On May 15, 2024 Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Mnemonic: ALOPM), a biopharmaceutical company specializing in precision medicine for the treatment of resistant and metastatic cancers, and Navigo Proteins GmbH (Halle, Germany), a biopharmaceutical company specializing in the discovery and development of Precision Medicine applications based on the Affilin technology platform, reported the signature of a strategic collaboration agreement for the discovery and development of new systemic radiotheranostic agents (Press release, Navigo Proteins, MAY 15, 2024, View Source [SID1234643378]).
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OPM operates three technological platforms dedicated to precision medicine. OncoSNIPER is a technology using AI to select and validate new therapeutic targets involved in resistant and metastatic cancers, in particular kinases and targets expressed specifically on the tumor cell surface. The aim is to discover and develop new kinase inhibitors based on the Nanocyclix technology platform and new radioligand therapy agents from its 3rd technology platform, Promethe.
The construction of radiotheranostics is based on the identification of a specific target on the cancer cells’ surface (surface antigen), and on small molecule, peptide, antibody or small protein (like Affilin) targeting molecules that are highly specific for the identified target, enabling radioactivity (emitters a, β+- or γ) to be delivered to the tumor cell and thus triggering its detection and destruction. This therapeutic approach has already been clinically proven in the treatment of metastatic prostate cancer (Pluvicto; Novartis) and inoperable or metastatic gastroenteropancreatic neuroendocrine tumors (Lutathera; Novartis).
OPM has chosen Affilins, a proprietary technology from Navigo Proteins GmbH, as biological targeting molecules to support its Promethe platform.
Affilins are small proteins derived from human ubiquitin, a protein naturally present in all cells. A huge number of ubiquitin variants are available in large libraries where each variant is modified in a slightly different way on its surface and has lost its natural biological functions but potentially binds to a given target structure. Phage display selection and screening is applied to identify Affilins that bind selectively and with high affinity to the targeted surface antigen, like antibodies. The molecular weight of Affilins is 1/15th of an antibody improving the pharmacokinetics, particularly the distribution and route of elimination which is predominantly through the kidney. Unlike antibodies, Affilins are resistant to proteases, acids and bases and are highly thermostable facilitating their radiolabeling. Because they are human derived, Affilins have a low immunogenicity risk (unwanted immune reaction after injection). The molecules have no post-translational modification like antibodies which allows their production in simple bacterial systems. Affilins are highly engineerable and can be combined with other functional elements, enabling a modular design of molecules, adapted to clinical needs. For all these reasons, Affilin molecules are ideal for use as radiotheranostic targeting molecules.
Navigo Proteins GmbH, a protein engineering company based in Halle, Germany, is headed by a strong and experienced team committed to leveraging Affilin technology in multiple areas. This collaboration will enable OPM and Navigo to build a first-class entity in the field of radioligand therapy based on the complementary strengths of the two companies. Navigo’s Board is composed of leading professors and scientists in the field of radioligand therapy, such as Oliver Buck (co-founder of ITM and member of the board of directors of Telix Pharmaceuticals).
Under the terms of the agreement, research will initially focus on two different targets in the field of oncology, particularly in resistant and metastatic digestive tract tumors, and molecules will be developed to the stage of drug candidates. Oncodesign Precision Medicine will fund this program over the next 3 years. This agreement is a first step towards a strong strategic alliance between OPM and Navigo Proteins GmbH with the vision to expand the partnership to additional targets.
Philippe GENNE, Co-founder, Chairman and CEO of Oncodesign Precision Medicine, said: " This strategic alliance will provide OPM with the opportunity to rapidly develop its portfolio of radiotheranostics and leverage its extensive knowledge and expertise in the discovery of next generation radioligand therapies. This is a promising therapeutic area that will revolutionize the treatment of inoperable and metastatic tumors. We are proud and delighted to benefit from the technology developed by Navigo, our partner in this collaboration, which in addition to its expertise in terms of Affilin engineering, is also a bio-industrial company with the ability to support innovative bioprocessing of Biologics, often a delicate stage in the development of such molecules. Our objective is to build a world-class player in the field of radioligand therapies in the near future."
Jan HOFLACK, Co-Founder and Chief Medical Officer of Oncodesign Precision Medicine added: " Our Promethe technology represents the 3rd key element in our fight against cancers without therapeutic solution. It is highly complementary to our other technologies, Oncosniper and Nanocyclix. These 3 approaches enable us to position ourselves on metastatic and resistant cancers, using immuno-oncology and radiotheranostics. These methods could be used in synergy in the future. Navigo’s Affilins give us access to a cutting-edge platform in terms of targeting vectors. The strengths and expertise of OPM and Navigo are highly complementary, which is the main reason for our alliance. Despite the logistical challenges associated with these radioligand therapy molecules, their potential to act both as imaging diagnostics at low doses and with an appropriate radioisotope, and as therapeutics at higher doses and with an isotope able to annihilate cancer cells, make them tremendous tools to fight cancers without a solution for the benefit of patients."
Henning Afflerbach, CEO of Navigo Proteins GmbH, concludes: "Our collaboration with Oncodesign Precision Medicine provides us with the ideal opportunity to advance our platform in radiotheranostics towards clinical application. Our proprietary Affilin technology offers unparalleled modularity combined with exceptional biodistribution properties making Affilins invaluable tools in our quest to revolutionize cancer treatment. By leveraging OPM’s expertise in preclinical development, targeted oncology and bio-industrial capabilities, we are keen to tackle together key challenges in targeted therapeutics development. Our alliance with OPM underscores the synergy between our strengths and expertise, aiming to deliver innovative solutions that benefit patients worldwide."
About radiotheranostics
This is a radiotherapy technique used in nuclear medicine in the field of oncology. Unlike external radiotherapy, irradiation is targeted by molecules able to bind to tumors. These are radiolabeled and administered intravenously, in the same way as chemotherapy or other targeted therapy. External radiotherapy is currently used in more than 50% of clinical protocols in oncology, but it is only feasible in the case of a single tumor or a limited number of tumors (oligometastases). Radioligand therapies, on the other hand, are well suited for the treatment of disseminated metastases.
Technologically, radioligand therapies are based on the administration of a targeting molecule containing a radioactive isotope (= radiopharmaceutical) aimed at specifically destroying tumors. Its effectiveness comes from the highly localized energy released in radioactive decay, which results in cell death preferentially of tumor cells, while not damaging adjacent healthy tissue. These particle-emitting radioisotopes are directed at targets over-expressed by tumor cells, using highly specific targeting molecules capable of recognizing and attaching to them. The specificity of the targeting molecule for a tumor marker enables healthy tissue to be spared and guarantees greater efficacy while limiting side effects, a strategy that is particularly well suited to disseminated diseases.
One of the advantages of radioligand therapies is the potential to create a theranostic agent, i.e. a radiopharmaceutical which, depending on the nature of the radiation from the chosen isotope, enables diagnostic imaging (prediction/therapeutic monitoring, β+ or γ emitters) or patient therapy (β-, α, auger emitters).