On November 8, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the initiation of a proof-of-concept Phase Ib clinical trial to assess the safety and efficacy of mitazalimab in combination with MesoPher, an experimental dendritic cell vaccine, in patients with pancreatic cancer (Press release, Alligator Bioscience, NOV 8, 2021, View Source [SID1234594700]). The trial will be led by investigators at Erasmus MC University Medical Center Rotterdam, The Netherlands.
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The first patient has been dosed in the phase I proof-of-concept study trial, REACtiVe-2, that will enroll up to 18 patients with pancreatic cancer. REACtiVe-2 will assess the safety and efficacy of Alligator´s second generation CD40 agonist, mitazalimab in combination with the investigational cancer vaccine MesoPher, which is comprised of autologous dendritic cells loaded with allogeneic tumor lysate (PheraLys), in patients with progressive metastatic pancreatic cancer. Mitazalimab is currently in Phase II trial in pancreatic cancer patients in combination with chemotherapy. MesoPher, under development by Amphera B.V., is currently in a Phase III trial in mesothelioma and a phase II trial in pancreatic cancer. The investigator sponsored trial, REACtiVe-2, will be performed at Erasmus MC University Medical Center Rotterdam.
The clinical study is supported by strong preclinical data that was recently published in the high-ranking peer-reviewed journal "Journal of Immunotherapy of cancer" (Lau SP, et al. J Immunother Cancer 2020). This study demonstrates that CD40 agonists in combination with dendritic cells loaded with allogeneic tumor lysate mediates powerful and significant anti-tumor effects in pancreatic cancer models.
"This new trial is an important step forward in expanding the potential of mitazalimab in a patient population with high medical needs," said Alligator’s CEO, Søren Bregenholt. "Erasmus MC University Medical Center Rotterdam is the ideal partner for the clinical evaluation of mitazalimab´s ability to enhance the response of a promising cancer vaccine in pancreatic cancer."