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

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2 years ago

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–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.

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Benzinga

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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

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Press Release

BiFinance Lists EVOCARE-USDT and Launches Trading Competition with Exclusive Rewards

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27 minutes ago

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March 19, 2026

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BiFinance, a leading Web3 digital asset trading platform, has officially announced the listing of EVOCARE (EVOCARE) and the launch of a dedicated trading competition, offering users multiple participation opportunities and enhanced engagement.

EVOCARE Officially Listed on BiFinance

According to the official announcement, BiFinance has listed the EVOCARE USDT trading pair, with deposit and trading services opened on March 12, 2026.

EVOCARE represents an innovative Web3 healthcare initiative focused on building a digital therapy ecosystem. As The World Therapy Store, EvoCare aims to connect patients, therapists, and healthcare creators through a scalable and compliant infrastructure, integrating real-world medical services with blockchain technology and bringing real-world utility into the Web3 space.

The platform combines regulated healthcare services with Web3 utility infrastructure, creating a scalable global ecosystem for therapy, rehabilitation, and digital health services. EvoCare is designed to enable German-quality therapeutic care to be delivered anywhere in the world through a clinically supervised digital healthcare platform.

Official Website:

https://evocare.healthcare

The EVOCARE token serves as the core of the ecosystem, supporting:

Digital therapy service payments

Creator support mechanisms

Access to regulated healthcare solutions

By linking real healthcare demand with tokenized utility, EVOCARE creates a sustainable and value-driven ecosystem backed by real-world applications.

Trading Competition Now Live with Trading Competition Details

To celebrate the listing, BiFinance has launched the EVOCARE Trading Competition, allowing users to trade EVOCARE USDT and compete for benefits.

Participants can:

Trade EVOCARE USDT to climb leaderboard rankings

Receive benefits based on trading performance

Unlock additional advantages such as trading additional benefits

The competition is designed to encourage active participation while benefiting both new and experienced traders.

Expanding the RWA and Utility-Driven Ecosystem

The listing of EVOCARE reflects BiFinance’s continued commitment to supporting projects with real-world utility and strong growth potential. By bridging traditional sectors such as healthcare with blockchain infrastructure, BiFinance further strengthens its “virtual + real” ecosystem strategy.

Through ongoing listings, trading campaigns, and ecosystem collaboration, BiFinance aims to provide users with:

High-quality asset access

Enhanced trading opportunities

A more diversified and utility-driven Web3 experience

About BiFinance

BiFinance is a Web3 digital asset trading platform focused on the integration of Real-World Assets (RWA) and blockchain technology. The platform is committed to building a secure, compliant, and scalable financial ecosystem, connecting traditional finance with the decentralized world.

With a growing global presence and continuous innovation in both product and ecosystem design, BiFinance is accelerating the evolution of digital finance through its “Bi+Finance” model.

Media Contact

Organization: BiFinance

Contact Person: Ben

Website: https://www.bifinance.com

Email:
listing@BiFinance.com

Country:Canada

Release id:42777

The post BiFinance Lists EVOCARE-USDT and Launches Trading Competition with Exclusive Rewards 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

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Press Release

Advanced Strapless Goalkeeper Gloves Officially Released, Available at Just Keepers

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27 minutes ago

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March 19, 2026

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Hinckley, Leicestershire, United Kingdom, 19th Mar 2026 – Just Keepers has added advanced strapless goalkeeper gloves to its selection, reflecting growing interest in strap-free designs within the goalkeeping community.

The Goalkeeper gloves feature a slip-on construction, removing the need for a traditional wrist strap and offering a clean, streamlined fit. This design approach aligns with the preferences of goalkeepers seeking simplicity and a more natural feel during play.

With a reduced structure around the wrist, the gloves are suited for both training and match environments, supporting comfort and ease of movement on the pitch.

Strapless gloves are becoming an increasingly talked-about option among goalkeepers. Their inclusion reflects the shift towards more simplified designs in modern goalkeeping gear.

The addition highlights ongoing changes in goalkeeper equipment, as players continue to explore new styles and fits that suit their individual preferences.

For more information
https://www.just-keepers.com/goalkeeper-gloves/goalie-gloves/reusch-gk-gloves/

About Just Keepers Ltd

Just Keepers is a dedicated retailer specialising exclusively in goalkeeping equipment, offering a curated selection tailored to the specific needs of the position. Its range covers goalkeeper gloves, technical clothing, and essential accessories suited for both training sessions and competitive matches. Catering to players at every level, from beginners to professionals, the company focuses on purpose-built gear, durability, and consistent performance across its lineup.

Media Contact

Organization: Just Keepers Ltd

Contact Person: Just Keepers Ltd

Website: https://www.just-keepers.com/

Email: Send Email

City: Hinckley, Leicestershire

Country:United Kingdom

Release id:42820

The post Advanced Strapless Goalkeeper Gloves Officially Released, Available at Just Keepers 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

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Press Release

Macmillan Lawyers and Advisors Supports Brisbane Businesses with Strategic Legal Advisory Services

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57 minutes ago

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March 19, 2026

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Australia, 19th Mar 2026 – Macmillan Lawyers and Advisors, a respected Brisbane-based commercial law firm, has strengthened its strategic legal advisory services to support businesses across Brisbane navigating complex commercial and regulatory environments. The firm provides guidance to organisations at various stages of development, including business establishment, dispute resolution, and financial restructuring.

Operating from Level 38, 71 Eagle Street in Brisbane City, Macmillan Lawyers and Advisors works with businesses ranging from emerging enterprises to established companies. Legal advice is designed to assist organisations managing contractual obligations, regulatory compliance requirements, and operational challenges.

Across Australia, businesses continue to face evolving regulations, economic pressures, and changing market conditions. These developments have increased demand for legal advisory services that help organisations identify risks and address complex legal matters early.

Macmillan Lawyers and Advisors provides services across several areas of commercial law, including contract law, commercial disputes, intellectual property protection, bankruptcy and insolvency matters, liquidation processes, and turnaround strategies. Legal support focuses on helping businesses understand their legal responsibilities while developing practical approaches to commercial challenges.

Kyle Macmillan, Principal of Macmillan Lawyers and Advisors, said strategic legal guidance plays an important role for businesses operating in a changing commercial environment.

“Businesses across Brisbane are navigating an environment that requires careful legal and strategic planning,” said Macmillan. “Access to experienced legal advisory services assists organisations in addressing disputes, contractual obligations, and financial restructuring matters in a structured and informed manner.”

The firm provides legal support throughout different stages of the corporate lifecycle. Early-stage assistance includes advice on company establishment, governance structures, shareholder agreements, and intellectual property protection. For established organisations, services often involve dispute resolution, contract negotiation, and regulatory compliance guidance.

Macmillan Lawyers and Advisors also advises businesses experiencing financial difficulty or operational restructuring. Legal support in insolvency, bankruptcy, and turnaround planning helps organisations understand available legal options and obligations during periods of financial stress.

Industry professionals note that early legal guidance can assist businesses in managing disputes and addressing potential financial challenges before problems escalate. Strategic legal planning is increasingly viewed as an important component of responsible corporate governance and long-term stability.

Macmillan noted that ongoing changes within regulatory environments highlight the importance of consistent legal insight.

“Changes within regulatory environments and market conditions highlight the importance of ongoing legal insight for businesses,” Macmillan said. “Strategic advisory services will continue to support organisations as they adapt to future challenges while maintaining compliance and operational resilience.”

For media enquiries, Macmillan Lawyers and Advisors, a business lawyer Brisbane firm providing commercial legal services to organisations across Queensland, can be contacted at Level 38, 71 Eagle Street, Brisbane City QLD 4000. Enquiries may be directed by phone on (07) 3518 8030 or via email at admin@macmillan.law.

Media Contact

Organization: Macmillan Lawyers and Advisors

Contact Person: Kyle Macmillan

Website: https://macmillan.law/

Email: Send Email

Contact Number: +61735188030

Address:Level 38/71 Eagle St

Address 2: Brisbane City QLD 4000

Country:Australia

Release id:42813

The post Macmillan Lawyers and Advisors Supports Brisbane Businesses with Strategic Legal Advisory Services 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

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