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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.