SupraVax: Cleveland Clinic Ewing Sarcoma Vaccine Trial Update
Update on the Personalized SupraVax Trial for Ewing sarcoma - Dr. Pete Anderson and Dr. Timothy Chan (CCF)
One of our biggest research initiatives focuses on developing a personalized, next-generation mRNA vaccine for Ewing sarcoma. After challenges in securing a biopharma partner to manufacture this vaccine for this rare cancer, we are thrilled to have partnered with a non-profit contract research organization (CRO) willing to produce this cutting-edge therapeutic for a Phase I clinical trial.
The design of the vaccine construct has been finalized and an engineering vaccine lot is being produced now. With this engineering sample, the team is working on obtaining remaining in vivo (mouse model) IND-enabling safety data - a crucial step in validating the vaccine construct. This process is expected to take approximately two months to produce the pilot vaccine, followed by another 1 – 1.5 months of in vivo (mouse model) testing.
If the vaccine receives IND approval from the FDA, the Little Warrior Foundation — thanks to its generous donors — is prepared to fund the vaccine manufacturing and clinical trial.
Pending successful validation and regulatory approvals (IRB, etc.), the team cautiously projects a Phase I clinical trial launch in Q3 or Q4 of 2025. The trial is designed to enroll 24 patients, with the potential for an expansion cohort if efficacy is demonstrated. Per FDA pre-IND guidelines, enrollment will begin with adults (18+), followed by the adolescent and young adult (AYA) population (13-17), and finally pediatric patients (7-12).
The nanostructured lipid carrier-mRNA vaccine is fusion-specific, making tumor breakpoint profiling necessary. However, not all patients' HLA genotypes will effectively bind and present the vaccine-encoded cancer-associated antigens to the immune system. As a result, not all screened patients with a gene fusion associated with Ewing sarcoma will be eligible. Patient enrollment will be determined entirely by the medical team at Cleveland Clinic.
We remain committed to advancing this promising therapy with the hope that it will bring new and better treatment options to the Ewing sarcoma patient community.
With Hope and Swords Up,
- Little Warrior Foundation