Theriva Biologics

Theriva Biologics logo
🇺🇸United States
Ownership
Public
Established
2001-01-01
Employees
22
Market Cap
-
Website
http://www.therivabio.com
Introduction

Theriva Biologics, Inc.(formerly Synthetic Biologics, Inc.) is a clinical stage company, which engages in the development of therapeutics to preserve the microbiome to protect and restore the health of patients. Its product portfolio includes SYN-020 and SYN-004. SYN-020 is intended to prevent the antibiotic-mediated microbiome damage, C. difficile infections (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host disease (aGVHD) in allogeneic HCT recipients. SYN-004 is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection, antibiotic-associated diarrhea, and the emergence of antimicrobial resistance. The company was founded by Steven H. Kanzer in January 2001 and is headquartered in Rockville, MD.

investing.com
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Theriva Biologics outlines Phase 3 study for cancer drug

Theriva Biologics announced FDA's advice against expanding its VIRAGE Phase 2b study into Phase 3 for VCN-01, recommending a separate Phase 3 study with gemcitabine/nab-paclitaxel. The company also gained EU orphan drug status for VCN-01 for retinoblastoma and reported positive Phase 1 trial outcomes. Additionally, Theriva Biologics announced a 1-for-25 reverse stock split and received FDA's Rare Pediatric Drug and Fast Track Designations for VCN-01 in metastatic pancreatic adenocarcinoma.
stocktitan.net
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Theriva Biologics Gets FDA Guidance on VCN-01 Phase 3 Trial Design for Pancreatic Cancer

Theriva Biologics announced FDA guidance recommending a standalone Phase 3 study of VCN-01 with gemcitabine/nab-paclitaxel for metastatic pancreatic cancer, rather than expanding the ongoing VIRAGE Phase 2b study.
biospace.com
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Theriva Biologics Announces Orphan Medicinal Product Designation Granted by the ...

Theriva Biologics announces European Commission's orphan medicinal product designation for VCN-01, its oncolytic adenovirus for treating retinoblastoma, following FDA's previous orphan drug and rare pediatric disease designations. VCN-01 aims to degrade tumor stroma, enhancing chemotherapy and immunotherapy effects, with promising results from a Phase 1 trial.
globenewswire.com
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Theriva Biologics Announces Orphan Medicinal Product

Theriva Biologics announces the European Commission's adoption of the EMA's recommendation to grant orphan medicinal product designation to VCN-01 for retinoblastoma treatment, following the FDA's previous orphan drug and rare pediatric disease designations for VCN-01.
pharmabiz.com
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Theriva Biologics announces positive outcome of DSMC review in phase 1b/2a trial of ...

Theriva Biologics announced positive DSMC review results for SYN-004 in a phase 1b/2a trial for preventing aGVHD in allogeneic HCT recipients. Cohort 2 showed typical AEs/SAEs, no study drug-related issues, and SYN-004 not detected in blood. DSMC recommended proceeding to Cohort 3 with cefepime. CEO Steven A. Shallcross highlighted SYN-004's potential to improve treatment for susceptible patients.
finance.yahoo.com
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Theriva™ Biologics Announces Positive Outcome of Data and Safety Monitoring Committee

Theriva Biologics announces positive DSMC review of SYN-004 Phase 1b/2a trial results, recommending study proceed to Cohort 3. No AEs or SAEs related to study drug were observed, and no SYN-004 was detected in patient blood samples. The trial aims to prevent aGVHD in allogeneic HCT recipients by degrading IV beta-lactam antibiotics within the GI tract.
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