Business Wire IndiaEczacıbaşı-Monrol Nuclear Products Co. (Monrol) is delighted to announce that it has reached an agreement in principal with FutureChem based in Seoul, South Korea, a radiopharmaceutical company, for the clinical supply of radioisotope, Lu-177 n.c.a. (Lutetium-177 non-carrier-added), to support FutureChem’s Investigational New Drug IND-enabling Phase 2 clinical trial with Ludotadipep, 177Lu-FC705 to assess the efficacy and safety for repeated administration of the recommended Ludotadipep dose in patients with metastatic castration resistant prostate cancer (mCRPC). Clinical supply contract signed by two parties on 18th of Oct 2022 in Barcelona. A new supply contract between Monrol and FutureChem will be signed following the commercialization of the product in South Korea and US.
Monrol General Manager Aydın Küçük,added: “We are delighted to be working with FutureChem to have a clinical supply agreement to support clinical development program of an innovative radiopharmaceutical product Ludotadipep, 177Lu-FC705 to assess the efficacy and safety in patients with metastatic castration resistant prostate cancer (mCRPC). Collaboration with FutureChem is another example of we continue our mission to improve quality of life for cancer patients and transform patient care for the future.”
Dae Yoon Chi, Chief Executive Officer, FutureChem said: “FutureChem is thrilled to be partnering with Monrol, a company with a broad set of offerings to support our development programs and pipeline. We look forward to rolling out the supply of high-quality radioisotopes to our Phase 2a clinical trial patients in US soon. We have a future prospect to expand this partnership, supply of radioisotope, Lu-177 n.c.a. by Monrol for the commercialization of the Ludotadipep, 177Lu-FC705”.
Monrol is one of the world’s largest nuclear medicine companies leading innovation for the development and manufacturing of GMP grade radioisotopes and radiopharmaceuticals having headquarters in Istanbul. Monrol is distributing its world-class radiopharmaceutical products portfolio with excellence in global markets. Monrol is a CDMO, providing early development support to its customers as well as offering fully integrated services for today’s nimble, lean, virtual companies effectively taking new product concepts into clinical trials, demonstrating proof of concept and going into first-in-human studies. Monrol is committed to transform and improve patient journey in cancer treatment with its radiopharmaceutical products portfolio distributing to more than 50 countries around the globe. To learn more, visit www.monrol.com and LinkedIn.
Since its establishment in 1999, FutureChem has led the radiopharmaceuticals industry through research and development. FutureChem is the global forerunner in the production of radiopharmaceutical precursors and compounds, development of remarkable radiopharmaceuticals, and worldwide commercialization of new medicine.
FutureChem developed competitive technologies and innovative products with a mission to grow the company into a world-class radiopharmaceuticals enterprise, so to contribute a healthy and happy society, protecting the health of patients.
For more information, please visit www.futurechem.co.kr
About FC705 and 177Lu-FC705
2nd generation PSMA-targeted therapeutic radiopharmaceuticals. 177Lu-FC705 belongs to the 2nd generation of albumin binders introduced drugs. Its hydrophilicity is higher than that of other compounds, and has low nonspecific binding. 177Lu-FC705 will have constantly increasing uptake in prostate cancer due to the introduction of albumin binder while it will be rapidly excreted from normal organs. In this regard, 177Lu labeled 177Lu-FC705 can be expected to have high therapeutic effect and very low damage to normal organs. Currently, efficacy of 177Lu-FC705 is being clinically tested in Phase 2 in Korea and 1/2a in US.
About n.c.a. Lutetium-177
Lutetium-177 n.c.a is a radioisotope of choice for targeted radionuclide therapy. Lu-177 n.c.a production process enables treatment options that have the potential to improve treatment outcomes for certain cancer patients today and more potential treatment options in future under clinical development. The unique properties of Lu-177 n.c.a. make it a theranostically desirable radioisotope for peptide receptor radionuclide therapy (PRRT) to treat certain cancers like Neuro Endocrine Tumors (NET) and Prostate cancer. N.c.a. Lutetium-177 DMF by Monrol listed by FDA.
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