Theriva™ Biologics Announces US FDA Fast Track Designation for VCN-01 for the Treatment of Metastatic Pancreatic Cancer
Friday, May 24, 2024
Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapies designed to treat cancer and related diseases in areas of high deprivation, today announced that the US Food and Drug Administration (FDA) has granted fast track designation (FTD) to the lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve free survival progression and overall survival in patients with metastatic pancreatic adenocarcinoma. In VIRAGE, the ongoing multinational Phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as first-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC). Previously, the FDA granted orphan drug designation to VCN-01 for the treatment of PDAC.
"The FDA's decision to grant FTD to CNV-01 highlights the urgent need for new treatment options for PDAC, which is the fourth leading cause of cancer-related death in the US and Europe," said Steven A. Shallcross, CEO of Theriva Biologics. "VIRAGE, our Phase 2b trial evaluating VCN-01 in metastatic PDAC, continues to advance, with enrollment expected to complete in the third quarter of 2024. The FTD is an important step that strengthens our ability to accelerate the review of and build on compelling clinical data that underline the multiple modes of action and therapeutic potential of VCN-01 in combination with chemotherapy or immunotherapy. "We will spare no effort in our mission to advance new therapeutic options for these patients."
The FTD is designed to help treatments reach patients sooner by facilitating the development and accelerating the review of therapies with the potential to treat serious conditions and fill an unmet medical need. Program benefits of FTD include early and frequent interactions with the FDA during the clinical development process and, if relevant criteria are met, the FDA may also review portions of a marketing application before the sponsor submit the complete application.
About pancreatic ductal adenocarcinoma
Pancreatic cancer occurs in two broad histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less frequently, cancers that can arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma ("PDAC") accounts for more than 90% of all pancreatic tumors. It can be located in the head of the pancreas or in the tail of the body. Pancreatic cancer typically metastasizes to the liver and peritoneum. Other less common metastatic locations are the lungs, brain, kidney and bones. In its initial stages, pancreatic cancer does not usually give rise to any characteristic symptoms. In many cases, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer is diagnosed in its later stages (locally advanced non-metastatic or metastatic stage of the disease), when surgical resection and possibly curative treatment are not possible. In general terms, only 10% of cases are considered to be resectable at the time of appearance, while 30-40% of patients are diagnosed in a locally advanced/unresectable stage and 50-60% present metastasis. from distance.
About VCN-01
VCN-01 is an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stromal barrier that serves as an important physical and immunosuppressive barrier to cancer treatment. This unique mode of action allows VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) improve access and perfusion of co-administered chemotherapy products; and (iii) increase tumor immunogenicity and expose it to the patient's immune system and co-administered immunotherapy products. Systemic administration allows VCN-01 to exert its actions in both the primary tumor and metastases. VCN-01 has been administered to more than 80 patients in Phase 1, investigator-sponsored clinical trials in various types of cancer, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with a immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer and retinoblastoma (by intravitreal injection). For more information about these clinical trials, visit Clinicaltrials.gov.
About Theriva™ Biologics, Inc.
Theriva™ Biologics (NYSE American: TOVX) is a diversified clinical-stage company developing therapies designed to treat cancer and related diseases in areas of high deprivation. The Company has been developing a novel oncolytic adenovirus platform designed for intravenous, intravitreal, and antitumor delivery to trigger tumor cell death, improve access of co-administered oncology therapies to the tumor, and promote a robust and sustained antitumor response. by the patient's immune system. The Company's main candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stromal barrier that serves as an important physical and immunosuppressive barrier to the cancer treatment; (2) SYN-004 (ribaxamasse), designed to degrade certain commonly used IV beta-lactam antibiotics in the gastrointestinal (GI) tract in order to prevent damage to the microbiome, thereby limiting the overgrowth of pathogenic organisms such as VRE (enterococci). resistant to vancomycin) and reducing the incidence and severity of acute graft-versus-host disease (aGVHD) in recipients of allogeneic hematopoietic cell transplants (HCT); and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP (current good commercial practice) conditions and intended to treat both local and systemic GI diseases. For more information, see the Theriva Biologics website at www.therivabio.com .
Forward-looking statements
This press 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 terms such as "may," "should," "potential," "continue." , "expects", "anticipates", "intends", "plans", "believes", "estimates" and similar expressions, and include statements regarding the continued progress of VIRAGE, registration in VIRAGE which is expected to be completed in the third quarter of 2024; the Society's ability to expedite the review of the FTD and take advantage of compelling clinical data that underscore the multiple modes of action and therapeutic potential of VCN-01 in combination with chemotherapy or immunotherapy; and continue to fulfill our mission of advancing new therapeutic options for these patients. Important factors that could cause actual results to differ materially from current expectations include, but are not limited to, the Company's ability to obtain benefits from the FTD, the ability of the Company and VCN to achieve clinical milestones when anticipated, including the ability to continue enrolling patients as planned and completion of VIRAGE enrollment in Q3 2024, generating clinical data establishing that VCN-01 may lead to improved clinical outcomes in patients with PDAC and others solid cancers, that the Company's and VCN's product candidates demonstrate safety and efficacy, as well as results consistent with previous ones, the ability to conduct clinical trials on time and achieve the desired results and benefits, the ability to obtain the regulatory approval for the commercialization of the product candidates or to meet ongoing regulatory requirements, regulatory limitations relating to the Company's and VCN's ability to promote or commercialize their product candidates for the specific indications, acceptance of the product candidates in the market and the success of the development, marketing or sale of the company's and VCN's products, developments by competitors that render such products obsolete or uncompetitive, the company's and VCN's ability to maintain licensing agreements, the continued maintenance and growth of the company's and VCN's patent assets, the ability to remain well-funded, and other factors described in the company's annual report on Form 10-K for the year ended December 31, 2023 and in its other filings with the SEC, including subsequent periodic reports on Form 10-Q and current reports on Form 8-K. The information contained in this communication is provided only as of the date of this communication,and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise, except as required by law.
For more information, please contact:
Investor Relations:
Chris Calabrese
LifeSci Advisors, LLC
ccalabrese@lifesciadvisors.com
917-680-5608
Source: globenewswire.com
