Theriva Biologics

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' SYN-004 Shows Positive Safety Profile in Phase 1b/2a Trial for aGVHD Prevention

8 months ago

• The Data and Safety Monitoring Committee (DSMC) has recommended advancing Theriva Biologics' SYN-004 trial to Cohort 3 after reviewing Cohort 2 data. • SYN-004 demonstrated a favorable safety profile in allogeneic hematopoietic cell transplant (HCT) recipients, with adverse events typical for this patient population. • Pharmacokinetic data showed no SYN-004 absorption into the bloodstream and expected piperacillin metabolism, supporting its mechanism of action. • The Phase 1b/2a trial evaluates SYN-004's ability to protect the gut microbiome and prevent acute graft-versus-host-disease (aGVHD) in HCT recipients.

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.