CRB-701 / CSPC Pharma, Corbus Pharma - LARVOL DELTA

FDA Grants Fast Track Designation to Corbus Pharmaceuticals’ Nectin-4 Targeting ADC CRB-701 in Head and Neck Squamous Cell Carcinoma (Corbus Pharmaceuticals Press Release) - "An ongoing Phase 1/2 clinical trial is evaluating the safety, pharmacokinetics, and efficacy of CRB-701 in patients with advanced solid tumors known to be associated with high Nectin-4 expression."

Fast track • Squamous Cell Carcinoma of Head and Neck

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 (ESMO 2025) - No abstract available

Clinical • P1/2 data • Oncology • Solid Tumor • NECTIN4

SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC (clinicaltrials.gov) - P2 | N=430 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. | N=250 ➔ 430 | Initiation date: May 2025 ➔ Aug 2025 | Trial primary completion date: Sep 2027 ➔ Dec 2027

Enrollment change • Trial initiation date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Corbus Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides a Corporate Update (Corbus Pharmaceuticals Press Release) - "CRB-701: The Company expects to complete dose optimization and identify the recommended Phase 2 dose (RP2D) in the fourth quarter of 2025....CRB-601: The first participant was dosed in December 2024 in the dose escalation monotherapy portion of a Phase 1 study which is being conducted in the U.S. and Europe. The Company is on track to report dose escalation data in Q4 2025."

P1 data • Trial status • Oncology • Solid Tumor

Corbus Pharmaceuticals Announces Upcoming Presentation of Dose Expansion Phase 1/2 Clinical Data for its Nectin-4 Targeting ADC CRB-701 at the 2025 ESMO Annual Congress (GlobeNewswire) - "Corbus Pharmaceuticals...announced today that an abstract on updated clinical data from its Phase 1/2 clinical study conducted in the United States and Europe of CRB-701 (SYS6002) has been accepted for presentation as a poster at the European Society for Medical Oncology (ESMO) Congress 2025....The abstract, a 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 by Perez et al, will be presented as a poster (# 967P) on Sunday, October 19....The three-part Phase 1/2 study (NCT06265727) is evaluating the safety, pharmacokinetics and efficacy of CRB-701 in participants with advanced solid tumors associated with high Nectin-4 expression....Dose optimization is on-going with dosing at 2.7 mg/kg and 3.6 mg/kg cohorts in HNSCC, cervical and mUC tumors. The Company expects to complete dose optimization and identify a recommended Phase 2 dose in the fourth quarter of 2025."

P1/2 data • Trial status • Cervical Cancer • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Corbus Pharmaceuticals Announces First Patient Dosed with its Nectin-4 Targeting ADC CRB-701 in Combination with Pembrolizumab (Corbus Pharmaceuticals Press Release) - "Corbus Pharmaceuticals Holdings, Inc...announced the dosing of the first participant in the PD-1 combination arm of its Phase 1 study investigating CRB-701 in solid tumors (the Phase 1 Western study). Participants in this arm of the study are being randomized to the 2.7 mg/kg and 3.6 mg/kg cohorts in combination with Keytruda (pembrolizumab)....The Company expects to provide a data update and establish the recommended Phase 2 dose (RP2D) in the fourth quarter of this year."

P1 data • Trial status • Cervical Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

SYS6002 Plus JMT101 and Enlonstobart Injection as First-Line Treatment for HNSCC (clinicaltrials.gov) - P2 | N=250 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Corbus Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides a Corporate Update (Corbus Pharmaceuticals Press Release) - "Dose optimization and RP2D determination on schedule for completion in Q4 2025 for the Nectin-4 ADC CRB-701 in HNSCC, cervical and mUC tumors....Dose escalation study on schedule for completion in Q4 2025 for the anti-αvβ8 integrin mAB-CRB-601 in solid tumors."

Trial completion date • Trial status • Cervical Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Corbus Pharmaceuticals Reports Q4 and 2024 Financial Results and Provides a Corporate Update (Corbus Pharmaceuticals Press Release) - "CRB-701: Dose optimization is underway with dosing at 2.7 mg/kg and 3.6 mg/kg cohorts in HNSCC, cervical and mUC tumors. More cohorts may be added to address additional tumor types in the expansion phase. The Company expects to complete dose optimization and establish a recommended Phase 2 dose ('RP2D') under Project Optimus in the fourth quarter of 2025....CRB-601 is a potent and selective anti-αvβ8 integrin monoclonal antibody for the treatment of solid tumors....We expect to complete dose escalation in the fourth quarter of 2025."

Trial status • Cervical Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Phase I dose-escalation study of the next-generation nectin-4 targeting antibody–drug conjugate CRB-701 (SYS6002) in US and UK patients with urothelial cancer and other solid tumors. (ASCO-GU 2025) - P1/2 | "CRB-701, a next-generation nectin-4 targeted ADC, has third-generation linker technology that is specifically designed to reduce the dose-limiting toxicities (DLTs) reported with ADCs (e.g. enfortumab vedotin [EV]). PK, safety and efficacy observations are consistent with those from a previous study in Han Chinese patients. CRB-701 was well tolerated and, relative to EV at similar doses, demonstrated signs of a differentiated PK profile, including a longer half-life and lower free MMAE levels. CRB-701 development will continue to dose expansion."

Clinical • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer • NECTIN4

CRB-701 (SYS6002) A Next Generation Nectin-4 Targeting ADC Demonstrates Encouraging Safety and Broader Efficacy in Phase 1 Study in the US and UK Presented at ASCO-GU 2025 (Corbus Pharmaceuticals Press Release) - P1/2 | N=420 | NCT06265727 | Sponsor: Corbus Pharmaceuticals Inc. | "PK: PK profile seen in the Western study was comparable to that generated in the China study. CRB-701 demonstrated a longer ADC half-life and lower free-MMAE exposure relative to enfortumab vedotin (EV). Efficacy: A total of 26 participants with eight tumor types were evaluable for efficacy at the time of this data cut. Responses were observed in several tumor types including previously unexplored HNSCC tumors: mUC: Western study (n=4, 1 PR, 1 SD and 2 PD); China study (n=9, ORR 44%). Both mUC PD participants in the Western study were previously treated with EV. Cervical: Western study (n=2, 1 CR and 1PD); China study (n=7, ORR 43%). HNSCC: Western study (n=7, 4 PR, 2 SD and 1 PD)."

P1 data • PK/PD data • Cervical Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Corbus Pharmaceuticals Announces Clinical Data for CRB-701 from Western Dose Escalation Study to be Presented at 2025 ASCO-GU (Corbus Pharmaceuticals Press Release) - "Corbus Pharmaceuticals Holdings, Inc...announced that the abstract for its first-in-human dose escalation clinical study conducted in the United States and Europe ('Western study') of CRB-701 (SYS6002) has been released. The corresponding up-to-date data will be presented as a poster during the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU)."

P1 data • Solid Tumor • Urothelial Cancer

Clinical Studies Conducted at Florida Cancer Specialists & Research Institute Expanding Treatment Options and Improving Outcomes for Patients with Gastrointestinal and Genitourinary Cancers (PRNewswire) - "Clinical research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) is expanding treatment options and contributing to improved outcomes for patients diagnosed with gastrointestinal and genitourinary cancers. FCS research study results are featured at two global gatherings sponsored by the American Society of Clinical Oncology (ASCO)....At the ASCO 2025 Genitourinary Cancers Symposium, Cesar Augusto Perez, MD, as first author, will present results of a Phase I dose-escalation study of the next-generation nectin-4 targeting antibody–drug conjugate CRB-701 (SYS6002) in US and UK patients with urothelial cancer and other solid tumors."

Clinical data • P1 data • Preclinical • Colorectal Cancer • Gastric Cancer • Urothelial Cancer

Corbus Pharmaceuticals Announces that Clinical Data for CRB-701 from Western Dose Escalation Study to be Presented at ASCO GU 2025 (GlobeNewswire) - "Corbus Pharmaceuticals Holdings...announced data from its first-in-human dose escalation clinical study conducted in the United States and the United Kingdom ('Western study') of CRB-701 (SYS6002) will be presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU)...The poster is titled Phase 1 Dose-Escalation Study of Next-Generation Nectin-4 Targeting Antibody-Drug Conjugate CRB-701 (SYS6002) in US And UK Patients with Urothelial Cancer and other Solid Tutors (Perez, et al) and will be presented on Friday February 14, 2025 [Poster Session B: Urothelial Carcinoma; Poster BD# G30]."

P1 data • Solid Tumor • Urothelial Cancer

FDA Grants Fast Track Designation to CRB-701 for the Treatment of Relapsed or Refractory Metastatic Cervical Cancer (Corbus Pharmaceuticals Press Release) - "Corbus Pharmaceuticals Holdings, Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer....Corbus recently completed enrollment of the dose escalation part of its Phase 1 clinical trial of CRB-701 (SYS6002) (NCT06265727) that is being conducted in the U.S. and Europe....The Company expects to report the first data from the dose escalation clinical study in Q1 2025."

Fast track • P1/2 data • Cervical Cancer

Corbus Announces Enrollment Completion of Dose Escalation Stage of Phase 1 Clinical Trial of Its Next Generation Nectin-4 Targeting ADC (CRB-701) (Corbus Pharmaceuticals Press Release) - "Corbus Pharmaceuticals Holdings, Inc...announced today that it has completed enrollment of the dose escalation part of its bridging Phase 1 clinical trial of CRB-701 (SYS6002). The dose escalation part of this open label study (NCT06265727) is being conducted in the US and the UK....The company expects to share the first data from dose escalation in Q1 2025."

Enrollment closed • P1/2 data • Oncology • Solid Tumor

Corbus Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Key Corporate Updates - CRB-701:...Dose escalation commenced in the Phase 1 clinical trial of CRB-701-01 in April 2024. The Phase 1 portion of the open label study design (NCT06265727), being conducted in the U.S. and Europe, will evaluate the safety, efficacy and PK of CRB-701 in participants with advanced solid tumors associated with high nectin-4 expression. The Phase 1 trial initiates with dose escalation followed by dose optimization and concludes with dose expansion to determine the recommended Phase 2 dose. The Company expects to complete the dose escalation phase in Q4 2024 and present the USA dose escalation data in Q1 2025."

P1 data • Trial status • Solid Tumor

Clinical update related to the first-in-human trial of SYS6002 (CRB-701), a next-generation nectin-4 targeting antibody drug conjugate. (ASCO 2024) - "No low-grade peripheral neuropathy, skin rash or fatigue, known toxicities that rate limit the usage of enfortumab vedotin (EV) have occurred. SYS6002 (CRB-701) demonstrates promising anti-tumor activity with a well-tolerated safety profile in patients with advanced nectin-4 positive solid tumors. Dose escalation at 4.5 mg/kg Q3W and dose expansion at 3.6 mg/kg Q3W are ongoing."

Clinical • P1 data • Cervical Cancer • Dermatology • Fatigue • Oncology • Pain • Solid Tumor • Urothelial Cancer • NECTIN4

CRB-701: “CRB-701 continues to be well tolerated with mainly grade 1 or 2 AEs”; Solid tumors (Corbus Pharmaceuticals) - Corporate Presentation: “Still no DLTs or Grade 4 or 5 AEs observed to date including in the 4.5 mg/Kg cohort”

P1 data • Oncology • Solid Tumor

SYS6002 (CRB-701) A Next-Generation Nectin-4 Targeting Antibody Drug Conjugate Continues to Demonstrate Encouraging Safety and Efficacy Observed in Patients with Nectin-4 Positive Tumors in a Clinical Update Presented at ASCO 2024 (GlobeNewswire) - P1/2 | N=420 | NCT06265727 | Sponsor: Corbus Pharmaceuticals Inc. | "An additional 19 patients have been enrolled since January 2024 bringing the total to 37 of whom 25 were evaluable for efficacy; SYS6002 (CRB-701) demonstrated 44% ORR and 78% DCR in mUC and 43% ORR and 86% DCR in cervical cancer to date at doses ≥ 1.2mg/Kg; No dose limiting toxicities (DLTs) have been observed to date in doses up to and including 4.5 mg/Kg (cohort 7); Three cases of skin rash (including one grade 3) and one case of grade 1 neuropathy seen to date; all were resolved; Early PK data demonstrate consistently lower levels of free MMAE than enfortumab vedotin across all doses in study including 4.5 mg/Kg."

P1 data • Cervical Cancer • Gynecologic Cancers • Solid Tumor

Updated Phase 1 Clinical Data for SYS-6002 (CRB-701) to be presented at 2024 ASCO Annual Meeting (GlobeNewswire) - "Corbus Pharmaceuticals Holdings...announced today that the abstract [No. 3151] for a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) annual meeting...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....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....PK cohorts have been initiated at the 2.7mg/Kg & 3.6mg/Kg dose levels....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."

P1 data • Solid Tumor

Corbus Pharma maintains Outstanding rating from RBC as CRB-701 shows strong potential. [Google translation] (Investing.com) - "On Monday, RBC Capital weighed in on Corbus Pharmaceuticals...with a steady price target of $77.00. The company's analysts highlighted the potential of CRB-701, a Nectin-4-directed antibody-drug conjugate (ADC), ahead of next month's American Society of Clinical Oncology (ASCO) meeting....RBC expressed confidence that the drug could generate annual sales of approximately $1 billion in various solid cancer indications, including urothelial cancer (UC), cervical cancer (CC), and head and neck squamous cell carcinoma (HNSCC)."

Sales projection • Cervical Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Corbus Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update (Corbus Pharmaceuticals Press Release) - "The Phase 1 portion of the open label study design (NCT06265727), being conducted in the U.S. and Europe, will evaluate the safety, efficacy and pharmacokinetics...of CRB-701 in participants with advanced solid tumors associated with high Nectin-4 expression. The Phase 1 trial initiates with dose escalation followed by dose optimization and concludes with dose expansion to determine the recommended Phase 2 dose. The Company expects to present the U.S. dose escalation data by Q1 2025...Updated data from this study will be presented by CSPC as a poster at the ASCO 2024 Annual Meeting on June 1, 2024...Operating expenses decreased by $7.7 million to approximately $9.6 million for the three months ended March 31, 2024....The decrease was primarily attributable to the upfront licensing fee of $7.5 million due to CSPC for licensing of CRB-701 recorded during the first quarter of 2023."

Commercial • P1 data • Oncology • Solid Tumor

Corbus Pharmaceuticals Announces Abstract Accepted for Presentation at 2024 ASCO Annual Meeting (Corbus Pharmaceuticals Press Release) - "Corbus Pharmaceuticals Holdings, Inc...announced that an abstract providing updated data from the Phase 1, first-in-human clinical data from a dose escalation study being carried out by its partner CSPC in China with CRB-701 (SYS6002) has been accepted for presentation at the 2024 American Society of Clinical Oncology annual meeting, to be held May 31-June 4, 2024 in Chicago, IL."

P1 data • Oncology • Solid Tumor

Corbus Announces Dosing of First Patient in U.S. Phase 1 Clinical Trial of Its Next Generation Nectin-4 Targeting ADC (GlobeNewswire) - "Corbus Pharmaceuticals Holdings, Inc...announced today the first patient in the U.S. has been dosed in the Phase 1 clinical trial of CRB-701 (SYS6002), a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4."

Trial status • Oncology • Solid Tumor