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

ASCEND: A phase 1/2, dose-escalation, optimization, and dose-expansion study to evaluate the safety and antitumor activity of CR-001 in adults with locally advanced or metastatic solid tumors (ESMO 2026) - No abstract available

Clinical • Metastases • P1/2 data • Oncology • Solid Tumor

Crescent anticipates reporting: (The Manila Times) - "Proof-of-concept clinical data from the ASCEND trial of CR-001 in the first quarter of 2027, including initial safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity from dose escalation and backfill cohorts in first-line and previously treated patients in multiple solid tumor types. A backfill cohort of first-line NSCLC patients is planned as part of this readout. Initial data of CR-001 in combination with various standard of care chemotherapy regimens in first-line and previously treated patients by mid-2027 (Q2/Q3) utilizing the dose expansion part of the ASCEND trial. Initial data from the Phase 2 trial in China of CR-001 in combination with sac-TMT in mid-2027 (Q2/Q3)."

P1/2 data • P2 data • Non Small Cell Lung Cancer • Solid Tumor

Recent Business Highlights & Anticipated Milestones: CR-003 (The Manila Times) - "A Phase 1/2 trial of CR-003 (also known as 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. A Phase 1/2 combination trial of CR-003 and CR-001 is expected to initiate in the first half of 2027, with initial data anticipated by year-end 2027. Under the collaboration, Kelun-Biotech granted Crescent exclusive rights to research, develop, and commercialize CR-003 (SKB105) in the United States, Europe and all markets outside of Greater China."

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

CR-001-101: A Phase 1/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of CR-001 in Adult Participants with Locally Advanced or Metastatic Solid Tumors (clinicaltrialsregister.eu) - P1/2 | N=44 | Not yet recruiting | Sponsor: Crescent Biopharma Inc.

New P1/2 trial • Biliary Tract Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Endometrial Cancer • Gallbladder Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatocellular Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Rectal Adenocarcinoma • Solid Tumor • ALK • PD-L1

ASCEND: A phase 1/2, dose-escalation, optimization, and dose-expansion study to evaluate the safety and antitumor activity of CR-001 in adults with locally advanced or metastatic solid tumors. (ASCO 2026) - P1/2 | "Up to 290 patients are planned to be enrolled across the dose-escalation, tumor-specific backfill, and dose-optimization cohorts. This global trial is currently enrolling."

Clinical • First-in-human • Metastases • P1/2 data • Biliary Cancer • Biliary Tract Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Hepatocellular Cancer • Immune Modulation • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Crescent anticipates reporting (GlobeNewswire) - "(i) Proof-of-concept clinical data from the ASCEND trial of CR-001 in the first quarter of 2027, including initial safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity from dose escalation and backfill cohorts in first-line and previously treated patients in multiple solid tumor types. A backfill cohort of first-line NSCLC patients is planned as part of this readout; (ii) Initial data of CR-001 in combination with standard of care chemotherapy in first-line and previously treated patients in mid-2027 (Q2/Q3) utilizing the dose expansion part of the ASCEND trial; (iii) Initial data from the Phase 1/2 trial in China of CR-001 in combination with a Kelun-Biotech ADC in mid-2027 (Q2/Q3)."

P1/2 data • Biliary Tract Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastroesophageal Cancer • Hepatocellular Cancer • Non Small Cell Lung Cancer • Ovarian Cancer

Crescent Biopharma Announces Trial in Progress Presentation for ASCEND Study of CR-001, a PD-1 x VEGF Bispecific Antibody, at Upcoming American Society of Clinical Oncology (ASCO) 2026 Annual Meeting (GlobeNewswire) - "Enrollment is ongoing in ASCEND (NCT07335497), a global, open-label Phase 1/2 clinical trial evaluating CR-001 in multiple solid tumor types, including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological cancers, in both treatment-naïve and previously treated patients. The trial is expected to enroll up to 290 patients in dose-escalation, backfill and dose-optimization cohorts at centers across multiple regions, including the United States, Europe and Asia Pacific. The primary objectives of the study are to evaluate the safety and tolerability of CR-001."

Trial status • Biliary Tract Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastroesophageal Cancer • Hepatocellular Cancer • Non Small Cell Lung Cancer • Ovarian Cancer

Sichuan Kelun-Biotech…announced that it has received a clinical trial notice from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) approving the Investigational New Drug (IND) application for PD-1 x VEGF bispecific antibody SKB118 (also known as CR-001) for the treatment of advanced solid tumors (PRNewswire)

New trial • Solid Tumor

A phase I, open-label, multi-center dose-finding and expansion study to investigate the safety, tolerability, and preliminary efficacy of CR1-02 (5-FU-miR-15a) in patients with acute myeloid leukemia (AACR 2025) - "By modifying miR-15a with the cytotoxic pyrimidine 5-fluorouracil (5-FU), the 5-FU-miR-15a (CR1-02) miRNA has exhibited enhanced therapeutic efficacy, stability, as well as deliverability in multiple tumor types in pre-clinical testing.Aim: CR1-02 (EudraCT number: 2021-006332-46) is a phase I dose-escalation study evaluating the safety and tolerability of CR-001 in adults with relapsed/refractory (R/R) AML. A 3+3 study design was used with patients receiving dose levels of the synthetic double-stranded mimic of miR-15a (miRNA) (CR1-02) of 7.5 mg, 11.25 mg, 15 mg, and 18.75 mg/administration, weekly dosing...One patient (NRAS VAF 48%, ASXL1 41%, TP53 23%) responded with elimination of extramedullary pericardial AML disease after 4 doses of CR1-02 but progressed in bone marrow after 8+8 doses of CR-001 (eight study doses and an additional eight doses given under compassionate use approval from the Norwegian Medicines Agency) followed by trametinib-treatment as part of..."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • ASXL1 • BCL2 • BMI1 • CHEK1 • MIR15A • NRAS • TP53

Sustained Value Release of ADCs Under Development with Tiered Advancement of Innovation Pipeline (The Manila Times) - "The company is planning to initiate the Phase 1/2 clinical study for SKB118 in China in the first half of 2026...SKB571/MK-2750 (novel bsADC): The Phase 2 clinical trial in China is ongoing; SKB518 (novel ADC with a potential FIC target): The Phase 2 clinical trials are ongoing in China; SKB500 (novel ADC): The Phase 2 study is ongoing in China."

New P1/2 trial • Platinum sensitive • Trial status • Cervical Cancer • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Non Small Cell Lung Cancer • Peritoneal Cancer • Small Cell Lung Cancer • Solid Tumor

Crescent Biopharma Announces First Patient Dosed in ASCEND Phase 1/2 Clinical Trial of CR-001 for the Treatment of Advanced Solid Tumors (GlobeNewswire) - "ASCEND (NCT07335497) is a global, open-label Phase 1/2 clinical trial evaluating CR-001 in multiple solid tumor types, including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological cancers, in both treatment-naïve and previously treated patients. The trial is expected to enroll up to 290 patients....Crescent anticipates reporting proof-of-concept clinical data from the ASCEND trial in the first quarter of 2027, including initial safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity from dose escalation and backfill cohorts."

P1/2 data • Trial status • Gastrointestinal Cancer • Gynecologic Cancers • Non Small Cell Lung Cancer

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

Enrollment open • 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

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