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, the objective response rate (ORR) endpoint has already been achieved.

The United States Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to AlphaMedixTM (212Pb-DOTAMTATE) for the treatment of adult patients with unresectable or metastatic, progressive somatostatin receptor expressing gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who are naïve to peptide receptor radionuclide therapy (PRRT). AlphaMedixTM is the first Targeted Alpha Therapy to receive Breakthrough Therapy Designation.

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. 


Expanded access policy:

Currently, RadioMedix, Inc. and Orano Med, do not offer an expanded access program and are not accepting expanded access requests for AlphaMedix™. Our development resources are focused on conducting clinical trials that evaluate the safety and efficacy of our treatment. 

If you have additional questions about RadioMedix and Orano Med’s expanded access policy, please email us at support@radiomedix.com and partner@oranomed.com.  


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-PSMA

Prostate cancer

Program

212Pb-PSMA is a peptide targetting PSMA (Prostate-Specific Membrane Antigen) radiolabeled with 212Pb against prostate cancer developed by Orano Med. 

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.

212Pb - DARPin-DLL3

Small-cell lung cancer

Program

Orano Med has entered into a collaboration with Molecular Partners to develop a platform of Targeted Alpha Therapies using DARPIns radiolabeled with 212Pb. DARPin therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins capable of powerful and highly selective targeting of tumor cells. A single DARPin candidate can engage more than five targets, and its flexible architecture and small size offer benefits over other currently available protein therapeutics. The DARPin platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields.

Partner

Molecular Partners AG is a clinical-stage biotech company developing DARPin (designed ankyrin repeat protein) therapeutics. The Company has formed partnerships with leading pharmaceutical companies to advance DARPin therapeutics in the areas of oncology and virology and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas. 

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 PRRT

Undisclosed target

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. Orano Med uses biotechs developing phage display technologies to optimize the discovery of targeting peptides.

Partner

Phage display platform : 48Hour Discovery is a company with a dynamic peptide discovery platform that has revolutionized drug discovery through its innovative approaches to peptide design. Leveraging cutting-edge technologies, the platform accelerates the identification and optimization of peptides with therapeutic potential, offering a novel pathway to addressing unmet medical needs.

212Pb PRRT

Undisclosed target

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. Orano Med uses biotechs developing phage display technologies to optimize the discovery of targeting peptides.

Partner

Phage display platform : Orbit Discovery Ltd is a peptide discovery company focused on the use of novel bead and microfluidic technology platforms to improve the throughput of functional screening. The Orbit technologies encompass target protein expression and purification, including multi-spanning membrane proteins; affinity screening to identify panels of target binding therapeutic candidates; and functional screening in cell-based assays.

212Pb PRRT

Undisclosed target

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. Orano Med uses biotechs developing phage display technologies to optimize the discovery of targeting peptides.

Partner

Phage display platform : Biosynth secures life science supply chains with manufacture and supply of high-quality products thanks to its expertise and capability run across Complex Chemicals, Peptides and Key Biologics. Knowing of the importance of 3D conformation for many biological interactions, Biosynth’s peptide discovery chemists are experts in discovering and optimizing constrained peptides, using the proprietary CLIPS™ technology, that bind the target protein of interest.

212Pb PRRT

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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