Synektik SA

ISTANBUL & SEOUL--(BUSINESS WIRE)-- Eczacıbaşı-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”. ENDS About Monrol 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 and LinkedIn. About FutureChem 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 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.

Manufacturing giant Lonza can add more FDA-approved therapies to its repertoire. The company announced that two therapies manufactured at its Houston site, Zynteglo and Skysona, have netted commercial approval in Q3 of this year. Both drugs are made by bluebird bio and were approved in August and September . This marks three cell and gene therapies that Lonza makes in Houston. Lonza’s cell and gene therapy manufacturing site in Houston had passed pre-licensing inspection for viral vector manufacturing and then eventual manufacturing of the cell therapies in 2021 and 2022 respectively. “The two new approvals represent an important milestone for bluebird bio and the patients who can now benefit from these therapies. The successful approvals reflect our colleagues’ dedication to supporting our customers in bringing these cell and gene therapies to market,” said Alberto Santagostino, SVP and head of cell and gene technologies at Lonza, in a statement. Japanese giant Eisai has opened the doors to a new facility. The company has finished construction on its new injection/research building called the “Eisai Medicine Innovation Technology Solutions” (EMITS). The building, which cost Eisai 10 million yen ($68 million) will be Eisai’s home for formulation and modality research, including areas such as antibodies, ADCs and other small molecules. The site will manufacture materials for clinical trials as well as have other capabilities for testing and research. Construction on the 11,000-square-meter, three-story building began last year at the Kawashima Industrial Park, which is Eisai’s manufacturing base. German manufacturer Evonik has netted a “long-term supply agreement” with Phathom Pharmaceuticals to develop and eventually commercialize drugs to counter gastric acid-related diseases. The agreement will see Evonik produce large-scale volumes of vonoprazan at its manufacturing facilities in Tippecanoe, IN, and Dossenheim, Germany. “The manufacture of vonoprazan requires multi-step syntheses involving complex chemistries. We are delighted to be able to bring the right mix of technologies and assets to this collaboration,” said Thomas Riermeier, head of the health care business line at Evonik, in a statement . While no other details of the deal were disclosed, the move comes as Evonik is making some moves in Tippecanoe. This summer , Evonik announced plans to build a new, global-scale production facility for producing pharmaceutical lipids at the Tippecanoe site. The total investment for the site will amount to $220 million. Charles River is leaning further into AAV production with the introduction of a new piece of technology. The company has launched its “nAAVigation vector platform” which aims to streamline the path of AAV production without the need for a lot of process development. According to the company, the platform can reduce the manufacturing of viral vector gene therapies by around 55%, and down to around eight months. The platform is based on a proprietary cell line, which can help with its clients’ “scale-up and serotype needs.” It also allows for AAV programs to scale up to 500L. “The launch of the nAAVigation Vector Platform process is the latest in a series of portfolio enhancements aimed at supporting our cell and gene therapy clients from early target identification through clinical-stage manufacturing. By increasing speed and efficiency for viral vector production, nAAVigation will help accomplish our ultimate goal of delivering safe, effective therapies to patients faster” said Kerstin Dolph, the corporate SVP for biologics solutions at Charles River, in a statement . Monrol, a Turkish-based manufacturer of radiopharmaceuticals, is looking to the heart of Europe for its next project. The company will establish a legal entity and a manufacturing site in Germany. The site will manufacture radiopharmaceutical products for radioligand therapies that are used to treat cancer patients on behalf of clients. The site is expected to be opened by 2026 and will cost Monrol €30 million ($29.3 million). However, no other details such as the size or the location in Germany have been revealed so far. Endpoints News reached out to Monrol for more details but did not receive a comment. The company currently has 14 manufacturing sites, with six in Turkey and others dotted throughout the world including Bulgaria, Romania, Dubai, Egypt, Libya, Kuwait, Pakistan and Iraq.

LOS ANGELES, Oct. 4, 2022 /PRNewswire/ -- ImaginAb Inc., a global biotechnology company developing 89Zr crefmirlimab berdoxam (CD8 ImmunoPET) imaging agent and next generation therapeutic radiopharmaceuticals (RPT), is pleased to provide the following business update. Summary: ImaginAb has made significant progress this year in its clinical development plans as it pursues the goal to achieve regulatory approval of CD8 ImmunoPET imaging agent across multiple geographies and increases the number of partnerships using this technology. In January 2022, ImaginAb announced a major expansion of its pipeline with four active programs focused on the development of Radiopharmaceutical Therapies (RPT). CD8 ImmunoPET Progress: ImaginAb continues the clinical development of CD8 ImmunoPET with a target to file a Biologics License Application (BLA) submission in the next two years. The clinical development program consists of company and investigator-sponsored studies. Phase I IBM study: In August 2021, ImaginAb completed its Phase I IBM study showing utility of CD8 ImmunoPET to detect disease pathology in Inclusion Body Myositis (IBM) patients. Phase IIa 'BOT' study: In December 2021, ImaginAb completed recruitment of its Phase IIa 'baseline-on treatment' (BOT) study and in July 2022 it concluded the 12-month follow-up process of subjects and has now entered the data analysis stage. Preliminary analyses are encouraging, and initial findings will be shared at the Society of Immunotherapy of Cancer (SITC) conference being held in Boston, in November 2022. Phase IIb 'iPREDICT' study: ImaginAb formally launched its Phase IIb 'iPREDICT' study to measure CD8 ImmunoPET imaging predictivity and prognosis, building on the data from its promising Phase IIa 'BOT' study. The study aims to enrol 80 patients over 22 sites across US, Australia, and Europe, focusing on many cancer types including Melanoma, Merkel Cell, Renal Cell, Non-Small Cell Lung Cancer and selected solid tumors. Data is anticipated in 2024. In this study, Roche is providing access to atezolizumab (Tecentriq®) to Non-Small Cell Lung Cancer Patients. Phase IIb iCiT study: ImaginAb started recruitment in June 2022, which is being performed in conjunction with Memorial Sloan Kettering Cancer Center (MSKCC) and funded by the Melanoma Research Alliance and ImaginAb with the goal to collect whole tumor samples to provide additional supportive evidence for diagnostic performance and explore utility of CD8 ImmunoPET in the neoadjuvant setting. ImaginAb supports the exploration and expanded use of CD8 ImmunoPET by exploring alternative indications and provision of funding to investigator-initiated studies. COVID-19: In June 2022, University of California Davis presented preliminary data regarding the utility of CD8 ImmunoPET in imaging COVID-19 patients. CD8 ImmunoPET Partnership Agreements: Over the last year, ImaginAb has signed multiple partnership agreements with several biotech and pharma companies to license its technology, demonstrating third party endorsement and establishing ImaginAb's pioneering CD8 ImmunoPET technology as integral to immuno oncology clinical trials in countries all over the world. ImaginAb has publicly disclosed and announced the following partnerships: Multi-year license agreement with Bayer to use CD8 ImmunoPET imaging agent in its oncology trials at clinical sites across multiple countries License agreement with international biotechnology company, Genmab A/S, to utilize CD8 ImmunoPET in its clinical trials, accessing ImaginAb's global supply chain Signed agreements with two leading iCRO's allowing them to provide ImaginAb technology more widely to pharma and biotech customers. Agreement to supply global, industry-leading imaging CRO company, Invicro LLC, with CD8 ImmunoPET for use in pharma and biotech clinical and preclinical studies Partnership expansion enabling the world's largest oncology-focused imaging CRO, Imaging Endpoints, to supply CD8 ImmunoPET direct to biopharma for use in clinical trials in oncology, IBM, and COVID-19. Exclusive Territorial Licensing Agreement : In May 2022, ImaginAb signed an exclusive license agreement with DongCheng Pharmaceutical Group, the second largest radiopharmaceutical company in China, to utilize and commercialise CD8 ImmunoPET in pharma and biotech clinical trials in China. ImaginAb has agreed to receive substantial milestone and royalty payments. CD8 ImmunoPET Global Manufacturing Agreements: Having entered into multiple productive clinical supply and global manufacturing agreements (GMA) this year, ImaginAb has established a leading global network for manufacturing and distributing its CD8 ImmunoPET imaging agent. These GMA agreements include: Turkey-based radiopharmaceuticals company, Monrol, to supply, manufacture and distribute CD8 and radiopharmaceutical isotopes for ImaginAb's iPREDICT study and other partner pharma studies PharmaLogic, the fastest growing radiopharmaceutical manufacturer in North America, to manufacture and distribute CD8 ImmunoPET for ImaginAb. On September 12th, 2022, the GMP contract manufacturing organization (CMO) successfully delivered the first tracer dose to a US clinical site. The production launch increased ImaginAb's manufacturing and distribution capacity in North America, providing additional flexibility in clinic scheduling for injection and scan for immune-oncology clinical trials. DuChemBio, South Korea's leading radiopharmaceutical company, agreed to supply, manufacture, and distribute CD8 ImmunoPET to pharma sponsored trials in South Korea and other Asian countries which are new to ImaginAb. RadioPharmaceutical Therapy (RPT) Progress : ImaginAb announced in summer 2021 that it had active programs developing RPT agents based on its proprietary minibody and cys-dibody platforms. In less than one year, the team have identified potential clinical candidates for two cancer targets and is currently initiating IND enabling studies. To support this work and to secure isotope supply for clinical studies and commercialization, ImaginAb announces the following supply agreement: Next-generation nuclear technology company, SHINE Technologies, agree to supply (n.c.a.) lutetium-177 for the clinical development of ImaginAb's investigational radiopharmaceuticals Commenting on ImaginAb's progress this year, Ian Wilson, Chief Executive Officer of ImaginAb, said: "The leadership team at ImaginAb is excited to be making progress with our own clinical studies as we pursue our goal to file BLA submissions for 89Zr crefmirlimab berdoxam across multiple geographies, in addition we have expanded our pipeline further into the radiopharmaceutical therapy field. We have had a transformational year which has seen ImaginAb complete many key development milestones. We currently have licensing agreements with more than fourteen different customers and repeat business from existing customers including Astra Zeneca, Pfizer and Boehringer Ingelheim, enable use of our product in their clinical trials. We look forward to continuing our progress into 2023." About ImaginAb ImaginAb is a clinical stage, revenue-generating biotech company, with offices in the United States and the United Kingdom. ImaginAb is focused on developing next generation imaging and therapeutic radiopharmaceuticals (RPT) based on their proprietary Minibody and Cys-diabody platform. 89Zr crefmirlimab berdoxam (CD8 ImmunoPET agent) is currently in Phase II clinical trials and is used by numerous Pharmaceutical and Biotech companies in their immuno-oncology clinical trials.   The company has a clearly defined purpose and growth strategy, enabling them to work closely with research and commercial partners to transform patient care, and help people live better and healthier lives. For more information visit About CD8 ImmunoPET The 89Zr crefmirlimab berdoxam (CD8 ImmunoPET) imaging agent is an 89Zr-labelled minibody that has been designed to bind to the CD8 receptor on human T cells and is used for quantitative, non-invasive PET imaging of CD8 T cells in patients. CD8 T cells are the main effector cells involved in the immune response against tumor cells induced by immunotherapies and they also play a key role in multiple autoimmune diseases. As such, quantitative imaging of CD8 T cells may be used to diagnose the immune status of a patient, to measure the efficacy of immunotherapies and has potential to predict patient outcomes. SOURCE ImaginAb