Our Pipeline
OVERVIEW
Theriva™ Biologics’ oncolytic viruses have the potential to treat a broad range of difficult-to-treat tumor types and may be combined with a variety of cancer therapies.
In the VIRAGE Phase 2b clinical trial in patients with PDAC, VCN-01 (zabilugene almadenorepvec) combined with
standard-of care (SoC) chemotherapy gemcitabine/nab-paclitaxel improved outcomes compared to SoC chemotherapy
alone. VCN-01 has also demonstrated the potential to resensitize refractory HNSCC patients to the immune checkpoint
inhibitor durvalumab and improve eye survival in children with refractory/recurrent retinoblastoma.
The diversity of tumor types and coadministered cancer treatments highlight the broad anticipated utility of Theriva’s systemic, selective, and stroma-degrading oncolytic viruses.
- VIRAGE Ph 2b Study Complete
- Orphan Drug Designation (US, EU)
- Fast Track Designation (US)
- Ph 1 Study Complete
- Orphan Drug Designation (US)
- Rare Pediatric Disease Designation (US)
*Based on Management’s current beliefs and expectations. aGVHD acute graft-vs-host disease; allo-HCT allogeneic hematopoietic cell transplant. Gem/nab-P gemcitabine/nab-paclitaxel. HNSCC head and neck squamous cell carcinoma. IV intravenous. IVit intravitreal. PDAC pancreatic ductal adenocarcinoma
Clinical Trial Overview
VIRAGE trial (EudraCT 2022-000897-24; NCT05673811) is a multicenter, open label, randomized, 2-parallel arm, Phase IIb study evaluating intravenous VCN-01 (zabilugene almadenorepvec) in combination with first-line standard-of-care chemotherapy (SoC) in patients with newly-diagnosed metastatic pancreatic adenocarcinoma. The study enrolled 92 evaluable patients across 14 sites in Spain and the USA. Patients were randomized in a 1:1 ratio into one of two treatment arms:
Arm I:
Nab-paclitaxel and gemcitabine 28-day cycles as SoC (no VCN-01).
Arm II:
Up to two doses of VCN-01 administrated in combination with nab-paclitaxel and gemcitabine cycles as SoC.
The first dose of VCN-01will be administered 7-days prior to the first dose of the first cycle of nab-paclitaxel and gemcitabine SoC. The second dose of VCN-01 is scheduled to be administered approximately 3 months later, 7-days prior to the first dose of the fourth cycle of nab-paclitaxel and gemcitabine SoC.
The primary endpoints for the study are overall survival and the safety and tolerability of VCN01. Secondary endpoints include progression-free survival/time-to-progression, objective response rate, and changes in the tumor biomarker Ca19.9. Exploratory measures include patient quality of life and measures of VCN-01 biodistribution, mechanism of action, and immune response.
Sponsor: VCN Bioscience S.L. (a wholly-owned subsidiary of Theriva Biologics, Inc.)
ICO-VCN-H&N-2018 (NCT03799744) is a phase I trial to evaluate the safety, tolerability, and potential antitumor activity of intravenous VCN-01 oncolytic adenovirus in combination with durvalumab (MEDI4736) in subjects with recurrent/metastatic squamous cell carcinoma of the head and heck. The study evaluates escalating single doses of VCN-01 combined with a fixed dose of durvalumab. In Arm I, VCN-01 is administered on the same day as the first dose of durvalumab (concomitant schedule) while in Arm II VCN-01 is administered 2-weeks prior to the first dose of durvalumab (delayed schedule).
Sponsor: Institut Català d’Oncologia
UPCC#03821 (NCT05057715) is a phase I trial to evaluate the safety and feasibility of intravenous injection of VCN-01 oncolytic adenovirus in combination with huCART-meso cells in patients with either pancreatic cancer or ovarian cancer. The study evaluates escalating single doses of VCN-01 administered 14 days prior to intravenous infusion of huCART-meso cells. An optional cohort administering huCART-meso cells 10-days prior to VCN-01 is also included.
Sponsor: University of Pennsylvania
FSJD-RTB-2015 (NCT03284268) is a phase 1 clinical trial evaluating the safety and potential activity of intravitreal VCN-01 oncolytic adenovirus in children with refractory retinoblastoma. The study is evaluating escalating doses of VCN-01 administered by 2 intravitreal injections separated by 14 days.
Sponsor: Fundació Sant Joan de Déu
Study CO20/134663 (EudraCT 2020-003405-59, ISRCTN51762486) is a phase I trial to determine the safety of IV VCN-01 in patients with high-grade primary or secondary brain tumors and to evaluate the potential for systemically administered VCN-01 to reach tumors in the brain of these patients. In this trial, patients will be administered a single IV dose of VCN-01 approximately 8-15 days prior to scheduled surgical resection of their brain tumor. VCN-01 levels will be measured in resected brain tumor samples.
Sponsor: The University of Leeds.
NCT04692181 is a phase 1b/2a clinical trial evaluating the safety, tolerability and potential systemic absorption of oral SYN-004 into the systemic circulation of adult allogeneic hematopoietic cell transplant recipients who develop fever after conditioning therapy and are treated with either IV β-lactam antibiotics meropenem (MER), piperacillin tazobactam (PIP/TAZO), or cefepime (FEP). The trial is also designed to evaluate potential protective effects of SYN-004 on the gut microbiome as well as generate preliminary information on potential therapeutic benefits and patient outcomes of SYN-004 in allogeneic HCT recipients, including prevention of acute graft-versus host disease (aGVHD). The trial is expected to enroll up to 36 participants in three sequential IV beta-lactam antibiotic cohorts. Safety and pharmacokinetic data for each cohort will be reviewed by an independent Data and Safety Monitoring Committee that will make a recommendation on whether to proceed to the next IV beta-lactam antibiotic.
Sponsor: Washington University in St. Louis