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.

AlphaMedix^TM 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.

AlphaMedix^TM entered Phase 2 clinical trials in 2021 to assess its efficacy in the treatment of neuroendocrine tumors.  After completing recruitment of patients who had never previously received radioligand therapy in 2023, recruitment of the second cohort of patients who progressed after receiving it was also completed in 2024. 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 AlphaMedix^TM (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). AlphaMedix^TM 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. 

• More results on the AACR Journals site

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:

• 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

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

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.

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.

In 2024, Orano Med and Molecular Partners announced  the debut of their lead Radio-DARPin therapy candidate MP0712, targeting DLL3 and radiolabeled with lead-212, in an oral presentation. The data presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 Annual Meeting provide strong support for MP0712’s clinical development in small-cell lung cancer  and other DLL3+ neuroendocrine tumors. 

The preclinical data presented at SNMMI include results from in vivo studies demonstrating strong and homogeneous tumor uptake of ²¹²Pb-DLL3 RDT, as well as significant and durable inhibition of tumor growth at clinically relevant doses. The safety results seen across the tested dosing levels in mice suggest a favorable safety profile and potential for clinical use. ²¹²Pb-DLL3 RDT candidates were engineered by tuning their biophysical properties to achieve an optimal safety/antitumor activity profile in vivo. The selected lead candidate, MP0712, demonstrated a promising biodistribution profile in mouse xenograft tumor models, with close to 60% of injected dose detectable in the tumor and encouraging tumor to kidney ratios over two.  

Check out the présentation : ²¹²Pb-DLL3 Radio-DARPin shows promising Preclinical Antitumor Efficacy in Small Cell Lung Cancer

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. 

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.

Following the promising results of MP0712, Orano Med is developing a second molecule with Molecular Partners. 

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. 

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.

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.

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.

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.