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

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6 months 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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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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UVKXE Releases Anti-Scam Guide, Enhancing User Security Protections

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20 hours ago

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November 23, 2024

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DENVER — Recently, the globally renowned cryptocurrency trading platform UVKXE has published its latest anti-scam guide to address the escalating threats of online scams, establishing a comprehensive protective barrier for users worldwide. The guide focuses on various scamming tactics prevalent in the cryptocurrency sector, highlighting what users should be aware of during transactions and asset management, while also providing effective preventive measures.

Kevin Anderson, CEO of UVKXE, noted: “As the cryptocurrency market continues to expand, more cybercriminals are turning their attention to cryptocurrency users, developing sophisticated scam techniques. As a well-known platform in the cryptocurrency trading field, UVKXE has a responsibility to help users identify and mitigate these potential risks. Through the release of this anti-scam guide, we aim to further enhance user awareness and safeguard their digital asset security.”

The guide outlines the common characteristics of these scams, such as phishing emails that typically use UVKXE or similar official-sounding names, along with forged logos and links, to deceive users into providing their login credentials and sensitive information. It also advises users to always choose official channels when downloading applications to avoid malicious software. Furthermore, UVKXE emphasizes that the platform will never proactively request users to provide sensitive information such as passwords or verification codes in any form.

In addition to the anti-scam guide, UVKXE will launch a series of interactive activities, utilizing community forums and video tutorials to educate users about safety knowledge and help them recognize and respond to potential threats. The UVKXE security team stated that these activities will not only provide real-time updates on scams but also offer users opportunities for direct communication and inquiries.

The investment in technology and education is reflected not only in the publication of the anti-scam guide but also in daily operations and maintenance. Kevin Anderson concluded: “Every protective measure and security technology implemented by UVKXE is designed to ensure the safety of user assets. In the future, we will continue to advance this mission, providing users with safer and more convenient cryptocurrency trading services.”

Media Contact:
Company Name: UVKXE CRYPTO TECH CO.,LTD.
Company website: https://www.uvkxe.co
Contact person’s full name: Mayang
Email id: mayang@uvkxe.co

Disclaimer: This content is provided by sponsor. The statements, views and opinions expressed in this column are solely those of the content provider. The information provided in this press release is not a solicitation for investment, nor is it intended as investment advice, financial advice, or trading advice. It is strongly recommended you practice due diligence, including consultation with a professional financial advisor, before investing in or trading cryptocurrency and securities. Please conduct your own research and invest at your own risk.

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Press Release

UVKXE Clarification Statement: A Legally Compliant Trading Platform with International Accreditation

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20 hours ago

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November 23, 2024

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DENVER — Recently, the Securities Commission Malaysia (SC) published a list on its official website of cryptocurrency trading platforms that have not met its local registration requirements, mentioning UVKXE. UVKXE takes this matter seriously and wishes to clarify its credentials and compliance status to its users.

Global Compliance Credentials of UVKXE

UVKXE is committed to operating under legal and compliant principles, upholding a user-first core value. The platform has obtained several certifications from international authoritative regulatory bodies, including but not limited to:

U.S. MSB License
UVKXE has obtained the MSB license issued by the U.S. FinCEN. This certification represents the highest recognition by the U.S. government for financial service institutions, ensuring that UVKXE can legally conduct cryptocurrency-related business.

U.S. SEC License
As one of the few cryptocurrency trading platforms registered with the U.S. Securities and Exchange Commission (SEC), UVKXE complies with securities and investment-related legal regulations, providing users with a safer and more transparent investment environment.

Background on the Malaysian Public List

The list published by the Securities Commission Malaysia mainly targets trading platforms that have not met local registration requirements, such as Binance and Bursa Malaysia, rather than denying the platform legality. UVKXE has obtained multiple authoritative licenses internationally, and its compliance is beyond doubt. UVKXE is in communication with relevant departments to understand local specific regulations and to advance the registration process, ensuring compliance with local market requirements.

Commitment to Legal Compliance and User-Centric Values

UVKXE will use this event as an opportunity to further enhance its global compliance framework, actively adapting to regulatory environments in various countries, and providing users with more professional and diversified financial services. We sincerely thank all users for their trust and support! UVKXE promises that no matter where it operates, the platform will always adhere to the core philosophy of “user-first”, moving together with global users towards a safer, more open, and transparent new era of the digital economy.

Media Contact:
Company Name: UVKXE CRYPTO TECH CO.,LTD.
Company website: https://www.uvkxe.co
Contact person’s full name: Mayang
Email id: mayang@uvkxe.co

Disclaimer: This content is provided by sponsor. The statements, views and opinions expressed in this column are solely those of the content provider. The information provided in this press release is not a solicitation for investment, nor is it intended as investment advice, financial advice, or trading advice. It is strongly recommended you practice due diligence, including consultation with a professional financial advisor, before investing in or trading cryptocurrency and securities. Please conduct your own research and invest at your own risk.

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Press Release

UVKXE Strengthens Security Strategy, Leading Innovations in Anti-Scam Technology for Crypto Platforms

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20 hours ago

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November 23, 2024

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DENVER — Recently, the globally recognized cryptocurrency trading platform UVKXE officially announced the completion of its latest security system upgrade. This upgrade significantly enhances the cybersecurity defenses of the platform and introduces cutting-edge anti-scam technologies. Through this technological update, UVKXE demonstrates its commitment to user asset security and proactive measures against potential future cyber threats.

Kevin Anderson, CEO of UVKXE, stated: “User trust is the foundation of UVKXE, and ensuring the security of user assets is always our top priority. This security system upgrade incorporates AI deep learning, real-time risk control, and efficient anomaly detection algorithms, aiming to create a safe and trustworthy trading environment for users. We will continue to optimize the security measures for user assets, ensuring that every user can trade confidently on UVKXE.”

The focus of this security system upgrade is primarily on anti-scam technologies. In response to the ever-evolving online threats and scam tactics in recent years, UVKXE has strengthened its multi-layered protective mechanisms, effectively enhancing the security and responsiveness of the system. The upgrade introduces AI-driven anti-scam technology, which intelligently analyzes user behavior through deep learning algorithms, allowing for rapid identification and isolation of suspected scamming activities. The AI anti-scam system can monitor and analyze large volumes of trading data in real time, immediately freezing any suspicious transactions or account activities to safeguard user assets.

Kevin Anderson further explained: “Traditional anti-scam methods often rely on post-event analysis, whereas the new system of UVKXE can identify risks promptly before incidents occur, taking immediate action to prevent losses.”

In terms of anomaly detection, the system of UVKXE combines the transaction histories, asset conditions, login locations, and other multidimensional data of users to accurately pinpoint potential security vulnerabilities. Through anomaly detection technology, each user login and transaction can be monitored in real time, with timely alerts prompting users to confirm actions, further enhancing the security of the platform.

Kevin Anderson concluded: “We hope every user can enjoy a secure trading experience on UVKXE. By continually optimizing our security strategies, we aim to provide a safer and more convenient cryptocurrency trading experience for our users.”

Media Contact:
Company Name: UVKXE CRYPTO TECH CO.,LTD.
Company website: https://www.uvkxe.co
Contact person’s full name: Mayang
Email id: mayang@uvkxe.co

Disclaimer: This content is provided by sponsor. The statements, views and opinions expressed in this column are solely those of the content provider. The information provided in this press release is not a solicitation for investment, nor is it intended as investment advice, financial advice, or trading advice. It is strongly recommended you practice due diligence, including consultation with a professional financial advisor, before investing in or trading cryptocurrency and securities. Please conduct your own research and invest at your own risk.

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Cloud PR Wire

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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.

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