“The potential of Voyager-V1, which has shown early clinical activity in patients with solid tumors, encourages us,” says Alise Reicin, Head of Global Clinical Development in the Biopharmaceutical Sector at Merck KGaA, Darmstadt, Germany, who works as EMD Serono in the United States and Canada. “We look forward to exploring how the combination of Voyager-V1 and Avelumab can advance patient care.” ROCHESTER, Minn. – July 18, 2018 – Vyriad Inc., a clinic, an individual-managed Biotechnology Society, which focuses on the development of first-rate oncolytic virotherapy, is pleased to announce a cooperation agreement with Merck KGaA, Darmstadt, Germany, and Pfizer to have its Phase 1 solid tumor clinical trial program combined with a combined study with an anti-PD-L1 antibody. For more information on this new immuno-oncology association study, see clinicaltrials.gov. As part of the agreement, NKMax America will sponsor studies and Merck KGaA, Darmstadt, Germany and Pfizer will provide Avelumab for a new test arm added to the existing U.S. Phase I clinical trial (NCT03941262) on fire-resistant tumors. Depending on the modification, up to 18 patients with all types of solid tumors, refractory up to conventional treatment and independent of PD-L1 status, are enrolled up to progression or unacceptable toxicity to obtain SNK01 plus a checkpoint inhibitor. Registration of this arm is expected to begin in September 2020. Both parties will have access to clinical data. Important Information on the Safety of the U.S.
FDA-approved Label Alerts and Precautions for Aveumab (BAVENCIO®) include immunosuppressed side effects (such as lung disease, hepatitis, colitis, endocrinopathies, nephritis and kidney failure and other adverse effects), reactions related to infusion and fetal toxicity. Alerts and precautions for avelumab (BAVENCIO®) include immunosuppressed side effects (such as lung disease and hepatitis, including fatal cases), colitis, colitis, Endocrinopathies, nephritis and kidney failure and other adverse effects [possibly severe and containing lethal cases]), infusion-related reactions, hepatotoxicity, severe cardiovascular events (MACE) [which may be severe and have involved fatal cases] and embryo-fetal toxicity. Karl-Ludwig Kley, Chairman of Merck KGaA`s Board of Directors in Darmstadt, Germany, said: “We are delivering on our promise to strengthen the three pillars of our business: health, performance materials and the science of life.