CR-001 / Crescent Biopharma, Sichuan Kelun Pharma - LARVOL DELTA

ASCEND: CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=290 | Not yet recruiting | Sponsor: Crescent Biopharma, Inc.

New P1/2 trial • Biliary Tract Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

The U.S. Food and Drug Administration (FDA) has cleared Crescent’s IND for CR-001... (The Manila Times) - "Phase 1/2 ASCEND global clinical trial to evaluate CR-001 in first-line and previously treated patients on track to initiate in first quarter of 2026, with proof-of-concept data anticipated in first quarter of 2027...The Phase 1/2 ASCEND global clinical trial plans to enroll both treatment-naïve and previously treated patients with multiple solid tumor types, including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological tumors. The trial is expected to enroll up to 290 participants in the dose-escalation, back-fill and dose-optimization cohorts designed to enable robust assessment of the clinical profile of CR-001."

IND • New P1/2 trial • P1/2 data • Gastrointestinal Cancer • Gynecologic Cancers • Non Small Cell Lung Cancer

Kelun-Biotech and Crescent Biopharma Announce Strategic Partnership to Develop and Commercialize Novel Oncology Therapeutics (PRNewswire) - "The partnership involves Crescent's CR-001, a PD-1 x VEGF bispecific antibody, and Kelun-Biotech's SKB105, an integrin beta-6 (ITGB6)-directed antibody-drug conjugate (ADC) with a topoisomerase payload. Both candidates are being developed for the treatment of solid tumors and are expected to enter Phase 1/2 monotherapy clinical trials in the first quarter of 2026...In addition, Kelun-Biotech has granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105 in the United States, Europe and all other markets outside of Greater China."

Licensing / partnership • New P1/2 trial • Solid Tumor

Recent Business Highlights & Upcoming Milestones: CR-001, a PD-1 x VEGF bispecific antibody (The Manila Times) - "Crescent remains on track to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for CR-001 in the fourth quarter of 2025 and expects to report proof-of-concept clinical data from a global Phase 1 trial in patients with solid tumors in the second half of 2026."

IND • P1 data • Oncology • Solid Tumor

Preclinical development of CR-001, a novel tetravalent PD-1 x VEGF bispecific antibody with cooperative pharmacology and potent anti-tumor activity (SITC 2025) - "Specifically, ivonescimab, a cooperative PD-1 x VEGF bispecific antibody, demonstrated superiority to anti-PD-1 in randomized Phase 3 trial.1 2 CR-001 is a tetravalent bispecific antibody targeting PD-1 and VEGF. These data support clinical development of CR-001.Ethics Approval All animal protocols were reviewed and approved by the IACUC institution of the respective CROs. Further animals were housed, provided enrichment and monitored in accordance with the institution's SOPs and protocols."

IO biomarker • Preclinical • Oncology • PD-1

Crescent Biopharma to Present Preclinical Data for CR-001, a PD-1 x VEGF Bispecific Antibody, at the Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting (GlobeNewswire) - "In data to be presented at SITC, CR-001 demonstrated cooperative pharmacology in vitro with increased binding to PD-1 in the presence of VEGF, augmenting the PD-1/PD-L1 signaling blockade and enhancing T-cell activation....CR-001 also showed potent anti-tumor activity in a xenograft mouse model, and was well-tolerated in non-human primates after a single intravenous dose with robust PD-1 receptor occupancy....IND submission for CR-001 on track for fourth Quarter of 2025 to support initiation of global phase 1 trial in patients with solid tumors."

IND • Preclinical • Solid Tumor

Crescent Biopharma to Present at the TD Cowen 45th Annual Health Care Conference (GlobeNewswire) - "Company to highlight lead program CR-001, a tetravalent VEGF1 x PD-1 bispecific antibody in development for treating solid tumors...announced management will present at the TD Cowen 45th Annual Health Care Conference on March 5, 2025, at 9:10 am ET."

Clinical • Solid Tumor

Crescent Biopharma Strengthens Leadership Team with Appointment of Three Key Executives (PRNewswire) - "...'Our lead asset CR-001 remains on track for IND filing in the fourth quarter of this year, with first clinical data readout anticipated in the second half of 2026. Likewise, our novel ADCs CR-002 and CR-003 remain on track, with an IND for CR-002 expected in mid-2026. We continue to expect our reverse merger with GlycoMimetics to close in the second quarter of 2025, and the addition of these new leaders, along with the wealth of industry experience they bring, ensures we are well positioned to continue our momentum and capitalize on the rich set of opportunities before us'."

Commercial • IND • Solid Tumor

GlycoMimetics Enters Into Acquisition Agreement With Crescent Biopharma (Businesswire) - "Concurrent financing of approximately $200 million anticipated to fund operations through 2027....GlycoMimetics...announced today it has entered into an acquisition agreement with Crescent Biopharma, Inc. ('Crescent'), a privately held biotechnology company advancing a pipeline of oncology therapeutics designed to treat solid tumors. Upon completion of the transaction, the Company plans to operate under the name Crescent Biopharma, Inc...including advancement of the Company’s lead program CR-001, a tetravalent PD-1 x VEGF bispecific antibody, through preliminary proof of concept clinical data in solid tumor patients expected in the second half of 2026....The Company anticipates that the IND for CR-001 will be filed in 4Q25 or 1Q26, and interim Phase 1 data from patients is expected in 2H26."

IND • M&A • P1 data • Solid Tumor