Group 1 - The event was well-attended, indicating strong interest in the company's data and discussions, particularly regarding head and neck research [2] - The organization of the event was acknowledged, highlighting the efforts of LifeSci and the team involved in the webcast and recording [2] - The CEO of Corbus, Yuval Cohen, introduced the panel and expressed gratitude for the audience's presence [3]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Financial Status - As of June 30, 2025, the company holds $117 million in cash, cash equivalents, and investments[8] - Approximately 123 million common shares are outstanding, with roughly 142 million fully diluted shares[8] CRB-701 (Next-Generation Nectin-4 Targeting ADC) - CRB-701 aims to reduce PADCEV®-associated toxicities and extend ADC half-life to reduce dosing frequency[11] - CRB-701 has a precise and stable DAR of 2, leading to a longer half-life, improved binding affinity, and selectivity, resulting in a 2x rate of internalization compared to PADCEV®[14] - In a patient-derived tumor model, CRB-701 demonstrated a 745% reduction in mean tumor volume compared to PADCEV®, with p<005[18] - CRB-701 shows lower levels of free MMAE compared to PADCEV®; at a matched MMAE dose, CRB-701 had 35% Cmax and 38% AUC 0-21d of free MMAE compared to PADCEV®[20] - In HNSCC patients, CRB-701 at 36 mg/kg showed an ORR of 476% (10/21) and a DCR of 619%[41] - In cervical cancer patients, CRB-701 at 36 mg/kg showed an ORR of 375% (6/16) and a DCR of 688%[59] - In mUC patients, CRB-701 at 36 mg/kg showed an ORR of 556% (5/9) and a DCR of 889%[69] CRB-913 (Oral Cannabinoid Type-1 Inverse Agonist) - CRB-913 is designed as a best-in-class next-generation CB1 inverse agonist with higher peripheral restriction compared to monlunabant or rimonabant[86, 89] - At a dose of 10 mg/kg, CRB-913 has a brain:plasma AUC ratio of 1:50, compared to 1:5 for monlunabant and 1:1 for rimonabant[91] Upcoming Milestones - Clinical data readouts are expected for all three drug candidates (CRB-701, CRB-913, CRB-601) in the second half of 2025[7]

Corbus Pharmaceuticals Holdings (NasdaqCM:CRBP) Update Summary Company Overview - **Company**: Corbus Pharmaceuticals Holdings - **Focus**: Development of CRB-701, an antibody-drug conjugate (ADC) targeting head and neck cancer, cervical cancer, and bladder cancer Key Industry Insights - **Market Opportunity**: There is a significant unmet need in the head and neck cancer market, particularly for patients who have undergone multiple lines of therapy and have limited treatment options available [15][41] - **Patient Demographics**: The median number of prior lines of therapy for patients in the study was three, indicating a heavily pretreated population [6][17] Core Points and Arguments - **Differentiated Product Profile**: CRB-701 has a unique pharmacokinetic profile with a drug-antibody ratio of two, allowing for higher total antibody delivery and a more favorable safety profile compared to other ADCs [5][6] - **Dosing Regimen**: The drug can be administered every three weeks, which is appreciated by physicians and may improve patient compliance [4][23] - **Safety and Efficacy**: The overall burden of treatment-emerging adverse events is low, with a grade 3 adverse event level of around 35%, significantly lower than competitors like TIVDAK, which reported 59% [7][32] - **Patient Case Studies**: Anecdotal evidence from patient case studies demonstrates the potential for CRB-701 to provide significant clinical benefits, including long-term survival and improved quality of life [12][13][14] Additional Important Insights - **Recruitment Success**: The trial's design was patient-friendly, allowing for faster recruitment by including patients with a broader range of health statuses and prior treatments [20][21] - **Biomarker Considerations**: There is ongoing discussion about the role of biomarkers, such as nectin-4 levels, in predicting treatment response, with current data suggesting that expression levels may not be a reliable predictor [55][60] - **Future Directions**: The immediate clinical need for CRB-701 is identified as a monotherapy option for patients in the second or third line of treatment, particularly those who have progressed after immunotherapy and platinum-based therapies [41][42] Conclusion Corbus Pharmaceuticals is positioned to address a significant unmet need in the treatment of head and neck cancer with CRB-701, which offers a differentiated safety and efficacy profile compared to existing therapies. The company is focused on leveraging its unique product characteristics and patient-friendly trial design to enhance recruitment and ultimately improve patient outcomes in a challenging treatment landscape.

Core Insights - Corbus Pharmaceuticals announced data from its Phase 1/2 clinical study of CRB-701, a next-generation antibody-drug conjugate targeting Nectin-4, to be presented at the ESMO25 Congress in Berlin [1][6][10] Study Overview - The multi-center Phase 1/2 study is being conducted in the U.S. and Europe, enrolling patients with various solid tumors, including head and neck squamous cell carcinoma (HNSCC), cervical cancer, and metastatic urothelial carcinoma (mUC) [2][9] - A total of 167 patients were enrolled, with 122 evaluable for efficacy, and a median of 3 prior lines of therapy [2][17] Efficacy Results - The objective response rates (ORR) for the 3.6 mg/kg dose were 47.6% in HNSCC, 37.5% in cervical cancer, and 55.6% in mUC [3][6] - Disease control rates (DCR) were reported as 61.9% for HNSCC, 68.8% for cervical cancer, and 88.9% for mUC [3][4] Safety Profile - No dose-limiting toxicities (DLTs) were observed during dose escalation, indicating a favorable safety profile [5][11] - The most common treatment-emergent adverse events (TEAEs) included dysgeusia (18.6%), anemia (21.0%), fatigue (21.6%), alopecia (24.0%), and keratitis (32.3%) [11] Biomarker Insights - Clinical responses were observed in patients with both high and low Nectin-4 expression, as well as in patients with varying HPV and PD(L)-1 statuses [7][8] Future Plans - The company plans to meet with the FDA to review the data and expects to initiate registrational studies by mid-2026 [9][12] - An HNSCC Key Opinion Leader (KOL) event will be held during ESMO25 to discuss the data further [10]

Core Insights - Corbus Pharmaceuticals Holdings Inc. announced the release of an abstract for its Phase 1/2 clinical study at the ESMO Congress 2025, focusing on safety data from 70 participants and updated efficacy data from 167 enrolled participants [2][4] - The ongoing clinical trial evaluates the safety, pharmacokinetics, and efficacy of CRB-701, a next-generation antibody-drug conjugate targeting Nectin-4, primarily in patients with advanced solid tumors such as head and neck squamous cell carcinoma (HNSCC) and cervical tumors [5][6] Clinical Study Details - The clinical study includes 167 enrolled participants, with 122 evaluable for efficacy across various tumor types: HNSCC (n=41), cervical (n=37), metastatic urothelial tumors (n=23), and others (n=21) [2][5] - The poster presentation titled "Phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with urothelial and non-urothelial solid tumours" will take place on October 19, 2025 [3] Event Information - Corbus will host an in-person and virtual KOL event to discuss the data, featuring insights from leading experts in HNSCC, scheduled for October 19, 2025, at the Berlin Germany Marriott [4][9] Product Information - CRB-701 (SYS6002) is designed to target Nectin-4, utilizing a site-specific, cleavable linker and a homogeneous drug-antibody ratio of 2, with monomethyl auristatin E (MMAE) as the cytotoxic payload [6] - The FDA has granted two Fast Track designations to CRB-701 for HNSCC and cervical cancer [6][7] Company Overview - Corbus Pharmaceuticals is a clinical-stage company focused on oncology and obesity, with a pipeline that includes CRB-701, CRB-601 (an anti-integrin monoclonal antibody), and CRB-913 (a CB1 receptor inverse agonist for obesity treatment) [7]

Core Insights - U.S.-listed biotech and healthcare stocks experienced significant bullish activity in after-hours trading, with Turn Therapeutics Inc. leading the surge with a 134.29% increase to $16.40 following its Nasdaq debut [1] Group 1: Company Performances - Talphera Inc. reached a new 52-week high in regular trading and added 4.55% after hours to close at $1.38, driven by momentum despite no new updates [2] - Personalis Inc. rose 1.50% to $8.81 in after-hours trading, having hit a 52-week high earlier in the day, likely due to ongoing investor interest in precision oncology [2] - Ionis Pharmaceuticals Inc. climbed 3.64% to $72.51 after hours, supported by its Innovation Day presentation and reaffirmation of its pipeline strategy, leading to a new 52-week high during regular trading [3] - Sensei Biotherapeutics Inc. increased 5.23% to $12.08, with anticipation building ahead of its pipeline updates scheduled for October 20 [3] - Corbus Pharmaceuticals Holdings Inc. gained 4.77% to $14.06, preparing for participation in the Piper Sandler Virtual Oncology Symposium on October 9 [4] - Longeveron Inc. advanced 5.71% to $0.9801, with expectations for insights into its regenerative medicine pipeline at the ROTH Healthcare Opportunities Conference [4] - Palisade Bio Inc. rose 5.00% to $2.10 in after-hours trading, buoyed by a recent $138 million public offering that strengthened its balance sheet ahead of Phase 2 trials [5] Group 2: Market Trends - The after-hours session showcased a mix of technical breakouts, event-driven anticipation, and momentum trading, indicating a fertile environment for volatility and investment opportunities in the biotech sector [6]

NORWOOD, Mass., Oct. 07, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage oncology and obesity company, today announced that Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, will participate in a Fireside Chat at the Piper Sandler Virtual Oncology Symposium, to be held October 9-10, 2025. Piper Sandler clients can register for the event through their representative. Corbus Fireside ChatOctober 9, 2025, 10:00AM ETHosted by Biren ...

Core Viewpoint - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - Society Pass Incorporated (SOPA) has increased by 139% to $3.34 - Critical Metals Corp. (CRML) has risen by 79% to $14.30 - Sanmina Corporation (SANM) is up 26% at $144.61 - Palisade Bio, Inc. (PALI) has gained 25% to $2.00 - Advanced Micro Devices, Inc. (AMD) has increased by 24% to $205.07 - Odyssey Marine Exploration, Inc. (OMEX) is up 22% at $2.46 - Youxin Technology Ltd (YAAS) has risen by 21% to $3.14 - NioCorp Developments Ltd. (NB) is up 18% at $9.38 - Snow Lake Resources Ltd. (LITM) has increased by 14% to $5.66 - Plug Power Inc. (PLUG) is up 7% at $4.10 [3] Premarket Losers - Rich Sparkle Holdings Limited (ANPA) has decreased by 15% to $22.10 - CCH Holdings Ltd Ordinary Shares (CCHH) is down 15% at $3.73 - Xcel Brands, Inc. (XELB) has fallen by 14% to $2.04 - Quantum Computing Inc. (QUBT) is down 13% at $21.39 - Rent the Runway, Inc. (RENT) has decreased by 12% to $4.70 - MDJM Ltd (UOKA) is down 11% at $2.96 - CID HoldCo, Inc. (DAIC) has fallen by 9% to $2.72 - Algorhythm Holdings, Inc. (RIME) is down 9% at $2.47 - Corbus Pharmaceuticals Holdings, Inc. (CRBP) has decreased by 8% to $13.50 - Art's-Way Manufacturing Co., Inc. (ARTW) is down 7% at $2.58 [4]

Core Viewpoint - Corbus Pharmaceuticals is hosting a KOL event to discuss dose optimization data from its Phase 1/2 clinical trial of CRB-701, targeting advanced solid tumors with high Nectin-4 expression [1][3]. Group 1: Event Details - The KOL event will take place on October 19, 2025, at the Berlin Germany Marriott, starting at 10 AM CEST [2]. - The event will include insights from leading experts in head and neck squamous cell carcinoma (HNSCC) and a live Q&A session [2]. Group 2: Clinical Trial Information - The ongoing clinical trial (NCT06265727) is evaluating the safety, pharmacokinetics, and efficacy of CRB-701 in patients with advanced solid tumors, primarily focusing on HNSCC and cervical cancer [3]. - Data from over 100 participants will be presented, highlighting the trial's significance in the oncology field [1]. Group 3: About CRB-701 - CRB-701 is a next-generation antibody drug conjugate (ADC) that targets Nectin-4, utilizing a cleavable linker and a drug antibody ratio of 2, with monomethyl auristatin E as the payload [7][8]. - Nectin-4 is recognized as a clinically validated tumor-associated antigen in urothelial cancer [8]. Group 4: Company Overview - Corbus Pharmaceuticals is a clinical stage oncology and obesity company focused on innovative scientific approaches to treat serious illnesses [9]. - The company's pipeline includes CRB-701, CRB-601 (an anti-integrin monoclonal antibody), and CRB-913 (a CB1 receptor inverse agonist for obesity) [9].