Trial advances forward with no dose-limited toxicities observed to date.
MINNEAPOLIS (May 1, 2026) – OX2 Therapeutics, Inc. today announces it has reached its Recommended Phase 2 Dose (RP2D) in its ongoing clinical trial evaluating ARL200 + GBM6-AD Vaccine in pediatric patients with newly diagnosed Diffuse Midline Glioma and recurrent High-Grade Glioma.
The privately held company has treated 10 of the planned 15 patients in the Phase I study and expects to reach its enrollment threshold later this year. Six of the 10 treated patients remain in stable condition based on ongoing observations, with the longest case now extending to 17 months from initial diagnosis. To date, no dose-limiting toxicities (DLTs) have been observed.
“This milestone of reaching Recommended Phase 2 Dose reflects the collaborative efforts of investigators, clinicians and families participating in the study,” said Jeff Liter, CEO of OX2 Therapeutics. “Our ongoing collaboration with the Neuro-Oncology team at Children’s Minnesota has been critical in advancing the exploration of new therapeutic options for devastating cancers.”
“We are thrilled to report that patients treated in the trial have had no significant side-effects. They have been thriving and living life to the fullest, and they have hope that this trial might help improve their outcome and that by participating in this trial they are helping future patients,” said Dr. Anne Bendel of Children’s Minnesota. “We are grateful to OX2 for allowing us to partner with them on this important clinical trial and we are looking forward to advancing ARL200 + GBM6-AD Vaccine to a multicenter international Phase 2 trial to confirm the effectiveness of this treatment.”
OX2 developed the first immune checkpoint peptide platform, ARL200, targeting the immune system to attack solid tumors and received FDA fast track and rare disease priority. ARL200 aims to regulate the immune system and optimize its response against a wide range of cancers. Diffuse Midline Glioma and recurrent High-Grade Glioma remain among the most challenging pediatric cancers to treat, underscoring the need for innovative therapeutic approaches and continued clinical research.
About OX2 Therapeutics
Founded in 2016, OX2 Therapeutics, Inc. (www.ox2therapeutics.com) is a clinical-stage biopharmaceutical company developing new therapies to turn cancers into manageable and potentially curable diseases.