secwatch.observer — SEC 8-K summary
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Issuer:     ADAPTIN BIO, INC. (APTN)
CIK:        0001938571
Form:       8-K
Filed at:   2026-08-25T20:10:32+00:00
Accession:  0001213900-26-093520
Event type: other_material
Sentiment:  positive
Materiality: 0.55
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Adaptin Bio opens enrollment in Phase 1 trial of APTN-101 for glioblastoma
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- Enrollment opened in Phase 1 open-label dose-escalation trial of APTN-101 (BRiTE T-cell engager) for EGFRvIII-positive GBM, at Duke University, up to 15 adult patients.
- Primary endpoint is proportion of patients with dose-limiting toxicity per dose level; secondary endpoints include pharmacokinetics and objective response rate (modified RANO).
- Preclinical data: APTN-101 showed >7-fold increase in brain distribution vs EGFRvIII engager alone and complete tumor eradication in 70-80% of mice models.
- GBM is ~15,000 new U.S. cases/year; market valued at $3.02B (2025), projected $4.44B by 2030 (8% CAGR).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1938571/000121390026093520/0001213900-26-093520-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1938571/000121390026093520/ea0303128-8k_adaptin.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-093520

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer