CRB-601 / Corbus Pharma - LARVOL DELTA

CRB-601 is a potent and selective anti-αvβ8 integrin monoclonal antibody (mAB) designed to block the activation of latent TGFβ in the tumor micro-environment to treat solid tumors. (Corbus Pharmaceuticals Press Release) - "A study-in-progress poster was presented at the 2025 Society for Immunotherapy of Cancer (SITC)."

Trial status • Solid Tumor

First-in-human phase 1/2 study of the integrin αvβ8-blocking antibody CRB-601 in patients with solid tumors (SITC 2025) - P1/2 | "Antitumor activity, biomarker and PK data will be presented at the congress.Conclusions Early phase 1/2 results suggest that CRB-601 is well tolerated with a favorable safety profile. These initial results suggest that further dose exploration with CRB-601 either alone or in combination with a PD-1 inhibitor is warranted.Trial Registration ClincalTrials.gov NCT06603844Ethics Approval Nebraska Hematology Oncology WCG 20243082 START - San Antonio Salus IRB START2023.01 Sarah Cannon - SCRI Oncology Partners Castle IRB IORG0010151 Sarah Cannon - OU Health Stephenson Cancer Center Castle IRB IORG0010151 AdventHealth Oncology Hematology WCG 20243082 Sarah Cannon - Florida Cancer Specialists/Lake Nona Castle IRB IORG0010151 University Hospital Cleveland University Hospitals IRB 20241088 Cedars-Sinai Medical Center Cedars-Sinai Office of Research Compliance and Quality Improvement 167906 UC San Diego WCG 20243082 The Clatterbridge Cancer Center NHS Foundation Trust UK..."

Clinical • First-in-human • IO biomarker • P1/2 data • Head and Neck Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Corbus Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides a Corporate Update (Corbus Pharmaceuticals Press Release) - "CRB-701: The Company expects to complete dose optimization and identify the recommended Phase 2 dose (RP2D) in the fourth quarter of 2025....CRB-601: The first participant was dosed in December 2024 in the dose escalation monotherapy portion of a Phase 1 study which is being conducted in the U.S. and Europe. The Company is on track to report dose escalation data in Q4 2025."

P1 data • Trial status • Oncology • Solid Tumor

Corbus Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides a Corporate Update (Corbus Pharmaceuticals Press Release) - "Dose optimization and RP2D determination on schedule for completion in Q4 2025 for the Nectin-4 ADC CRB-701 in HNSCC, cervical and mUC tumors....Dose escalation study on schedule for completion in Q4 2025 for the anti-αvβ8 integrin mAB-CRB-601 in solid tumors."

Trial completion date • Trial status • Cervical Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Corbus Pharmaceuticals Reports Q4 and 2024 Financial Results and Provides a Corporate Update (Corbus Pharmaceuticals Press Release) - "CRB-701: Dose optimization is underway with dosing at 2.7 mg/kg and 3.6 mg/kg cohorts in HNSCC, cervical and mUC tumors. More cohorts may be added to address additional tumor types in the expansion phase. The Company expects to complete dose optimization and establish a recommended Phase 2 dose ('RP2D') under Project Optimus in the fourth quarter of 2025....CRB-601 is a potent and selective anti-αvβ8 integrin monoclonal antibody for the treatment of solid tumors....We expect to complete dose escalation in the fourth quarter of 2025."

Trial status • Cervical Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

First-in-human Study of CRB-601-01 to Treat Patients with Advanced Solid Tumor. (clinicaltrials.gov) - P1/2 | N=156 | Recruiting | Sponsor: Corbus Pharmaceuticals Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • PD-L1

Corbus Pharmaceuticals Announces Dosing of First Patient in its First-In-Human Study of CRB-601 to Treat Patients with Advanced Solid Tumors (Corbus Pharmaceuticals Press Release) - "Corbus Pharmaceuticals Holdings, Inc...announced the dosing of the first patient in the Phase 1 portion of the clinical study of CRB-601 for the treatment of patients with advanced solid tumors (NCT06603844)."

Trial status • Oncology • Solid Tumor

Corbus Pharmaceuticals Reports 3rd Quarter 2024 Financial Results and Provides a Corporate Update (Corbus Pharmaceuticals Press Release) - "The Company expects to dose the first patient in Q4 2024 for the Phase 1 portion of the CRB-601 clinical study NCT06603844 for the treatment of patients with advanced solid tumors."

Trial status • Oncology • Solid Tumor

First-in-human Study of CRB-601-01 to Treat Patients with Advanced Solid Tumor. (clinicaltrials.gov) - P1/2 | N=156 | Not yet recruiting | Sponsor: Corbus Pharmaceuticals Inc.

Metastases • New P1/2 trial • Oncology • Solid Tumor • PD-L1

Corbus Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides a Corporate Update (Corbus Pharmaceuticals Press Release) - "In January 2024, the FDA cleared the IND for CRB-601, and the Company expects to initiate a Phase 1 study of CRB-601 in Q4 2024."

New P1 trial • Oncology • Solid Tumor

Corbus Pharmaceuticals Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Corporate Update (Corbus Pharmaceuticals Press Release) - "In January 2024, the FDA cleared the IND and the Company expects to enroll the first patient in the Ph1 study in the summer of 2024. The Company expects to complete the CRB-601 Ph1 dose-escalation study (monotherapy and in combination with PD-1) by the end of 2024....Operating expenses for Q4 2023 decreased by $0.7 million to approximately $10.1 million for the three months ended December 31, 2023, compared to $10.8 million in the comparable period in the prior year. The decrease was attributable to reductions in compensation expense and legal expenses offset by an increase in development costs for CRB-701 and CRB-601, attributable to moving both drugs into clinical studies in 2024."

Commercial • New P1 trial • Obesity • Solid Tumor

Corbus Pharmaceuticals Announces FDA Clearance of IND Application for its anti-αvβ8 monoclonal antibody (CRB-601) (GlobeNewswire) - "Corbus Pharmaceuticals Holdings...announced the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug application of CRB-601, a potentially best-in-class TGFβ blocking monoclonal antibody targeting the integrin αvβ8....The Company expects to enroll the first participant in a Phase 1 study in the first half of 2024....Pre-clinical data presented demonstrates robust anti-tumor activity in solid tumor models."

IND • New P1 trial • Solid Tumor

Corbus Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Corbus Pharmaceuticals Holdings, Inc.,,today provided a corporate update and reported financial results for the third quarter of 2023....The potential of CRB-701 was further highlighted in a 'Meet the Expert' webinar hosted by Corbus that featured several notable oncology experts...Alexander Spira..."

Oncology • Solid Tumor

Corbus Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Corbus Pharmaceuticals Holdings, Inc.,,today provided a corporate update and reported financial results for the third quarter of 2023....Operating expenses increased by $1.3 million to approximately $9.5 million for the three months ended September 30, 2023, compared to $8.2 million in the comparable period in the prior year. The increase was primarily attributable to manufacturing costs to support the Phase 1 clinical trial material for CRB-601 offset by a reduction in general and administrative compensation expenses."

Commercial • Oncology • Solid Tumor

CRB-601, an integrin αvβ8 blocking antibody entering phase I: pre-clinical and translational biomarkers for indication selection (SITC 2023) - "Conclusions Pre-clinical studies demonstrate that CRB-601 is a potent and selective integrin avβ8 blocking mAb that demonstrates immunomodulatory effects reflected in changes in the tumor lymphocyte population, cytokine profile and gene expression. Understanding gene and protein expression levels for various solid tumors may enable rational indication selection."

IO biomarker • Preclinical • Oncology • Solid Tumor • CD8 • TGFB1

CRB-601, a selective integrin αvβ8-blocking antibody, prevents TGFβ activation, promotes immune cell remodeling, and exhibits potent antitumor activity (SITC 2023) - "The encouraging results from this study, such as tumor growth inhibition and significant immune cell infiltration, hint at the potential of CRB-601 as a promising cancer immunotherapy. Investigational New Drug (IND) enabling studies are currently underway."

Immune cell • IO biomarker • Breast Cancer • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • IL2 • TGFB1

Corbus Pharmaceuticals Presents Results of Two Pre-Clinical Studies on its Anti-αVβ8 Monoclonal Antibody (CRB-601) at the 2023 SITC Annual Meeting (GlobeNewswire) - "In a study titled 'CRB-601, an integrin αvβ8 blocking antibody entering Phase I: pre-clinical and translational biomarkers for indication selection'....researchers evaluated the anti-tumor activity, immunological changes and biomarkers of response of CRB-601 in pre-clinical mouse models. Results showed: CRB-601 demonstrated immunomodulatory effects as reflected in changes in cytotoxic CD8+ T cell population and gene expression in the TME. Integrin avβ8 blockade led to modulation in TGFβ pathway related genes and downregulation of pathway biomarker pSMAD2."

Preclinical • Oncology

Corbus Pharmaceuticals Presents Results of Two Pre-Clinical Studies on its Anti-αVβ8 Monoclonal Antibody (CRB-601) at the 2023 SITC Annual Meeting (GlobeNewswire) - "A second study titled CRB-601, a selective integrin αvβ8-blocking antibody, prevents TGFβ activation, promotes immune cell remodeling, and exhibits potent antitumor activity (Maneesh Singh, et al), researchers assessed the tumor growth inhibition of CRB-601+/- anti PD-1 in three tumor models (MC38, EMT6, and 4T1). Results showed: CRB-601 advances immunotherapeutic strategies by antagonizing integrin αvβ8, enhancing the efficacy of immune checkpoint inhibitors in vivo....The synergistic administration of CRB-601 with anti-PD-1 agents significantly enhances tumor-specific cytotoxic T-cell responses, suggesting an enriched T-cell precursor population."

Preclinical • Oncology • Solid Tumor

Corbus Pharmaceuticals to Present Latest Pre-Clinical Data on its Anti-aVb8 Monoclonal Antibody (CRB-601) at the 2023 SITC Annual Meeting (PRNewswire) - "Corbus Pharmaceuticals Holdings...announced that an abstract highlighting pre-clinical data on its CRB-601 anti-aVb8 integrin monoclonal antibody has been accepted for presentation as a poster at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), to be in San Diego, CA November 1-5, 2023....The IND submission for CRB-601 is anticipated in Q4 2023, and the Company expects to enroll the first patient in its Phase 1 study in the first half of 2024."

IND • New P1 trial • Preclinical • Solid Tumor

Corbus Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Corporate Update (PRNewswire) - "The dose exploration of CRB-701 in Nectin-4 positive solid tumors is ahead of schedule. CSPC, our development partner, is enrolling its Phase 1 dose escalation study in China and Corbus now estimates this escalation will be completed by the end of 2023 and plans to initiate an abbreviated Phase 1 in the US in the first quarter of 2024 leveraging the clinical experience from China....The IND submission for CRB-601 is anticipated in Q4 2023, and the Company expects to enroll the first patient in its Phase 1 study in the first half of 2024....Operating expenses decreased by $4.1 million to approximately $8.2 million for the three months ended June 30, 2023, compared to $12.3 million in the comparable period in the prior year. The decrease was primarily attributable to a litigation settlement payment of $5.0 million in 2022 and reduction in general and administrative expenses in the current period offset by increases in product development expenses for CRB-701 and CRB-601."

Commercial • IND • New P1 trial • Oncology • Solid Tumor

Corbus Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Corporate Update (Corbus Pharmaceuticals Press Release) - "Clinical development is underway and will focus on Nectin-4 positive tumors, including urothelial cancer. CSPC has commenced a Phase 1 dose escalation study in China for patients with advanced solid tumors. Corbus plans to bridge data from this Phase 1 trial to support a U.S. clinical trial starting in mid-2024....IND submission for CRB-601 is on track for the second half of 2023. The Company expects to enroll the first patient in the Phase 1 study by the end of 2023."

IND • New P1 trial • P1 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

CRB-601, an αvβ8 Blocking Antibody, Prevents Activation of TGF and Exhibits Antitumor Activity Associated with Immune Cell Remodeling of Tumor Microenvironment (FCI 2023) - No abstract available

Biomarker • Immune cell • Tumor microenvironment • Oncology

Corbus Pharmaceuticals to Present Latest Pre-Clinical Data on CRB-601 avβ8 Blocking Antibody at the New York Academy of Sciences' Frontiers in Cancer Immunotherapy Meeting (PRNewswire) - "Corbus Pharmaceuticals Holdings...announced that an abstract highlighting pre-clinical data for CRB-601, its avβ8 blocking antibody, has been accepted for oral presentation in the main program of the New York Academy of Sciences' 2023 Frontiers in Cancer Immunotherapy meeting, taking place in New York, NY May 2-4, 2023."

Preclinical • Oncology

CRB-601, an avβ8 blocking antibody, prevents activation of TGFb and exhibits anti-tumor activity associated with immune cell remodeling of the tumor microenvironment (AACR 2023) - "CRB-601 is a potent and selective integrin αvβ8 blocking monoclonal antibody that can overcome tumor immune exclusion and enhance the activity of immune checkpoint inhibitors. CRB-601 antitumor activity correlated to increased αvβ8 RO and downregulation of TGFβ signaling. Investigational New Drug (IND) enabling studies are in progress."

Biomarker • Immune cell • Tumor microenvironment • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • IFNG • PTPRC

Corbus Pharmaceuticals Hosting Virtual ’Meet the Expert’ Series: Blocking TGFβ with CRB-601--a New Play for an Old Target (Corbus Pharmaceuticals Press Release) - "Corbus Pharmaceuticals Holdings, Inc...announced that the Company will host the first in the series of virtual 'Meet the Expert' events titled Blocking TGFβ with CRB-601—a New Play for an Old Target, on April 25th at 11:00 AM ET....This event will focus on CRB-601, an anti-integrin αvβ8 monoclonal antibody that blocks the activation of latent-TGFβ expressed within the tumor microenvironment....In non-clinical studies, CRB-601 significantly inhibits tumor growth both as a single agent and in combination with checkpoint inhibition."

Preclinical • Oncology • Solid Tumor