NEXT STEPS
The Clone 3 Antibody secreted by the parent cell line created by the company has now been pharmaceutically produced in a form (called the "recombinant" antibody) that will ultimately be used in the treatment of patients. A technical step -- achieved by producing a recombinant antibody protein -- has been successfully achieved to produce the recombinant form which increases and standardizes the pharmaceutical production of the monoclonal antibody.
The required process -- to create the recombinant Clone 3 Antibody -- has been accomplished by first isolating corresponding DNA from the parent cell line genomic blueprint which encodes to produce the existing monoclonal antibody and then inserting the genetic code into a fast producing and FDA approved cell line. With this now accomplished, the newly produced recombinant antibodies are being tested in PBMC-based in vitro neutralization assays against a full panel of live HIV isolates. These tests are being conducted at University of Antwerp, Institute of Tropical Medicine, Antwerp, Belgium and Texas BioMedical Research Institute, San Antonio, Texas. Thereafter, macaque trials will be completed at the Michale E. Keeling Center for Comparative Medicine and Research at M.D. Anderson, Bastrop, Texas.
Clinical trials are planned thereafter -- leading to patient application.
