Pilochem AG, Seibersdorf Labor GmbH and Isotopia announce supply, development, and manufacturing agreements

Collaboration allows Pilochem to secure access to 177Lutetium N.C.A., a medical isotope used in multiple clinical trials for radiopharmaceutical therapies in areas of high unmet medical needs and CMO manufacturing for lead candidate.

Under these agreements, Isotopia will supply high quality 177 Lu-n.c.a to Seibersdorf Laboratories for the purpose of conducting development and manufacturing activities for Pilochem’s proprietary therapeutic candidate, OncoFAP-23.

OncoFAP-23 is a novel small molecule ligand developed for Targeted Radionuclide Therapy which selectively binds to Fibroblast Activation Protein (FAP), an antigen expressed in a variety of solid human malignancies, while being undetectable in most healthy tissues. Philochem’s scientists demonstrated that 177Lu-OncoFAP-23 exhibits, in pre-clinical models, a very high and selective tumor uptake and with a significantly extended residence time at the site of disease, compared to other 177Lu-FAP-ligands.

177Lu n.c.a is used in Targeted Radionuclide Therapy in the field of Precision Medicine in Oncology. By binding n.c.a. 177Lu isotopes to tumor-specific targeting molecules, the resulting radiopharmaceutical targets the tumor and delivers precise cell-killing radiation that spares normal healthy tissue. Isotopia has developed a reliable and unique GMP method to produce a highly pure form of 177Lu.  177Lu n.c.a contains no Mercury (Hg) and no metastable 177Lu-m, therefore there is no need for cost intensive clinical waste management. 

Seibersdorf’s CEO, Martina Schwaiger stated:

"The new agreement is a great opportunity for our team and we are pleased to be working with Philochem and Isotopia Molecular Imaging on this important sector of medical care.” 

Sammuele Cazzamalli, PhD, Head of Small Molecule Therapeutics at Pilochem commented:

"We are delighted to start working with Isotopia and Seibersdorf Laboratories on the manufacturing of our Targeted Radioligand Therapeutics. This collaboration is important to pursue Philochem’s bench-to-bedside translational research, with competitive timelines, on our novel best-in-class 177Lu-OncoFAP-23.”

“This three-way collaboration demonstrates the ability to provide the full support for clinical development” stated Keren Moshkoviz, Director of Business Development at Isotopia. “Isotopia’s aim is to play a significant role in early developments that will benefit patients in the future. We try to build a platform that can drive new products into the clinic in a simple and agile way.

We are excited to work with the Pilochem and Seibersdorf Laboratories team to bring this product to the clinic .”

About Pilochem and the Philogen Group

Philochem is a fully owned subsidiary of the Philogen Group, a Swiss-Italian clinical-stage biotechnology company listed on the Italian Stock Exchange. Philogen is engaged in the discovery and development of novel pharmaceutical and biopharmaceutical products. Philogen’s strategy is to selectively deliver bioactive agents (such as radionuclides, cytokines, or drugs) to the site of disease using antibodies or small organic ligands. This technology has generated a strong proprietary pipeline of clinical-stage products and preclinical compounds in an array of disease indications. Philogen is headquartered in Siena, Italy, and has research activities at its subsidiary company Philochem near Zurich, Switzerland. Philogen has signed agreements with several major pharmaceutical companies.

Contact: Emanuele Puca \ Investor Relations                     
Tel: +41 (0) 43 544 88 00
Email: emanuele.puca@philogen.com                    
www.philochem.ch \ www.philogen.com                                            

About Isotopia

Isotopia Molecular Imaging Ltd. is a dominant 177Lu n.c.a supplier, its development team is a multidisciplinary team consisting of nuclear pharmacists, radiochemists, nuclear engineers, and physicists. The experienced Isotopia team, together with its nuclear pharmacy, cyclotron facility, 177Lu production site and sterile manufacturing plant, are a well-established platform for manufacturing and collaborations. Isotopia creates collaborations between the scientific and medical community to further develop and experiment with new markers for imaging applications and molecular therapy.

Contact: Keren Moshkoviz                         
Tel: +972 (54) 8182398  
Email: KMoshkoviz@isotopia.co.il                      

About Seibersdorf Labor GmbH (Seibersdorf Laboratories)

Seibersdorf Labor GmbH is an Austrian company specialized in high quality laboratory and analysis work, application-oriented research and development as well as consulting and training.

The teams of Seibersdorf Laboratories are service, know-how and technology provider and cover a broad area of scientific expertise: development, production and quality control of radiopharmaceuticals, anti-doping and forensic analysis, radiation protection, ionizing and non-ionizing radiation, radio frequency engineering and electromagnetic compatibility. The experts of Seibersdorf Laboratories represent Austria on various international committees.

Contact: Roland Müller \ Head Pharmaceuticals

 Tel: +43 50 550 3470

Email: Roland.mueller@seibersdorf-laboratories.at


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