8-KAccepted Oct 15, 4:26 PM ET
Crescent Biopharma: announces clinical pipeline updates
Accepted (ET)
4:26 PM
Oct 15, 2026
Filed
Oct 15, 2026
Documents
11
Size
157.4 KB
Summary
Crescent Biopharma: announces clinical pipeline updates
What happened
- Crescent Biopharma, Inc. issued a press release on Oct 15, 2026 announcing clinical pipeline updates.
- The filing says CR-001 is enrolling patients in combination cohorts in the global Phase 1/2 ASCEND trial; ASCEND completed dose escalation and has enrolled more than 125 treatment-naive and previously treated patients across multiple solid tumor types. The company is on track to report initial monotherapy data from ASCEND in the first quarter of 2027, including overall response rate from a first-line non-small cell lung cancer cohort of up to 12 patients.
- The filing says enrollment has commenced in ASCEND chemotherapy combination expansion cohorts, with initial combination data anticipated in mid-2027 across multiple tumor types and regimens.
- The filing says the U.S. Food and Drug Administration allowed Crescent to proceed with an IND for CR-002; the company is on track to initiate the global Phase 1/2 APOLLO trial in the fourth quarter of 2026, with initial data expected in the second half of 2027.
- The filing says Kelun-Biotech is conducting Phase 1/2 and Phase 2 combination trials of CR-001 (SKB118) with sacituzumab tirumotecan in China and plans a Phase 1/2 trial of CR-001 with CR-003 (SKB105) in the first half of 2027. Kelun-Biotech’s Phase 1/2 trial of CR-003 in China is ongoing, with proof-of-concept data expected in the first quarter of 2027. Crescent has exclusive rights to CR-003 outside Greater China.
Key details
- Press release date: Oct 15, 2026.
- ASCEND: completed dose escalation; >125 patients enrolled; initial monotherapy data expected in the first quarter of 2027; up to 12 patients in the 1L NSCLC ORR cohort.
- Combination expansion initial data: anticipated mid-2027 for multiple tumor types and regimens listed in the filing.
- CR-002: IND allowed; APOLLO trial initiation targeted in the fourth quarter of 2026; initial APOLLO data expected in the second half of 2027. CR-003 proof-of-concept data from China expected in the first quarter of 2027.
Why it may matter
- Item reported: Item 8.01 — other events. The filing covers a press release that announced clinical development updates for CR-001, CR-002 and CR-003, trial timelines, enrollment status, and the company’s partnership with Kelun-Biotech.
- This filing does not show why the insider traded or why the company acted.