June 28, 2011 Alachua, FL. Altor BioScience and Florida Biologix team up to move an important interleukin-15 (IL-15)-based immunotherapeutic, ALT-803, to the clinic as a novel cancer therapy. ALT-803, a proprietary IL-15 super agonist/IL-15Rα-Fc fusion complex, has demonstrated impressive anti-tumor activities in various pre-clinical cancer models and could potentially make a life-changing difference for patients with solid and hematological tumors. 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 Liter 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 CEO, 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 and finish projects. We are thrilled to be able to expand this relationship with them to move this promising anti-cancer drug into clinical development.”
Florida Biologix Director, Dr. Richard Snyder, stated, “We are appreciative of Altor’s confidence in Florida Biologix’ capability and are excited to be a member of the team to develop this potentially life-changing therapy for cancer patients.”
About Florida Biologix
Florida Biologix® is a Phase I/II biologics contract development, manufacturing and testing organization that offers a range of biopharmaceutical services to the biotechnology industry and research institutes. They provide exceptional customer service, close project collaboration, and clear and honest communication. Florida Biologix’ in-house quality departments reside within the 23,000 square foot, state-of-the-art GMP facility, designed for multi-product bulk substance manufacturing, cell therapy product manufacturing and aseptic vial filling; an adjacent building houses the 5,000 square foot process development laboratories.
Florida Biologix staff are not only experts in biologics manufacturing, based on a foundation of science and engineering, but are also approachable, trustworthy, and believe that the best way to build long-term relationships with clients is through open communication and on-time delivery.
About Altor BioScience Corporation
Altor is a venture-backed, privately held biotechnology company developing targeted immunotherapies for treating cancer, viral infections, and inflammatory diseases based on its proprietary STARTM, tissue factor antagonist and interleukin-15 platform technologies. Altor currently has two product candidates in four mid-stage clinical trials. Phase II trials for ALT-801 and ALT-836, Altor’s lead STARTM and tissue factor antagonist products, respectively, are supported by SBIR Phase II/Bridge grants from NIH/NCI and NIH/NHLBI. Visit www.altorbioscience.com for details.
