VCN-01

Sirius Therapeutics Secures $50 Million in Series B2 Funding to Advance siRNA Therapies for Cardiometabolic Diseases

14 days ago

• Sirius Therapeutics has completed a nearly $50 million Series B2 financing round led by a corporate venture capital firm, with participation from new investor BioTrack Capital and existing investors. • The funding will accelerate clinical development of the company's siRNA therapeutics for cardiometabolic disorders, including SRSD107, which is poised to begin Phase 2 trials in Europe for thromboembolic disorders. • Since its founding in 2021, Sirius has established innovation centers in the US and China, advanced three programs to clinical stage, and raised approximately $150 million in total funding.

Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones

4 months ago

• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor. • Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025. • Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025. • Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.

Theriva Biologics Receives FDA Guidance on Phase 3 Design for VCN-01 in Metastatic Pancreatic Cancer

6 months ago

• Theriva Biologics received FDA guidance on the Phase 3 study design for VCN-01 in metastatic pancreatic cancer, advising against expanding the Phase 2b VIRAGE study. • The FDA recommended a standalone Phase 3 study of VCN-01 combined with gemcitabine/nab-paclitaxel, agreeing with Theriva's proposed design and statistical elements. • Theriva Biologics completed target enrollment for the VIRAGE Phase 2b study and plans to request another FDA meeting to discuss Phase 3 protocol details. • VCN-01, an oncolytic adenovirus, aims to selectively replicate within tumor cells, degrade tumor stroma, and enhance chemotherapy effectiveness in treating metastatic PDAC.

VCN-01 Receives Orphan Drug Designation from European Commission for Retinoblastoma Treatment

7 months ago

• Theriva Biologics' VCN-01, an oncolytic adenovirus, has been granted orphan medicinal product designation by the European Commission for retinoblastoma treatment. • This designation emphasizes the urgent need for new treatment options for retinoblastoma, a rare and life-threatening eye cancer in children. • VCN-01 previously received orphan drug and rare pediatric disease designations from the U.S. FDA for retinoblastoma, highlighting its potential. • The European Commission's decision provides Theriva with benefits like market exclusivity and reduced regulatory fees to support VCN-01's development.

Theriva Biologics Completes Enrollment in Phase 2b VIRAGE Trial of VCN-01 for Metastatic Pancreatic Cancer

8 months ago

• Theriva Biologics has achieved target enrollment of 92 patients in its Phase 2b VIRAGE trial for metastatic pancreatic ductal adenocarcinoma (PDAC). • The VIRAGE trial evaluates VCN-01, an oncolytic adenovirus, in combination with gemcitabine/nab-paclitaxel as a first-line therapy for PDAC. • VCN-01 has received Orphan Drug and Fast Track designations from the FDA for the treatment of PDAC, highlighting its potential impact. • The company is planning regulatory discussions to determine the next steps for VCN-01's clinical development, including a possible interim data analysis.

FDA's July Roundup: Approvals, Fast Tracks, and Designations in Oncology

10 months ago

• The FDA approved FoundationOne Liquid CDx as a companion diagnostic for niraparib and abiraterone in BRCA-mutated metastatic castration-resistant prostate cancer. • Several therapies received fast track designations, including OBX-115 for advanced melanoma and ADI-270 for metastatic clear cell renal cell carcinoma. • Biologics license applications were accepted for remestemcel-L in pediatric steroid-refractory acute graft-vs-host disease and tabelecleucel for Epstein-Barr virus-positive posttransplant lymphoproliferative disease. • The Oncologic Drugs Advisory Committee voted to require comprehensive phase assessments for new trial designs in perioperative regimens for non-small cell lung cancer.

FDA Grants Fast Track Designation to VCN-01 for Metastatic Pancreatic Cancer

a year ago

• The FDA has granted Fast Track designation to VCN-01 in combination with gemcitabine and nab-paclitaxel for metastatic pancreatic adenocarcinoma. • VCN-01 previously received Orphan Drug Designation from the FDA for pancreatic ductal adenocarcinoma (PDAC) in June 2023. • The ongoing phase 2b VIRAGE trial is evaluating intravenous VCN-01 with standard chemotherapy in first-line PDAC patients. • VCN-01 is designed to selectively replicate within tumor cells, break down tumor stroma, and enhance the effectiveness of chemotherapy.