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Theriva Biologics, Inc.


Theriva Biologics is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s transformed pipeline incorporates lead clinical-stage drug candidate, VCN-01, a systemically-administered oncolytic adenovirus engineered to break down the stroma barrier that protects tumors from cancer therapies and hides them from the patient’s immune system. Theriva has established preclinical proof-of-concept with their unique Albumin Shield™ platform, which is designed to protect systemically administered OVs from inactivation by the patient’s immune system. These unique and differentiated mechanisms are intended to improve the anti-tumor effect of the OV and co-administered chemotherapy and immuno-oncology products. Importantly, degrading the stroma can also expose tumor antigens, turning “cold” tumors “hot” and enable a sustained anti-tumor response by the patient’s immune system. With funding into Q3 2024, TOVX is poised to progress the proposed clinical and preclinical programs to meaningful milestones. • Received regulatory clearance from the FDA and Spanish Competent Authority (AEMPS) and began dosing patients in the VIRAGE Phase 2 clinical trial of systemically administered VCN-01 in Pancreatic Ductal Adenocarcinoma (PDAC). • First patient dosed (Q1 2023) with VCN-01 in an investigator sponsored study of brain tumors at the University of Leeds. • Expected to hold a pre-IND meeting with the FDA (Late 2023) prior to the initiation of a clinical study evaluating VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma (2024). • Reported positive clinical data and initiated the second cohort of the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) designed to prevent potentially fatal adverse outcomes in patients who undergo allogeneic hematopoietic cell transplant (HCT) to treat hematologic cancers.