Brian Abrahams

Leland Gershell

Dae Gon Ha

David Szeto

Elemer Piros

Kenny Chan

Kenny Shannon

Maurice Raycroft

Maury Raycroft

- Corbus Pharmaceuticals announced the presentation of **positive Phase 1/2 clinical study data for CRB-701** (SYS6002) at the 2025 European Society for Medical Oncology (ESMO25) Congress.  **[1595097_4bb19ba5e9a54d308d590f6298d971c6_1]** 
- At the **3.6 mg/kg dose**, CRB-701 demonstrated an **Objective Response Rate (ORR)** of **47.6% in HNSCC**, **37.5% in cervical cancer**, and **55.6% in mUC** based on data as of September 1, 2025.  **[1595097_4bb19ba5e9a54d308d590f6298d971c6_0]** **[1595097_4bb19ba5e9a54d308d590f6298d971c6_1]** 
- The study indicated a **favorable safety and tolerability profile** for CRB-701, with a **low discontinuation rate of 6.0%** and **no Grade 4 or 5 treatment-related adverse events**.  **[1595097_4bb19ba5e9a54d308d590f6298d971c6_0]** **[1595097_4bb19ba5e9a54d308d590f6298d971c6_2]** 
- The company plans to **initiate registrational studies by mid-2026** and has received **two FDA Fast Track designations** for CRB-701 in HNSCC and cervical cancer.  **[1595097_4bb19ba5e9a54d308d590f6298d971c6_0]** **[1595097_4bb19ba5e9a54d308d590f6298d971c6_4]** **[1595097_4bb19ba5e9a54d308d590f6298d971c6_5]**

Corbus Pharmaceuticals Presents Positive CRB-701 Phase 1/2 Clinical Data at ESMO25

- Corbus Pharmaceuticals will present updated **Phase 1/2 clinical study data for CRB-701** at the European Society for Medical Oncology (ESMO) Congress 2025 on **Sunday, October 19**.  **[1595097_56f85782cfac4d6a9d1f735378e042e0_0]** 
- The poster presentation will include data from a **September 1, 2025 data cut** on **167 enrolled participants**, with **122 evaluable for efficacy** in various solid tumors, including head and neck squamous cell carcinoma (HNSCC) and cervical tumors.  **[1595097_56f85782cfac4d6a9d1f735378e042e0_0]** 
- CRB-701 is a **next-generation Nectin-4-targeting antibody-drug conjugate** that has received **two FDA Fast Track designations** for HNSCC and cervical cancer.  **[1595097_56f85782cfac4d6a9d1f735378e042e0_1]** 
- The company will also host an **HNSCC KOL event** on **October 19th** in Berlin, Germany, to review and discuss the data.  **[1595097_56f85782cfac4d6a9d1f735378e042e0_0]**

Corbus Pharmaceuticals to Present CRB-701 Phase 1/2 Data at ESMO 2025

- The U.S. Food and Drug Administration (FDA) has granted **Fast Track designation** to Corbus Pharmaceuticals' **CRB-701** for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy.  **[1595097_0001193125-25-204389_crbp-ex99_1.htm:0]** **[1595097_0001193125-25-204389_crbp-20250916.htm:1]** **[1595097_0001193125-25-204389_crbp-20250916.htm:2]** 
- This is the **second Fast Track designation** for CRB-701, with the first granted in December 2024 for relapsed or refractory metastatic cervical cancer.  **[1595097_0001193125-25-204389_crbp-ex99_1.htm:0]** 
- Corbus Pharmaceuticals is scheduled to present **dose optimization data** from the Phase 1/2 study of CRB-701 at **ESMO 2025 on October 19, 2025**.  **[1595097_0001193125-25-204389_crbp-ex99_1.htm:0]**

Corbus Pharmaceuticals Receives FDA Fast Track Designation for CRB-701 in HNSCC

Corbus Pharmaceuticals Holdings (CRBP)