Theriva™ Biologics (NYSE American: TOVX), a leading diversification clinical-stage company focused on developing therapies to treat cancer and related diseases, has announced significant advancements in its research projects. The company expects to complete enrollment for its Phase 2b clinical trial, known as VIRAGE, in the third quarter of 2024. This trial, which combines VCN-01 with chemotherapy to treat metastatic pancreatic ductal adenocarcinoma (PDAC), has recently received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA).
Steven A. Shallcross, CEO of Theriva Biologics, expressed satisfaction with the progress of VIRAGE and the FTD designation of VCN-01, an oncolytic virus designed to enhance chemotherapy and immunotherapy delivery. According to Shallcross, this advancement underscores the urgent need for new therapeutic options for metastatic pancreatic adenocarcinoma, a particularly deadly disease. The VIRAGE trial is evaluating VCN-01 in combination with gemcitabine/nab-paclitaxel as first-line treatment for patients with metastatic PDAC.
In the field of retinoblastoma, the company is evaluating the positive results of a Phase 1 trial in pediatric patients and has initiated discussions with opinion leaders and regulators to develop an optimized clinical strategy. Theriva Biologics also received Rare Pediatric Disease Designation (RPDD) for VCN-01 in the treatment of retinoblastoma, opening the possibility of a priority review voucher if approved for use.
The SYN-004 (ribaxamase), another prominent therapeutic candidate, is also progressing in its development. Dosage and safety monitoring in the second cohort of a Phase 1b/2a clinical trial in patients undergoing allogeneic hematopoietic cell transplants have been completed. According to the company, enrollment for the third cohort could begin in the second half of 2024, provided adequate funding is available.
Theriva Biologics has shared its financial results for the second quarter of 2024, showing a 45% decrease in general and administrative expenses compared to the same period last year. Research and development expenses also decreased slightly, although future increases are expected as clinical trials of VCN-01 in PDAC and retinoblastoma progress, along with other preclinical initiatives. The company reported a decline in the value of its goodwill from $5.5 million to $1.5 million due to an increase in the company’s specific risk premium, among other factors.
Theriva Biologics continues to strengthen its position in the field of oncolytic therapies, with a focus on maximizing the therapeutic potential of VCN-01 and expanding its product portfolio. With a cash reserve of $16.6 million as of June 30, 2024, the company feels prepared to face the next stages of its ambitious development programs, aiming to provide new medical solutions in areas where significant unmet needs still exist.
via: MiMub in Spanish
