Connect with us

Press Release

Theriva Biologics Receives Fast Track Designation From FDA For VCN-01 For Treating Metastatic Pancreatic Cancer

Published

2 years ago

on

–News Direct–

By Kyle Anthony, Benzinga

Theriva Biologics (AMEX: TOVX) is an immuno-oncology company developing oncolytic viruses, otherwise known as cancer cell-infecting viruses, to overcome the protective barrier surrounding solid tumors and selectively kill tumor cells. As a company engaged in developing differentiated clinical-stage therapeutics, Therivas mission is to change patient outcomes by working to improve the current standard of care and transform the cancer therapy landscape.

The firms management and scientific advisory board is comprised of determined and experienced leaders who are committed to offering patients with difficult-to-treat cancers the chance of a longer life. The company recently achieved a significant milestone as the U.S. FDA granted Fast Track Designation (FTD) to its candidate VCN-01 to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. Previously, the FDA granted orphan drug designation to VCN-01 for treatment of pancreatic ductal adenocarcinoma (PDAC).

Company Background

Founded in 2001 and operating as Synthetic Biologics from 2012, the company was previously focused on developing biologic and drug candidates for various indications, including infectious diseases and gastrointestinal disorders. The company rebranded to Theriva Biologics in September 2022 to reflect its evolving focus on oncolytic viruses and cancer therapies. Regarding the impetus behind the firms rebranding, Steven A. Shallcross, Chief Executive Officer of Theriva Biologics, said, The rebranding solidifies our strategic transformation and reflects our sharpened focus on advancing unique, oncolytic viruses optimized for IV administration. We continue to build on the incredible progress made to date and are diligently advancing our oncolytic adenovirus pipeline. This includes lead clinical-stage program VCN-01, designed to break down the tumor stroma, and preclinical-stage program VCN-11, leveraging our proprietary Albumin Shield Technology to protect systemically administered oncolytic viruses from the host immune system. These two differentiated programs are intended to improve the anti-tumor effect of the oncolytic virus, co-administered chemotherapies and/or immuno-oncology therapeutics. Together, VCN-01 and VCN-11 position Theriva at the forefront of oncolytic virus development. We are excited about Therivas path towards strategic growth, renewed corporate strategy and remain on track to deliver on upcoming value-driving milestones.

Theriva Biologics Pipeline

As Steven A. Shallcrosss preceding quote suggests, Theriva Biologics' leading clinical-stage program, VCN-01, has displayed promise as a treatment solution. Presently, VCN-01 is part of an ongoing phase 2 clinical trial, entitled VIRAGE, where it is being tested in combination with standard-of-care chemotherapy for patients with pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. VCN-01 was also administered with the checkpoint inhibitor durvalumab (an FDA-approved immunotherapy for cancer) in a phase 1 study in patients with head and neck cancers and is currently being evaluated in combination with huCART-meso cells cells manufactured using a patients own white blood cells, which are modified to target cancer cells or cells that help cancer to grow in an investigator-sponsored study in patients with either pancreatic cancer or ovarian cancer.

Beyond VCN-01, Theriva Biologics is also developing SYN-004 (ribaxamase), which is aligned with the companys oncology focus and seeks to mitigate adverse outcomes for patients who will undergo bone marrow transplant (allogeneic hematopoietic cell transplantation) to treat hematologic cancers. 80% to 90% of these patients will be treated with an intravenous -lactam antibiotic, and this antibiotic treatment has been strongly associated with increased incidence and severity of acute graft-vs-host disease (aGVHD), vancomycin-resistant Enterococci (VRE) infection and Clostridioides difficile infection (CDI). Preventing one or all of these outcomes by SYN-004 co-administration may significantly improve treatment outcomes and reduce patient mortality.

VCN-01 Receives Fast Track Designation By The U.S. FDA

Theriva Biologics achieved a significant milestone as the FDA granted Fast Track Designation (FTD) to VCN-01. This designation, in combination with gemcitabine and nab-paclitaxel standard-of-care chemotherapy drugs is aimed at improving progression-free survival and overall survival in patients with metastatic pancreatic cancer. This recognition underscores Theriva Biologics' commitment to advancing cancer treatment and the potential of VCN-01 in this field.

Pancreatic cancer is one of the leading causes of cancer death globally. The increasing incidence of this cancer across the U.S. and other parts of the world is one of the factors driving the need for drugs used in its treatment. According to research published by Fortune Business Insights, the global pancreatic cancer treatment market size was $2.86 billion in 2023 and is projected to grow from $3.30 billion in 2024 to $10.69 billion by 2032.

Attaining FTD is a seminal achievement for pharmaceutical drug companies, as the designation is designed to help treatments reach patients faster by facilitating the development and expediting the review of therapies with the potential to treat serious conditions and fill an unmet medical need. Benefits of FTD to programs 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 submits the complete application.

Regarding Theriva Biologics receiving the FTD, Shallcross said, The FDAs decision to grant FTD to VCN-01 highlights the urgent need for new treatment options for PDAC, which accounts for the 4th highest cause of cancer-associated deaths in the US and Europe. VIRAGE, our Phase 2b trial evaluating VCN-01 in metastatic PDAC continues to progress, with enrollment expected to be completed in the third quarter of 2024. FTD is an important step that furthers our ability to expedite the review of and build upon the compelling clinical data that underscores VCN-01s multiple modes of action and therapeutic potential in combination with chemotherapy or immunotherapy. We will continue to deliver on our mission to advance new therapeutic options for these patients.

Based on the strength of the science and its relevance, VIRAGE was accepted for presentation as a trial-in-progress poster at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago, IL, from May 31-June 4.

The Path Forward

Theriva Biologics' approach to cancer treatment differentiates it from its peers, potentially placing the company in a unique market position. As incidences of pancreatic cancer continue to rise globally, drug treatment options, such as VCN-01, will likely rise in demand. With VCN-01 receiving FTD from the U.S. FDA, this milestone speaks to the drug's efficacy and long-run potential. As such, the benefit that Theriva Biologics provides and the value proposition the firm espouses could continue to grow and have increased industry resonance.

Featured photo by National Cancer Institute on Unsplash.

Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders.

This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice.

Contact Details

Benzinga

+1 877-440-9464

info@benzinga.com

Company Website

http://www.benzinga.com

View source version on newsdirect.com: https://newsdirect.com/news/theriva-biologics-receives-fast-track-designation-from-fda-for-vcn-01-for-treating-metastatic-pancreatic-cancer-427600911

Benzinga

comtex tracking

COMTEX_453481266/2655/2024-06-07T08:44:04

About Author

Cloud PR Wire

See author's posts

Disclaimer: The views, suggestions, and opinions expressed here are the sole responsibility of the experts. No Digi Observer journalist was involved in the writing and production of this article.

Related Topics:
Continue Reading

Press Release

Smart Home Ahead Launches 2026 Survival Guide to End the 168 Billion Dollars Smart Home Frustration

Published

55 minutes ago

on

April 13, 2026

By

United States, 13th Apr 2026 – As the global smart home market surges toward a staggering $168 billion valuation, a surprising number of users continue to struggle with one fundamental issue: getting their devices to actually work together. Addressing this growing frustration, Smart Home Ahead has officially launched its highly anticipated “2026 Survival Guide,” a comprehensive beginner-friendly resource designed to simplify smart home adoption and eliminate common setup failures.

Despite rapid advancements in smart technology, recent industry insights reveal that nearly 19% of users fail during the initial setup phase. From incompatible devices to unreliable connections, many homeowners find themselves overwhelmed by complexity rather than empowered by convenience. Smart Home Ahead’s latest guide directly tackles this problem by shifting the conversation away from gadgets and toward a more strategic, long-term solution.

“The biggest mistake people make is starting with devices instead of infrastructure,” said Daniel Carter, spokesperson for Smart Home Ahead. “Our guide introduces a ‘Network-First’ philosophy, which is the key to building a reliable and scalable smart home in 2026 and beyond.”

Unlike traditional buying guides that focus heavily on product recommendations, the “2026 Survival Guide” emphasizes foundational planning. It explains why investing in a strong and stable home network is critical before adding smart devices. By doing so, users can avoid connectivity issues, reduce device conflicts, and ensure seamless automation across their entire ecosystem.

A major highlight of the guide is its focus on the emerging “Matter” standard—a revolutionary development in smart home technology. Matter is designed to unify different brands and platforms, allowing devices from various manufacturers to communicate effortlessly. According to Smart Home Ahead, 2026 marks a turning point where Matter-enabled devices are finally delivering on the long-promised vision of true interoperability.

“The industry has talked about seamless integration for years, but now it’s actually happening,” Carter added. “Matter is changing the game, and our guide helps users understand how to take full advantage of it without unnecessary trial and error.”

The guide also provides practical, step-by-step advice tailored for beginners. It breaks down complex technical concepts into easy-to-understand language, making it accessible for homeowners with little to no prior experience in smart technology. From choosing the right network setup to identifying compatible devices, readers are equipped with actionable insights that can save both time and money.

In addition to addressing technical challenges, the guide highlights the financial impact of poor planning. Many consumers end up spending hundreds or even thousands of dollars on devices that fail to integrate properly. By adopting the Network-First approach, users can make smarter purchasing decisions and avoid costly mistakes.

Smart Home Ahead’s initiative comes at a crucial time when consumer demand for smart home solutions is at an all-time high. With increasing interest in home automation, energy efficiency, and security, the need for clear, reliable guidance has never been greater. The “2026 Survival Guide” aims to bridge this gap by offering a practical roadmap that aligns with the latest technological advancements.

The full guide is now available on the company’s website, where readers can explore in-depth strategies and expert recommendations for building a future-ready smart home. By focusing on simplicity, compatibility, and long-term success, Smart Home Ahead is positioning itself as a trusted authority in the rapidly evolving smart home landscape.

For more information visit https://smarthomeahead.com/build-a-smart-home-in-2026-the-complete-beginner-guide/ 

About Smart Home Ahead

Smart Home Ahead is a U.S.-based technology and lifestyle platform dedicated to helping consumers navigate the rapidly evolving world of smart home innovation. The company provides expert insights, practical guides, and up-to-date resources designed to simplify home automation for beginners and enthusiasts alike. With a strong focus on usability, compatibility, and future-ready solutions, Smart Home Ahead empowers users to build smarter, more connected living spaces with confidence. Through educational content and industry analysis, the platform continues to bridge the gap between complex technology and everyday convenience.

Media Contact

Organization: Smart Home Ahead

Contact Person: Daniel Carter

Website: https://smarthomeahead.com

Email: Send Email

Country:United States

Release id:43964

The post Smart Home Ahead Launches 2026 Survival Guide to End the 168 Billion Dollars Smart Home Frustration appeared first on King Newswire. This content is provided by a third-party source.. King Newswire makes no warranties or representations in connection with it. King Newswire is a press release distribution agency and does not endorse or verify the claims made in this release. If you have any complaints or copyright concerns related to this article, please contact the company listed in the ‘Media Contact’ section

file

About Author

Cloud PR Wire

See author's posts

Disclaimer: The views, suggestions, and opinions expressed here are the sole responsibility of the experts. No Digi Observer journalist was involved in the writing and production of this article.

Continue Reading

Press Release

Digital Smart AI Launches Scalable AI Solutions and GPU Rental Platform for Global Businesses

Published

1 hour ago

on

April 13, 2026

By

United States, 13th Apr 2026 – As artificial intelligence continues to drive global digital transformation, Digital Smart AI has introduced a comprehensive suite of AI solutions alongside a flexible GPU computing rental platform, designed to help businesses access advanced computing capabilities without the high cost of traditional infrastructure. With AI applications such as content generation, image synthesis, and predictive analytics becoming increasingly essential across industries, many organizations still face significant barriers due to the cost and complexity of building in-house computing systems. Digital Smart AI aims to address this challenge by providing scalable, on-demand AI tools and GPU resources that allow companies to develop, deploy, and expand AI-driven operations more efficiently.

The platform focuses on usability and flexibility, enabling both technical teams and non-technical users to integrate AI into their workflows. Its AI solutions cover a range of practical use cases, including automated content generation, visual asset creation through AI image tools, and customized AI integration services that support business system upgrades. By simplifying deployment and reducing technical thresholds, Digital Smart AI helps organizations accelerate adoption while maintaining operational efficiency.

At the core of its offering is a GPU rental model that provides high-performance computing power without requiring large capital investment. Instead of purchasing and maintaining expensive hardware, businesses can access scalable GPU resources based on real-time demand, allowing them to optimize costs while maintaining flexibility. The platform also handles infrastructure management, including system maintenance, updates, and security, reducing the operational burden on clients. Supported by stable computing architecture and monitoring systems, the service is designed to deliver reliable performance for demanding workloads such as AI model training and large-scale data processing, with continuous technical support available to ensure smooth operations.

The rapid growth of large-scale AI models has significantly increased global demand for computing power, with training processes often requiring extensive resources and long-term investment. This trend has created a gap between companies with access to advanced infrastructure and those without. Digital Smart AI’s shared computing approach offers a practical alternative by making high-performance GPU resources more accessible, enabling startups and enterprises alike to participate in AI innovation without the need for significant upfront investment. By lowering barriers to entry, the platform supports faster experimentation, shorter development cycles, and more efficient scaling of AI applications.

Digital Smart AI positions itself as a technology provider focused on delivering accessible AI infrastructure and solutions for modern businesses. By combining scalable computing resources with user-oriented AI tools, the company aims to support organizations in navigating the evolving AI landscape and unlocking new opportunities for growth and innovation.

Media Contact

Organization: Digital Smart – AI

Contact Person: DARRYL JOEL DORFMAN

Website: https://www.ai-digitalsmart.com/

Email: Send Email

Country:United States

Release id:43963

The post Digital Smart AI Launches Scalable AI Solutions and GPU Rental Platform for Global Businesses appeared first on King Newswire. This content is provided by a third-party source.. King Newswire makes no warranties or representations in connection with it. King Newswire is a press release distribution agency and does not endorse or verify the claims made in this release. If you have any complaints or copyright concerns related to this article, please contact the company listed in the ‘Media Contact’ section

file

About Author

Cloud PR Wire

See author's posts

Disclaimer: The views, suggestions, and opinions expressed here are the sole responsibility of the experts. No Digi Observer journalist was involved in the writing and production of this article.

Continue Reading

Press Release

Outdoor Renovations Expands Dedicated Landscape Services to 10 Austin-Area Communities

Published

2 hours ago

on

April 13, 2026

By

Austin landscape contractor Outdoor Renovations extends full-service design, build, and maintenance capabilities to ten Central Texas residential communities after completing more than 200 projects.

Austin, Texas, United States, 13th Apr 2026 — Outdoor Renovations, a licensed landscape contractor serving the greater Austin metro area, has expanded its dedicated design, build, and maintenance services to ten of Central Texas’s most established residential communities. The expansion establishes a comprehensive landscape contracting presence in Westlake Hills, Lakeway, Bee Cave, Dripping Springs, Tarrytown, Barton Creek, Rollingwood, Steiner Ranch, Circle C Ranch, and Travis Heights.

Founded in 2022 by Licensed Landscape Contractor Kyle Stoutenger, who brings more than 16 years of hands-on experience in the Central Texas trades, Outdoor Renovations has completed more than 200 residential and commercial projects across the Austin metro area. The company maintains a 99 percent client satisfaction rate and provides a one-year service guarantee on all completed work.

Eight Landscape Services Under One Roof

The expansion brings the full scope of Outdoor Renovations’ capabilities to each of the ten communities. The firm provides custom landscape design with to-scale 2D plans and photorealistic 3D renderings, professional hardscaping including patios, retaining walls, outdoor kitchens, and fire features, custom carpentry for pergolas, decks, fences, and privacy screens, expert softscaping and planting with species selected for Central Texas conditions, smart irrigation and drainage systems engineered for local water conservation requirements, professional landscape lighting, custom metal fabrication for gates, fences, and architectural elements, and property and pest management programs from weekly maintenance to all-inclusive concierge service.

All services are managed through a single point of contact from initial consultation through construction and ongoing property care. More information about each service is available at https://outdoorreno.com/services.

Local Expertise Across Ten Austin Communities

Each service area community presents distinct landscape challenges and opportunities that inform the design and construction approach.

Westlake Hills properties sit on steep limestone terrain with mature live oak canopies and stringent city ordinances. Lakeway’s lakeside community centers on outdoor entertaining spaces that complement Lake Travis and golf course views. Bee Cave’s rapidly growing Hill Country Galleria corridor presents opportunities to elevate builder-grade landscapes on newly developed lots. Dripping Springs, the gateway to Hill Country wine country, features expansive ranch properties across diverse terrain.

Tarrytown’s historic neighborhood requires landscape contractors familiar with heritage tree preservation and the area’s established mid-century character. Barton Creek’s estates along the Edwards Aquifer recharge zone demand specialized knowledge of watershed protection and fractured limestone soil conditions. Rollingwood’s generous lots near Zilker Park are well suited for comprehensive outdoor living installations.

Steiner Ranch’s master-planned community requires designs that satisfy HOA architectural review while maximizing Hill Country views. Circle C Ranch homeowners benefit from landscapes that integrate with the community’s extensive trail system and Slaughter Creek nature preserve. Travis Heights’ compact urban lots near South Congress call for vertical layering, multi-functional spaces, and creative hardscaping solutions.

A complete list of service areas and community-specific information is available at https://outdoorreno.com/locations.

Commitment to Central Texas Conditions

Stoutenger noted that the expansion reflects accumulated expertise specific to the region’s demands.

“Every community has its own soil conditions, terrain challenges, water requirements, and permitting considerations,” said Kyle Stoutenger, owner of Outdoor Renovations. “With more than 16 years in the trades, I know what materials perform in Central Texas heat, which plant species establish reliably, and how to engineer outdoor spaces that hold up to drought, storms, and the alkaline limestone soils that define the Hill Country. That depth of local knowledge is built into every project.”

Outdoor Renovations is a Licensed Landscape Contractor, fully bonded and insured. Complimentary on-site consultations are available for residential and commercial properties across the Austin metro area. Additional project information and service details can be found at https://outdoorreno.com.

Media Contact

Organization: Outdoor Renovations

Contact Person: Kyle Stoutenger

Website: https://www.outdoorreno.com

Email:
kyle@outdoorreno.com

City: Austin

State: Texas

Country:United States

Release id:43954

The post Outdoor Renovations Expands Dedicated Landscape Services to 10 Austin-Area Communities appeared first on King Newswire. This content is provided by a third-party source.. King Newswire makes no warranties or representations in connection with it. King Newswire is a press release distribution agency and does not endorse or verify the claims made in this release. If you have any complaints or copyright concerns related to this article, please contact the company listed in the ‘Media Contact’ section

file

About Author

Cloud PR Wire

See author's posts

Disclaimer: The views, suggestions, and opinions expressed here are the sole responsibility of the experts. No Digi Observer journalist was involved in the writing and production of this article.

Continue Reading

LATEST POST

Like Us
Follow Us
Subscribe Us
Follow Us