secwatch.observer — SEC 8-K summary
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Issuer:     Beyond Air, Inc. (XAIR)
CIK:        0001641631
Form:       8-K
Filed at:   2024-12-06T23:59:59+00:00
Accession:  0001493152-24-049048
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Beyond Cancer (Beyond Air) gets Israeli MoH approval for Phase 1b LV UNO + anti-PD-1 trial for solid tumors
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- Israeli Ministry of Health approved Phase 1b trial of LV UNO in combination with anti-PD-1 therapy for solid tumors.
- Trial will enroll up to 20 patients with unresectable solid tumors that progressed or were stable on PD-1 inhibitors.
- Primary endpoint: objective response rate (ORR) and duration of response per RECIST v1.1; secondary immune-related response.
- Four Israeli sites; patient screening Q1 2025; topline data expected second half of 2025.
- Preclinical data showed single UNO dose increased PD-L1 expression and improved survival vs anti-PD-1 alone.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1641631/000149315224049048/0001493152-24-049048-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1641631/000149315224049048/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-049048

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