Methods and composition for cell-based therapy as well as somatostatin receptor-based therapy are described. For example, in certain aspects methods for administering an anti-tumor therapy using a signaling defective somatostatin receptor mutant are described. Furthermore, the invention provides compositions and methods involve a somatostatin constitutively active somatostatin receptor mutant.

The present disclosure relates to the synthesis of radionuclide complex solutions, in particular for their use in the commercial production of radioactive drug substances, for diagnostic and/or therapeutic purposes. In particular, the synthesis method comprises the following steps in the following order: a. providing a radionuclide precursor solution into a first vial, b. transferring the radionuclide precursor solution into a reactor, c. providing a reaction buffer solution into said first vial containing residual radionuclide precursor solution, d. transferring the buffer reaction solution and residual radionuclide precursor solution from said first vial into the reactor, e. transferring a peptide solution comprising the somatostatin receptor binding peptide linked to a chelating agent, into the reactor, f. reacting the somatostatin receptor binding peptide linked to a chelating agent with said radionuclide in the reactor to obtain the radionuclide complex, g. recovering said radionuclide complex.

The present disclosure relates processes and systems for producing and/or purifying .sup.68Ga from an irradiated substrate of .sup.68Zn. In some embodiments, the process rely on the use two cation-exchange chromatography columns to separate .sup.68Ga from .sup.68Zn and other radionuclides and metallic impurities. The process achieves a high overall yield of .sup.68Ga and a high effective molar activity while being implementable in a time compatible with the short half-life of .sup.68Ga. In additional embodiments, the process is implemented by an automated system.

The present invention relates to formulations of radiolabelled compounds that are of use in radiotherapy and diagnostic imaging.

The present invention provides a dosage-specific treatment for lung and neuroendocrine tumors with a targeted radiotherapeutic somatostatin analogue, Re-P2045 in combination with topotecan or a histone deacetylase inhibitor. Patients are selected and dosing is determined using a technetium-labeled somatostatin analogue, .sup.99mTc-P2045.

The present invention relates to radionuclide complex solutions of high concentration and of high chemical stability, that allows their use as drug product for diagnostic and/or therapeutic purposes. The stability of the drug product is achieved by at least one stabilizer against radiolytic degradation. The use of two stabilizers introduced during the manufacturing process at different stages was found to be of particular advantage.

The present invention relates to radionuclide complex solutions of high concentration and of high chemical stability, that allows their use as drug product for diagnostic and/or therapeutic purposes. The stability of the drug product is achieved by at least one stabilizer against radiolytic degradation. The use of two stabilizers introduced during the manufacturing process at different stages was found to be of particular advantage.

In some aspects, the present disclosure provides compositions comprising an N4-based MMC ligand, a cell targeting group, and a fluorophore or a therapeutic compound comprising a formula: ##STR00001##
wherein the variables are as defined herein. In some embodiments, these compositions may be used in the imaging techniques or in the treatment of a disease or disorder such as cancer.

Methods and compositions for treating, diagnosing and staging cancers, in particular overexpressing the Human Epidermal growth factor Receptor 2 protein (HER2+) given rise to in breast, gastric, gastroesophageal, ovarian, pancreatic cancer and brain tumors, which may be metastatic to the brain or other site. More specifically, the invention provides for Targeted Radionuclide Therapy (TRNT) with a compound of the invention having a peptide that targets the HER2+ cells, a second component for combining metals into complexes through a ring structure (DOTA), and a third radioisotope component, Lu-177 and Ga-68, in which embodiments further include a companion diagnostic, and in which embodiments further include anti-integrin precision medicines for cancers expressing αvβ3 and αvβ5 integrins, HER2+, vascular endothelial growth factor, vitronectin, fibronectin, tenascin, reelin, kindlin and talin. TRNT may be administered alone or in combination with standard-of-care; an immunooncologic and/or chemotherapeutic, adjuvantly or neoadjuvantly.

##STR00001##

A chelator having the general structure (I) for chelating ra-diometals such as .sup.225Ac under mild conditions is provided. (I) The chelator can be coupled to a biological targeting moiety to facilitate targeted delivery of the chelated radiometal in a mammalian subject.