Our pipeline of investigational Molecular Nuclear Medicine product candidates addresses a number of significant unmet diagnostic and medical needs.
Investigational Candidates in Clinical Development:
Lutetium Lu 177 dotatate (Lutathera®)Therapeutics
NETSPOT® (SOMAKIT-TATE)Diagnostics: PET
SOMAKIT TOC™Diagnostics: PET
ANNEXIN V-128Diagnostics: SPECT
68Ga PSMA-R2Diagnostics: PET
Lutetium Lu 177 dotatate. Lutetium Lu 177 dotatate is a Lu-177-labeled somatostatin analogue peptide currently in development for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. Lutetium Lu 177 dotatate belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy (“PRRT“), which involves targeting carcinoid tumors with radiolabeled somatostatin analogue peptides. This novel compound has received orphan drug designation from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Lutetium Lu 177 dotatate is also currently administered on a compassionate use and named patient basis for the treatment of NETs and other tumors over-expressing somatostatin receptors in ten European countries and in the US under an Expanded Access Program (EAP) for midgut NETs. NDA and MAA submissions to the FDA and EMA are currently under review.
NETSPOT® (formerly known as Somakit-TATE) and SomaKit TOC™. Somakit-TATE and SomaKit TOC™, or our Somakit products, are novel drug kits for radiolabeling somatostatin analogue peptides to help diagnose somatostatin receptor positive NET lesions. These products have received orphan drug designation from the EMA and the FDA. In June 2016, AAA received the FDA approval for NETSPOT® and in December 2016, the European Commission approved SomaKit TOC™.
Annexin V-128 (99MTc-rhAnnexin V-128). Annexin V-128 is a SPECT diagnostic candidate for the assessment of apoptotic and necrotic processes, which are present in a number of pathological conditions in oncology and cardiovascular disease, as well as in autoimmune disorders. A Phase I trial of Annexin V-128 was conducted at the University of Ottawa Heart Institute in Canada in December 2014 to assess its safety, tolerability, biodistribution and dosimetry in Canada. Annexin V-128 is currently in a Phase I/II trial for the treatment of rheumatoid arthritis and ankylosing spondylitis and two Phase II studies in cardiovascular and cardio-oncology indications.
177Lu-PSMA-R2 and 68Ga-PSMA-R2. 177Lu-PSMA-R2 and 68Ga-PSMA-R2 are in development to treat, image, monitor and stage prostate cancer. 177Lu-PSMA-R2 will be aimed at treating and monitoring prostate cancer and 68Ga-PSMA-R2 should act as its companion diagnostic and help diagnose and stage the disease. AAA has signed an exclusive license agreement with Johns Hopkins University in Baltimore, Maryland to develop and market PSMA-R2, in prostate cancer.
177Lu-NEOBOMB1 and 68Ga-NEOBOM1. NeoBOMB1 is a unique new generation antagonist bombesin analogue targeting GRPR-expressing malignancies. Our plan is to radiolabel NeoBOMB1 to develop a theragnostic pair: 177Lu-NeoBOMB1 for treatment and a 68Ga-NeoBOMB1 for diagnosis. AAA has signed an exclusive license agreement with Erasmus University Medical Center (UMC) and Demokritos National Center for Scientific Research to develop NeoBOMB1. AAA is currently planning three clinical studies in different indications including gastrointestinal stromal tumors, prostate cancer and breast cancer.