Pipeline

AlphaMedix^TM is a somatostatin receptor targeting peptide radiolabeled with ²¹²Pb. Somatostatin receptors are overexpressed in most neuroendocrine tumors, a heterogeneous group of rare neoplasms that originate from neuroendocrine cells. These neoplasms occur mostly in the gastrointestinal tract and pancreas, but can also occur in other tissues including thymus, lung, and other uncommon sites such as ovaries, heart, and prostate.

After the promising results of the Phase 1 clinical trial launched early 2018, a Phase 2 was initiated late 2021 to assess the efficacy of Alphamedix^TM in the treatment of neuroendocrine tumors. The study is currently recruiting patients in the US.

Find out more :

• www.clinicaltrials.gov
• Presentation of preliminary results of the phase 1 on the website of The Journal of Nuclear Medicine

RadioMedix, Inc. is a clinical stage biotechnology company, based in Houston, Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is developing radiopharmaceuticals for PET imaging and therapeutic (alpha and beta-labeled) radiopharmaceuticals. RadioMedix has also established 21 CFR 211 compliant contract service facilities for academic and industrial partners: Full cGMP manufacturing and analytical suites for human clinical trials, and commercial phase manufacturing of the radiopharmaceuticals, in addition to small animal Molecular Imaging Center for the pre-clinical evaluation of new targets in vitro and in vivo.

• Our partners: RadioMedix and Excel Diagnostics & Nuclear Oncology Center.

²¹²Pb-GRPR is an anti-GRPR (Gastrin-Releasing Peptide Receptor) peptide radiolabeled with ²¹²Pb developed by Orano Med targeting different types of solid tumors including several types of breast and prostate cancer tumors. Based on promising preclinical results, Orano Med has obtained the FDA's approval to launch investigations of a new drug. The phase 1 clinical trial commenced at the end of 2022 and is enrolling patients in the US.

• Find out more : www.clinicaltrials.gov

Due to longer accumulation of antibodies targeting antigens expressed by solid tumors (usually several days), Orano Med is developing new approaches to label ²¹²Pb to peptides offering a more suitable pharmacokinetic profile for ²¹²Pb half-life. Orano Med is working on several targets expressed in various type of cancers.

²¹²Pb-PRIT program (pre-targeted radio immunotherapy) is a joint development program with Roche to create a novel, advanced alpha radioimmunotherapy platform to target and kill cancer cells with a specific focus on malignant disease with a high unmet medical need.

Roche is a Swiss pharmaceutical company and the world leader in the oncology field. Orano Med and Roche launched a strategic alliance in 2012 to develop a new platform. As part of this new alliance, Roche and Orano Med have built a research laboratory located in France dedicated to the co-development of targeted alpha therapy.

Alpha 37 is a ²¹²Pb-conjugated anti-CD37 antibody under development for the treatment of chronic lymphocytic leukemia, orphan diseases with still significant unmet medical needs. CD-37 is an interesting target as it is widely expressed in a number of hematological malignancies.

Nordic Nanovector is a Norwegian biopharmaceutical company dedicated to extending and improving the lives of patients with hematological cancers through the development and commercialization of innovative targeted therapeutics. Nordic Nanovector and Orano Med signed a collaboration agreement in 2016 to investigate the potential of a ²¹²Pb-conjugated anti-CD37 antibody.

Orano Med has entered into a partnership with Crescendo Biologics in order to explore the benefits of use of VH antibodies in applications of Targeted Alpha Therapy.

Crescendo Biologics is a biotechnology company specialized in the development of enhanced T cells and their application in oncology. Crescendo Biologics and Orano Med signed a collaboration agreement in 2021.

Orano Med is one of M²OLIE's partners in the project “Navigated molecular diagnostics and therapy”, coordinated by the Emb-Lab of the Mannheim University of Applied Sciences. The project focuses on the development and implementation of methods for automated situation recognition. Orano Med’s objective is to collaborate with Mannheim University’s teams to develop new targeting compounds to be labeled with ²¹²Pb.

M²OLIE (“Mannheim Molecular Intervention Environment“) is one of nine Research Campuses in Germany that have been funded by the Federal Ministry of Education and Research since 2012 as part of the “Research Campus – Public-Private Partnership for Innovation” Initiative. The goal of M²OLIE is to establish the M²OLIE Closed Loop, a patient-centered and time-optimized infrastructure for innovative tumor therapies.