Theriva Biologics, a leading company in the clinical development phase of innovative therapies for the treatment of cancer and other diseases, has taken a crucial step in its research. The firm has achieved its goal of enrolling 92 evaluable patients in the Phase 2b VIRAGE clinical trial. This study focuses on evaluating the efficacy of VCN-01, a promising treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC), and its achievement has been made possible thanks to the valuable financial support from the Spanish Government, channeled through its National Plan for Knowledge Transfer.
The VIRAGE trial has been carried out in 15 centers distributed between Spain and the United States, and its purpose is to evaluate the combination of VCN-01 with standard chemotherapy treatments in newly diagnosed patients with metastatic PDAC. This treatment has obtained special designations from the FDA and EMA as an orphan drug and fast track medicine. These designations could pave the way for a transition to a Phase 3 study next year, which would be a crucial advancement in the treatment of this aggressive form of cancer.
Theriva Biologics CEO, Steven A. Shallcross, expressed his satisfaction with the progress of the trial, highlighting the potential of the innovative mechanism of action of VCN-01 to change the way PDAC and other difficult cancers like retinoblastoma are treated. Theriva is in the process of expanding its manufacturing capacity, an effort that is supported by government funding and a modest capital increase.
In addition to its achievements in treating PDAC, Theriva Biologics has also made progress in addressing retinoblastoma. VCN-01 has received orphan drug designation from the European Commission and the FDA for this condition. The Phase 1 trial concluded with encouraging results, according to the study’s monitoring committee report.
Meanwhile, the company has successfully completed Cohort 2 of the Phase 1b/2a clinical trial of SYN-004 (ribaxamase), focused on preventing acute graft-versus-host disease in recipients of hematopoietic cell transplants. Theriva Biologics is currently seeking funding to continue this program in a new cohort, emphasizing its commitment to developing innovative medical solutions.
In terms of its financial results for the third quarter of 2024, Theriva Biologics reported a significant increase in general and administrative expenses, while research and development expenses showed a decrease. The company also faces a reduction in the value of its shares, leading to significant impairment charges, attributable to an increase in perceived risk in the markets.
With $16.4 million in cash and equivalents available at the end of September, Theriva Biologics continues with its ambitious plans for clinical development and expansion in the manufacturing field. The company expresses its gratitude for the constant support from Spanish authorities and reaffirms its intention to consolidate its position within the competitive international biotech landscape.
via: MiMub in Spanish