Updated Phase 1 Clinical Data for SYS-6002 (CRB-701) to be presented at 2024 ASCO Annual Meeting
Corbus Pharmaceuticals (NASDAQ: CRBP) announced that an abstract titled 'Clinical Update Related to the First-In-Human Trial of SYS6002 (CRB-701)' will be presented at the 2024 ASCO Annual Meeting. This presentation will occur on June 1, 2024, and will provide updated clinical data from a Phase 1 trial. The trial involves dose escalation spanning seven levels and employs a Bayesian Optimal Interval design. The study aims to establish the Maximum Tolerated Dose (MTD) and Phase 2 dose for SYS6002 (CRB-701) in patients with advanced solid tumors unresponsive to standard treatments. Key findings include safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. The study is conducted in China by Corbus's partner CSPC, with a parallel Phase 1 study recently initiated in the U.S., where the first patient was dosed in April 2024.
- SYS6002 (CRB-701) targets Nectin-4, a promising mechanism for treating advanced solid tumors.
- The trial includes seven dose levels with sophisticated Bayesian Optimal Interval design, enhancing dose precision.
- Updated data includes approximately 3 additional months of clinical information, increasing the robustness of the findings.
- Initiation of Phase 1 study in the U.S., expanding the geographical scope and potential impact of the trial.
- The study focuses mainly on safety and tolerability, with preliminary anti-tumor activity not yet fully established.
- Patients enrolled have advanced solid tumors that are unresponsive to standard treatments, indicating a challenging patient population.
- Results are still early-stage (Phase 1), meaning significant hurdles and uncertainties remain before potential market approval.
NORWOOD, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”) announced today that the abstract [No. 3151] for a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) annual meeting being held from May 31-June 4, 2024 in Chicago has been released. The ASCO abstract is titled: Clinical Update Related to the First-In-Human Trial of SYS6002 (CRB-701), A Next-Generation Nectin-4 Targeting Antibody Drug Conjugate and will be presented as a poster [#296] on June 1, 2024 from 9:00 AM -12:00 PM by Dr. Jian Zhang, Fudan University Shanghai Cancer Center.
The poster will update data contained in the abstract [cut-off mid-January 2024] with approximately 3 months additional clinical data [cut-off end of April 2024] from dose escalation and PK cohorts. Dose escalation spans 7 dose levels (0.2, 0.6, 1.2, 1.8, 2.7, 3.6 & 4.5 mg/kg) and makes use of a Bayesian Optimal Interval (BOIN) design with accelerated titration. PK cohorts have been initiated at the 2.7mg/Kg & 3.6mg/Kg dose levels. The trial is evaluating the safety and tolerability of SYS6002 (CRB-701) to determine the Maximum Tolerated Dose (MTD) and/or the Phase 2 dose in patients with advanced solid tumors who have failed or were intolerant to standard treatment. Patients were enrolled based on Nectin-4 staining, with the exception of metastatic urothelial cancer (mUC) urothelial cancer patients, who were considered to be Nectin-4 positive. Beyond determining safety and tolerability, the pharmacokinetic (PK) and preliminarily anti-tumor activity of SYS6002 (CRB-701) are reported. This study is being conducted by Corbus’s partner CSPC in China. Corbus has commenced a Phase 1 dose escalation study in the U.S. and dosed the first patient in April 2024.
About CRB-701
CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4 with a site-specific cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. SYS6002 (CRB-701) is currently being explored in a dose escalation on a Q3W schedule, with a view to reducing free-MMAE concentrations in plasma, reducing the associated toxicities that are known to dose limit the Nectin-4 ADC PADCEV® (enfortumab vedotin) Additionally, by administering SYS6002 (CRB-701) on a Q3W schedule there is an opportunity to increase clinical convenience and patient compliance.
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a precision oncology company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ pipeline includes CRB-701, a next generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
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INVESTOR CONTACT:
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
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