aibioAdaptin Bio opens enrollment in Phase 1 trial of APTN-101 for glioblastoma
Tickers APTN
Adaptin Bio said on August 20, 2026 that enrollment has opened for a Phase 1 study of APTN-101 in patients with glioblastoma. The study is being conducted with Duke University and expects to enroll up to 15 adults.
Key facts
- Company
- ADAPTIN BIO, INC. (OTC: APTN)
- News type
- Company Updates
- Primary source
- Adaptin Bio press release (Form 8-K, Exhibit 99.1)
Adaptin Bio, Inc. (OTCQB: APTN) said on August 20, 2026 that enrollment has opened for a Phase 1 clinical trial of APTN-101, its brain-targeted therapy for glioblastoma, the most common and aggressive primary brain tumor. The company announced the trial in a press release that it filed on August 25, 2026 as Exhibit 99.1 to a Form 8-K.
The trial design
The study is open-label with a dose-escalation design. Its primary objective is to evaluate the safety profile and maximum tolerated dose of APTN-101 in adult patients with WHO Grade IV malignant glioma, meaning glioblastoma that expresses epidermal growth factor receptor variant III, known as EGFRvIII. The study is expected to enroll up to 15 adult patients. The primary endpoint is the proportion of patients with a dose limiting toxicity at each dose level.
Secondary endpoints are the pharmacokinetics of APTN-101 and the objective response rate based on modified Response Assessment in Neuro-Oncology Criteria. Exploratory endpoints include changes in cytokine levels, the formation of anti-BRiTE antibodies, overall survival and progression free survival.
Mustafa Khasraw, M.D., a professor at the Duke University School of Medicine, led the preclinical development team for APTN-101 and is the principal investigator of the trial. The BRiTE platform was developed by researchers at Duke, which is the study site for the first-in-human trial.
The drug and the preclinical data
BRiTE stands for Brain Bispecific T cell Engager. The company says APTN-101 is engineered to cross the blood-brain barrier and target EGFRvIII, a protein linked to aggressive brain tumors. In preclinical studies, the release says, APTN-101 gave more than 7-fold greater distribution of the EGFRvIII T-cell engager into the brain compared with the engager alone. It also led to complete eradication of EGFRvIII glioblastoma tumors in 70% to 80% of mice. The company describes the treatment as having an excellent safety profile and minimal off-target effects in preclinical models. These are the company's own characterizations, not independent findings.
The platform uses the enhanced hitchhiking capabilities of manipulated immune cells to deliver therapeutic agents directly to brain tumors. The company says additional BRiTE targets are being evaluated.
The disease and the market
CEO Michael J. Roberts, Ph.D., said: "Opening enrollment in the Phase 1 trial is an important milestone in the clinical development of APTN-101, a potential best-in-class therapy for the treatment of glioblastoma." The release says patients with glioblastoma currently have a median survival of only 12 to 18 months, with 5% of patients surviving beyond five years.
The company
Adaptin Bio is a Delaware company with offices in Charlotte, North Carolina. Its 10-K/A for fiscal 2025 reports 8,903,229 shares of common stock outstanding as of June 11, 2026. It reports an aggregate market value of $9.3 million held by non-affiliates as of June 30, 2025. The company is a smaller reporting company and an emerging growth company, and it files as a non-accelerated filer.
Financial position
The XBRL data show research and development expense of $1.8 million for 2025 and $1.8 million for 2024. The net loss was $5.2 million for 2025, compared with $3.1 million for 2024. Cash from operations was negative $4.8 million in 2025 and negative $649,283 in 2024.
Year-end cash and cash equivalents were $459,174 for 2025, according to the 10-Q filed August 13, 2026, and $34,085 for 2024. The company reported cash and cash equivalents of $670,488 as of June 30, 2026. The release lists, among its risks, the company's ability to raise additional money to fund its operations for at least the next 12 months as a going concern.
How far this is from a result
Opening enrollment is a start, not a result. Mouse data do not predict human outcomes, "best-in-class" is the company's phrase for a drug that has not yet been given to a patient, and the trial is small, open-label and built to find a safe dose, not to show benefit. Cash was $670,488 at June 30, 2026, a small fraction of the $4.8 million of operating cash used in 2025, and the company lists its ability to raise money as a going concern among its risks. The release does not say how the trial will be paid for.