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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

Galatea by Inkitt Celebrates 100+ Five-Star Reviews Amid Rising Popularity

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California, USA, 3rd May 2026, ZEX PR WIRE  Galatea, the rapidly growing digital reading platform developed by Inkitt, has surpassed 100 five-star reviews, marking a significant milestone in its continued rise among global readers. The achievement highlights strong user satisfaction and reinforces Galatea’s position as more than just a reading app. As part of Inkitt’s broader story-to-screen ecosystem, Galatea plays a central role in transforming reader-driven content into multi-format entertainment, extending all the way to television through CandyJar.

This milestone arrives at a time when audiences are actively seeking more flexible and engaging ways to consume stories. Galatea has responded by offering a format that aligns with modern habits while still preserving the emotional depth that readers expect from strong storytelling.

A Milestone That Reflects Real Reader Loyalty

Reaching over 100 five-star reviews signals more than short-term success. It reflects consistent reader satisfaction and an ability to maintain engagement over time. Users frequently highlight how seamlessly the platform fits into their daily routines, whether they are reading during short breaks, while commuting, or winding down at night.

This accessibility has helped Galatea build a loyal user base. Readers are not simply downloading the app and leaving. They return regularly to continue stories, explore new releases, and stay connected to ongoing narratives. The growing number of five-star reviews demonstrates that users are finding lasting value in the experience.

In an environment where attention is divided across multiple platforms, this level of retention is notable. Galatea has managed to create a product that readers continue to engage with long after their first interaction.

A Reading Experience Designed for Modern Habits

Galatea has built its platform around the idea that reading should adapt to the reader. Instead of presenting long chapters that require uninterrupted time, the platform delivers stories in episodic segments that are easy to consume. This structure makes reading more approachable and encourages consistent engagement.

The platform also offers multiple formats within a single story. Readers can move seamlessly between ebook and audiobook modes, allowing them to switch based on their situation. In addition, Galatea includes chat-style storytelling, where narratives unfold through text-message-like conversations. This format introduces variety and reflects how people naturally communicate today.

Audio is another defining feature of the platform. Full narration and carefully designed sound elements support the storytelling experience and add depth to each scene. Rather than acting as a background feature, audio plays an active role in shaping how stories are experienced.

Together, these features create a reading environment that feels flexible, engaging, and suited to modern lifestyles.

A Story-to-Screen Pipeline That Sets It Apart

Galatea’s growth is closely tied to Inkitt’s larger story-to-screen model, which differentiates it from traditional reading platforms. The process begins on Inkitt, where writers share their work and reader engagement determines which stories gain traction. The most promising titles are then published on Galatea, where they reach a wider audience in enhanced formats.

From there, the most successful stories move into television development on CandyJar. This structured pipeline allows content to evolve naturally, moving from written storytelling to screen adaptation based on proven audience demand.

This model offers a clear pathway for writers. Instead of navigating uncertain publishing routes, authors can see their work progress step by step, guided by reader response. It also ensures that the stories adapted for television already have a built-in audience, reducing risk and increasing the likelihood of success.

For readers, the pipeline adds another layer of engagement. Stories they discover on Galatea have the potential to expand into visual formats, creating a deeper connection to the content. This continuity strengthens the overall experience and sets the platform apart in a crowded market.

Content That Reflects What Readers Actually Want

Galatea’s content strategy is built on real user behavior. By leveraging data from Inkitt, the platform identifies stories that already resonate with readers. This ensures that the content available on Galatea aligns closely with audience preferences.

Genres such as romance, fantasy, thriller, drama, and Young Adult continue to perform strongly, reflecting consistent demand across a wide range of readers. At the same time, the platform introduces new voices and perspectives, maintaining a balance between familiar themes and fresh ideas.

This approach reduces the uncertainty often associated with content selection. Instead of relying on predictions, Galatea uses measurable engagement to guide its decisions. The result is a library that feels both curated and relevant.

For writers, this system creates meaningful opportunities. Success is determined by reader response, allowing emerging authors to gain visibility and build an audience based on the strength of their work.

Listening to Feedback and Improving the Experience

The increase in five-star reviews also reflects Galatea’s responsiveness to its users. Feedback plays a direct role in shaping the platform’s development. Readers frequently mention features such as customizable settings, smooth navigation, and the ability to switch between formats without interruption.

These elements contribute to a user-friendly experience that appeals to a broad audience. Small improvements, driven by real feedback, continue to enhance the platform’s usability.

Galatea’s ability to adapt has become a key strength. As user expectations evolve, the platform remains focused on refining its features while maintaining the core aspects that readers value.

Meeting the Demand for Flexible Storytelling

Modern readers are looking for flexibility, and Galatea has positioned itself to meet that demand. The platform allows users to engage with stories in different ways, depending on their preferences and schedules.

Whether through short reading sessions, audiobook listening, or interactive chat-based formats, users can choose how they want to experience each story. This adaptability makes it easier to stay engaged without disrupting daily routines.

The ability to move between formats also adds to the overall experience. A reader can begin a story in text form, continue it as an audiobook, and explore chat-style interactions within the same narrative. This level of flexibility keeps the platform dynamic and appealing.

Building a Community Around Stories

As Galatea continues to grow, it is also building a strong and engaged community. The increasing number of five-star reviews reflects not only individual satisfaction but also a shared enthusiasm among users.

Readers actively recommend the platform, share feedback, and contribute to its visibility. This organic growth has played an important role in expanding Galatea’s reach.

For writers, this community creates valuable opportunities for connection and recognition. Authors can engage with readers directly and see how their work resonates in real time. This interaction strengthens the relationship between creators and their audience.

Each positive review adds to the platform’s credibility and encourages new users to explore what it has to offer.

Looking Ahead

Surpassing 100 five-star reviews marks an important milestone, but it also signals continued growth. Galatea remains focused on expanding its content library, improving its features, and strengthening its role within Inkitt’s story-to-screen ecosystem.

The integration with CandyJar creates new possibilities for content development, allowing stories to move beyond the app and reach wider audiences. This connection positions Galatea as a key part of a larger entertainment strategy rather than a standalone platform.

As more readers discover the app, the platform is expected to continue building momentum and attracting new users. The steady increase in positive feedback suggests that it is meeting the expectations of its audience and adapting effectively to changing preferences.

Conclusion

Galatea’s achievement of over 100 five-star reviews reflects its ability to deliver a reading experience that aligns with modern expectations. By combining flexible formats, data-driven content, and a clear path from story to screen through CandyJar, the platform offers something distinct in the digital reading space.

As part of Inkitt’s broader vision, Galatea represents more than a reading app. It is a central piece of a storytelling ecosystem where ideas begin with readers and have the potential to grow into larger forms of entertainment. With strong user engagement and a clear direction for growth, Galatea continues to establish itself as a platform that understands both storytelling and the people who enjoy it.

For more information, please feel free to visit https://galatea.com/ 

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Press Release

Milestone Launches Project : Tsavkisi, The First Design-Code Community Near Tbilisi

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Milestone has launched Project : Tsavkisi, a residential land-plot development situated on a hillside in the Tsavkisi area, just an 18-minute drive from Tbilisi, Georgia. The project comprises 63 individual land plots, each offering panoramic views of the surrounding forest and the city.

Tbilisi, Georgia, 2nd May 2026 – Milestone has launched Project : Tsavkisi, a residential land-plot development situated on a hillside in the Tsavkisi area, just an 18-minute drive from Tbilisi, Georgia. The project comprises 63 individual land plots, each offering panoramic views of the surrounding forest and the city.

Project : Tsavkisi is a thoughtfully planned community with a unified architectural identity, seamlessly integrated into the natural landscape. It is designed for those who wish to build a residence in a scenic setting while remaining just minutes away from central Tbilisi.

The presale is now open.

The development spans 10 hectares, with 24,000 m² dedicated to curated shared public spaces, including children’s playgrounds, sports courts, and forest walking paths. The project includes professionally maintained shared areas and green zones, along with 24/7 secured territory. 

The architectural vision of Project : Tsavkisi is rooted in a landscape-oriented approach. To create a unique living environment, the project has developed a set of architectural guidelines – a Design Code, where every element is thoughtfully connected to the next. The Code extends from façade materials and roofing guidelines to color selection. A recommended palette of muted, earth-derived tones is designed to maintain visual harmony with the natural landscape. The project adopts a low-density development strategy that maintains visual openness and integrates seamlessly with the natural terrain, avoiding high retaining walls and other intrusive structural elements. 

Homeowners are offered the flexibility to develop individual designs in accordance with the Design Code or to select from a catalogue of nine pre-designed residential houses. They have been created in collaboration with established architectural studios, recognized for their experience in residential design and landscape-driven planning.

The project is designed for residents who lead active urban lives but seek a home in a quiet, natural setting, without sacrificing their connection to the city. Project : Tsavkisi sets a benchmark for holistic suburban development, where each residence contributes to a unified architectural identity.

About Milestone

Milestone is a Georgian real estate development and management company based on innovative vision and ideas, defining environments for quality life. Expanding its portfolio, the company is currently developing a new residential project in the heart of Tbilisi, set to be introduced soon. 

Media Contact

Organization: Milestone

Contact Person: Lasha Eliadze

Website: https://www.projecttsavkisi.ge/

Email:
info@milestone.ge

Contact Number: +995598399899

City: Tbilisi

Country:Georgia

Release id:44575

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Dark Watch Integration with Leading Service Platform Sets a New Standard of Care in Therapist Safety

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Integration embeds real-time safety intelligence into therapists’ booking and payment workflows—helping therapy practices and service-based businesses identify and prevent high-risk interactions before appointments begin.

United States, 2nd May 2026 —May 1, 2026—Dark Watch, the embedded safety intelligence layer for modern commerce, today announced that its integration with a leading service-based platform is now live. The integration introduces a proactive safety capability designed to help prevent assaults and high-risk incidents in therapist-client environments.

Service-based businesses, particularly those in the wellness, spa, and personal care sectors, often involve private, one-on-one interactions between staff and clients. These environments are built on trust, but they can also expose therapists to elevated risk, such as from inappropriate behavior, harassment, boundary violations, and, in some cases, physical assault. Despite this, most booking and payment systems provide little to no visibility into potential risk before an appointment begins.

Historically, businesses have relied on reactive measures to mitigate these risks, e.g., incident reporting, internal notes, or post-event responses. The Dark Watch integration shifts that model upstream, enabling businesses to identify potential risk signals before an appointment is confirmed or a client arrives.

“A service-based business should not have to rely on reactive measures to reduce risk,” said Noel Thomas, CEO of Dark Watch. “Therapists are operating in one-on-one settings where the risk is real, and expectations are changing. Businesses shouldn’t have to choose between experience and protection. Dark Watch embeds security directly into the booking and payment layer, delivering real-time risk mitigation at the moment it matters most. The result is a new standard of care—one that protects therapists, strengthens brand trust, and delivers measurable safety benefits without disrupting the client experience.”

Through the integration, Dark Watch’s intelligence layer is embedded directly into booking and payment workflows. As appointments are scheduled, the system evaluates a range of risk signals that help identify patterns associated with prior inappropriate behavior, unsafe interactions, or indicators that warrant additional review.

The integration enables businesses to receive discreet, real-time insights at the moment of booking—before a therapist is assigned, before a client arrives, and before a potentially unsafe interaction occurs.

For operators, this creates a new layer of protection: improving therapist safety by identifying high-risk appointments early, increasing operational confidence when interacting with new clients, reducing the likelihood of incidents, and supporting staff retention in roles where safety concerns can drive turnover.

By embedding this capability directly into the platform layer, businesses can adopt proactive safety without adding friction to the booking experience or requiring additional tools. The system operates quietly in the background, preserving the client experience while enhancing staff protection.

The launch reflects a broader shift across the experience economy. Platforms are increasingly expected to safeguard not only transactions, but also the people behind them. As awareness grows around therapist safety in one-on-one service environments, proactive protection is becoming a critical expectation and an emerging standard of care.

Dark Watch’s technology is gaining traction across a growing set of platforms spanning payments, financial services, and real-world commerce systems. With multiple platform deployments now live or underway, the company continues to expand its footprint as a safety intelligence layer embedded directly into the infrastructure that powers everyday interactions.

Together, these deployments are establishing a new standard: protecting therapists and staff before the interaction begins.

For more information, visit https://darkwatch.io 

About Dark Watch

Dark Watch delivers an embedded safety intelligence layer for payment platforms, financial institutions, and real-world commerce systems. The platform leverages advanced AI and proprietary intelligence sources to identify risk signals tied to unsafe behavior, harassment patterns, and high-risk interactions—before transactions occur.

Media Contact

Organization: Dark Watch

Contact Person: Noel Thomas

Website: https://darkwatch.io

Email: Send Email

Country:United States

Release id:44597

The post Dark Watch Integration with Leading Service Platform Sets a New Standard of Care in Therapist Safety 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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