secwatch.observer — SEC 8-K summary
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Issuer:     CRESCENT BIOPHARMA, INC. (CBIO)
CIK:        0001253689
Form:       8-K
Filed at:   2026-10-15T20:26:10+00:00
Accession:  0001628280-26-066006
Event type: other_material
Sentiment:  positive
Materiality: 0.55
Item codes: 8.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Crescent Biopharma updates pipeline: CR-001 ASCEND combo cohorts enrolling; CR-002 IND cleared
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- ASCEND Phase 1/2 trial of CR-001 (PD-1 x VEGF bispecific) completed monotherapy dose escalation; initial data expected Q1 2027, including ORR in up to 12 1L NSCLC patients and data from >125 patients.
- Chemo combo expansion cohorts enrolling in ASCEND; initial data mid-2027 across 1L NSCLC, 1L pMMR/MSS CRC, 3L CRC, 1L biliary, 1L pMMR endometrial, and gastric/GEJ cancers.
- Partner Kelun-Biotech runs China trials of CR-001 (SKB118) plus TROP2 ADC sac-TMT: Phase 2 NSCLC data mid-2027; Phase 2 EGFR-mutant NSCLC initiating; Phase 1/2 with CR-003 (SKB105) to start H1 2027.
- CR-002 (PD-L1 topoisomerase inhibitor ADC) received FDA IND allowance in Oct 2026; global Phase 1/2 APOLLO trial to start Q4 2026 in advanced solid tumors, initial data H2 2027.
- Kelun-Biotech granted Crescent exclusive rights to CR-003 (SKB105), an integrin-beta 6 ADC, for US, Europe and markets outside Greater China; China Phase 1/2 proof-of-concept data expected Q1 2027.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1253689/000162828026066006/0001628280-26-066006-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1253689/000162828026066006/cbio-20261015.htm
  HTML page:      https://secwatch.observer/filing/0001628280-26-066006

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