MimiVax and Roswell Park Launch Phase 2 Trial of SurVaxM Cancer Vaccine for Metastatic Neuroendocrine Tumors
Key Insights
MimiVax (search) and Roswell Park Comprehensive Cancer Center have opened a phase 2 clinical trial evaluating SurVaxM cancer vaccine combined with temozolomide for patients with progressing metastatic neuroendocrine tumors (search).
The peptide vaccine targets survivin (search) protein, which is expressed in approximately 52% of neuroendocrine tumor specimens and correlates with more aggressive disease and shorter survival.
Phase 1 data demonstrated that SurVaxM was well tolerated in NET patients and produced measurable clinical benefit with elevated antibody responses.
MimiVax (search) Inc. and Roswell Park Comprehensive Cancer Center have jointly launched a phase 2 clinical trial (NCT06202066) evaluating the cancer vaccine SurVaxM in combination with temozolomide for patients with progressing metastatic neuroendocrine tumors (search) (NETs). The study is being conducted at Roswell Park in Buffalo, New York, under the direction of principal investigator Dr. Jasmeet Kaur.
Trial Design and Patient Population
The phase 2 study compares the safety and efficacy of temozolomide combined with SurVaxM versus temozolomide alone in patients with metastatic NETs that are progressing. SurVaxM is a peptide vaccine designed to stimulate an immune response against survivin (search), a protein expressed in many tumor types.
The trial builds directly on phase 1 findings from NCT03879694, in which SurVaxM was well tolerated in NET patients and demonstrated measurable clinical benefit with elevated antibody responses.
Targeting Survivin in Neuroendocrine Tumors
Roswell Park's previous research has shown that survivin (search) is present in approximately 52% of neuroendocrine tumor 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.
"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," said Dr. Jasmeet Kaur, gastrointestinal oncologist and study principal investigator. "We are excited to see if the next trial confirms a meaningful clinical benefit that advances patient care."
Addressing Unmet Medical Need
Neuroendocrine tumors (search) are a rare type of cancer that arise from hormone-producing cells throughout the body, most commonly in the gastrointestinal tract and lungs. Their incidence has increased significantly over the past two decades, with an estimated 28,000 people diagnosed in the U.S. each year.
While many NETs grow slowly, metastatic disease carries a poor prognosis and treatment options are limited once first-line therapy fails. Immunotherapy has shown limited efficacy in NETs to date, making the identification of new immunologic targets and approaches important to patient care.
Broader Development Program
The launch of this study follows MimiVax (search)'s completion of data collection for its phase 2b SURVIVE trial in newly diagnosed glioblastoma (search). SurVaxM is also being assessed in pediatric brain tumors (search) and multiple myeloma (search).
"This phase 2 trial is the result of years of careful, collaborative science between MimiVax (search), Roswell Park Comprehensive Cancer Center, and the neuroendocrine tumor community," said Michael Ciesielski, PhD, CEO and co-founder of MimiVax. "NET patients deserve more options, and we are excited to see if SurVaxM can become a new treatment for them."
Robert Fenstermaker, MD, Roswell Park Chair Emeritus in Neurosurgery and a co-founder of MimiVax (search), noted: "The phase 2 NET study underscores the breadth of cancers in which survivin (search) 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."
About SurVaxM
SurVaxM is a first-in-class, patented peptide mimic immunotherapeutic vaccine that targets survivin (search), a cell-survival protein present in approximately 95% of glioblastomas and in roughly half of all neuroendocrine tumors (search) and many other cancers. Delivered via subcutaneous injection, SurVaxM is engineered to stimulate patients' own immune response to recognize and attack survivin-expressing cancer cells, with the goal of controlling tumor growth and preventing recurrence. SurVaxM holds FDA Fast Track Designation for newly diagnosed glioblastoma (search).