Australian firm Telix Pharmaceuticals negotiated a worldwide license to develop and commercialize Wilex’s late clinical-stage imaging agent Redectane®, a radiolabeled form of the monoclonal antibody girentuximab, for cancer imaging applications. The agreement also extends to developing radiolabeled girentuximab as a potential radioimmunoconjugate therapeutic for a range of tumor types. Wilex could receive up to $3.7 million in upfront and milestone payments for the imaging program, plus global sales royalties.
Wilex has already completed an initial Phase III imaging study with Redectane in clear cell renal cell carcinoma (ccRCC). The firm has also been granted a special protocol assessment (SPA) by the FDA for the planned confirmatory Phase III study required to obtain marketing approval. Under terms of the deal, Telix will shoulder all future development, manufacturing, and commercialization costs for the Redectane molecular imaging program. The firm will initially invest in an improved manufacturing process for the antibody. Redectane binds to and accumulates in tumor cells expressing the carbonic anhydrase-9 (CAIX) antigen. Wilex claims that the use of Redectane to enable tumor tissue visualization by positron emission tomography (PET) and computed tomography (CT) could aid in therapy planning for renal cancer patients and could also have utility in the diagnosis, staging, and treatment response in monitoring of other cancer types, including lung and ovarian.
The therapeutic Redectane program will build on early clinical trials indicating that lutetium 177 (177Lu)-labeled girentuximab has disease-stabilizing effects on patients with advanced metastatic renal cancer. Telix will investigate the use of CAIX-targeting agents with beta- and alpha-emitting radionuclides for the potential treatment of a range of tumor types. Wilex would also receive royalties on sales of any therapeutic developed under the agreement.
In October 2016, Wilex's R&D subsidiary Heidelberg Pharma signed a research collaboration with Nordic Nanovector to develop antibody drug conjugates for treating leukemias. In September, Heidelberg Pharma reported an agreement with Celonic, centered on cell line development and antibody production, for Heidelberg’s first antibody-targeted amanitin conjugate (ATAC) candidate HDP-101, for treating multiple myeloma. The Celonic deal followed on from an option agreement signed by Heidelberg with the Max Delbrück Center for Molecular Medicine, centered on the latter’s B-cell maturation antigen antibodies, on which HDP-101 is founded.