secwatch.observer — SEC 8-K summary
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Issuer:     ImageneBio, Inc. (IMA)
CIK:        0001835579
Form:       8-K
Filed at:   2022-04-06T23:59:59+00:00
Accession:  0001193125-22-096765
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Ikena Oncology advances IK-175 combination cohort to stage two in Phase 1b trial for urothelial carcinoma
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- IK-175 (AHR antagonist) Phase 1b trial (NCT04200963) combination with nivolumab expansion cohort advanced to stage two in April 2022.
- Patients are advanced/metastatic urothelial carcinoma progressed after multiple prior therapies including checkpoint inhibitors.
- Simon two-stage design requires predefined ORR threshold (RECIST 1.1) to be met in stage one before advancing to stage two.
- Monotherapy expansion cohort had previously advanced to stage two in September 2021.
- Initial clinical data from the trial expected to be submitted to an oncology conference in H2 2022.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1835579/000119312522096765/0001193125-22-096765-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1835579/000119312522096765/d311568d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-096765

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