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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

The Mining Future Introduces the Bitmain Antminer KS5 20Th—Efficiency and Profits in Crypto Mining

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The Mining Future, one of the leading provider of cryptocurrency mining solutions in Middle East and Latin Amercia, is excited to announce the arrival of the Bitmain Antminer KS5 20Th, a new mining rig designed to help cryptocurrency miners boost their efficiency and profits. With a focus on delivering top performance, the KS5 20Th is here to meet the growing demands of today’s mining world.

The Bitmain Antminer KS5 20Th offers an impressive 20 terahashes per second (TH/s), making it perfect for miners looking to stay ahead in the competitive crypto space of Kaspa mining. Whether it is about mining on small scale or as part of a larger operation, this rig can provide the power any Kaspa miner needs to succeed.

Lower Energy Use, Bigger Profits

One of the biggest challenges for miners is the cost of electricity. The Bitmain Antminer KS5 20Th helps tackle this issue thanks to its high efficiency rates, thus using less energy without sacrificing performance. That means lower electricity bills and a quicker return on investment, allowing it to run a more profitable operation.

Built to Last and Ready for the Future

Not only is the Antminer KS5 20Th powerful, but it is also built to last even in the most tough environments. With a durable design and advanced cooling system, it can handle long hours of continuous operation without impacting its uptime. And with its high performance it can stay ahead of the curve despite the increasing network difficulty and the demands of more power, providing a competitive advantage for its owners.

Simple and Easy to Use for Everyone

The Antminer KS5 20Th has been designed to make it easy to set up and use. Its straightforward controls make it accessible to all types of miners, and with Bitmain’s customer support, you can be sure your mining operation is running smoothly without any hassle.

Hosting Services Now Available

For an even simpler mining experience, the miners can delegate its operations to professional crypto mining hosting service facilities. The Mining Future is now expanded its offering of hosting services for the Bitmain Antminer KS5 20Th. Its hosting solutions provide reliable infrastructure at a very affordable rates, so any miner can focus on just enjoying the profits while leaving all technicalities to the technical experts.

A Smart Investment in the Future of Mining

As cryptocurrency mining continues to grow, having powerful and efficient hardware is more important than ever. The Bitmain Antminer KS5 20Th gives miners the edge they need to stay profitable and competitive in this rapidly changing industry.

For more information or to set up a free consultation, please visit www.theminingfuture.com or contact their team at contact@theminingfuture.com.

About The Mining Future

The Mining Future provides top-notch crypto mining hardware and services, offering the latest technology to obtain maximum efficiency and profitability. Offering reliable equipment and cutting-edge hosting infrastructure, the company enables miners minimize downtime, extend equipment lifespan, and maximize profits.

Contact Details:

Contact Person: Gilbert Corbella

Phone No: 48 535 235 364

Address: Dubai Silicon Oasis, Dubai Digital Park, Building A2,  Premises 10800-001, Dubai, United Arab Emirates.

Website URL:     https://www.theminingfuture.com/

Email Address:  contact@theminingfuture.com

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Press Release

The Mining Future Expands Antminer Hosting Services for S21 Series

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The Mining Future, one of the leading provider of cryptocurrency mining solutions in Middle East and Latin Amercia, is pleased to announce an exciting expansion to include the latest Antminer Hosting services. With a focus to staying ahead of the curve, The Mining Future now offers specialized hosting solutions for the latest Antminer models, including the S21 200T, S21 Pro 234T, S21 Hydro 335T, S21 XP Hydro 473T, and KS5 Pro 21T.

This service update addresses the latest releases from Bitmain’s top performing models, as well as accommodating the growing demand for more efficient, high-performing hosting solutions that support the newest technological advancements in crypto mining. By offering cutting-edge hosting solutions for these powerful devices, The Mining Future continues its commitment to enabling miners optimize their mining operations while increasing their profitability.

What’s New?

With the S21 series known for its impressive hashing power and energy efficiency, The Mining Future’s hosting services are designed to ensure maximum uptime and minimal operational costs. Here’s what miners can expect:

  • Antminer S21 200T Hosting – Take advantage of the S21 200T’s capabilities with optimized energy consumption and enhanced operational efficiency.
  • Antminer S21 Pro 234T Hosting – Experience industry-leading performance with infrastructure designed to support the S21 Pro’s superior hashing power.
  • Antminer S21 Hydro 335T and S21 XP Hydro 473T Hosting – Benefit from advanced cooling systems tailored for the S21 Hydro, maximizing productivity without increasing energy costs.
  • Antminer KS5 Pro 21T Hosting – Secure a hosting environment that ensures stability and peak performance for the top Kaspa miner model KS5 Pro, guaranteeing continuous operation and zero downtime.

Why Choose The Mining Future for Antminer Hosting?

The Mining Future can provide cutting edge cooling technology, reliable power management, and 24/7 monitoring. Its advanced Antminer Hosting services deliver the highest levels of efficiency and performance for the newest miners in the industry. Their secure, scalable facilities are built to handle the increasing power needs of these cutting-edge machines, giving miners a competitive advantage in today’s fast-paced cryptocurrency market.

For more information or to set up a free consultation, please visit www.theminingfuture.com or contact their team at contact@theminingfuture.com.

About The Mining Future

The Mining Future provides top-notch crypto mining hardware and services, offering the latest technology to obtain maximum efficiency and profitability. Offering reliable equipment and cutting-edge hosting infrastructure, the company enables miners minimize downtime, extend equipment lifespan, and maximize profits.

Contact Details:

Contact Person: Gilbert Corbella

Phone No: 48 535 235 364

Address: Dubai Silicon Oasis, Dubai Digital Park, Building A2,  Premises 10800-001, Dubai, United Arab Emirates.

Website URL:     https://www.theminingfuture.com/

Email Address:  contact@theminingfuture.com

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Press Release

Treendale Pet Medical Offers Trusted Vet Services Near Dalyellup

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Australia, 22nd Oct 2024, Treendale Pet Medical, a leading veterinary hospital in Australind, has expanded its services to pet owners near Dalyellup. The clinic provides a full range of routine and advanced veterinary care, ensuring that pets in the region have access to high-quality medical support.

Treendale Pet Medical Offers Trusted Vet Services Near Dalyellup

Offering both routine and specialised treatments, Treendale Pet Medical addresses a variety of pet health needs. Services include general health check-ups, dentistry, senior health screenings, and advanced diagnostics. The hospital also provides specialised care, with expert teams dedicated to areas such as oncology, orthopaedic surgery, and neurology.

Dr. Rob Hill, Director of Treendale Pet Medical, shared the clinic’s commitment to extending services to Dalyellup, “The expansion of services near Dalyellup reflects a continued dedication to providing quality veterinary care in the South West. Pet owners in the area now have convenient access to comprehensive veterinary services, delivered with the same level of care that defines the hospital in Australind.”

Treendale Pet Medical offers a broad spectrum of veterinary services, ranging from preventive care to complex medical treatments. The clinic’s routine services include dental care, imaging, and telemedicine consultations, all aimed at supporting long-term pet health. Preventive measures, such as health screenings and regular check-ups, are essential to maintaining the well-being of pets and identifying potential health issues early.

For pets with more advanced medical needs, Treendale Pet Medical offers specialised services such as cancer treatment, pain management, and orthopaedic surgery. The clinic is equipped with state-of-the-art facilities to handle complex cases, providing solutions for conditions that require expert intervention.

Emergency services are also available at the clinic, ensuring immediate care for pets facing urgent health crises. With a team trained to manage emergencies, Treendale Pet Medical provides critical care when it is most needed.

Treendale Pet Medical Offers Trusted Vet Services Near Dalyellup

Dr. Hill also highlighted the clinic’s forward-looking approach to veterinary care, “As advancements in veterinary medicine continue, there is an ongoing commitment to expanding services and introducing new technologies. The goal is to ensure that pets in Dalyellup and surrounding areas benefit from the latest treatments available, regardless of the complexity of their condition.”

Treendale Pet Medical’s comprehensive services include advanced imaging, reproductive services for breeders, and specialist care in dermatology, orthopaedics, and ophthalmology. The hospital’s wide range of offerings is designed to meet the varied health needs of pets, from preventive health management to complex medical procedures.

With the clinic’s location in Australind, pet owners near Dalyellup now have access to expert veterinary care close to home. This expansion ensures that pet health remains a priority in the region, offering families the convenience of comprehensive medical services for their pets without the need for long-distance travel.

For more information about the vet near Dalyellup, Treendale Pet Medical can be contacted at +61 8 9796 1388 or via email at reception@treendalevet.com.au. The clinic is located at 109 The Blvd, Australind WA 6233.

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Contact Number: 61897961388

Address:109 The Blvd

Address 2: Australind WA 6233

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