-Clinical trial is being conducted at St. James’s University Hospital, United Kingdom, in collaboration with the University of Leeds-

ROCKVILLE, Md, USA I January 09, 2023 I Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the first patient has been dosed in the Phase 1 investigator sponsored clinical trial of VCN-01, an intravenous oncolytic adenovirus, for patients with high-grade brain tumors who are scheduled for surgical resection.

“We are pleased to dose the first patient and evaluate the ability of our lead oncolytic adenovirus, VCN-01, to enter brain tumors following systemic administration,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “This design builds on the data that we obtained from previous trials of systemically delivered VCN-01 for treating metastatic pancreatic cancer, another difficult to treat disease. If the results show that VCN-01 gains entry to brain tumors that are otherwise only accessible through surgery, this could be transformative for patients by enabling multiple treatments with VCN-01 without the complications of brain surgery. We look forward to driving this program forward and addressing the unmet need for the thousands of patients with primary or metastatic brain tumors who could potentially benefit from this novel oncolytic therapy.”

Trial Design:

The Phase 1, open-label, non-randomized trial is designed to evaluate the safety, tolerability and intratumoral presence of VCN-01 administered intravenously at a single dose of 1 x 1013 vp (virus particles) in up to 12 patients with recurrent high-grade glioma or brain metastases, prior to planned surgery. All patients will undergo surgical resection of their tumors between eight and 15 days following VCN-01 infusion, allowing for assessment of any toxicities and their resolution. More information about the trial is available here.

The clinical trial is being led by Dr. Adel Samson, an expert in clinical immunotherapy and Head of the Translational Cancer Immunotherapy Group at the University of Leeds, as well as Professor Susan Short of Clinical Oncology and Neuro-oncology and Head of the Brain Cancer Research Section at Leeds Institute of Cancer and Pathology. The trial is funded by The Brain Tumour Charity and Cancer Research UK.

Dr. Samson commented, “Patients with recurrent high-grade primary brain tumors typically have a poor prognosis, and often have to undergo one or more surgical interventions to remove their tumors. The leaky vasculature of many brain tumors may provide an excellent opportunity for systemically administered VCN-01 to enter the tumor, where it can replicate and initiate tumor cell killing, immune stimulation and destruction of tumor stroma. This could provide a more effective and less invasive therapeutic option for these patients.”

About Theriva Biologics, Inc.

Theriva Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s subsidiary Theriva Biologics, S.L., has been developing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients); and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics’ website at www.therivabio.com.

SOURCE: Theriva Biologics