Sanofi, RadioMedix, and Orano Med announce licensing agreement on next-generation radioligand medicine for rare cancers
As part of its effort to develop innovative treatments for people living with rare cancers, Sanofi has entered into an exclusive licensing agreement with RadioMedix, Inc., a US clinical-stage biotechnology company developing radiopharmaceuticals for PET imaging and targeted alpha therapy (TAT) against unmet medical needs in cancer, and Orano Med, a French clinical-stage biotechnology company, subsidiary of the Orano Group, developing lead-212 (212Pb) radioligand therapies (RLTs) against cancer.This collaboration between Sanofi, RadioMedix and Orano Med focuses specifically on the late-stage project, AlphaMedixTM (212Pb-DOTAMTATE), which currently is being evaluated for the treatment of adult patients with unresectable or metastatic, progressive somatostatin-receptor expressing neuroendocrine tumors (NETs), a rare cancer. AlphaMedixTM is a TAT which consists of a somatostatin receptor-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles.
First Targeted Alpha Therapy to receive a Breakthrough Therapy Designation
RadioMedix, Inc. and Orano Med, two clinical stage radiopharmaceutical companies, today announced that 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 a Targeted Alpha Therapy currently in Phase 2 clinical development, which consists of an SSTR-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles. Due to their high energy and short path length, alpha emitters enable specific targeting and killing of individual cancer cells, while minimizing toxicity to surrounding healthy tissue. AlphaMedixTM is the first Targeted Alpha Therapy to receive Breakthrough Therapy Designation.
RadioMedix and Vect-Horus announce first dosing of Glioblastoma Multiforme and Pancreatic ductal adenocarcinoma patients with 68Ga-RMX-VH
RadioMedix and Vect-Horus are pleased to announce that they have successfully dosed the first patients in an exploratory Investigational New Drug (eIND) application to evaluate 68Ga-RMX-VH for the diagnostic of Glioblastoma Multiforme (GBM) and Pancreatic ductal adenocarcinoma (PDAC). This radiotracer will serve as a companion diagnostic for future Targeted Alpha Therapy (TAT) for these cancers. 68Ga-RMX-VH is a positron-emitting tomography (PET) agent that targets the Low-Density Lipoprotein Receptor (LDLR) overexpressed in some solid tumors such as GBM and PDAC. The objective of this exploratory study is to evaluate the safety, dosimetry, and bio-distribution of 68Ga-RMX-VH in patients with solid tumors. GBM is the most common malignant primary brain tumor in adults and is a serious and life-threatening disease. PDAC is one of the most chemo-resistant and radio-resistant types of cancers due to the dense pancreatic connective tissue and the diversity of genetic mutations.
RadioMedix announces a $40 million Series A financing for the advancement of novel Targeted Alpha Therapy platform and diagnostic companion radiopharmaceuticals to address unmet needs in oncology. Michael Lee-Chin appointed to the board of the company.
RadioMedix, Inc. (“RadioMedix” or “Company”), a clinical-stage biotechnology company announced the arrangement with Portland Investment Counsel Inc. (“Portland”) to complete an equity round of $40 million of a Series A funding round. Radiomedix is committed to the advancement of a targeted alpha therapy (TAT) pipeline and diagnostic companion radiopharmaceuticals for rare and aggressive cancers.
The proceeds of the financing will be applied to developing RadioMedix’s flagship radiopharmaceutical AlphaMedixTM, a lead-212 (Pb212) labelled somatostatin analogue TAT agent for the treatment of metastatic or inoperable somatostatin expressing neuroendocrine tumors, in addition to other diagnostic and therapeutic (theranostic) radiopharmaceuticals that are under development by the Company to address needs in oncology.
RadioMedix and Orano Med Complete Patient Enrolment in Phase II Trial of Targeted Alpha-Emitter AlphaMedix in Neuroendocrine Cancers
RadioMedix and Orano Med, two clinical stage radiopharmaceutical companies, today announced that the last patient has been dosed in the Phase II trial of the targeted alpha emitter therapy, 212Pb-DOTAMTATE (AlphaMedix™). This trial is being conducted to evaluate the safety and effectiveness of AlphaMedix™ in peptide receptor radionuclide therapy (PRRT) of naive patients with somatostatin receptor-expressing neuroendocrine tumors (NET), regardless of the location of the primary tumor. Top-line data from the trial is expected in mid-2024. Remarkably, based on data already collected, the objective response rate (ORR) endpoint has already been achieved and is more than twice as high as the current standard of care.
RadioMedix Inc. Announces the Acquisition of its 225Ac-PSMA I&T program, a Targeted Alpha Therapy (TAT) for Metastatic Castration Resistant Prostate Cancer, by Fusion Pharmaceuticals Inc.
RadioMedix, Inc. (“RadioMedix” or “Company”), a clinical-stage radiopharmaceutical company announced the acquisition of it’s 225Ac-PSMA-I&T asset by Fusion Pharmaceuticals. Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. 225Ac-PSMA-I&T is currently being evaluated under a phase 2 physician-sponsored investigational new drug (IND) under the acronym of TATCIST trial. RadioMedix will also provide manufacturing support to Fusion for the TATCIST trial and first pivotal clinical trial to evaluate the safety and efficacy of 225Ac-PSMA-I&T for metastatic castration-resistant prostate cancer (mCRPC). As currently designed, the trial is expected to evaluate approximately 100 patients with four treatment cycles per patient, occurring every eight weeks. Patients are initially dosed at 100 kBq/kg.
