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By Meg Flippin, Benzinga
Theriva™ Biologics (AMEX: TOVX), the clinical-stage immuno-oncology company developing therapies for difficult-to-treat cancers, hit several milestones during 2023, potentially positioning it for a strong year ahead.
That could be good news for patients with pancreatic, retinoblastoma, head and neck, brain or ovarian cancers. If Theriva is right, its oncolytic viruses can overcome the protective barrier surrounding solid tumors and selectively kill tumor cells. Its developmental therapies are designed to enable systemic delivery – which means they can target the tumor and distant metastases and have the potential to enhance current standard-of-care therapies, the company says. Theriva’s oncolytic viruses can be administered intravenously or as a direct injection into the tumor or tumor compartment.
Trials Underway
Announcing its financial results for the full year 2023, Theriva reported ending the year in a good position with VCN-01, its lead therapy candidate. VCN-01 is currently in a phase 2b trial for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) and in investigator-sponsored studies in a number of indications. As of late March, dosing was underway and enrollment continues to progress for VIRAGE, the randomized, controlled, multicenter open-label phase 2b trial of VCN-01 in combination with standard-of-care chemotherapy as a first-line therapy in newly diagnosed metastatic PDAC patients.
The trial is targeting enrollment of 92 evaluable patients and the company reports it's on track to complete enrollment in the first half of this year. Patients are being enrolled in six sites in the U.S. and nine in Spain and will continue without any changes to the protocol after an evaluation by the Independent Data Monitoring Committee (IDMC) found no safety concerns.
Intravenous VCN-01 has been well tolerated and demonstrated a safety profile consistent with prior clinical trials, Theriva reports. Importantly, it said no additional toxicities were observed in patients receiving a second dose of VCN-01. That means repeated systemic dosing of VCN-01 is feasible from a safety perspective, paving the way for Theriva to focus on whether the repeated dose VCN-01 regimen may lead to improved clinical outcomes for patients.
“We believe VCN-01’s differentiated mechanism of action has the potential to address the urgent need for new treatment options for patients with PDAC by degrading the tumor matrix and increasing tumor access by VCN-01 and co-administered cancer therapies,” said Theriva CEO Steven Shallcross during a conference call to discuss full year 2023 earnings. To date, more than 100 patients have been dosed with VCN-01 in clinical trials in patients with a broad range of cancers, including PDAC, retinoblastoma, colorectal cancer and head and neck squamous cell carcinoma (HNSCC). Additional investigator-sponsored studies have been initiated in patients with brain cancers and ovarian cancers.
Beyond Pancreatic Cancer
Treating pancreatic cancer with VCN-01 isn’t the only area Theriva focused on during the year. The company is also engaged in a phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma. That trial is making progress, with the company completing patient treatment. The trial is designed to evaluate escalating doses of VCN-01 administered by two intravitreal injections separated by 14 days. The investigator-sponsored phase 1 trial will complete patient follow-up in the first half of 2024, and the results will help inform the planned phase 2 trial design, Theriva says. Additionally, the University of Pennsylvania continues to enroll and treat patients in their phase 1 investigator-sponsored trial administering VCN-01 with huCART-meso cells to patients with ovarian or pancreatic cancers. VCN-01 is designed to increase tumor immunogenicity and improve access by additional therapies such as huCART-meso cells.
Dosing is also underway for the ongoing phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD). Theriva said SYN-004 appears to be well tolerated.
Collaborating And Expanding Partnerships
Not one to rest, Theriva was also busy during the year expanding collaborations and identifying new areas that may benefit from VCN-01. Late last year it signed an exclusive option to license intellectual property from Sant Joan de Déu-Barcelona Children’s Hospital (SJD) to explore the therapeutic potential of VCN-01 in combination with topoisomerase I inhibitors. This strengthens a long-term research collaboration with SJD and builds on an ongoing trial evaluating VCN-01 in pediatric cancers.
The company is also pursuing licensing discussions for its SYN-020 intestinal alkaline phosphatase asset. SYN-020 is a recombinant bovine intestinal alkaline phosphatase (IAP) formulated for oral delivery to the small intestine and designed to diminish fat absorption and intestinal inflammation, tighten the gut barrier to mitigate “leaky gut” and promote a healthy microbiome. It has the potential to become a multi-indication therapeutic capable of addressing disorders stemming from gastrointestinal (GI) inflammation. Theriva is doing all this and keeping costs down. For the year ended December 31, 2023, general and administrative expenses decreased 28% to $7.1 million from $9.9 million in the year-earlier period. Meanwhile, the company increased spending on research and development by 22%, with an eye on the future based on an observed uptick in demand for its compounds.
“In 2023, we continue to make steady progress to drive forward our oncology-focused portfolio designed to address unmet needs for difficult-to-treat cancers,” said Shallcross on the earnings call. “Our primary efforts and resources are focused on pursuing multiple therapeutic opportunities for our lead clinical candidate VCN-01. We'll continue to look for ways to drive additional value for our shareholders and for the long-term success of what we're trying to do, namely delivering promising treatments for very, very difficult-to-treat cancers.”
Featured photo by National Cancer Institute on Unsplash.
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