Crescent Biopharma Targets First-Quarter 2027 Data For CR-001 And Early-2028 Phase 3 Start
An 8-K sets readout timing from early 2027 and reports FDA clearance to proceed with a second drug, CR-002.
Crescent Biopharma said its cancer antibody CR-001 finished dose escalation and that initial monotherapy data are due in the first quarter of 2027, according to an 8-K filed Thursday. The filing also says the FDA allowed a second drug, CR-002, to proceed to human trials.
What the 8-K says
CR-001 is a PD-1 x VEGF bispecific antibody being tested in the global Phase 1/2 ASCEND trial. Crescent has completed dose escalation and enrolled participants across several tumor types at sites in the United States, Europe and South Korea.
The first-quarter 2027 readout is to include response rate from a first-line non-small cell lung cancer cohort of up to 12 patients. It will also carry safety, tolerability, pharmacokinetic and pharmacodynamic data from more than 125 treatment-naive and previously treated patients across multiple solid tumor types.
Enrollment has also started in chemotherapy-combination cohorts, with initial data anticipated in mid-2027. The filing lists seven settings, including first-line lung cancer with paclitaxel and carboplatin or pemetrexed and carboplatin, first-line colorectal cancer with mFOLFOX6, and second-line gastric cancer with paclitaxel.
Pending results and further talks with regulators, Crescent plans to start the first of multiple Phase 3 trials of CR-001 in early 2028.
The second drug and the China trials
CR-002, a topoisomerase inhibitor antibody-drug conjugate aimed at PD-L1, received FDA allowance to proceed under an Investigational New Drug Application in October 2026. The Phase 1/2 APOLLO trial is on track to begin in the fourth quarter of 2026 in advanced solid tumors, and initial data are expected in the second half of 2027.
Kelun-Biotech is running China trials of CR-001, also called SKB118, with sac-TMT, a TROP2-directed ADC. Initial data from its Phase 2 lung cancer trial are expected in mid-2027, and a Phase 1/2 trial pairing CR-001 with CR-003 is expected to begin in the first half of 2027.
Kelun-Biotech granted Crescent exclusive rights to CR-003, an integrin-beta 6-targeted ADC, in the United States, Europe and all markets outside Greater China. Crescent plans to use China-generated data to support global development.
What to watch
Proof-of-concept data for CR-003 from Kelun-Biotech's China trial are expected in the first quarter of 2027, the same quarter as the first ASCEND monotherapy readout. At Thursday's close, shares were $12.48, against $12.58 at the prior close.
The next dated markers are the fourth-quarter 2026 APOLLO start and the first-quarter 2027 ASCEND readout.
Sources
- 8-K Filing — CRESCENT BIOPHARMA, INC. (CBIO) — SEC EDGAR
