France-based Advanced Accelerator Applications (AAA) purchased rights to Italian biopharma Dompé’s FabOvar, an iodine-131-labeled, humanized mAb fragment currently in preclinical development for the treatment of ovarian cancer. The two firms will actively collaborate on the product, with Dompé producing the API and AAA manufacturing the labeled product. They claim FabOvar’s selective binding of the overexpressed α-folate receptor makes it an ideal candidate for the treatment of peritoneal metastasized ovarian cancer.
The FabOvar deal comes just a week after Dompé took a 7.7% equity stake in AAA as part of the latter’s €40 million round of fundraising with new and existing investors. The investment by Dompe was its first in AAA. Dompe’s CEO, Eurgenio Aringhieri was also elected to the AAA board.
AAA was established in 2002 as a spin-out from the European Organization for Nuclear Research (CERN) in Geneva to develop molecular imaging and molecular therapy products for personalized medicine based primarily on its expertise in PET. The firm says it is currently involved in 25 research projects with 71 external academic and commercial partners.
AAA’s lead therapeutic candidate, Lutate (177Lutetium DOTA0 Tyr3-Octreotate), is in late-stage development for the treatment of metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutate is a radiolabeled somatostatine analog designed to selectively target overexpressed somatostatine receptors on tumor cells and destroy them through delivered radiation. Orphan drug designation for the GEP-NET indication has been granted in the U.S. and Europe.
A pivotal European and U.S.-based Phase III study evaluating Lutate will be carried out by CRO Pierrel Research in about 300 GEP-NET patients. AAA says a previous investigator-sponsored study involving over 600 patients at the Erasmus Medical Center in Rotterdam showed that Lutate extended survival by 3.5–6 years in comparision with current treatments including chemotherapy. Lutate also improved quality of life, especially in patients with demonstrating tumor regression, the firm notes.