<![CDATA[MimiVax and Roswell Park Open Phase 2 Trial of SurVaxM for Patients with Metastatic Neuroendocrine Tumors]]>

Press Release|Articles|May 11, 2026 MimiVax and Roswell Park Open Phase 2 Trial of SurVaxM for Patients with Metastatic Neuroendocrine Tumors Author(s)Roswell Park Comprehensive Cancer Center Listen0:00 / 0:00 Key Takeaways A randomized phase 2 design evaluates safety and activity of adding SurVaxM to temozolomide in progressing metastatic NETs versus temozolomide monotherapy. SurVaxM targets survivin, aiming to induce humoral and cellular immune responses against survivin-expressing tumor cells and potentially limit outgrowth of new malignant clones. Prior translational work identified survivin in ~52% of NET specimens, with expression associated with more aggressive behavior and inferior survival, supporting biomarker-driven rationale. Development parallels broader SurVaxM programs, including a phase 2b newly diagnosed glioblastoma study (Fast Track), plus evaluations in pediatric brain tumors and multiple myeloma.SHOW MORE Roswell Park Comprehensive Cancer Center launched a phase 2 trial evaluating SurVaxM plus temozolomide in progressing neuroendocrine tumors. Biotechnology company MimiVax Inc. and Roswell Park Comprehensive Cancer Center today jointly announced the launch of a phase 2 clinical trial (NCT06202066) evaluating SurVaxM in combination with temozolomide in patients with progressing neuroendocrine tumors, also known as NETs. The study is being conducted at Roswell Park in Buffalo, New York, under the direction of principal investigator Dr. Jasmeet Kaur.The phase 2 study compares the safety and effect of temozolomide combined with SurVaxM to temozolomide alone in patients with metastatic NETs that are progressing.SurVaxM is a peptide vaccine that has been shown to produce an immune system response against cancer cells that express the protein survivin, and may block the growth of new tumor cells. The new clinical 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.“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,” says 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.”Neuroendocrine tumors 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 NET disease carries a poor prognosis, and treatment options are limited once patients progress on first-line therapy. Immunotherapy has shown limited efficacy in NETs to date, making the identification of new immunologic targets and approaches important to patient care.The phase 2 trial builds on Roswell Park’s previous NET research, which demonstrated that survivin, the protein targeted by SurVaxM, is expressed in approximately 52 percent of NET specimens, and that its expression correlates with more aggressive tumor biology and shorter survival. Importantly, the phase 1 study demonstrated that SurVaxM was safe and generated measurable immune responses in NET patients.“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,” says gastrointestinal oncologist Jasmeet Kaur, MD, FACP, study principal investigator and Assistant Professor at Roswell Park. “We are excited to see if the next trial confirms a meaningful clinical benefit that advances patient care.”The initiation of this phase 2 trial comes as MimiVax begins data analysis from its phase 2b SURVIVE trial of SurVaxM in newly diagnosed glioblastoma. SurVaxM is also being evaluated in pediatric brain tumors and multiple myeloma.“The phase 2 NET study underscores the breadth of cancers in which survivin is a relevant therapeutic target,” notes Robert Fenstermaker, MD, Roswell Park Chair Emeritus in Neurosurgery and a co-founder of MimiVax. “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.”For more information about this study or other Roswell Park clinical trials, please call 1-800-ROSWELL (1-800-767-9355) or send an e-mail to [email protected]. Additional information is available at clinicaltrials.gov (NCT06202066).The Roswell Park research team expresses grateful thanks to the donors whose support for the Roswell Park Alliance Foundation and events like the Ride for Roswell provided the seed funding that allowed SurVaxM research to advance to clinical trials for patients with neuroendocrine tumors or other forms of cancer.About SurVaxMSurVaxM is a first-in-class, patented peptide mimic immunotherapeutic vaccine that targets survivin, a cell-survival protein present in approximately 95% of glioblastomas and in roughly half of all neuroendocrine tumors 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 and is being evaluated across multiple cancer indications, including glioblastoma, neuroendocrine tumors, multiple myeloma, and pediatric brain cancer.About MimiVax Inc.MimiVax Inc. is a Delaware-incorporated, clinical-stage biotechnology company formed as a spinoff from Roswell Park Comprehensive Cancer Center in Buffalo, New York. The company is dedicated to disrupting cancer through the development of highly innovative immunotherapies designed to improve patient survival. MimiVax holds an exclusive global license to commercialize SurVaxM, along with an extensive worldwide patent portfolio. For more information, visit www.mimivax.com.About Roswell ParkFrom the world’s first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated and prevented worldwide. The Roswell Park team of 4,000+ makes compassionate, patient-centered cancer care and services accessible across New York State and beyond. Rated “Exceptional” by the National Cancer Institute, Roswell Park, 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. To learn more about Roswell Park Comprehensive Cancer Center and the Roswell Park Care Network, visit www.roswellpark.org, call 1-800-ROSWELL (1-800-767-9355) or email [email protected]. NewsletterStay up to date on the most recent and practice-changing oncology dataSubscribe Now! 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