MimiVax and Roswell Park Open Phase 2 Trial of SurVaxM for Patients with Metastatic Neuroendocrine Tumors

MimiVax Inc. and Roswell Park Comprehensive Cancer Center jointly announced the launch of a Phase 2 clinical trial (NCT06202066) evaluating SurVaxM in combination with temozolomide in patients with progressing metastatic neuroendocrine tumors (NETs). The study is being conducted at Roswell Park in Buffalo, New York, under principal investigator Jasmeet Kaur, MD.

The trial compares the safety and effect of temozolomide combined with SurVaxM to temozolomide alone in patients with metastatic NETs that are progressing. It builds on Phase 1 findings (NCT03879694), in which SurVaxM was well tolerated in NET patients and produced measurable clinical benefit with elevated antibody responses.

Neuroendocrine tumors are a rare cancer type arising from hormone-producing cells, most commonly in the gastrointestinal tract and lungs; approximately 28,000 people are diagnosed in the U.S. each year. Roswell Park’s earlier research found that survivin, the protein targeted by SurVaxM, is expressed in approximately 52% of NET specimens, and that its expression correlates with more aggressive tumor biology and shorter survival.

“This Phase 2 trial is the result of years of collaborative science between MimiVax, Roswell Park, and the NET community,” said Michael J. Ciesielski, PhD, Chief Executive Officer. “NET patients deserve more treatment options.”

“Patients need more treatment options for NETs, and the Phase 1 data gave us confidence,” said Jasmeet Kaur, MD, principal investigator and Assistant Professor at Roswell Park. “We are excited to see if the next trial confirms meaningful clinical benefit.”

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About SurVaxM: SurVaxM is a first-in-class, patented peptide mimic immunotherapy that targets survivin, a cell-survival protein present in approximately 95% of glioblastomas and roughly half of neuroendocrine tumors, along with many other cancers. Delivered by subcutaneous injection, it is designed to stimulate a patient’s immune response against survivin-expressing cancer cells. SurVaxM holds FDA Fast Track designation for newly diagnosed glioblastoma and is being evaluated across glioblastoma, neuroendocrine tumors, multiple myeloma and pediatric brain cancer.

About MimiVax: MimiVax Inc. is a Delaware-incorporated, clinical-stage biotechnology company formed as a spinoff from Roswell Park Comprehensive Cancer Center. The company holds an exclusive global license to commercialize SurVaxM, along with an extensive worldwide patent portfolio.

About Roswell Park: Roswell Park Comprehensive Cancer Center, founded in 1898, was one of the first NCI-designated comprehensive cancer centers in the country and remains the only one in Upstate New York, rated “Exceptional” by the National Cancer Institute.