Orano Med SAS

iStock, JHVEPhoto Thursday’s agreement with Orano Med is the second in as many months. Sanofi in September made its first foray into the radioligand space with a $110 million licensing deal with Orano Med and Texas biotech RadioMedix. Sanofi on Thursday announced a partnership with radiopharma-focused Orano Med, paying approximately $326 million to obtain a 16% stake in the biotech. The companies will work collaboratively to advance next-generation radiotherapies for rare cancers. Leveraging Orano’s expertise in alpha therapies, the partners will discover, design and develop radioligand treatments based on lead-212 alpha-emitting isotopes. Sanofi and Orano have yet to reveal specific disease targets. Sanofi CEO Paul Hudson in a statement said that the agreement “unites our respective expertise in biopharma and nuclear technology to drive groundbreaking progress in the fight against cancer.” The partnership also falls in line with the pharma’s ongoing efforts to reshape and reprioritize its pipeline assets, with a focus on difficult-to-treat malignancies including hematologic cancers and solid tumors with “critical unmet needs,” according to Sanofi. Among Sanofi’s high-priority targets are multiple myeloma, acute myeloid leukemia and certain types of gastrointestinal and lung cancers. Orano’s targeted alpha therapy platform combines two key advancements in cancer therapeutics—the targeted nature of biologic treatments and the “short-range cell-killing capabilities” of radioisotopes, according to the biotech’s website . Candidates developed using this platform consist of an alpha-emitting lead-212 atom, a biological vector and a linker between the two. This structure gives rise to the unique mechanism of action of targeted alpha therapies that allows them to destroy target cancer cells while also minimizing off-target impacts and damage to nearby healthy tissues. According to Sanofi, Orano’s alpha treatments aim to change “the standard of care in some rare cancers,” potentially prolonging patients’ lives while also boosting their quality of life. Sanofi last month made its first foray into the space with a $110 million licensing deal with Orano Med and Texas biotech RadioMedix. At the center of the three-way agreement is AlphaMedix, a lead-212 targeted radioligand therapy, being developed for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Targeted radiotherapies have continued to be an attractive area for Big Pharma investment. Novartis is currently the radiopharma frontrunner with its FDA-approved prostate cancer therapy Pluvicto, alongside the GEP-NETs treatment Lutathera. In August 2024, Novartis put $2.7 billion on the line to further deepen its radiotherapy expertise, inking a peptide discovery partnership with Japan-based PeptiDream to use its platform technology to discover new macrocyclic peptides that it can conjugate into radioligand therapies. Close on Novartis’ heels are Bristol Myers Squibb, which in December 2023 acquired radiopharma specialist RayzeBio for $4.1 billion , and Eli Lilly, which in October 2023 bought Point Biopharma for $1.4 billion .

The Indianapolis buildout follows Orano Med’s decision to start work on a similar facility in Valenciennes, France, to serve the European market. Amid a nuclear medicine boom, France’s Orano Med has chosen the U.S. to establish a manufacturing plant as it progresses on its radiopharma journey. Orano Med—which is working on targeted alpha therapies for cancer—on Thursday inaugurated its first Alpha Therapy Laboratory (ATLab) in Brownsburg near Indianapolis, Indiana. The site marks the world’s first industrial-scale facility dedicated to production of lead-212-based radioligand therapies, according to the company. Radiopharmaceuticals are guided radioactive drugs that can help diagnose diseases in smaller amounts and can treat cancers and other conditions in higher quantities. Unlike current approved beta-emitting-isotope-based radiotherapies like Novartis’ Pluvicto and Lutathera, Orano Med’s approach leverages the alpha-emitting isotope lead-212. Traditionally, radiotherapies have utilized beta particles because beta emitters were more easily available, Julien Dodet, CEO and president of Orano Med, said via email. That said, the Orano CEO figures using alpha particles can help boost the effectiveness of drug prospects. Orano Med has invested $20 million into ATLab Indianapolis, which it says will cover 30,000 square feet of floor space and create 25 new jobs within the company. The Indianapolis buildout follows Orano Med’s decision to start work on a similar facility in Valenciennes, France, to serve the European market. Together, the facilities are expected to allow Orano Med to crank out 10,000 radiopharma doses per year across the globe by 2025. The company aims to be able to produce 100,000 doses by 2030, according to its press release. Orano Med—a subsidiary of the nuclear materials leader Orano—is a clinical-stage biotech working to developing lead-212-based radiotherapies against cancer.  Orano Med CEO Dodet noted that it’s important for radioligand therapy developers to hash out manufacturing and supply early given that radiotherapies must be produced “just-in-time” to be delivered to patients, thanks to the short half-life of isotopes. Despite the growing demand for radiopharmaceuticals—and especially for alpha emitters—existing manufacturing facilities are aging, with many relying on radioisotopes derived from Cold War-era sources or purchased from the U.S. Department of Energy, “which cannot keep up with demand," the CEO added. Radiopharmaceuticals have recently garnered significant interest among oncology-focused companies, with Novartis continuing to lead the charge. While Novartis already markets two FDA-approved radiotherapies, the company showed its continued interest in the field with its recent purchase of Mariana Oncology for up to $1.75 billion. As for its approved radiotherapies, Pluvicto and Lutathera generated a combined $1.6 billion last year. Manufacturers and suppliers have been getting in on the action too, such as CDMO Nucleus RadioPharma, which recently inked its first commercial contract to help manufacture ARTBIO’s Pb212-radiolabeled therapies from its facility in Rochester, Minnesota.

HOUSTON & PARIS--(BUSINESS WIRE)-- 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. “The FDA's Breakthrough Therapy Designation underscores AlphaMedixTM potential as an innovative treatment that could redefine how patients with neurendocrine tumors are treated. We believe that AlphaMedix™ has potential to demonstrate substantial benefit over currently FDA approved PRRT with beta-particle emitters for patients with metastatic or inoperable SSTR-expressing GEP-NETs. The FDA's decision is a great news for patients suffering from this illness, and an important milestone to expedite the development of this new therapy,” said Ebrahim Delpassand, MD, Chairman and Chief Executive Officer of RadioMedix. The Breakthrough Therapy Designation is based on the results from phase 1 and the ongoing phase 2 clinical trials that assessed the safety and efficacy of AlphaMedixTM. In the phase 1 study, treatment was well-tolerated, with a response rate (ORR according to RECIST 1.1) of 62.5% for the GEP-NET patients who had never received PRRT with LutatheraTM, which is based on the beta-particle emitter Lutetium-177. In the phase 2 trial, the target response rate has already been achieved ahead of top-line data, expected in mid-2024. “Receiving FDA Breakthrough Therapy Designation for AlphaMedixTM is a great achievement for everyone involved and confirms the strong interest of the medical community for Targeted Alpha Therapies with lead-212. Based on positive results from our clinical studies to date, we are convinced that Targeted Alpha Therapies, such as AlphaMedixTM, will lead the next generation of radioligand therapies, providing increased cytotoxicity against cancer cells but limited toxicity to adjacent healthy cells. This recognition from the FDA reinforces Orano Med’s commitment to make innovative lead-212-based therapies available to the medical community and patients worldwide,” said Julien Dodet, President and Chief Executive Officer of Orano Med. About Breakthrough Therapy Designation Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). About neuroendocrine tumors Neuroendocrine tumors (NETs) are a heterogeneous group of rare neoplasms that originate from neuroendocrine cells. These neoplasms occur mostly in the gastrointestinal tract and pancreas (GEP-NETs) but can also occur in other tissues including the thymus, lung, and other uncommon sites such as ovaries, heart, and prostate. Most NETs strongly express somatostatin receptors (SSTRs). In the United States, around 12,000 patients annually are expected to be diagnosed with neuroendocrine tumors, with an average 5-year survival rate of 60% at a metastatic stage. About Targeted Alpha Therapy Targeted alpha therapy (TAT) relies on a simple concept: combining the ability of biological molecules to target cancer cells with the short-range and highly energetic cell-killing capabilities of alpha-emitting radioisotopes. Alpha decay consists of the emission of a helium nucleus (alpha particle) together with very high linear energy transfer and a range emission of only few cell layers, resulting in irreparable double strand DNA breaks in cells adjacent only to area of alpha emission. This approach results in an increased cytotoxic potential toward cancer cells while limiting toxicity to nearby healthy cells. As a result, alpha emitters are considered as the most powerful payloads to be found for targeted therapies. About RadioMedix RadioMedix, Inc. is a clinical-stage biotechnology company, and sponsor of the AlphaMedix™ trials, based in Houston and Humble, Texas. The company is focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. RadioMedix is developing radiopharmaceuticals for PET imaging and therapy (alpha- and beta-labeled agents). The company established contract service facilities for academic and industrial partners including a drug discovery center for the early probe development, a pre-clinical core facility for in vitro and in vivo evaluation of radiopharmaceuticals, and cGMP and analytical suite for Phase I-III clinical trials, and the large-scale post-approval commercial manufacturing facility, the Spica Center. More information about RadioMedix, visit: About Orano Med Orano Med is a clinical-stage biotechnology company that develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (212Pb), a rare alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT). The company is developing several treatments using 212Pb combined with various targeting agents. Orano Med has 212Pb manufacturing facilities, laboratories, and R&D centers in France and in the US and is currently investing to further expand its GMP-manufacturing capacities for 212Pb radiolabeled pharmaceuticals in North America and Europe. More information about Orano Med, visit: . View source version on businesswire.com: Contacts Mike Sinclair Halsin Partners +44 (0) 7968 022075 msinclair@halsin.com Source: Orano Med View this news release online at: