MimiVax and Roswell Park open phase 2 trial of SurVaxM for metastatic neuroendocrine tumours

A new phase 2 clinical trial has opened at Roswell Park Comprehensive Cancer Center to evaluate the cancer vaccine SurVaxM in combination with temozolomide for patients with progressing metastatic neuroendocrine tumours.The study, sponsored jointly by MimiVax and Roswell Park, is led by principal investigator Dr Jasmeet Kaur.The trial will compare temozolomide plus SurVaxM with temozolomide alone in patients whose disease continues to advance. SurVaxM is a peptide vaccine designed to stimulate an immune response against survivin, a protein expressed in many tumour types. Earlier phase 1 findings showed the vaccine was well tolerated in neuroendocrine tumour patients and produced measurable clinical benefit with elevated antibody responses.Michael Ciesielski, PhD, CEO and co‑founder of MimiVax, said: “This phase 2 trial is the result of years of careful, collaborative science between MimiVax, Roswell Park Comprehensive Cancer Center, and the neuroendocrine tumor community. NET patients deserve more options, and we are excited to see if SurVaxM can become a new treatment for them.”Neuroendocrine tumours arise from hormone‑producing cells, most commonly in the gastrointestinal tract and lungs. Although many grow slowly, metastatic disease carries a poor prognosis and treatment options are limited once first‑line therapy fails. Immunotherapy has shown little benefit in this setting, increasing interest in new immunologic targets such as survivin.Roswell Park’s previous research has shown survivin is present in around 52 percent of neuroendocrine tumour specimens and is associated with more aggressive disease and shorter survival. The phase 1 study confirmed SurVaxM was safe and generated immune responses in this patient group.Dr Jasmeet Kaur said: “Patients need more options to treat NETs, and the phase 1 data gave us confidence this is a safe, immunologically active approach to try in a larger patient population. We are excited to see if the next trial confirms a meaningful clinical benefit that advances patient care.”The launch of this study follows MimiVax’s completion of data collection for its phase 2b SURVIVE trial in newly diagnosed glioblastoma. SurVaxM is also being assessed in paediatric brain tumours and multiple myeloma.Robert Fenstermaker, MD, noted: “The phase 2 NET study underscores the breadth of cancers in which survivin is a relevant therapeutic target. Once discarded as too difficult a target, our research into survivin is yielding results that are giving hope to patients with some of the toughest cancer diagnoses.”