Theriva Achieves Target Patient Enrollment In VIRAGE Phase 2b Trial of VCN-01

Theriva achieves target patient enrollment in VIRAGE phase 2b trial of VCN-01 with gemcitabine/nab-paclitaxel to treat metastatic pancreatic cancer

Overview

Theriva Biologics, Inc., a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, announced that it has achieved their target patient enrollment in the VIRAGE phase 2b clinical trial evaluating the company’s lead product candidate VCN-01 plus standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). VCN-01 is a systemically-administered, tumour selective, stroma-degrading oncolytic adenovirus that has been granted Orphan Drug Designation and Fast Track Designation by the US Food and Drug Administration (FDA) for the treatment of PDAC.

Statement from the CEO: Theriva Biologics

• We are delighted to have achieved target enrollment for our VIRAGE phase 2b trial in metastatic PDAC,” said Steven A. Shallcross, chief executive officer of Theriva Biologics. 
• Rapid progress in the VIRAGE trial is a testament to physician interest in VCN-01 and the significant unmet need for an effective treatment for this deadly disease. We are currently planning regulatory engagements to discuss next steps in VCN-01 clinical development, including the potential for an interim data analysis.

Pancreatic Cancer

• Cancer of the Pancreas Consists of Two Main Histological Types: 

1. cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, 
2. cancers may arise from the endocrine compartment of the pancreas. 

• Pancreatic ductal adenocarcinoma (PDAC) accounts for more than 90% of all pancreatic tumours. 
• It can be located either in the head of the pancreas or in the body/tail. 
• Pancreatic cancer usually metastasizes to the liver and peritoneum. 
• Other less common metastatic sites are the lungs, brain, kidney and bone. 
• In its early stages, pancreatic cancer does not typically result in any characteristic symptoms, so in most cases it is diagnosed in its late stages (locally advanced non-metastatic or metastatic disease) when surgical resection and possibly curative treatment is not possible. 
• It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.

About the Adenovirus: VCN-01

• VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumour cells and degrade the tumour stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. 
• This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by 

1. selectively infecting and lysing tumour cells; 
2. enhancing the access and perfusion of co-administered chemotherapy products; and 
3. increasing tumour immunogenicity and exposing the tumour to the patient’s immune system and co-administered immunotherapy products. 

• Systemic administration enables VCN-01 to exert its actions on both the primary tumour and metastases.
• In addition to the VIRAGE phase 2b trial, VCN-01 has been administered to over 80 patients in phase 1 and investigator-sponsored clinical studies of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection).

VIRAGE Multicenter Clinical Trial

• VIRAGE is a two-arm phase 2b open-label, randomized, controlled, multicenter clinical trial in patients with histologically confirmed, newly-diagnosed metastatic PDAC. 
• The study is being conducted at 16 sites across the US and Europe with a target enrollment of 92 evaluable patients; 46 in each of the control and treatment arms. 
• In both the control and treatment arms, patients are treated with gemcitabine/nab-paclitaxel standard of care chemotherapy in 28-day cycles. 
• In the treatment arm only, patients also receive single doses of intravenous VCN-01 administered seven-days prior to the first and fourth cycles of gemcitabine/nab-paclitaxel treatment. 
• Primary endpoints for the trial are overall survival and VCN-01 safety/tolerability. 
• Additional endpoints include progression free survival, objective response rate, and measures of biodistribution, VCN-01 replication, and immune response.

About the Company: Theriva Biologics

• Theriva Biologics is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. 
• The company is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumour cell death, improve access of co-administered cancer therapies to the tumour, and promote a robust and sustained anti-tumour response by the patient’s immune system.

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