Ryvu Therapeutics & BioNTech Enter Global Collaboration to Develop & Commercialize Immuno-Modulatory Small Molecule Candidates

Ryvu Therapeutics S.A. and BioNTech SE recently announced the companies have entered into a multi-target research collaboration for several small molecule immunotherapy programs as well as an exclusive license agreement for Ryvu’s STING agonist portfolio as stand-alone small molecules.

The global collaboration will consist of two parts: BioNTech will receive a global, exclusive license to develop and commercialize Ryvu’s STING agonist portfolio as stand-alone small molecules, including as monotherapy and in therapeutic combinations. In addition, BioNTech and Ryvu will jointly undertake drug discovery and research projects to develop multiple small molecule programs directed at exclusive targets selected by BioNTech, primarily focused on immune modulation within oncology, with potential applications in other disease areas. BioNTech has the option to license global development and commercialization rights to these programs at the development candidate stage.

“Small molecules targeting novel immune signaling pathways have a great potential to increase the efficacy of cancer immunotherapies,” said Prof. Ugur Sahin, MD, Chief Executive Officer and Co-Founder of BioNTech. “The collaboration with Ryvu provides us with the opportunity to complement our immunotherapy pipeline with a portfolio of potent immunomodulatory molecules.”

“Ryvu is excited to bring its expertise in immuno-oncology to work with a global leader in the development of immunomodulatory targeted therapies,” added Paweł Przewięźlikowski, Chief Executive Officer, Ryvu. “BioNTech’s expertise in immunomodulatory mechanisms is a great match for Ryvu’s platform, and we fully expect to develop differentiated, therapeutically effective and safe molecules with our combined expertise.”

Under the terms of the agreement, BioNTech will pay Ryvu an upfront fee of €20 million in exchange for certain rights to Ryvu’s STING agonist portfolio as standalone small molecules and for certain rights and options to license multiple small molecule programs as part of a multi-target research collaboration. In addition, BioNTech has committed to make an equity investment of €20 million.

BioNTech will fund all discovery, research and development activities, including Ryvu’s discovery and research activities under the multi-target research collaboration. Ryvu will be eligible to receive success-based development, regulatory and commercialization milestone payments, as well as low single-digit royalties on the annual net sales of any products that are successfully commercialized under the collaboration.

The STING pathway plays a critical role during infections and autoimmune disease, but also is one of the key innate immunity pathways responsible for antitumor immunity, as it’s activated by tumor-derived DNA. Therefore, therapeutic targeting of STING is a potential new target for cancer therapies as it leads to potent activation of innate and adaptive immune response. In preclinical studies, as presented at SITC 2021 and AACR 2021, Ryvu’s STING agonists activated all STING haplotypes and led to high activation of proinflammatory cytokine production and long-lasting immune responses after systemic administration in vivo.

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific immune checkpoint modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, visit www.BioNTech.com.

Ryvu Therapeutics S.A. is a clinical-stage drug discovery and development company focused on novel small-molecule therapies that address emerging targets in oncology. Internally discovered pipeline candidates make use of diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinase, synthetic lethality, and immuno-oncology targets. Ryvu’s most advanced programs are RVU120 – a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in Phase I clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome, and Phase 1/2 for the treatment of r/r metastatic or advanced solid tumors, and SEL24 (MEN1703) – dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently in Phase 2 clinical studies in acute myeloid leukemia. The company was founded in 2007 and is headquartered in Krakow, Poland. Ryvu is listed on the Warsaw Stock Exchange and is a component of the sWIG80 index. For more information, visit www.ryvu.com.