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Corbus Pharmaceuticals Holdings, Inc. reports clinical-stage drug-development news in oncology and obesity. Updates center on CRB-701, a next-generation Nectin-4 antibody-drug conjugate licensed from CSPC Megalith Biopharmaceutical, including data presentations in head and neck squamous cell carcinoma and cervical cancer, FDA interactions and Fast Track designations.
Company news also covers CRB-913, a peripherally restricted oral CB1 inverse agonist for obesity, and CRB-601, an anti-integrin monoclonal antibody targeting TGFβ activation. Recurring items include clinical trial disclosures, medical-meeting presentations, management conference appearances, governance changes and operating or financial results.
Corbus Pharmaceuticals (NASDAQ:CRBP) presented Phase 1 study results for CRB-701 (SYS6002), a next-generation Nectin-4 targeting ADC, at ASCO-GU 2025. The Western study, conducted in the US and UK, mirrored the four highest doses used in the China study and showed comparable safety and PK profiles with no dose-limiting toxicities.
Key findings include: low levels of peripheral neuropathy (4% combined rate), positive clinical responses in urothelial (mUC) and cervical cancer patients, and notably, multiple responses in head and neck squamous cell carcinoma (HNSCC). The Western study enrolled 38 participants across eight tumor types, with 26 evaluable for efficacy. Dose optimization is ongoing at 2.7 mg/kg and 3.6 mg/kg Q3W.
The drug demonstrated encouraging safety with mainly grade 1 or 2 adverse events, and showed efficacy even in tumors with low Nectin-4 expression levels.
Corbus Pharmaceuticals (NASDAQ: CRBP) announced the release of abstract data from their first-in-human dose escalation clinical study of CRB-701 (SYS6002), which will be presented at the 2025 ASCO Genitourinary Cancers Symposium in San Francisco. The Western study, conducted in the US and Europe, includes updated data from 38 patients as of December 2024, expanding from the 31 patients covered in the September 2024 abstract.
The three-part Phase 1 study (NCT06265727) evaluates CRB-701's safety, pharmacokinetics, and efficacy in patients with advanced solid tumors showing high Nectin-4 expression. Part A evaluated four predetermined doses (1.8, 2.7, 3.6, and 4.5 mg/kg Q3W), followed by Parts B and C focusing on dose optimization and expansion to determine recommended doses and preliminary efficacy signals.
Corbus Pharmaceuticals Holdings (NASDAQ: CRBP) has announced its participation in the upcoming Guggenheim SMID Cap Biotech Conference, scheduled for February 5-6, 2025, in New York. The company's CEO, Yuval Cohen, Ph.D., will engage in a fireside chat discussion led by analysts and conduct one-on-one meetings with investors.
The presentation is set for February 5, 2025, at 2:30 PM. The format will include both the fireside discussion and individual investor meetings, with a webcast link provided for virtual attendance.
Corbus Pharmaceuticals (NASDAQ: CRBP) announced that data from its first-in-human dose escalation clinical study of CRB-701 (SYS6002) will be presented at the 2025 ASCO Genitourinary Cancers Symposium in San Francisco. The study, conducted in the US and UK, focuses on a next-generation Nectin-4 targeting antibody-drug conjugate.
The Phase 1 study (NCT06265727) consists of three parts and evaluates safety, pharmacokinetics, and efficacy in patients with advanced solid tumors showing high Nectin-4 expression. Part A of the study examined four predetermined doses: 1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg, and 4.5 mg/kg Q3W. The study will continue with Part B (dose optimization) and Part C (dose expansion) to determine recommended doses and assess preliminary efficacy.
Corbus Pharmaceuticals (NASDAQ: CRBP) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference, scheduled for January 13-16, 2025, in San Francisco, CA. CEO Yuval Cohen, Ph.D., will deliver a presentation on January 16, 2025, at 11:15 a.m. PST and will be available for one-on-one investor meetings during the conference.
The prestigious healthcare conference is an invitation-only event, and interested parties are advised to contact their J.P. Morgan representative for attendance details.
Corbus Pharmaceuticals (NASDAQ: CRBP) has initiated the Phase 1 clinical trial of CRB-601, dosing its first patient for the treatment of advanced solid tumors. CRB-601 is a monoclonal antibody targeting latent TGFβ activation by blocking the integrin αVβ8.
Pre-clinical data has shown that CRB-601 successfully overcomes tumor immune exclusion and enhances the effectiveness of immune checkpoint inhibitors in vivo. The study (NCT06603844) represents a significant step in evaluating CRB-601's potential in immunotherapy and its ability to modulate TGFβ signaling.
Corbus Pharmaceuticals announced that the FDA has granted Fast Track designation to CRB-701 for treating relapsed or refractory metastatic cervical cancer. CRB-701 is a next-generation antibody drug conjugate targeting Nectin-4, featuring a site-specific, cleavable linker and a precise drug antibody ratio of 2 using MMAE payload. The company has completed enrollment for the dose escalation portion of its Phase 1 clinical trial, which is evaluating safety, pharmacokinetics, and efficacy in patients with advanced solid tumors associated with high Nectin-4 expression. Initial data from the dose escalation study is expected in Q1 2025.
Corbus Pharmaceuticals (NASDAQ: CRBP) has announced its participation in the 7th Annual Evercore HealthCONx Conference, scheduled for December 3-5, 2024, in Coral Gables, FL. CEO Yuval Cohen, Ph.D., will engage in a fireside chat and conduct one-on-one investor meetings during the event. The fireside chat is specifically scheduled for December 3, 2024, at 4:15 p.m. ET, with a webcast available for viewing.
Corbus Pharmaceuticals (NASDAQ: CRBP) has announced its participation in the upcoming Jefferies London Healthcare Conference, scheduled for November 19-21, 2024, in London, UK. The company's CEO, Yuval Cohen, Ph.D., will engage in a fireside chat and conduct one-on-one investor meetings during the event. The fireside chat is specifically scheduled for November 19, 2024, at 10:30 a.m. GMT, with a webcast link provided for interested parties.
Corbus Pharmaceuticals reported Q3 2024 financial results and corporate updates. The company completed enrollment for the dose escalation part of its Phase 1 trial for CRB-701, with first data expected in Q1 2025. New pre-clinical data for CRB-913 was presented at Obesity Week 2024, with Phase 1 trial expected to start in Q1 2025. The company reported a net loss of $13.8 million, or $1.15 per share. Operating expenses increased to $15.5 million. Cash position stands at $159.4 million, expected to fund operations through Q3 2027. The company raised $35.6 million through ATM program and paid off an $11.8 million loan.