This section highlights FDA-related milestones and regulatory updates for drugs developed by Corbus Pharmaceuticals (CRBP).
Over the past two years, Corbus Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CRB-601, CRB-701, and CRB-913. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CRB-601 - FDA Regulatory Timeline and Events
CRB-601 is a drug developed by Corbus Pharmaceuticals for the following indication: Designed to block the activation of latent TGFβ in the tumor microenvironment.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CRB-601
- Announced Date:
- December 9, 2024
- Indication:
- Designed to block the activation of latent TGFβ in the tumor microenvironment
Announcement
Corbus Pharmaceuticals 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).
AI Summary
Corbus Pharmaceuticals has reached an important milestone by dosing the first patient in the Phase 1 part of its clinical study for CRB-601 in patients with advanced solid tumors (NCT06603844). CRB-601 is a monoclonal antibody that targets latent TGFβ by blocking the integrin αVβ8. This study is designed to explore new ways to mobilize the immune system against tumors and potentially improve the effects of existing immune therapies.
Pre-clinical data showed that CRB-601 may help overcome tumor immune exclusion, boosting the activity of immune checkpoint inhibitors. The early stage dose escalation study aims to gather valuable insights on the drug's safety and its potential to trigger an immune response. Researchers hope that these results could lead to advancements in immunotherapy for patients with advanced solid tumors.
Read Announcement
CRB-701 - FDA Regulatory Timeline and Events
CRB-701 is a drug developed by Corbus Pharmaceuticals for the following indication: Targets the expression of Nectin-4 on cancer cells.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CRB-701
- Announced Date:
- June 25, 2025
- Indication:
- Targets the expression of Nectin-4 on cancer cells
Announcement
Corbus Pharmaceuticals announced the dosing of the first participant in the PD-1 combination arm of its Phase 1 study investigating CRB-701 in solid tumors (the Phase 1 Western study).
AI Summary
Corbus Pharmaceuticals has reached an important milestone in its Phase 1 Western study of CRB-701 for solid tumors. The company announced that the first participant in the PD-1 combination arm has been dosed. In this part of the study, patients are receiving CRB-701 alongside Keytruda® (pembrolizumab). Test subjects are randomly assigned to one of two dosing groups, either 2.7 mg/kg or 3.6 mg/kg. This trial aims to evaluate the safety and effectiveness of combining these treatments, specifically targeting cancers with high Nectin-4 expression.
The study focuses on patients with advanced solid tumors, including those with Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer. With over 100 participants already dosed in the monotherapy cohort, the initiation of the PD-1 combination arm marks a significant development as the researchers work to determine the best dose for future trials.
Read Announcement- Drug:
- CRB-701
- Announced Date:
- March 11, 2025
- Indication:
- Targets the expression of Nectin-4 on cancer cells
Announcement
Corbus Pharmaceuticals provided a corporate update
AI Summary
Corbus Pharmaceuticals provided a corporate update that highlighted significant progress in its clinical pipeline. The update focused on CRB-701, a next-generation antibody drug conjugate that targets Nectin-4 on cancer cells. Early clinical data from a Phase 1 study in Western patients showed a promising safety profile with low levels of peripheral neuropathy and skin toxicity, as well as encouraging signs of effectiveness in multiple advanced tumor types, including urothelial, cervical, and head and neck cancers. The company is currently optimizing the dosing in cohorts of 2.7 mg/kg and 3.6 mg/kg, aiming to establish a recommended Phase 2 dose under Project Optimus by the end of 2025. Additionally, the FDA granted Fast Track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer, underlining its potential as a valuable treatment option.
Read Announcement- Drug:
- CRB-701
- Announced Date:
- February 11, 2025
- Indication:
- Targets the expression of Nectin-4 on cancer cells
Announcement
Corbus Pharmaceuticals announced that the abstract for its first-in-human dose escalation clinical study conducted in the United States and Europe ("Western study") of CRB-701 (SYS6002) has been released.
AI Summary
Corbus Pharmaceuticals announced that the abstract for its first-in-human dose escalation clinical study, called the Western study, has been released. The study evaluates CRB-701 (SYS6002), a next-generation antibody-drug conjugate targeting Nectin-4, in patients with urothelial cancer and other advanced solid tumors.
The trial, conducted in the United States and Europe, is divided into three parts. Part A focuses on dose escalation and tests four predetermined doses to assess safety, pharmacokinetics, and initial efficacy signals. Updated results from 38 patients, expanding on earlier data from 31 patients, will be presented as a poster at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium.
This study represents a significant step in optimizing the dosing of CRB-701 and further exploring its potential as an innovative treatment option for cancer patients.
Read Announcement - Drug:
- CRB-701
- Announced Date:
- December 3, 2024
- Indication:
- Targets the expression of Nectin-4 on cancer cells
Announcement
Corbus Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer.
AI Summary
Corbus Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its drug CRB-701, aimed at treating relapsed or refractory metastatic cervical cancer. This special FDA designation is designed to speed up the development and review process for drugs that show promise in addressing serious conditions with unmet medical needs. CRB-701 is a next-generation antibody drug conjugate that targets the Nectin-4 protein on cancer cells, using a precise formulation that includes a cleavable linker and MMAE as its cytotoxic payload.
The Fast Track status reflects the potential of CRB-701 to offer new treatment options for patients with aggressive cervical cancer. The drug is currently under investigation in a Phase 1 clinical trial in the U.S. and Europe, with initial dosing data expected to be released in the first quarter of 2025.
Read Announcement
CRB-913 - FDA Regulatory Timeline and Events
CRB-913 is a drug developed by Corbus Pharmaceuticals for the following indication: For Obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CRB-913
- Announced Date:
- June 30, 2025
- Indication:
- For Obesity
Announcement
Corbus Pharmaceuticals Holdings Inc. announced the initiation of the multiple ascending dose (MAD) portion of its Phase 1 trial for CRB-913, a highly peripherally restricted CB1 inverse agonist for the treatment of obesity.
AI Summary
Corbus Pharmaceuticals Holdings Inc. has announced the launch of the multiple ascending dose (MAD) portion of its Phase 1 trial for CRB-913, a highly peripherally restricted CB1 inverse agonist designed to treat obesity. This next phase of the trial comes after favorable safety and pharmacokinetics data from the single ascending dose (SAD) study, where no treatment-related neuropsychiatric events were observed even at higher dosages. The MAD study will test once-daily dosing over 7 days in healthy volunteers, focusing on safety, tolerability, and pharmacokinetics as the doses increase.
With key data from both parts of the Phase 1 trial expected to be completed by the third quarter of 2025, the company is optimistic about CRB-913’s potential. Positive results from this study will help set the stage for a Phase 1b dose-range finding study in obese patients later in the year.
Read Announcement- Drug:
- CRB-913
- Announced Date:
- March 28, 2025
- Indication:
- For Obesity
Announcement
Corbus Pharmaceuticals Holdings, Inc announced today the dosing of the first subject in the single ascending dose / multiple ascending dose (SAD/MAD) portion of the Phase 1 trial of CRB-913 for the treatment of obesity.
AI Summary
Corbus Pharmaceuticals Holdings, Inc. announced a significant milestone in its obesity treatment program with the dosing of the first subject in the single ascending dose/multiple ascending dose (SAD/MAD) portion of its Phase 1 trial for CRB-913. This second-generation, highly peripherally restricted cannabinoid type-1 (CB1) receptor inverse agonist is designed to aid weight loss while reducing the risk of neuropsychiatric side effects seen in earlier drugs like rimonabant. Pre-clinical studies highlight that CRB-913 is markedly more peripherally restricted compared to other similar compounds.
The current SAD/MAD trial is scheduled for completion in Q3 2025, with plans to begin a Phase 1b dose-range finding study in Q4 2025, which is expected to conclude in the second half of 2026. This study marks an important step for Corbus in addressing unmet needs in obesity treatment.
Read Announcement
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