Minerva Biotechnologies was founded in 1999 by Dr Cynthia Bamdad (inventor of the universal DNA chip & protein chip) to develop "next generation" biochips: affinity nanoparticles. Minerva enjoys a broad and dominant intellectual property position in the field of nanotechnology with over 100 patent applications filed with US and worldwide rights reserved. Minerva’s intellectual property covers a wide range of uses for its nanoparticle systems in fields as diverse as drug discovery, proteomics, opto-electronics and nano-scale biosensors. A competing nanoparticle company is Nanosphere (NASDAQ: NSPH; $300 MM market cap). However, in contrast to Nanosphere, Minerva’s nanoparticles address a much larger market and do not require the use of expensive, dedicated equipment for analysis. Since the second year of operations the Company has focused squarely on drug discovery and diagnostics for cancer and has used its nanotechnology in-house to expedite the process. Minerva is seeking a research and development partnership with a US based diagnostic company to facilitate shared development of the technology. The agreement should generate an early revenue stream for Minerva as well as drive market awareness of the need for Minerva’s molecularly targeted anti-cancer therapeutics.

Minerva used its proprietary nanoparticle technology to elucidate a key molecular mechanism that is involved in cancer stem cell growth and metastasis. Cancer stem cells are the progenitor cells within the tumor that continue to proliferate and repopulate the tumor. As an example of the importance of these cells, recently Oncomed Inc. of Redwood City, CA (private) announced a $1.5 billion partnership with Bristol Myers Squibb for a different cancer stem cell antigen. Minerva’s molecular target is a cell surface receptor, called MUC1, which according to extensive scientific literature is aberrantly expressed on 75% of all human solid tumors – 96% of breast cancers, 47% of prostate cancers, as well as high percentages of ovarian, colorectal, non-small cell lung, and pancreatic cancers. Overexpression is correlated with poor clinical outcome. Using its unique nanoparticle platform, Minerva believes it has discovered the molecular mechanism of cleavage to a new form, called MUC1*, which activates the tumor to unregulated cell growth and metastasis. In collaboration with a leading diagnostic reference lab in the US, Minerva has shown that MUC1* is expressed to much higher levels than MUC1. The Company currently has identified antibody-based and small molecule therapeutics that disable the receptor and block cancer cell growth. These therapeutics are specific to MUC1* and are currently in animal testing. Therapeutics that are targeted against related receptors include OSI’s Tarceva, ImClone’s Erbitux, and Genentech’s Herceptin. Annual sales of these therapeutics are from $0.5-$1.2 billion. However, the distribution of MUC1 and its activated receptor MUC1* in human cancers is much greater than any of these targets. Thus we believe the Minerva technology could be an even bigger blockbuster than any of these validated therapeutics. Currently there are only two companies actively approaching MUC1 therapies. One is using a cancer vaccine that we believe has critical problems due to the biology of the target and the difficulties in cancer vaccines (Phase II testing); the other is using a toxin conjugated to MUC1 (Phase I testing) and we believe Minerva’s patents have earlier claims. Neither company is blocking MUC1*, therefore we believe that Minerva’s technology will be proven as the required approach to targeting the proliferating cancer stem cells.

In association with prestigious investigators from the University of California, Santa Barbara, Minerva has shown that one of its therapeutics will actually enhance human hematopoietic stem cell survival and proliferation. Minerva has filed for extensive patent coverage around this unique and exciting therapy. The Company is currently assessing in animal models whether or not this effect can be extended in vivo to enhance stem cell and blood cell production following chemotherapy. If as predicted, the Minerva lead biologics candidate enhances blood cell production of all lineages following chemotherapy, it could be a major advance in preventing one of the major side effects of chemotherapy. Current competitors include Amgen’s and J&J’s erythropoietin and Amgen’s G-CSF, with combined worldwide sales of approximately $10 billion in 2007.

Minerva intends to progress an antibody-based therapeutic and a small molecule therapeutic through to IND filing (investigational new drug application and the beginning of human clinical trials) over the next two years. Minerva has all of the expertise to accomplish these goals and will outsource the majority of the work. Typical upfront license fees for co-development partnerships by large pharma or biotech for analogous drugs is $25 MM and $200-500MM in milestones and double digit royalties. Recently the pharma model has been to simply acquire the company. For instance, CoGenysis which is developing an albumin linked G-CSF at IND stage, was acquired by Teva recently for $400 MM. Since the Minerva stem cell therapy enhances all hematopoietic lineages (not just neutrophils as does G-CSF), and Minerva has extensive additional technology and drug candidates, we would expect substantially greater valuations.

Minerva is seeking to commercialize its proprietary diagnostic test that identifies MUC1*-positive cancers with a US leading diagnostic reference laboratory. This test predicts prognosis and thus directs the physician to appropriate therapies for that particular patient. Our evidence indicates that this test will also identify which women will adopt early drug resistance to the breast cancer drug Herceptin. These patients would then be treated much more aggressively and potentially with a MUC1*-disabling drug in addition to Herceptin.

Robert Weinberg, Ph.D. is a Founder of the Whitehead Institute and Professor of Biology at MIT. Dr. Weinberg is world renown for his expertise and vision in the basic understanding of the mechanisms that underlie cancers. Weinberg discovered the first oncogene, Ras, and the first tumor suppressor, P53. Professor Weinberg is the head of a new MIT-based Ludwig Center for Molecular Oncology, overseeing a $20 million dollar fund focused on understanding the biology cancer metastasis.

Kenneth S. Kosik, M.D., is a Professor at and Director of the Neuroscience Research Institute at the University of California at Santa Barbara and former Professor of Neurology at Harvard Medical School. Dr. Kosik is a world renowned expert in the research and treatment of Alzheimer’s disease. A NOVA special featured Dr. Kosik and work researching genetic predisposition to Alzheimer’s disease. Dr. Kosik’s work is currently focused on micro RNAs and their role in the regulation of cancer.

Gilbert Omenn, M.D., Ph.D. is Professor of Internal Medicine, Human Genetics, and Public Health at the University of Michigan. Dr. Omenn served as Associate Director, Office of Science and Technology Policy, and Associate Director, Office of Management and Budget, in the Executive Office of the President in the Carter Administration. Dr. Omenn has been a director of Amgen Inc. since 1987.

Peter T. Lansbury Jr., Ph.D., is Professor of Neurology in the Center for Neurological Disease, Harvard Medical School and is a world-renowned expert in the molecular basis of neurodegenerative diseases. Professor Lansbury has received many honors and awards for elucidating the chemical basis of Alzheimer’s and Parkinson’s diseases, and developing an in vitro systems that mimic the diseases.