VCN-11 / Theriva Bio - LARVOL DELTA

Theriva Biologics Reports Third Quarter 2023 Operational Highlights and Financial Results (GlobeNewswire) - "Research and development expenses increased to $4.0 million for the three months ended September 30, 2023, from approximately $2.6 million for the three months ended September 30, 2022. This increase of 56% is primarily the result of higher clinical trial expenses related to our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, offset by decreased expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, Phase 1a clinical trial of SYN-020, and decreased manufacturing expenses related to our Phase 1a clinical trial of SYN-020.We anticipate research and development expenses to increase as we continue enrollment in our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC and our ongoing Phase 1 clinical trial in retinoblastoma, expand GMP manufacturing activities for VCN-01, and continue supporting our VCN-11 and other preclinical and discovery initiatives."

Commercial • Trial status • Eye Cancer • Gastrointestinal Cancer • Immunology • Inflammation • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Retinoblastoma • Solid Tumor

Theriva Biologics Reports First Quarter 2023 Operational Highlights and Financial Results (GlobeNewswire) - "Research and development expenses increased to $3.0 million for the three months ended March 31, 2023, from approximately $2.6 million for the three months ended March 31, 2022. This increase of 15% is primarily the result of increased clinical trial expenses related to VCN-01 not incurred in the prior year, offset by lower expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients....The Company anticipates research and development expense to increase as it continues enrollment in its VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, and its ongoing Phase 1 clinical trial in retinoblastoma, expands GMP manufacturing activities for VCN-01, and continues supporting its VCN-11 and other preclinical and discovery initiatives."

Commercial • Acute Graft versus Host Disease • Eye Cancer • Gastrointestinal Cancer • Graft versus Host Disease • Immunology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Retinoblastoma • Solid Tumor

Oncolytic Adenovirus with Hyaluronidase Activity That Evades Neutralizing Antibodies and Allows Re-administration: VCN-11 (ASGCT 2022) - "Similar hepatic toxicity was observed after single and repeated virus administration. These features suggest that VCN-11 is a safe and promising candidate to treat tumors in the presence of pre-existing immunity against adenovirus and using a multi-dosing strategy for therapy."

Oncolytic virus • Hepatology • Oncology

Synthetic Biologics Announces Presentation on VCN-11, a Novel Oncolytic Adenovirus Designed to Evade Neutralizing Antibodies at the Upcoming 25th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (GlobeNewswire) - "Synthetic Biologics, Inc...announced an upcoming oral presentation on novel oncolytic adenovirus VCN-11 at the 25th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), to be held virtually and in-person from May 16-19, 2022 in Washington, D.C....The presentation at ASGCT will include preclinical results showcasing the potential of VCN-11 to balance safety, with no major toxicities observed, and effectively target tumors after intravenous re-administration, even in the presence of high level NAbs."

Preclinical • Oncology

Synthetic Biologics Completes Acquisition of VCN Biosciences (GlobeNewswire) - "The acquisition transforms Synthetic Biologics’ pipeline with the addition of VCN's lead clinical-stage drug candidate, VCN-01, as well as preclinical stage VCN-11, both of which are next-generation OVs in development for the treatment of cancers with high unmet need...'we plan to start a Phase 2 trial of VCN-01 in combination with gemcitabine/Abraxane® standard of care chemotherapy in PDAC patients....Additionally, we plan to initiate a Phase 2/3 pivotal trial of VCN-01 as either an adjunct to chemotherapy or a potential rescue therapy in advanced RB pediatric patients.'"

M&A • New P2 trial • New P2/3 trial • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Retinoblastoma • Solid Tumor