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Company Background

A&G Pharmaceutical (A&G), founded in 2000, is a privately held company based in Columbia, Md. A&G uses proprietary technology for rapid development of monoclonal antibodies (mAB) to unique cancer-specific theranostic targets, to develop novel therapy/diagnostic combination products that address a broad range of cancers. A&G holds a proprietary position on the detection and treatment of diseases related to the growth factor GP88 (progranulin). The company is currently developing a therapeutic mAB to treat lung and breast cancer. A&G has also developed clinically validated proprietary companion diagnostic products to identify and monitor patients treated with mAB. The company employs 22 people.

Technology Overview

Several peer reviewed studies have demonstrated that glycoprotein GP88 has a critical role in the proliferation and survival of cancer cells. A&G has developed a recombinant therapeutic anti-GP88 to treat cancers overexpressing GP88. Direct validation of GP88, as a novel therapeutic target, was provided by inhibition of GP88 expression and function in breast carcinoma cells resulting in both reduced proliferation in vitro and reduced malignancy in vivo. Xenograft data demonstrates that anti-GP88 is useful for the treatment of breast and lung cancers as a single agent. When used in combination with Tamoxifen in Tamoxifen-resistant tumors, anti-GP88 restores Tamoxifen sensitivity, leading to significant tumor reduction. Restored sensitivity to Tamoxifen and other anti-estrogen therapies is a major breakthrough, more than 50 percent of all patients on anti-estrogen develop resistance de novo or during treatment. Similar results were obtained with chemo resistant lung cancers. A&Gs pre-clinical candidate is ready to enter IND-enabling acute and repeat dose toxicology studies in primates.

Market Potential

GP88 therapy can address two leading cancers in the U.S., including: breast (220,000 new cases; 40,000 deaths annually) and lung (200,000 cases;160,000 deaths) cancers. More than 50 percent of lung cancer patients die within 5 years. There is an unmet need for targeted lung cancer therapies, especially among cancers that are chemo resistant. In the case of breast cancer even for Tamoxifen, a leading drug used to treat breast cancer, 40-50 percent of patients do not respond to initial treatment, while the majority of those patients that do respond can have the cancer become resistant during treatment. A&G has developed diagnostic kits to identify patients who are de novo resistant or who are becoming resistant and thus identify patients that are suitable for anti-GP88 therapy.

Competitive Advantage

• GP88 is uniquely placed as a novel biological target for development of products for oncology:
• GP88 is a critical biological player in development, proliferation and survival, and drug resistance for several cancers
• GP88 expression in tumor tissue has been statistically shown to be a prognostic indicator of poor patient outcome (disease-free and overall survival)
• GP88 is secreted by cancer cells and detectable in blood, making it an important target for therapeutic and diagnostic product development
• Inhibiting GP88 with mAB reduces tumor growth and reverses resistance to hormone therapy in breast cancer
• 2 GP88 Diagnostic tests have been clinically evaluated: (1) Tumor levels are prognostic, (2) Blood levels are linked to tumor growth and can be used to monitor treatment

Herceptin remains the last major combination therapeutic and companion diagnostic co-development in oncology. GP88 is positioned to be the next major theranostic product.

Financial Overview

A&G Pharmaceutical’s financial overview includes:

• Seed capitalization of $1.5 million in 2002
• Closed a Series A round of $2 million in 2005
• Raised a total of $6.4 million in 2006 in form of strategic investment. As part of license agreement with Celltrion they agreed to provide cash and candidate development including initial manufacturing process development and materials for toxicology.
• Completed Series B prime financing of $4 million 2008.
• Profits from sales of custom monoclonal antibodies (www.precisionantibody.com); anticipated revenues for 2012 are more than $2.8 million.
• Seeking a $5.0 million investment to fund toxicology and first-in-human clinical studies.

Intellectual Property

Fifty patent applications and 49 patents (15 U.S. patents) granted worldwide covering therapy and diagnostic use of GP88.

Commercialization Strategy

A&G will enter safety/efficacy clinical studies of anti-GP88 in lung/breast cancer. During early clinical trials, A&G will pursue agreement(s) with key player (s) in the pharmaceutical/biotech industry active in the field of oncology. Such agreement(s) will dictate the commercialization strategy for anti-GP88.

Pipeline Products

GP88 has been implicated in several cancers and as such A&G is interested in developing its proprietary theranostic pipeline for use in cancers of the GI, prostate, and brain. Using A&G’s proprietary antibody development technology the company is researching other cancer biomarkers for development along the theranostic pathway.

Management Team

A&G’s CEO, Ginette Serrero, Ph.D., has 25 years of experience in cancer research and 10 years in biotech management and has been instrumental in directing A&G’s vision and assembling the management team.

VP of Drug Discovery, Randy Barton, Ph.D., was previously the director of drug discovery, Boehringer Ingelheim, and has 20 years of experience validating small-molecule and biological drug candidates.

VP of R&D Jun Hayashi, Ph.D., is an immunologist and inventor of A&G’s proprietary mAB technology.

COO Michael Keefe, MBA, is seasoned in raising capital and managing the growth of start-ups.

VP of Product Management, David Hicks, has more than 20 years of experience with diagnostic products and clinical development.

Company Background

AcuityBio is a preclinical stage company focused on the commercialization of the company’s unique biocompatible, biodegradable drug delivery platform technology to prevent post-surgical locoregional tumor recurrence in early-stage lung cancer patients. AcuityBio’s formation in 2010 stemmed from a collaboration between lung cancer thoracic surgeon Dr. Yolonda Colson (Brigham and Women’s Hospital) and Professor of Chemistry/Biomedical engineering Mark Grinstaff (Boston University). Together with Drs. Grinstaff and Colson, AcuityBio was co-founded in 2010 with CEO Jay Schwartz, Ph.D., and co-inventor of the technology and Director of Research, Jesse Wolinsky, Ph.D. AcuityBio currently has two full-time employees.

Technology Overview

AcuityBio has developed chemotherapy-eluting ABC Mesh™ based on their proprietary slow-release, biodegradable ABC Polymer™ for the prevention of locoregional lung cancer recurrence. It functions by delivering paclitaxel locally at a slow and predictable rate directly at the resection site following lung cancer tumor removal surgery. This maintains a localized high level of drug while minimizing side effects without affecting healing, which will result in better patient outcomes. AcuityBio is currently evaluating applying ABC MeshTM to select soft tissue orphan oncology indications that have a high recurrence rate. This will allow a shortened time through a first-in-human trial as an “orphan” indication and accelerated FDA approval. AcuityBio has developed ABC Mesh to the preclinical stage, focusing on Chemistry Manufacturing and Control, engineering, and securing key manufacturing and supplier CMO/CRO vendor relationships. 

Market Potential

Lung cancer is responsible for more deaths annually in the U.S. than breast, colorectal, and prostate cancers combined. Surgical removal of the tumor (resection) is the standard of care for early-stage lung cancer patients, yet lethal, locoregional tumor recurrence continues to afflict about half of the 50,000 patients per year who receive surgical treatment with curative intent. 

Each year in the U.S., 221,000 new lung cancer cases are reported. Roughly one-quarter of these patients (about 50,000/year in the U.S.) will be considered candidates for surgical resection (the standard of care). The cost to the health care system resulting from the 50 percent endemic cancer treatment failure in the U.S. alone is a staggering $1 to $2 billion per year. Other early stage cancers also suffer from high locoregional recurrence rates, including stage II colorectal cancer (50,000 patients) and breast cancer lumpectomy patients (71,000). Several soft tissue “orphan” oncology indications more than 50,000 patients per year.

Competitive Advantage

Existing drug-eluting polymer products on the market do not possess the properties that are required for the development of an ideal soft tissue compliant, biocompatible, biodegradable drug-eluting implant with tunable drug release. ABC Mesh has all these features. ABC Mesh is an easy-to-manufacture, widely applicable drug delivery platform, which can predictably and locally deliver insoluble and water-sensitive drugs to soft tissue for more than 50 days. The implant has already been proven to be biocompatible (ISO10993), biodegradable, and physically compliant and capable of slow, controlled drug delivery.

Financial Overview

AcuityBio has received almost $3 million in non-dilutive capital through NIH, SBIR Phase I and II, government and Coulter Foundation grants, which will be sufficient to advance their ABC MeshTM program to a first IND. The company seeks $3.5 million to help propel its first product through preclinical and to Phase I safety trials for early-stage non-small-cell lung cancer and to support the clinical development of its orphan drug first-in-human trials

Intellectual Property

AcuityBio has negotiated with Boston University and Brigham and Woman’s Hospital-Harvard/Partners to obtain exclusive world-wide rights to issued patent (U.S. 7,671,095) and three pending patents covering compositions and methods of use. The company has determined it will have a freedom to operate clear of prior art.

Commercialization Strategy

The value proposition of ABC Mesh is that it combines clinical differentiation, ease of use, and positive patient impact at lower overall cost per patient. Thoracic surgeons, hospital purchasing agents, group purchasing organizations will be the company’s main customers. Customers will be compelled to choose ABC Mesh because of its compelling clinical data, key opinion leader, and contract sales channels. 

Pipeline Products

ABC Mesh is a platform technology that has been specialized to deliver water-insoluble or water-sensitive drugs that are traditionally difficult to formulate for administration. The company can tune the drug release rate and the implant’s degradation rate depending on the application. AcuityBio is actively pursuing other clinical indications including orphan indication that would benefit from their localized delivery technology. 

Management Team

John ‘Jay’ Schwartz, Ph.D., Co-Founder, CEO, and Chairman, has more than 20 years in life sciences technology development. He was research faulty at MIT working on drug delivery, is experienced in private equity fundraising, and has succeeded in securing multiple U.S. government grants. He co-founded the venture-backed engeneOS, bought by ADNEXUS, which was acquired by Bristol-Myers Squibb in 2007. Jay received his Ph.D. in Biochemistry and Molecular Biology from New York Medical College and pursued postdoctoral work at Harvard and MIT in drug delivery, protein engineering, and cardiovascular medicine.

Jesse Wolinsky, Ph.D., Co-Founder and Director of Research, is a co-inventor of the ABC Mesh. He holds a doctorate in Biomedical Engineering from Boston University and a Bachelor of Science in Materials Science and Engineering from the University of Florida where he specialized in Polymer Chemistry. 

Company Background 

Altor BioScience Corporation is a privately held, venture-backed, development-stage company engaged in the discovery and development of high-value, targeted immunotherapeutic agents for the treatment of cancer, viral infection, and inflammatory diseases, based on three revolutionary technology platforms. Altor was formed in 2002 by Hing C. Wong, Ph.D., and is based in Miramar, Fla., with 22 employees.

Technology Overview

Altor, a clinical-stage biopharmacteutical company with multiple on-going Phase II trials, has developed technology to produce biologically active, soluble T-Cell-Receptor molecules in a single-chain format (scTCR). These scTCRs can be modified into STAR™ fusion agents, which retain the ability of the TCR to specifically recognize novel targets on cancerous or virus-infected cells, including intracellular antigens that are not accessible to therapeutic antibodies. STAR molecules are ideally suited to deliver anti-cancer and anti-viral drugs, such as immunomodulatory cytokines, cytotoxic drugs, radioisotopes, and imaging agents, directly to diseased cells. Altor has developed a high-affinity scTCR that recognizes a peptide antigen derived from p53, which is over-expressed in roughly 50 percent of all human cancers. ALT-801 is a fusion of this p53-specific scTCR and the approved anti-cancer drug, Interleukin-2 (IL-2). ALT-801 is designed to deliver the IL-2 directly to the tumor site providing greater efficacy, lower toxicity, and better quality of life for patients.

Market Potential

ALT-801 would provide benefit to patients with bladder cancer, multiple myeloma, and melanoma. In 2010 in the U.S., 68,130 new cases of melanoma were diagnosed and 8,700 deaths occurred due to melanoma. In 2008, there were approximately 822,770 people alive in the U.S. who had a history of melanoma. It also estimated that 70,530 new cases of bladder cancer were diagnosed and 14,680 deaths occurred due to bladder cancer in the U.S. in 2010, and that there were approximately 537,428 people alive in the U.S. who had a history of bladder cancer in January 2008. In addition, an estimated 64,615 people in the U.S. were alive in 2008 with a history of multiple myeloma. This represents a market opportunity of over $3 billion in the U.S. alone. Bladder cancer, a major unmet medical need, is currently Altor’s main development focus.

Competitive Advantage

STAR agents significantly broaden the spectrum of tumor- and virally-specific antigens that can be targeted for therapeutic intervention. Altor has demonstrated scTCRs can be used to create targeting molecules to recognize antigens that cannot be targeted by monoclonal antibodies for diagnostic or therapeutic purposes. Although there are no TCR-based products on the market, monoclonal antibodies for cancer had sales of $24 billion in 2010. 

Financial Overview

Altor has raised $35.5 million in paid-in capital from institutional investors, including Sanderling Ventures and Florida Growth Fund, as well as from high net worth, private individuals. The company has been awarded $14 million in SBIR awards from NIH, FDA, and Gates Foundation grants. Altor is seeking $20 million in financing to support and complete the pivotal trial using ALT-801 for locally advanced and metastatic bladder cancer to gain accelerated approval.

Intellectual Property

STAR technology and ALT-801 are the subjects of 37 issued patents and 51 pending applications, including USP #7,456,263, EP 1,546,188. 

Commercialization Strategy

Altor’s short-term objectives are to continue clinical development of its lead product candidates, ALT-801 and ALT-803, through proof-of-principle Phase II clinical trials and then license these to a major biopharma/pharma partner for further development/commercialization. On a case-by-case basis, Altor will consider conducting a registration trial for FDA product approval.

Pipeline Products 

• ALT-801 (p53-TCR/IL-2 fusion protein) 
• Phase II for treating metastatic melanoma (NCT01029873) 
• Phase II for locally-advanced/metastatic bladder cancer (NCT01326871)
• Other Phase IB/II trials for superficial bladder cancer, multiple myeloma - supported by $3 million SBIR Bridge grant
• Phase I/IIAdonor lymphocyte infusion to treat Acute Myeloid Leukemia (NCT01478074) 
• ALT-836 (anti-Tissue Factor Antibody partnered with Genentech) 
• Phase II for treating ALI/ARDS (NCT00879606) and Phase I/IIA for solid tumors (NCT01325558)
• ALT-803 (non-targeted IL-15 super agonist/IL-15R-Fc fusion complex) 
• Pre-IND for treating solid and hematological tumors

Management Team

Hing C. Wong, Ph.D., President and CEO, is a 28-year veteran providing leadership, overall direction, fundraising, IND filing, and oversight of multiple products in clinical trials/commercialized. He has raised $65 million in private capital. 

Dean Taylor, Ph.D., Chief Business Development Officer, has 30 years of experience and is responsible for business development, contracts, strategy, and concluding deals.

Peter Rhode, Ph.D., Vice President, R&D, leads product development, supervises R&D and manages the manufacturing and IP portfolio, and oversees IND filings.

Jeff Weber, M.D., Ph.D., Consulting Medical Director, supports clinical development strategy and planning, and is a renowned clinical research oncologist and senior member of Moffitt Cancer Center.

Company Background

ApoCell, Inc., was founded in 2004 by Darren W. Davis to commercialize biomarker technologies that monitor the effectiveness of cancer drugs by measuring biomarker expression patterns in tumor biopsy specimens. ApoCell provides molecular analytical services supporting clinical trials for pharmaceutical/biotechnology companies, government, and academia. The company mission is to be in the forefront of scientific and technological developments for providing highly effective molecular diagnostic services and products to significantly improve the treatment and outcomes for people afflicted with cancer and other chronic diseases. ApoCell scientists have investigated and developed laboratory techniques that provide highly accurate mechanistic, predictive, and prognostic cancer information. 

ApoCell has seen continued growth in revenue from its service business since its inception. In 2011, ApoCell made the Inc. Magazine’s 500/5000 list with more than a 400 percent growth rate over the past three years and ranked the 13th fastest growing company in Houston, Texas. ApoCell has 41 employees and continues to hire additional staff to support the continued growth of its service and product development businesses. 

Technology Overview

The ApoStream™ system uses dielectrophoresis field-flow fractionation (DEP-FFF) technology to capture rare circulating tumor cells (CTCs) from blood. Growing evidence suggests that capture of CTCs from a blood sample may allow reliable early detection and molecular characterization of cancer for diagnosis or relapse and provide a minimally invasive method to guide and monitor the efficacy of cancer therapy. CTCs represent a potential alternative to tumor biopsy as a real-time ‘liquid biopsy’ and have been shown to be a prognostic indicator of survival. 

The ApoStream™ point-of-care (POC) is currently in the alpha prototype stage and will be launched as a Research Use Only Device (RUO) in the fall of 2012. ApoCell anticipates the final POC device will become a foundational platform for several next-generation diagnostics based on molecular profiling of CTCs for tailoring patient-specific therapy. 

Market Potential

A report by BCC Research indicates that the total global annual market for next-generation cancer diagnostics was $776 million in 2010, and is growing at a compound annual growth rate (CAGR) of 47 percent, to reach a forecast market size of $5.3 billion in 2015. Current clinical applications of CTCs have been shown to predict overall survival in breast, prostate, and colorectal cancer.

Competitive Advantage

The ApoStream™ rare cell capture technology is an improved approach from current marketed technology, in that it is the first device that enables antibody-free capture of viable cancer cells from a wide range of human cancers, including non-epithelial cancers or cancers with low or negative epithelial expression. The captured cells are not modified (no labeling or fixing) thereby enabling the cancer cells to be cultured and allowing RNA/DNA and protein analysis for complete cell characterization. 

ApoStream’s ability to capture viable, unlabeled CTCs from cancer patients will contribute to significant improvement for diagnosis, prognosis, and discovery of biomarkers associated with cancer progression and treatment, thereby advancing the clinical application of personalized medicine.

Financial Overview

Currently, ApoCell has funded the majority of its operations from its pharmaceutical and clinical trial services business. 

In 2009, a private equity investment of $5 million was raised for the development/commercialization of the ApoStream technology, and to expand the capabilities of the services business. 

In January of 2010, ApoCell was awarded a $2.9 million contract from the NCI/SAIC for development and delivery of 12 alpha research use only (RUO) prototypes along with several pre-clinical diagnostic applications. Subsequently, a SBIR Phase I grant for $200,000 was awarded to begin conversion of the RUO device into a clinical POC device.

ApoCell is currently looking for $10 to $15 million to further implement the technology into the ApoCell research services business and to fund the next development and commercialization stage of the ApoStream POC device.

Intellectual Property

ApoCell has an exclusive license from the University of Texas MD Anderson Cancer Center to commercialize the ApoStream technology. There are five patent families and 22 patents included in the license agreement. In addition, the company continues to file its own intellectual property (IP) and has several agreements with major pharma/biotech companies that permit ApoCell additional diagnostic rights. 

Commercialization Strategy

ApoCell plans to establish strategic partnerships with companies that can provide appropriate distribution channels for each stage of the device. Discussions are ongoing with several larger companies to target the RUO and clinical in vitro diagnostics (IVD) markets.

ApoStream will be rolled out in the following three phases during its development: 

• Research Only Device (RUO) – Academic, pharma/biotech research environment, and fee-for-service work
• Clinical Sample Device (IUO) – Internal services, diagnostics development, and analytical instruments markets
• In Vitro Diagnostic Device (IVD) – For use as a clinical instrument providing diagnostic assays

Pipeline Products

The ability to capture viable CTCs from various cancer types will allow researchers to culture these rare cells to advance scientific knowledge, including discovery of novel drug targets on these metastatic cells. Further, capturing adequate numbers of CTCs will allow for RNA/DNA molecular characterization and protein expression analysis.

Management Team

Darren W. Davis, Ph.D., President and CEO/CSO, is a world-recognized cancer researcher who has published 40 scientific articles and edited the book Antiangiogenic Cancer Therapy. 

David K. Hasegawa, M.S., is Vice President of Product Development. 

Kenna Anderes, Ph.D., is Vice President of Scientific Affairs.

Glen A. Ferguson, MBA, is Vice President of Molecular Biomarkers.

Jim M. Walther, MBA, is Vice President of ApoStream Business Development and Strategic Partnerships. 

Natalie Gassen, C.P.A., is Chief Financial Officer.

Vlada Melnikova, M.D., Ph.D., is Director of Molecular Biology.

Company Background

Arbor Vita Corporation (AVC) was founded in 1998, based on technology initiated at Howard Hughes Medical Institute (HHMI) at Stanford University. AVC focuses on the development of novel diagnostics and therapeutics using the proprietary PDZ platform to improve health care worldwide. AVC was the first to obtain FDA clearance for a rapid test for H5N1 Avian Flu in 2009, and it is now moving into commercialization of the HPV E6 Test. AVC also maintains a program to develop a treatment for HPV-induced cancers. Currently the company has 30 employees and several consultants. 

Technology Overview

PDZ protein domains play important regulatory roles in the cell. The AVC PDZ proteome platform combines informatics and chemistry to identify and validate important biological targets for development. Using its PDZ proteomic technology, AVC has developed one diagnostic product (H5N1 rapid test) 510(k) cleared by the FDA, a suite of diagnostics for HPV malignancy (one of which just completed a successful clinical trial), and a companion therapeutic for HPV cancer currently in pre-clinical development. The HPV E6 oncoprotein test platform addresses HPV neoplasia like cervical cancer, anal cancer, and oral cancers. In the clinical trial conducted by PATH (Seattle) and CICAMS (Chinese Academy of Medical Sciences, Beijing) the AVC E6 test achieved analytical sensitivity of less than 1,000 transformed cells, 99 percent specificity, and a positive predictive value (PPV) of 33 percent in a general screening population. In contrast current screening technologies (like Pap and HPV DNA/RNA) achieved lower specificity and a 5 percent PPV. The AVC HPV E6 rapid test that completed the clinical trial is suited for use in near point-of-care settings in developing countries and also physician’s offices.

Market Potential 

The current cervical cancer screening market is more than $1 billion in the U.S. Current screening technologies lack specificity which leads to over treatment and more testing. The AVC E6 test addresses this concern with a test that is 99 percent specific. In addition, the improved analytical sensitivity permits earlier detection of cervical cancer (and potentially anal and head-and-neck cancers) that is crucial for survival and to decrease morbidity associated with surviving cancer. AVC plans to commercialize the HPV E6 Test within the next two years.

Competitive Advantage 

Current cervical cancer screening (Pap and HPV DNA/RNA tests) suffers from low specificity, best captured by the term PPV. The 5 percent PPV typically seen in screening technologies means only 5 percent of the positives have disease and 95 percent do not. Low PPV leads to more testing, higher cost and greater morbidity. The HPV E6 Test achieves a 33 percent PPV for high-grade disease in the same general screening population. The improved PPV means better screening efficiencies, lower costs, and better outcomes for the patient.

Financial Overview 

The HPV E6 oncoprotein detection platform is supported by SBIR grants and private investments. To accelerate the commercialization of this new technology, AVC will require an infusion of $10 to $20 million in new investments.

Intellectual Property 

Most IP associated with the technology was developed by AVC and is patent protected in the U.S., Europe, and Asia. Ancillary patents to enable commercialization of this product have been licensed.

Commercialization Strategy 

AVC’s HPV E6 oncoprotein detection platform can be used in point-of-care settings, high-throughput reference labs, and as augmentation to traditional pathology lab assays. The initial focus will be non-U.S. countries, with an emerging middle class, that have not invested in the health care infrastructure that exists in the U.S. and Europe. This approach favors new technologies able to bypass current practices to provide improved care at a lower cost. AVC also plans to introduce its technology in the U.S. initially through specialty labs, and then to established medical communities.

Pipeline Products 

AVS’s initial focus is to commercialize the HPV E6 Test, followed by adapting the E6 platform to fit various environments. AVC also has a drug in pre-clinical development to address HPV-related cancer treatment and prevention.

Management Team 

Peter Lu, M.D., Founder and CEO, trained at Caltech, Stanford, and University of Washington with a background in medicine, molecular biology, and oncology.

Johannes Schweizer, Ph.D., VP of Research and Development, trained at Institute Pasteur and Stanford with a background in genetics, molecular biology.

Olga Petrauskene, Ph.D., Director of Commercialization, formerly at ABI.

Charles Trimble, Chairman, founded Trimble Navigation and is a successful entrepreneur who has brought new technology into practical use, such as GPS.