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

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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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Press Release

Strategic Alliance Targets Growth in Audio-Driven Media

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New Media FF & Emmy Nominee David Leon Launch Music Curation for Media—Driving Growth & Engagement Across High-Impact Creative Segments

Los Angeles, CA — Crafting the Score of Tomorrow: Emmy Nominee David Leon & New Media Film Festival Launch Music Curation for Media.  In a dynamic new collaboration, New Media Film Festival® and EMMY®-nominated music supervisor David Leon unveil Music Curation for Media—a category dedicated to the power of sound in storytelling. This initiative is designed to support creators in finding the perfect musical match for their projects, from short films to branded content.

New Media Film Festival® has long been a champion of innovation and empowerment, spotlighting creators working in classic media and being the forefront of technology in media. Now with music curation added to its roster, the festival continues its mission to elevate emerging formats and visionary voices.

“Brief. Curate. Review. Sync. Done.” Your soundtrack to storytelling starts here. newmediafestival.gumroad.com/l/mediacuration

Jamie Adler,  Nagin Cox, Ava Della Pietra, Pam Hurst Della Pietra, 2 X Emmy Winner Doug Leighton, Travis Gemoets, Media Futurist Susan Johnston, Emmy Nominee & CEO David Leon, 10 X Telly Winner Randy Bellous & Int’l Jazz Artist Irina Maleeva. Credit Jomel Fragante.

Hear the perfect match

 The Music Curation Workflow

Submit Brief – Share your project’s vision and musical needs.

Curate Music – EMMY Nominee David Leon identifies tracks that align creatively and financially.

 

Discover the true connection

Review & Budget Match – Collaborate to finalize selections and negotiate licensing.

Formalize Licensing – Sync license templates and expert support ensure smooth execution.

 

 Why Music Curation for Media Matters

In today’s content-saturated world, music isn’t just background—it’s narrative. The right track can elevate emotion, define brand identity, and transform a scene from forgettable to unforgettable. Music curation for media ensures that every beat is intentional, every transition seamless, and every story amplified through sound. It’s a creative discipline that blends instinct, strategy, and deep musical knowledge—especially vital for filmmakers, advertisers, and digital storytellers navigating tight timelines and complex licensing landscapes. This isn’t playlist-making—it’s precision storytelling through sound. David’s deep experience in score production, rights and clearances, and the festival’s extensive music capabilities ensures that every beat serves the story.

“With experience in rights and clearances, score production, and festival navigation, David brings both creative and strategic firepower to our team. We’re proud to partner with David in this exciting new chapter.” Susan Johnston – Founder/Director New Media Film Festival®

 

David Leon: The Force Behind the Sound

In his music career, David has held senior leadership roles across top-tier organizations in aerospace, entertainment, and broadcast music—bringing a wealth of experience from globally recognized institutions., David Leon brings unmatched creative and strategic firepower to this initiative. His work has shaped iconic media moments, and now he’s helping creators do the same.Beyond the studio, David is a sought-after speaker and educator, with appearances at TEDx, San Diego Comic-Con, and major industry panels. His passion for empowering storytellers through music makes him the ideal partner for this visionary collaboration.

 

About New Media Film Festival®: Since the festivals 2009 inception, Honoring Stories worth Telling has been New Media Film Festival® s mandate. As the 1st Major Festival celebrating innovation, story, mediums & platforms, New Media Film Festival® has led the way in the pursuit of stories worth telling, the exploration of new media technologies, boundary pushing resulting in new distribution models and creating and establishing new methodologies in the global monetization of content. The New Media Film Festival® embodies the transformative power of the cinematic arts and it reaches across cultural bridges to wed story and technology for everyone.

The festival is designed to both discover and cultivate highly creative work from emerging and seasoned content creators. Judges at the New Media Film Festival® include representatives from HBO, BBC, PBS, Marvel, the Academy of Motion Picture Arts and Sciences, the Television Academy, and other pioneers in the entertainment industry. Filmmakers vie for a chance at priceless awards. including a one on one meeting with Marvel or HBO, Studio time, Post and more. Accepted Filmmakers will benefit from a Red Carpet Press Junket, VIP Soiree, networking, international art exhibit, Q&A’s, and much more. www.newmediafilmfestival.com

 

 

 

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The post Strategic Alliance Targets Growth in Audio-Driven Media 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

Emerging Base Ecosystem Token MONK Gains Traction with Community-Led Airdrops and Staking

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A new memecoin titled MONK, built on the Base network, is quickly gaining momentum through an ecosystem that merges meme culture with active utility. The token, themed around a blue monkey character, has generated attention through consistent airdrop programs, staking incentives, and a growing cross-project strategy involving its partner token, DORGO.

Unlike many ephemeral meme tokens, MONK is structured with an emphasis on user participation. It features:

  •    3% buy/sell fees directed toward sustainability
  •    Liquidity staking rewards via a custom LP farm
  •    Airdrops to token holders and ecosystem participants
  •    A future roadmap involving NFT integrations and Base-native collaborations

The project has positioned itself as part of a broader narrative on Base, embracing memetic storytelling while introducing on-chain mechanics typically seen in more utility-based assets.

Recent activity includes:

  •    Weekly airdrop campaigns distributed to LP stakers and holders
  •    A meme contest designed to expand social visibility across platforms like X (Twitter) and Telegram
  •    A DAO structure planned under its partner project DORGO, with future governance tie-ins anticipated

With consistent on-chain volume, organic community engagement, and integrations into Base’s growing DeFi landscape, MONK is beginning to establish itself as more than a typical meme token instead acting as a social anchor in a developing network of interlinked projects.

   For media inquiries or listing-related questions, the team can be reached via their official site: www.monkisbased.com or contact@monkisbased.com via email.
Marketing Partner: crmoonboy (crmoon)

Socials:

Telegram: https://t.me/monkisbased

X/Twitter: https://x.com/monkisbased

 

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The post Emerging Base Ecosystem Token MONK Gains Traction with Community-Led Airdrops and Staking 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

BoostARA Transforming the Global Sports Industry Through Web3 and Computing Power Incentives

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BoostARA: Transforming the Global Sports Industry Through Web3 and Computing Power Incentives

With the global sports industry valued at over USD 600 billion and rapidly shifting toward digital and decentralized models, the market is entering a historic window for disruption and value creation.

As global audiences accelerate their migration to Web3, the sports industry is undergoing an unprecedented digital transformation. BoostARA emerges as the world’s first protocol to integrate “Web3 Sports × Computing Power Incentives,” reshaping the perception of sports value and establishing a new, on-chain sports economy.

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Guided by its core philosophy — “Exercise as Rights, Data as Assets, Participation as Value” — BoostARA is building a Web3-powered network defined by multi-dimensional participation, decentralized governance, and continuous community-driven incentives.

A. Dual Growth Engines: Technology and Mechanism Innovation

Unlike traditional Move-to-Earn (M2E) models, BoostARA introduces an innovative combination of on-chain incentives and computing power economics. Through mechanisms such as Base Computing Power + Referral Incentives + Tiered Team Computing Power, the platform achieves viral user growth and optimized reward distribution.

Leveraging AI recognition, oracle verification, and smart contracts, sports activities — including running, cycling, and ball games — are verified in real time and converted into on-chain assets, creating a closed-loop value cycle where exercise becomes assets.

BoostARA also implements a dual-layer DAO governance model, giving users direct influence over ecosystem development — from operational decisions and event arrangements to NFT issuance and virtual club management — ensuring a decentralized, community-built sports economy.

B. Multi-Layered Incentives Driving Sustainable Growth

To drive adoption and long-term engagement, BoostARA has designed a comprehensive reward framework covering:

– Static computing power mining

– Dynamic referral incentives

– Node dividends

– Tiered team-based bonuses

The platform’s native token, ARA, underpins this incentive model. Its economic framework incorporates:

– Daily emission reduction

– Transaction slippage control

– Liquidity pool dividends

– Token burning mechanisms

This model ensures healthy token circulation and a long-term deflationary trend.

Token Economics (Total Supply: 300 billion ARA):

– Mining Output: 295 billion

– Market Incentives: 3 billion

– Market Control: 1 billion

– Initial Liquidity: 1 billion

C. An Integrated Web3 Sports Ecosystem

Built on four core pillars — On-chain Sports × NFTs × Community Governance × Token Incentives — BoostARA’s ecosystem includes:

– BoostMove — On-chain sports data recognition

– BoostCard — NFT sports star cards

– BoostDAO — Governance and voting infrastructure

– BoostVault — Computing power incentive pool

Together, these components form a complete value chain, from activity tracking and asset creation to governance participation and reward distribution.

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D. Strategic Partnerships

BoostARA collaborates with:

– Global sports organizations and clubs from Europe’s top five leagues

– BOOSTARA Investment Group

– Sports platforms such as 188 Sports and SABA Sports

– Web3 infrastructure and AI providers including BSC, TokenPocket, Feixiaohao, MetaMask, DeepSeek, Chainlink, and OpenAI API partners.

E. A New Paradigm for Sports Value

BoostARA is more than a technological innovation — it is a digital renaissance of sportsmanship. Through blockchain and decentralized governance, BoostARA ensures that the passion and dedication of every athlete and fan are recognized and rewarded.

As the global sports industry enters a new era of digitization, tokenization, and collaborative governance, BoostARA — powered by technology and community — aims to redefine sports value and co-create the future of the digital sports economy.

Media Contact

Organization: BoostARA Public Relations

Contact Person: Lukas Wike

Website: https://www.boostara.io

Email: Send Email

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The post BoostARA Transforming the Global Sports Industry Through Web3 and Computing Power Incentives 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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