On October 15, 2026 Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported clinical pipeline momentum, including 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, as well as the initiation of additional antibody-drug conjugate (ADC) combination studies with CR-001.

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"Our team’s outstanding execution has enabled us to rapidly advance three programs into the clinic in 2026 and make significant progress in developing next-generation IO, ADC and combination therapies. Together with our partner, Kelun-Biotech, we have achieved seven IND clearances to date, and by mid-2027, we expect more than 2,000 patients to have been dosed across our portfolio. We remain focused on generating meaningful clinical data and expect to begin sharing results in the first quarter of 2027, including data from ASCEND, which is enrolling first-line NSCLC patients globally, including in the United States and Europe. We believe these data can support the initiation of the first of multiple Phase 3 studies of CR-001 in early 2028," said Joshua Brumm, chief executive officer of Crescent.

"Our partnership with Kelun-Biotech brings together two companies with a shared commitment to accelerating the development of potentially transformative therapies for people living with cancer. Multiple combination trials of CR-001 and sac-TMT are already underway in China, with additional ADC combination studies planned. In 2026, we established the foundation for the next phase of Crescent’s growth: delivering multiple important clinical readouts across our IO and ADC portfolio, beginning early next year," said Mr. Brumm.

Clinical Execution Progress in ASCEND, a Global Phase 1/2 Trial of CR-001

On track to report initial monotherapy data from ASCEND in Q1 2027

Crescent has completed dose escalation in the global Phase 1/2 ASCEND trial of CR-001, its investigational PD-1 x VEGF bispecific, developed in collaboration with Paragon Labs, with patients enrolled across several tumor types at clinical sites in the United States, Europe and South Korea.

The Company plans 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 NSCLC cohort of up to 12 patients.
Safety, tolerability, pharmacokinetic and pharmacodynamic data from more than 125 treatment-naïve and previously-treated patients across multiple solid tumor types.

Enrolling patients in standard of care chemotherapy combination cohorts

Enrollment has commenced in the standard of care chemotherapy combination expansion cohorts of ASCEND. Hundreds of participants are expected to enroll in this part of the study with various tumor types and chemotherapy regimens being evaluated, including:
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 1 (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
Crescent plans to report initial data from the chemotherapy combination cohorts in mid-2027 (Q2/Q3).

Data from these cohorts, along with monotherapy data from ASCEND, will inform future clinical development for CR-001. Pending results and further interactions with regulators, Crescent plans to initiate the first of multiple Phase 3 trials of CR-001 in early 2028.

Trial in progress posters on the ASCEND study design will be presented during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2026 Congress being held October 23-27, 2026 in Madrid, Spain and at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting being held November 4-8, 2026 in Phoenix, Arizona.

Multiple Studies Evaluating CR-001 in Combination with Novel ADCs

Under a collaboration agreement, Crescent granted Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., ("Kelun-Biotech") exclusive rights to research, develop, and commercialize CR-001 (also known as SKB118) in Greater China. Both Kelun-Biotech and Crescent have rights to independently develop CR-001 in combinations, including with their respective ADC pipelines. Kelun-Biotech is conducting multiple trials in China evaluating CR-001 in combination with sacituzumab tirumotecan (sac-TMT), its TROP2-directed ADC, and additional ADC combination studies are 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 (Q2/Q3).
A Phase 2 trial of sac-TMT in combination with CR-001 (SKB118) is now enrolling participants with advanced solid tumors.
A Phase 2 trial of sac-TMT in combination with CR-001 (SKB118) is initiating in epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-squamous NSCLC who have failed EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy.
A Phase 1/2 trial of CR-001(SKB118) in combination with CR-003 (also known as SKB105), an integrin-beta 6 (ITGB6)-directed ADC, is expected to commence in the first half of 2027.

Advancing a Differentiated ADC Pipeline

Earlier this month, CR-002, Crescent’s topoisomerase inhibitor ADC targeting PD-L1, internally developed in collaboration with Paragon Labs, received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration. Crescent is on track to initiate the global Phase 1/2 APOLLO trial this quarter in patients with advanced solid tumors, including NSCLC, head and neck squamous cell carcinoma (HNSCC), and various gastrointestinal and gynecological tumors. Initial data are expected in the second half of 2027.

Kelun-Biotech granted Crescent exclusive rights to research, develop, and commercialize CR-003 (SKB105), an ITGB6-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. Crescent plans to leverage data generated in China to support the global clinical development of CR-003 (SKB105).

(Press release, Crescent Biopharma, OCT 15, 2026, View Source [SID1234673484])