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Altor, Florida Biologix in IL-15 Pact

Florida Biologix to manufacture anti-cancer agent for early trials

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Altor BioScience and Florida Biologix will collaborate in the development of  ALT-803, an interleukin-15 (IL-15)-based immunotherapeutic, to the clinic as a novel cancer therapy. ALT-803, a proprietary IL-15 super agonist/IL-15Rα-Fc fusion complex, has demonstrated anti-tumor activities in various preclinical cancer models and could potentially make a life-changing difference for patients with solid and hematological tumors, according to a joint statement.

Florida Biologix will manufacture ALT-803 for clinical studies planned for early 2012. Florida Biologix will conduct an engineering run, cGMP manufacturing including mammalian cell culture at 400 L scale and chromatographic purification, formulation and aseptic fill of the cytokine complex. Initially, the product will be evaluated in a Phase I/IIa clinical trial against superficial bladder cancer at M.D. Anderson Cancer Institute in Orlando with the support of a Florida Department of Health – James & Esther King Biomedical Research grant awarded to Dr. Charles J. Rosser, M.D. Altor also plans to initiate other cancer trials using Florida Biologix-manufactured ALT-803.

Altor BioScience’s chief executive officer, Dr. Hing Wong, explained, “We chose to work with an experienced biologics manufacturing team that we believe will deliver a high-quality product within our budget and our aggressive timeline. Altor has successfully worked with Florida Biologix in the past on several fill/finish projects. We are thrilled to be able to expand this relationship with them to move this promising anti-cancer drug into clinical development.”

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