– Lead product candidate VCN-01 in combination with liposomal irinotecan demonstrates enhanced antitumor efficacy in human pancreatic mouse xenografts–
– Observed synergistic effects highlight the potential of VCN-01 in diverse chemotherapy combinations to improve therapeutic efficacy in pancreatic cancer –
ROCKVILLE, Md., April 22, 2024 (Globe Newswire) — Theriva is a diversified clinical-stage company developing therapeutics to treat cancer and related diseases in areas of high unmet need. ™ Biologics (NYSE American: TOVX) today announced preclinical data demonstrating enhanced antitumor efficacy in mice bearing human pancreatic cancer xenografts treated with lead product candidate VCN-01 and liposomal irinotecan. These data support the potential synergy between VCN-01 and first-line chemotherapy regimens for pancreatic cancer and will be featured in a poster presentation at the American Society for Cell and Gene Therapy (ASGCT) 27th The Annual Meeting will be held virtually and in Baltimore from May 7-11, 2024.
“Data to be discussed at the next ASGCT meeting suggest that the combination of VCN-01 and topoisomerase I inhibitors, such as liposomal irinotecan, may provide synergistic antitumor effects and improve treatment outcomes across indications. based on recent research findings,” said Steven A. Shallcross. , CEO of Theriva Biologics. “We look forward to leveraging these findings and evaluating the combination of VCN-01 with additional first-line pancreatic cancer chemotherapy regimens, including NALIRIFOX and FOLFIRINOX.” By combining these important steps, we continue to advance the ongoing VIRAGE Phase 2b trial evaluating the combination of VCN-01 and gemcitabine/nab-paclitaxel to treat pancreatic ductal adenocarcinoma (PDAC). “This brings us one step closer to building a portfolio of potentially improved therapeutic combinations for patients with PDAC who have high unmet medical needs.”
The main takeaways are:
Summary: The combination of VCN-01 + topoisomerase I (topo1) inhibitors, such as liposomal irinotecan, has an acceptable toxicity profile and may improve efficacy in the treatment of human pancreatic cancer.
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In vitro: Exposure of human pancreatic cancer cell lines to the topo1-inhibiting chemotherapeutic agents irinotecan, its active metabolite, SN-38, and topotecan increased viral protein expression.
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In Vivo: Synergistic effects of VCN-01 and liposomal irinotecan were observed in animals bearing subcutaneous human pancreatic tumors.
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In a human pancreatic mouse xenograft model, treatment with VCN-01 at a dose of 4×10Ten vp or liposomal irinotecan alone (both 10 mg/kg and 5 mg/kg doses) produced significant tumor growth inhibition compared to saline.
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Combination therapy of VCN-01 + liposomal irinotecan showed a significant reduction in tumor growth compared to each treatment alone at both doses.
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qPCR analysis performed on tumors harvested at the end of the study confirmed the presence of the viral genome and demonstrated ongoing transcriptional activity of VCN-01, which is consistent with viral activity in the days following administration. Consistent with replication.
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The full summary of poster presentations (1760) can be accessed through the ASGCT conference portal and posters will be available from Friday, May 10, 2024. Additional details for the poster are provided below.
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title: Enhanced antitumor efficacy by combination therapy of oncolytic adenovirus, VCN-01, and liposomal irinotecan in human pancreatic mouse xenografts
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Session title: Cancer – Oncolytic Virus
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Presenter: Dr. Sheila Connelly, Vice President of Research, Theriva Biologics, Inc.
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Poster session date and time: Friday, May 10, 2024 12:00 PM ET
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 uses intravenous (IV), intravitreal and We are advancing a novel oncolytic adenoviral platform designed for antitumor delivery. patient's immune system. The company's main candidates are as follows. (1) VCN-01 was designed to selectively and actively replicate within tumor cells and degrade the tumor stromal barrier, which serves as an important physical and immunosuppressive barrier to cancer therapy. It is an oncolytic adenovirus. (2) SYN-004 (ribaxasamase) is designed to break down certain IV beta-lactam antibiotics commonly used in the gastrointestinal (GI) tract to prevent microbiome damage; It limits the overgrowth of pathogenic microorganisms such as VRE (vancomycin-resistant enterococci) and reduces the number of enterococci. Incidence and severity of acute graft-versus-host disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. (3) SYN-020 is a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) manufactured under cGMP conditions and intended to treat both local gastrointestinal and systemic diseases. For more information, please visit his website at Theriva Biologics at www.therivabio.com.
Forward-looking statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as “may,” “should,” “could,” and “continue.” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates” and similar expressions. It also includes a description of the potential synergy between its lead product candidate, VCN-01, and pancreatic cancer first-line chemotherapy. regimen. Suggestions that the combination of VCN-01 and topoisomerase I inhibitors such as liposomal irinotecan may provide synergistic antitumor effects and improve treatment outcomes across indications. We will leverage these findings to evaluate the combination of VCN-01 with additional first-line pancreatic cancer chemotherapy regimens including NALIRIFOX and FOLFIRINOX. We also continue to advance the ongoing VIRAGE Phase 2b trial evaluating VCN-01 in combination with gemcitabine/nab-paclitaxel to treat metastatic pancreatic ductal adenocarcinoma (PDAC). Important factors that could cause actual results to differ materially from current expectations include establishing synergy between our lead product candidate, VCN-01, and first-line pancreatic cancer chemotherapy regimens; These include the ability to generate clinical data that inform oncology effects. Our and VCN's product candidates have demonstrated safety and efficacy and results consistent with previous results. our ability to complete clinical trials on time and achieve desired results and benefits; our ability to obtain regulatory approval or comply with current regulatory requirements for the commercialization of our product candidates, and regulatory limitations on our and VCN's ability to promote or commercialize our product candidates for certain indications; , the acceptance and success of our product candidates in the marketplace; the development, marketing or sale of our and VCN's products; development by competitors that renders such products obsolete or noncompetitive; the maintenance of our and VCN's license agreements; ability, the continued maintenance and growth of our and VCN's patent assets, our continued ability to obtain sufficient financing, and our annual report on Form 10-K for the year ended December 31, 2023 and our filings with the SEC. and other factors described in our other filings, including our subsequent periodic reports on Form 10-Q and our current report on Form 10-Q. Form 8-K. The information in this release is provided only as of the date of this release and, except as required by law, Theriva Biologics does not warrant that any future updates contained in this release, whether as a result of new information, future events or otherwise, We undertake no obligation to update forward-looking statements. .
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Source: Theriva Biologics, Inc.