On July 18, 2018 Vyriad Inc., a clinical-stage, privately held biotechnology company focused on the development of powerful first-in class oncolytic virotherapies, is reported that collaboration agreement with Merck KGaA, Darmstadt, Germany, and Pfizer to expand its ongoing Phase 1 clinical trial program in solid tumors to include a combination study of its lead asset, Voyager-V1, with avelumab*, a human anti-PD-L1 antibody (Press release, Vyriad, JUL 18, 2018, View Source [SID1234527771]). For more information on this novel immuno-oncology combination study, please see clinicaltrials.gov.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are delighted to be working with Merck KGaA, Darmstadt Germany, and Pfizer on this innovative combination treatment approach," said Stephen Russell, M.D., Ph.D., CEO of Vyriad. "Voyager-V1 is being administered to inflame the tumors, and avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models."
"We are encouraged by the potential of Voyager-V1, which has demonstrated early clinical activity in patients with solid tumors," said Alise Reicin, Head of Global Clinical Development at the Biopharma business of Merck KGaA, Darmstadt, Germany, which operates in the U.S. and Canada as EMD Serono. "We look forward to investigating how combining Voyager-V1 with avelumab may advance patient care."
"A primary focus of our clinical development program for avelumab is to evaluate the role and potential of immunotherapy combination regimens, in an effort to support patients with challenging cancers," said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-Oncology, Early Development and Translational Oncology, Pfizer Global Product Development. "We look forward to working with Vyriad to explore this novel combination for patients with solid tumors."
Avelumab has received accelerated approval** by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic Merkel cell carcinoma (MCC) and previously treated patients with locally advanced or metastatic urothelial carcinoma (mUC), and is under further clinical evaluation across a range of tumor types under a global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer.
*Avelumab is under clinical investigation for treatment of various solid tumors and has not been demonstrated to be safe and effective for this indication. There is no guarantee that avelumab will be approved for specific solid tumors by any health authority worldwide.
About Voyager-V1
Voyager-V1 (VSV-IFNβ-NIS) is derived from Vesicular Stomatitis Virus (VSV), a bullet-shaped, negative-sense RNA virus with low human seroprevalence, specifically engineered to replicate selectively in and kill human cancer cells. Voyager-V1 encodes human IFNβ to boost antitumoral immune responses and increase tumor specificity, plus the thyroidal sodium iodide symporter NIS to allow imaging of virus spread. Three first-in-human Phase 1 clinical studies of Voyager-V1 are exploring intravenous and intratumoral routes of administration.
About Avelumab
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.1-3 Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.3-5 In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.
Avelumab is currently being evaluated in the JAVELIN clinical development program, which involves at least 30 clinical programs, including seven Phase III trials and nearly 8,300 patients across more than 15 different tumor types. For a comprehensive list of all avelumab trials, please visit clinicaltrials.gov.
Indications in the U.S.**
The U.S. Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
Important Safety Information from the U.S. FDA-Approved Label
The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.
Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO for mMCC and patients with locally advanced or metastatic UC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.
For full prescribing information and medication guide for BAVENCIO, please see www.BAVENCIO.com.
Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, U.S.
Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany, and Pfizer Inc. The global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, U.S., enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer’s PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer.