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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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KeyCrew Media Selects ACME Real Estate as Verified Expert for Boutique Brokerage Operations, and LA Market Expertise

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KeyCrew Media, a real estate analytics and media network, has selected Courtney Poulos and her team at ACME Real Estate as a KeyCrew Verified Expert.

LOS ANGELES, CA, December 12, 2025 — KeyCrew Media, a real estate analytics and media network, has selected Courtney Poulos and her team at  ACME Real Estate as a KeyCrew Verified Expert. The boutique Los Angeles brokerage will contribute specialized insights on renovation-resale strategy, boutique brokerage operations, and LA market dynamics.

KeyCrew Verified Experts are carefully selected as prolific market trend authorities who demonstrate exceptional insight and expertise in their fields. These distinguished professionals and companies regularly contribute market insights, expert perspectives, and forward-looking analysis to help audiences navigate complex industry landscapes.

Founded in 2011 by Broker/Owner Courtney Poulos, ACME Real Estate has established itself as a premier boutique brokerage specializing in renovation-resale projects across Los Angeles. Operating in what Poulos calls “the NFL of real estate,” ACME has built its reputation on comprehensive agent training, ethical accountability, and exceptional client experiences without the backing of international capital funding.

ACME Real Estate offers a distinctive “one-stop shop” approach for real estate investors and renovation-resale specialists. The brokerage provides full-spectrum support from acquisition—including deal analysis and cost-benefit evaluation—through in-house design services at any price point, sophisticated appraisal packaging, and premium marketing. With 35 agents completing 178 transaction sides totaling $155 million in sales volume over the past 12 months, ACME has proven that boutique brokerages can compete against corporate giants through superior training and service.

“We’re honored that ACME Real Estate has been selected as a KeyCrew Verified Expert,” said Courtney Poulos, Broker/Owner. “We built ACME to fill a gap in the market—highly trained agents who the public can trust, comprehensive support for renovation-resale investors, and a commitment to quality over scale. This recognition validates what our clients already know: sometimes the underdogs deliver the highest quality service.”

ACME Real Estate’s areas of expertise include:

  • Renovation-Resale Strategy – Comprehensive acquisition analysis, cost estimation, design consultation, and resale marketing for investors
  • Boutique Brokerage Operations – Building and scaling quality-focused independent brokerages in competitive markets
  • Los Angeles Market Dynamics – Deep expertise in LA neighborhoods, market trends, and investment opportunities
  • Agent Training & Development – Mastery-based training programs emphasizing contract expertise and client psychology
  • Premium Property Marketing – High-end photography, printed materials, and strategic positioning for maximum market performance

About ACME Real Estate

ACME Real Estate is a boutique independent brokerage founded in 2011 and based in Los Angeles. With 35 agents and 178 transaction sides totaling $155 million in sales volume over the past 12 months, ACME specializes in renovation-resale projects and provides comprehensive support from acquisition through marketing and sale. The brokerage offers in-house design services at any price point, sophisticated appraisal packaging, and premium marketing execution. ACME serves both real estate investors and traditional buyers and sellers with what Broker/Owner Courtney Poulos describes as “the most concierge, attentive, well-trained group of underdogs you could ever have behind you.” Website: https://acmeflorida.com/

About KeyCrew Media

KeyCrew Media is the next generation real estate intelligence platform that leverages AI-powered analytics and first-person reporting from verified experts to produce forward-looking insights across local markets and niche asset classes. Proprietary market reporting is delivered through KeyCrew’s growing portfolio of niche media properties—including KeyCrew Journal, NextAsset News, and other specialized publications—as well as selectively syndicated to media partners that influence industry decision-makers. Learn more at keycrew.co

Media Contact

Organization: KeyCrew Media

Contact Person: Heather Hook

Website: https://www.keycrew.co

Email: Send Email

City: Baltimore

State: Maryland

Country:United States

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The post KeyCrew Media Selects ACME Real Estate as Verified Expert for Boutique Brokerage Operations, and LA Market Expertise 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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KeyCrew Media Selects Brooke Pfautz as Verified Expert for Vacation Rental Management and Property Technology

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KeyCrew Media, a real estate analytics and media network, has selected Brooke Pfautz, CEO and Founder of Vintory, as a KeyCrew Verified Expert.

NATIONWIDE, December 12, 2025 KeyCrew Media, a real estate analytics and media network, has selected Brooke Pfautz, CEO and Founder of Vintory, as a KeyCrew Verified Expert. Pfautz will contribute data-driven analysis on vacation rental management, property technology innovation, and industry consolidation trends.

KeyCrew Verified Experts are carefully selected as prolific market trend authorities who demonstrate exceptional insight and expertise in their fields. These distinguished professionals regularly contribute market insights, expert perspectives, and forward-looking analysis to help audiences navigate complex industry landscapes.

Brooke Pfautz brings unparalleled expertise to the vacation rental management sector, having helped over 950 companies scale their portfolios through strategic growth initiatives. As founder of both Vintory and Comparent, Pfautz has established herself as a leading voice on data-driven property acquisition, AI integration in hospitality operations, and market consolidation dynamics. Her work encompasses the largest database of vacation rental homeowners globally and the industry’s first comprehensive ranking system through the Comparent 100.

With 18 years of experience in the short-term rental industry, Pfautz successfully scaled Vantage Realty to over 500 properties before its acquisition. She has since focused on revolutionizing how professional vacation rental managers approach growth through Vintory’s data and marketing platform, which aggregates information from over 10 sources to create what she calls “stacked data architecture” — a proprietary approach that provides unprecedented accuracy in homeowner targeting.

Pfautz’s insights on artificial intelligence adoption have positioned her as a forward-thinking industry authority. She advocates that property managers not implementing AI-native tools by 2026 risk competitive obsolescence, emphasizing that data capture — particularly call recordings and guest communications — represents the critical intellectual property that will differentiate winners in an increasingly AI-driven marketplace.

“I’m honored to be selected as a KeyCrew Verified Expert,” said Brooke Pfautz. “The vacation rental management industry is at a pivotal moment where data quality and AI adoption will separate thriving companies from those left behind. Having helped nearly 1,000 companies with their growth strategies, I’ve seen firsthand how the right data and technology stack can transform a mid-sized operator into a market leader. I’m excited to share insights that help property managers navigate consolidation pressures, leverage their unique data assets, and position themselves strategically whether they’re scaling independently or preparing for acquisition.”

Pfautz’s areas of expertise include:

  • Vacation Rental Management Growth Strategies — Proven frameworks for inventory acquisition and scaling beyond 10 million in gross bookings
  • Property Technology & AI Integration — Strategic guidance on AI-native tools, data architecture, and competitive positioning
  • Market Consolidation & M&A Dynamics — Insights on institutional capital trends, acquisition metrics, and positioning for exit
  • Homeowner Data & Marketing Analytics — Expertise in multi-source data aggregation, targeting precision, and marketing ROI optimization

About Vintory

Vintory is a data, sales, and marketing platform that helps professional vacation rental managers grow their inventory through the world’s largest database of vacation rental homeowners. The platform combines proprietary stacked data architecture with tech-enabled marketing services, building targeted campaigns that drive qualified leads through custom CRM and automation systems. Vintory has supported over 950 property management companies with strategic growth initiatives. Website: www.vintory.com

About KeyCrew Media

KeyCrew Media is the next generation real estate intelligence platform that leverages AI-powered analytics and first-person reporting from verified experts to produce forward-looking insights across local markets and niche asset classes. Proprietary market reporting is delivered through KeyCrew’s growing portfolio of niche media properties — including KeyCrew Journal, NextAsset News, and other specialized publications — as well as selectively syndicated to media partners that influence industry decision-makers. Learn more at keycrew.co

Media Contact

Organization: KeyCrew Media

Contact Person: Heather Hook

Website: https://www.keycrew.co

Email: Send Email

City: Baltimore

State: Maryland

Country:United States

Release id:39013

The post KeyCrew Media Selects Brooke Pfautz as Verified Expert for Vacation Rental Management and Property Technology 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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KLOTA Launches Two Free Analysis Tools to Help E-Commerce Brands Improve Search and AI Visibility

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Sweden, 13th Dec 2025 – KLOTA AB, a Sweden-based digital performance and SEO consultancy, has announced the launch of two new free analysis tools designed specifically for serious e-commerce companies seeking stronger visibility, better performance, and clearer insights across search engines and AI-driven platforms. The newly released tools—the AI Visibility Analyzer and the Shopping Feed Analyzer—are currently available as free BETA services and deliver actionable results within approximately 10 minutes via email.

As search behavior rapidly evolves, e-commerce brands are no longer competing only for traditional Google rankings. Increasingly, consumers are discovering products and brands through AI-powered assistants such as ChatGPT, Claude, Perplexity, and Gemini. KLOTA’s new tools are built to address this shift, providing practical diagnostics that help online retailers understand where they stand and what to fix.

The AI Visibility Analyzer focuses on how well a website is seen, accessed, and understood by modern AI search engines and large language models. The tool evaluates critical factors such as AI-bot accessibility (including robots.txt and llms.txt), content clarity and readability, structured data, and core technical SEO elements. Based on this analysis, it generates an easy-to-understand AI Visibility Score ranging from 0 to 100, along with clear, prioritized recommendations that highlight the most impactful improvements.

“This is about helping companies prepare for the next generation of search,” said Anders Karlsson, Contact at KLOTA AB. “Many e-commerce brands are still optimizing only for classic search results, while AI assistants are already shaping how users discover information and products. The AI Visibility Analyzer makes this new landscape measurable and actionable.”

The second tool, the Shopping Feed Analyzer (Google Shopping Feed Analyzer ), is designed for e-commerce businesses actively running Google Shopping and Performance Max (PMax) campaigns. Poor feed quality is a common reason for disapproved products, limited reach, and underperforming ads. KLOTA’s tool performs an automated quality audit of a Google Shopping product feed , reviewing required attributes, product titles and descriptions, pricing accuracy, images, Google product categories, and overall compliance with Google’s specifications.

After the audit, users receive a detailed PDF report that includes an executive summary and a prioritized action list. This enables marketing and e-commerce teams to quickly identify errors, resolve disapprovals, and systematically improve feed quality for better campaign performance.

“Most feed issues are not strategic—they’re technical and fixable,” Karlsson added. “The challenge is knowing exactly where the problems are and what to address first. The Shopping Feed Analyzer removes that guesswork and gives teams a clear roadmap.”

Both tools are offered as free BETA services, reflecting KLOTA’s commitment to sharing expertise and helping e-commerce brands adapt to a more complex digital ecosystem. Once a website URL or product feed is submitted, the analysis is processed automatically and sent by email in about 10 minutes, making the tools accessible even for busy teams with limited technical resources.

While some information within the tools may be presented in English, the insights are designed to be universally applicable for international e-commerce brands aiming to compete more effectively in search, paid media, and AI-driven discovery.

With the launch of these tools, KLOTA reinforces its position as a forward-looking partner for e-commerce growth—bridging traditional SEO, paid shopping performance, and the emerging world of AI visibility.

For more information visit https://www.klota.se .

About KLOTA AB
KLOTA AB is a Sweden-based digital consultancy specializing in SEO, e-commerce optimization, and data-driven performance strategies. The company works with ambitious brands that want to improve visibility, traffic quality, and revenue across search engines, advertising platforms, and AI-powered discovery channels.

Media Contact

Organization: KLOTA AB

Contact Person: Anders Karlsson

Website: https://www.klota.se/

Email: Send Email

Address:Katrinedalsgatan 13A 504 51 BORÅS Sweden

Country:Sweden

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The post KLOTA Launches Two Free Analysis Tools to Help E-Commerce Brands Improve Search and AI Visibility 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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