Crescent Biopharma Inc.
10/15/2026 | Press release | Distributed by Public on 10/15/2026 14:26
Material Event (Form 8-K)
Item 8.01 Other Events.
On October 15, 2026, Crescent Biopharma, Inc. ("Crescent" or the "Company") issued a press release announcing clinical pipeline updates, including (i) enrolling patients in cohorts combining CR-001, a PD-1 x VEGF bispecific antibody, plus standard of care chemotherapy regimens in its global Phase 1/2 ASCEND trial, (ii) the initiation of additional antibody-drug conjugates ("ADCs") combination studies with CR-001, (iii) anticipated initiation of the Phase 1/2 APOLLO trial of CR-002, a topoisomerase inhibitor ADC targeting PD-L1, and (iv) the expected timing of clinical data readouts.
Clinical Execution Progress in ASCEND, a Global Phase 1/2 Trial of CR-001
In the global Phase 1/2 ASCEND of CR-001 as a monotherapy, the Company has completed dose escalation and enrolled participants across several tumor types at clinical sites in the United States, Europe and South Korea. The Company is on track to report initial monotherapy data from ASCEND in the first quarter of 2027, including preliminary antitumor response as measured by overall response rate ("ORR") from a first-line non-small cell lung cancer ("NSCLC") cohort of up to 12 patients and the safety, tolerability, pharmacokinetic and pharmacodynamic data from more than 125 treatment-naive and previously-treated patients across multiple solid tumor types.
Enrollment has also commenced in the standard of care chemotherapy combination expansion cohorts of ASCEND. The Company is targeting various tumor types and chemotherapy regimens for evaluation, including the types below, with initial data anticipated in mid-2027:
•First-line (1L) NSCLC: CR-001 + paclitaxel and carboplatin (squamous) or pemetrexed and carboplatin (non-squamous)
•1L mismatch repair proficient ("pMMR") / microsatellite stable ("MSS") colorectal cancer ("CRC"): CR-001 + mFOLFOX6
•Third-line (3L) CRC: CR-001 + trifluridine and tipiracil
•1L biliary tract cancer: CR-001 + gemcitabine and cisplatin
•1L pMMR endometrial cancer CR-001 + carboplatin and paclitaxel
•1L programmed cell death ligand ("PD-L1") - expressing gastric/gastroesophageal junction ("GEJ") cancer: CR-001 + capecitabine and oxaliplatin
•Second-line (2L) PD-L1-expressing gastric/GEJ cancer: CR-001 + paclitaxel
Pending results and further interactions with regulators, the Company plans to initiate the first of multiple Phase 3 trials of CR-001 in early 2028.
Kelun-Biotech Combination Studies
In partnership with the Company, Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech"), is conducting the following clinical trials in China to evaluate CR-001 (also known as SKB118) in combination with sacituzumab tirumotecan ("sac-TMT"), a TROP2-directed ADC, with additional ADC combination studies planned:
•A Phase 2 trial of CR-001 (SKB118) and sac-TMT in participants with locally advanced or metastatic NSCLC is ongoing with initial data expected in mid-2027;
•A Phase 2 trial of CR-001 (SKB118) and sac-TMT is enrolling participants with advanced solid tumors;
•A Phase 2 trial of CR-001 (SKB118) in combination with sac-TMT is initiating in EGFR-mutant locally advanced or metastatic non-squamous NSCLC who have failed epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy; and
•A Phase 1/2 trial of CR-001 (SKB118) in combination with CR-003 (also known as SKB105), an integrin-beta 6-directed ADC, is expected to commence in the first half of 2027.
ADC Pipeline
In October 2026, the Company's topoisomerase inhibitor ADC targeting PD-L1, CR-002, received allowance to proceed under an Investigational New Drug Application from the U.S. Food and Drug Administration. The Company is on track to initiate the global Phase 1/2 APOLLO trial in the fourth quarter of 2026 in patients with advanced solid tumors, including NSCLC, head and neck squamous cell carcinoma, and various gastrointestinal and gynecological tumors. Initial data are expected in the second half of 2027.
Kelun-Biotech granted the Company exclusive rights to research, develop, and commercialize CR-003 (SKB105), an integrin-beta 6-targeted ADC, in the United States, Europe and all markets outside of Greater China. A Phase 1/2 trial of
CR-003 (SKB105) in participants with advanced solid tumors conducted by Kelun-Biotech in China is ongoing and proof-of-concept data are expected in the first quarter of 2027. The Company plans to leverage data generated in China to support the global clinical development of CR-003 (SKB105).
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