Pipeline

A Diverse pipeline of 212Pb-labeled compounds


Based on the unique properties of 212Pb, Orano Med is developing a multi asset portfolio to combine 212Pb with diverse biological vectors targeting or binding to different specific cancer receptors or antigens. Our pipeline is composed of a mix of partnered compounds and internal developments.

AlphaMedixTM

Neuroendocrine tumors

Program

AlphaMedixTM 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.

AlphaMedixTM obtained particularly promising results in the phase 1 trial launched in 2018. The treatment was well-tolerated and a response rate (ORR: objective response rate according to the RECIST 1.1 method) of 67% was observed. In addition, a supplementary cohort of patients already having received a radioligand therapy and in whom the disease had progressed was recruited. A response rate of 60% was measured in these patients.

AlphaMedixTM entered Phase 2 clinical trials in 2021 to assess its efficacy in the treatment of neuroendocrine tumors. The last patient never previously having received radioligand therapy was included in 2023. Remarkably, based on the responses observed up till this date, 38% of patients had already responded to the treatment, a response rate which is twice that of other treatments currently available.

In an initial efficacy study, a single 10 µCi cycle of 212Pb-DOTAMTATE allowed the median life span of mice to be extended by a factor of 2.4. The efficacy was then improved by administering 3 cycles of 212Pb-DOTAMTATE and by decreasing the timing between cycles from three weeks to two weeks. Efficacy was further enhanced by adding a chemo-sensitizing agent, 5-fluorouracil, given in combination of three cycles of 212Pb-DOTAMTATE. These conditions yielded 79% tumor-free animals at the end of the 31-week study. 

Find out more :

Partner

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.

212Pb-GRPR

Solid tumors

(breast and prostate cancer)

Program

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.

212Pb PRRT

Solid tumors

(several targets)

Program

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

Solid tumors

Program

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.

Partner

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

Leukemia / Lymphoma

overexpressing CD37

Program

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.

Partner

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.

212Pb TAT / Crescendo Biologics

Undisclosed target

Program

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.

Partner

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.

212Pb TAT / M²OLIE

Undisclosed target

Program

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.

Partner

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. 

212Pb PRRT

Several targets

212Pb TAT

Several targets

Undisclosed

212Pb TAT

Several targets

Undisclosed

Partner with us

Orano Med has developed a strong expertise in the development of radiopharmaceuticals using 212Pb and is looking for new partners willing to add one of the most powerful payloads to their biological vector. Vectors with high specific affinity, a fast accumulation in tumor tissues, and rapid excretion as well are of particular interest to us! Don't hesitate to contact us: partner@oranomed.com

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