy program for advanced head/neck and lung cancer, at MD Anderson Cancer Center, Houston, TX. Dr. Moon holds medical licenses in the United States and in Korea. He is a well-respected lecturer and author of numerous academic publications.
Dr. Maxie Gordon, a medicine/psychiatry specialized primary care physician who has been extensively involved in biopharmaceutical industry serves as Chief Medical Officer.
BUSINESS ADVISORY BOARD
Phil Christen (SVP of marketing, Genetworx), Senior Business Advisor for marketing and he will also serve as a Business Development Advisor for BCD.
Annie John, Managing Director of JSY serves as Chief of Staff for BCD Innovations, Inc.
Mario Gobbo, MBA, Ph.D. serves as Chief Financial Officer.
Mr. Davis Harris, a well-known businessman in biotech arena serves as Senior Vice President of Business Development and Marketing.
Mr. Babu Philip, MBA, Financial Analyst serves as Vice President of Operations and Internal Auditor.
Dr. Richard Hull, a well-known medical ethicist, serves as Senior Ethics Advisor. Will guide BCD’s ethical issues related with genetic testing.
MOU with Genetworx
Based on novel microsatellite based DNA test, BCD has been finalizing a development/marketing agreement (MOU) with Genetworx (www.genetworx.com). Genetworx has several of the best bladder cancer test teams including VP of Tech Development - Dr. Beckman, SVP for marketing - Mr. Christen and Dr. Haber. Dr. Moon has had more than 3 years of relationship with each of them. This agreement will cover three important areas of the BCD’s commercialization strategy:
First: Genetworx will be the non-exclusive PY-1 test facility. It is the first test facility in the U.S. mostly covering tesingt done on the east side of the United States. The professional expertise from Genetworx will guide BCD to set up additional test facilities in the rest of the US territory.
Second: BCD is in the process of developing a PY-1 test kit, which will be brought into the 510k trial for the purpose of FDA Clearance.
Third: Genetworx will support us for the 510k trial of PY-1 and PY-3, with the goal of “FDA cleared hematuria screening and recurrent bladder cancer."
MOU with AI Biotechnology
Based on strong expertise in NEXGENE-HIGH THROUGH OUTPUT SEQUENCING, AI Biotechnology (www.aibiotech.com) can perform more than 200,000 PY-2 test/ year. In fact, the technological details of this collaboration have been discussed over the last year. Of note, JSY and AIB have had a long relationship. In fact, Dr. Reynolds, executive VP, and Dr Moon have been working together more than 10 years through MSA based clinical trials. This MOU will cover two important aspect of BCD’s commercialization strategy.
First: AIB will be the non-exclusive PY-2 test facility, the first high through output DNA sequencing facility in the U.S., mostly covering testing done on the east side of the United States. The professional expertise from AIB will guide our company to set up additional test facilities in the rest of the U.S. territory.
Second: AIB will support us for the PMA trial of BCD-2 and BCD-3, with the goal of “FDA approval hematuria screening test."
MOU with AFFYMETRIX
Based on Dr. Moon’s “recent discovery of new way of interpreting human genome," JSY and Affymetrix has entered the MOU for the development and commercialization of various SNP detecting kits. SNP is a single nucleotide polymorphism and this information can be applied for the prediction of various human pathophysiology including the risk assessment of bladder cancer among smokers.
First: JSY owns, controls, or otherwise has rights in proprietary SNPs necessary for the design of the JSY Custom Axiom Genotyping Array (the "MATERIAL"). The MATERIAL may include "genetic risk markers" for various cancers, including lung, breast, head and neck and prostate cancers. The MATERIAL also may include various "genetic risk markers" for metabolic and neuro-psychiatric diseases.
Second: both JSY and Affymetrix, will negotiate in good faith, at a future date, to enter into a supply and/or commercial production agreement with reasonable terms that may include the establishment of a testing facility.
In terms of PY-3 test, this MOU will enable BCD for the production of Affy based DNA Chip (PY-3 test KIT) from Affymetrix. Additionally, along the side of MOU, there have been discussions about future commercialization steps including co-marketing, co-distribution and a strong support from Affymetrix for test center set ups.
Post-doctoral Fellow in Immunology: A postdoctoral fellow position is open to study the functions and mechanisms of Treg cells in cancer and autoimmune diseases using mouse models. The ideal candidate will be a recent graduate within the last three years of obtaining a Ph.D. in immunology or a related field. Experience with tissue culture, procedures on mice, and standard molecular biology methodologies are desired. Excellent verbal and written skills in English are required.
Marketing Director: This position requires a Master’s Degree in Business or Health Care Administration required. Candidates with a Bachelor’s degree and at least 2 - 5 years relevant experience in the health and wellness industry may also be considered. This position requires 5 years of full cycle sales and marketing experience, with at least 3 years in the healthcare industry. Candidates must have strong personal computer skills and software knowledge, and the ability to compile and coordinate Marketing Budgets, high quality reports, proposals and written work product for clients. Candidates must have excellent written, verbal and oral communication skills to effectively interact with clients at all levels of the organization. Superb business writing, communication and presentation skills. Requires advanced negotiation skills and the ability to facilitate project teams to meet agreed upon deadlines and project milestones.
The Bladder Cancer Patent
JSY Cancer Research Foundation, based on discoveries by Dr. Moon, has been filing the following three unique patents.
1. Detection of bladder cancer by oral cavity DNA and unique Microsatellite Marker from urine (PY-1 test) and demonstration of concordance ofPY-1 test with Vysis FISH test
- This technology has two unique differences from the test developed by Dr Sidransky in Johns Hopkins
- It uses oral cavity DNA and urine DNA instead of blood DNA and urine DNA
- It uses only minimal microsatellite markers (4 to 8 markers)
- Therefore, the standard operation protocol is different from the existing patent
2. Discovery of DNA markers (PY-2 test) predicting "high risk for bladder cancer development"
- Discovery of PY-2 test combined with urine dip stick test as a superior method of screening microscopic hematuria as compared with urine dip stick test
3. Designing of DNA Chip based bladder cancer prediction test (PY-3 test)
Agre P, Preston GM, Smith BL, Jung JS, Raina S, et al. (1993) Aquaporin CHIP: the archetypal molecular water channel. Am J Physiol 265: F463–476.
Juna Lee, Se Jin Jang, Maria, Carol Greider, David Valle and Chulso Moon: Novel AS-TERT promoter polymorphism as a predictor of idiopathic pulmonary fibrosis. (Manuscript in prep, 2012)
Juna Lee, Jean-Charles Soria, Luo Wang, Se Jin Jang,Taekyeol Lee, Beom Soo Park, Min Joo Park, YoungKwang Chae, Sung Koo Kang, Kyung Jung Lee, Shi-Young Sun, Yoon-Soo Chang, Li Mao, David Sidransky, and Chulso Moon: Identification of antisense RNA transcript of human telomerase reverse transcriptase catalytic subunit. (Manuscript being submitted, 2012)
Sung Koo Kang, Young Kwang Chae, Janghee Woo,Myoung Sook Kim, Jin Hyen Baek2, Juna Lee, Jean Charles Soria, Se Jin Jang, David Sidransky, and ChulsoMoon: Cross-talk of Aquaporin 5 (AQP5) with Epidermal Growth Factor Receptor (EGFR). (Manuscript in prep, 2012)
Sung Koo Kang, Young Kwang Chae, Janghee Woo,Myoung Sook Kim, Jin Hyen Baek2, Juna Lee, Jean Charles Soria, Se Jin Jang, David Sidransky, and ChulsoMoon: Role of Aquaporin 5 (AQP5) in Iressa Resistance. (Manuscript in prep, 2012)
Janghee Woo, Juna Lee,Young Kwang Chae, MyoungSook Kim,Jin Hyen Baek,Jong Chul Park,Min Joo Park,Ian M. Smith, Barry Trink, Edward Ratovitski, Taekyul Lee,Bumsoo Park, Se Jin Jang, Jean C. Soria, Joseph A.Califano, David Sidransky, Chulso Moon: Membranous expression of AQP5. Plos ONE (manuscript in revisions, 2012)
Janghee Woo, Juna Lee,Young Kwang Chae, MyoungSook Kim,Jin Hyen Baek,Jong Chul Park,Min Joo Park,Ian M. Smith, Barry Trink, Edward Ratovitski, Taekyul Lee,Bumsoo Park, Se Jin Jang, Jean C. Soria, Joseph A.Califano, David Sidransky, Chulso Moon: Membranous expression of AQP5 in human lung tissue. (Manuscript in prep, 2012)
Young Kwang Chae1, Myungshin Kim2, Kyungja Han, Chan Kwon Jung, Yonggoo Kim, David Sidransky1, andChulso Moon: Aquaporin 5 (AQP5) is expressed in primary human leukemic cells. American Journal of Hematology (2012) in revisions
Janghee Woo, Juna Lee,Young Kwang Chae, MyoungSook Kim,Jin Hyen Baek,Jong Chul Park,Min Joo Park,Ian M. Smith, Barry Trink, Edward Ratovitski, Taekyul Lee,Bumsoo Park, Se Jin Jang, Jean C. Soria, Joseph A.Califano, David Sidransky, Chulso Moon: Overexpression of AQP5, a putative oncogene, promotes cell growth and transformation. Cancer Letters 264 (2008) 54-62
Woo J, Chae YK, Jang SJ, Kim MS, Baek JH, Park JC,Trink B, Ratovitski E, Lee T, Park B, Park M, Kang JH, Soria JC, Lee J, Califano J, Sidransky D, Moon C: Membrane trafficking of AQP5 and cAMP dependent phosphorylation in bronchial epithelium. Biochemical and Biophysical Research Communications 366 (2008) 321-327
Woo J, Lee J, Jang SL, Sidransky D, Moon C: The effect of aquaporin 5 overexpression on the Ras signaling pathway. Biochemical and Biophysical Research Communications 367 (2008) 291-298
Young Kwang Chae, Mi-Jung Kim, Janghee Woo, SeungKoo Lee, Gyungyub Gong, Yong Hee Kim, Myoung SookKim, Juna Lee, Jean Charles Soria, Se Jin Jang, DavidSidransky, and Chulso Moon: Expression of aquaporin 5 (AQP5) promotes tumor invasion in human non-small cell lung cancer. PLoS ONE (2008) 3(5): 2162
Young Kwang Chae,SungKooKang, Myoung Sook Kim,Janghee Woo, Juna Lee,StevenChang,DongWook Kim,Myungshin Kim, Seonyang Park, Inho Kim, BhumsukKeam, Jiyoung Rhee, Nam Hee Koo, Gyeongsin Park,Soo-Hyun Kim, Se-Eun Jang, Il-Young Kweon, DavidSidransky, Chulso Moon: Human AQP5 Plays a Role in the Progression of Chronic Myelogenous Leukemia (CML). PLoS ONE (2008) 3(7): 2594
Sung Koo Kang, Young Kwang Chae, Janghee Woo,Myoung Sook Kim, Jin Hyen Baek2, Juna Lee, Jean Charles Soria, Se Jin Jang, David Sidransky, and ChulsoMoon: Role of human aquaporin 5 (hAQP5) in colorectal carcinogenesis. American Journal of Pathology (2008) 173: 518-525
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