Phase 1 Clinical Data for SYS6002 (CRB-701) to be presented at 2024 ASCO GU
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Insights
The release of Phase 1 dose escalation study data for SYS6002 (CRB-701) by Corbus Pharmaceuticals is a significant step in the drug's clinical development. The focus on reducing toxicities associated with enfortumab vedotin (EV) by adjusting the dosing schedule to every three weeks (Q3W) could potentially address a critical limitation in current cancer treatments. The Bayesian Optimal Interval (BOIN) design with accelerated titration is noteworthy for its innovative approach to determining the most effective dose with the least side effects, which is a key concern in oncology.
The inclusion of patients with various types of advanced solid tumors, such as metastatic urothelial cancer (mUC), cervical cancer, triple-negative breast cancer (TNBC) and colorectal cancer (CRC), indicates a broad potential application for SYS6002 (CRB-701). The preliminary anti-tumor activity data will be crucial in gauging the efficacy of the treatment, while the pharmacokinetic (PK) data will help understand how the drug is processed in the body. The impact on Corbus's stock could be significant if the data presented shows promise, as it could lead to further investment in the drug's development and potentially fast-track it to later-stage trials.
As an oncology doctor, the development of a next-generation Nectin-4 targeting Antibody Drug Conjugate (ADC) like SYS6002 (CRB-701) is particularly exciting. Nectin-4 is an important biomarker and therapeutic target in several types of cancer and the use of ADCs represents a targeted approach to treatment that can minimize damage to healthy cells. The focus on reducing free-MMAE concentrations is a strategy to mitigate the toxicities commonly seen with ADCs, which could lead to improved patient outcomes.
Enrolling patients based on nectin-4 staining, with the exception of mUC patients presumed to be nectin-4 positive, demonstrates a precision medicine approach that could enhance the treatment's efficacy. The potential for SYS6002 (CRB-701) to be used both as a monotherapy and in combination with other treatments could offer a versatile new option in the oncologist's arsenal, pending favorable safety and efficacy results.
From a market perspective, the development of SYS6002 (CRB-701) by Corbus Pharmaceuticals and its partner CSPC Pharmaceutical Group in China could tap into the growing demand for advanced cancer therapies. The global ADC market is expected to grow significantly and a successful trial could position Corbus favorably within this space. The focus on diseases with high unmet medical needs, such as TNBC and mUC, aligns with market trends towards personalized and targeted therapies.
Investors will be closely watching the presentation of updated data at the ASCO GU symposium, as it could influence Corbus's market valuation. Positive results could lead to increased investor confidence and potential partnerships or funding opportunities. Conversely, any setbacks in the trial could have a negative impact on the company's stock performance. The geographical expansion of development plans to the U.S. and Europe suggests that Corbus is aiming for a broad market reach, which could be a strong growth driver if the clinical outcomes are positive.
NORWOOD, Mass., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), announced today that the abstract for the first-in-human Phase 1 dose escalation study of SYS6002 (CRB-701) has been released, and the corresponding up-to-date data will be presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). The data referred to in the abstract dates to September of 2023; the upcoming presentation will include data as of December 2023. The study is being conducted by Corbus’s partner CSPC Pharmaceutical Group in China. ASCO GU will be held January 25-27, 2024 in San Francisco, CA and online.
The abstract, a Phase 1 Dose-Escalation of SYS6002 (CRB-701), a next-generation Nectin-4 Targeting Antibody Drug Conjugate (ADC) by DingWei Ye, et al will be presented on Jan 26th between 11:30-1pm PST. 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 and thereby reducing the associated toxicities that are known to dose limit enfortumab vedotin (EV). Additionally, by administering SYS6002 (CRB-701) on a Q3W schedule there is an opportunity to increase clinical convenience and patient compliance. The dose escalation that will be presented currently spans 6 dose levels (0.2, 0.6, 1.2, 1.8, 2.7 & 3.6 mg/kg) and makes use of a Bayesian Optimal Interval (BOIN) design with accelerated titration. The trial is evaluating the safety and tolerability of SYS6002 (CRB-701) to determine the Maximum Tolerated Dose (MTD) and/or the Phase II 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.
The Poster will include an updated cumulative dataset, based on a data-cut of 18 December 2023, of safety, tolerability, preliminary anti-tumor activity (efficacy), pharmacokinetic (PK), and nectin-4 expression levels from patients with metastatic urothelial cancer (mUC), cervical cancer, triple-negative breast cancer (TNBC), and colorectal cancer (CRC).
Continued development of SYS6002 (CRB-701) as both a monotherapy and in combination is planned both in China (CSPC), U.S. and Europe (Corbus Pharmaceuticals Holdings, Inc.).
About CRB-701
CRB-701 (SYS6002) is a next-generation antibody-drug-conjugate (ADC) targeting nectin-4, that contains a third generation, 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. The Nectin-4 ADC PADCEV® is approved for use in late metastatic urothelial cancer and recently received an expanded label under an accelerated approval from the Food and Drug Administration for use in combination with KEYTRUDA® for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.
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
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's restructuring, trial results, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
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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
FAQ
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