James Walther
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.
ApoCell
VP Business Development - Diagnostics
Daniel Wang
Oranoxis has a strong R&D team and we are enthusiastic in applying biomedical sciences. We actively pursue quick and accurate solutions for detections of small and big molecules in human body and environment, to help disease diagnosis, drug monitoring, personalized drug monitoring for efficient and safe dosing. We work hard to serve medical professionals, law enforcement, environment protection and personal care.
Oranoxis, Inc.
President
Claire Weston
Vala Sciences
Senior Scientist
Hing C. Wong, Ph.D.
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.
