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.
相关临床试验
8
1 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2001
进行中（未招募）
1
12.5%
已完成
7
87.5%
暂无批准数据
- Researchers at The Institute of Cancer Research, London, used immuno-PET to track PD-L1 dynamics across the entire body after oncolytic virus injection in mouse models of head and neck cancer. - Scans revealed a sharp but transient spike in PD-L1 levels in the spleen and tumor-draining lymph nodes three days after treatment, returning to baseline by day seven. - The findings suggest a narrow therapeutic window during which combining oncolytic viruses with checkpoint inhibitors may be most effective. - Separately, a Phase I trial combining VCN-01 oncolytic virus with durvalumab showed promising survival outcomes in advanced head and neck cancer patients, with over 60% alive at one year.
- Theriva Biologics has out-licensed SYN-020, a recombinant bovine intestinal alkaline phosphatase, to Rasayana Therapeutics for development across multiple metabolic and inflammatory disorders. - The licensing agreement includes a $300,000 upfront payment and potential milestone payments totaling up to $38 million, with Rasayana assuming all development and commercialization costs. - SYN-020 demonstrated good tolerability in Phase 1 studies and is designed to reduce fat absorption, intestinal inflammation, and promote gut barrier integrity for treating gastrointestinal dysfunction. - The therapy targets the gut-organ axis biology and is positioned to enter Phase 2 clinical testing under Rasayana's development program for chronic inflammatory diseases.
- The European Medicines Agency provided scientific advice supporting Theriva Biologics' proposed Phase 3 trial design for VCN-01 combined with standard chemotherapy in metastatic pancreatic ductal adenocarcinoma. - EMA agreed with key trial parameters including sample size, adaptive design, and repeated dosing regimen based on improved survival outcomes observed in patients receiving multiple VCN-01 doses. - Theriva plans to meet with FDA in the first half of 2026 to finalize the pivotal multinational Phase 3 trial protocol, with cash runway extending to Q1 2027.
- Theriva Biologics will present expanded data from the VIRAGE Phase 2b trial of VCN-01 in metastatic pancreatic cancer at ESMO 2025, building on previous clinical results from 142 patients treated across multiple cancer types. - The company will showcase preclinical data for VCN-12, a next-generation oncolytic adenovirus armed with additional transgenes designed to improve tumor cell lysis and enhance stroma degradation compared to VCN-01. - New preclinical research demonstrates the feasibility of intracranial VCN-01 administration for brain tumor treatment, with investigators concluding the findings provide strong rationale for further development in this indication. - SYN-004 interim safety and pharmacokinetic data from an ongoing Phase 1b/2a trial in allogeneic hematopoietic cell transplant recipients will be presented at IDWeek 2025.
- Theriva Biologics announced the presentation of blinded safety and pharmacokinetic data from its ongoing Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant recipients at the ESCMID Global congress in Vienna. - The randomized, double-blinded, placebo-controlled trial evaluates SYN-004's safety and tolerability at 150 mg four times daily for up to 28 days in patients receiving IV beta-lactam antibiotics for fever treatment. - SYN-004 is designed to degrade IV beta-lactam antibiotics in the gastrointestinal tract to maintain gut microbiome balance and prevent acute graft-versus-host-disease in transplant recipients. - A previous Phase 2b trial of 412 patients demonstrated that SYN-004 protected the gut microbiome from antibiotic-mediated dysbiosis and reduced colonization by pathogenic organisms like vancomycin-resistant Enterococci.
- 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.
- 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.
- 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.
- 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.
- 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.
