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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.

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Edmund Dorsz Says the CNC Trade Is Losing Its Mentors, Not Just Its Workers

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The Shortage Everyone Talks About Is the Wrong One

Georgia, USA, 16th October 2026, ZEX PR WIRE, Every few months another report says manufacturing cannot find enough skilled workers. Edmund Dorsz has heard that line for most of his career, and he thinks it skips the actual problem.

“Companies will post for a CNC programmer with five years of experience,” he says, “but they won’t say who is supposed to teach that person the parts of the job that never show up in a manual.”

Dorsz has worked across CAD and CAM systems including Siemens NX, SolidWorks, Mastercam, and CATIA V5. He says the software is rarely the hard part. The hard part is judgment, the kind that comes from someone standing next to a new hire at a machine and explaining why a toolpath that looks fine on screen will chatter on the actual part.

What Gets Lost When Nobody Is Assigned to Teach

Dorsz says the mentorship that used to happen informally, a senior programmer walking a newer one through a setup, has gotten thinner as shops run leaner and schedules get tighter.

“Nobody decided to stop training people,” he says. “It just stopped being anyone’s job in particular, so it happens less.”

He points to a gap he sees often: new programmers who are strong in the software but have never had to explain a toolpath choice to someone running the machine. “You can model a part perfectly and still hand the floor something that’s a headache to cut,” he says. “That’s not a software problem. That’s an experience problem.”

Dorsz owned and ran Accelerated Precision Tooling Company in California before moving into his current role, so he has seen the gap from both sides, as an employer trying to staff a shop and as a programmer trying to get a part right the first time.

Why He Still Makes Time for It

Dorsz says he takes training requests from coworkers seriously, even when it slows down his own week. “If someone asks me to walk through why I set a part up a certain way, I’ll stop and do it,” he says. “It costs me twenty minutes. It can save them a scrapped part later.”

He is careful to draw a line between correcting someone’s work and dismissing it. “I had people do that to me early on, and it didn’t make me better, it just made me quiet,” he says. “I’d rather someone ask a question twice than guess once and be wrong.”

He also pushes back on the idea that patience is a soft skill that does not belong on a shop floor. “Precision work is unforgiving,” he says. “But that doesn’t mean the people doing it have to be. You can hold a tight tolerance and still be easy to work with.”

What He Tells Programmers Starting Out

Dorsz says the advice he gives newer programmers is less about which CAD/CAM system to learn and more about staying curious once they know one. “Get good at your first system, but don’t stop there,” he says. “The programmer who only knows one way to solve a problem runs out of options fast.”

He also tells them not to treat the screen as the whole job. “The part doesn’t live in the software,” he says. “It lives on the machine. Go stand next to it when you can.”

To read more, visit the website here.

About Edmund Dorsz

Edmund Dorsz is a CNC programmer and manufacturing engineer based in Newnan, Georgia. He has worked with Siemens NX, AutoCAD, SolidWorks, Mastercam, and CATIA V5, and previously owned Accelerated Precision Tooling Company in California. He has been with Clayton International Inc. since January 2025.

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Midwest Ragdolls Highlights Why a Kitten’s Early Environment Matters

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Veterinarian Dr. Jennifer Creed discusses why everyday experiences with people, animals, and household activity matter when families research how a kitten was raised.

Illinois, USA, 16th October 2026, ZEX PR WIRE, Long before a kitten arrives in a new home, it has already spent weeks learning about the world around it. The people it encounters, the animals nearby, and the everyday activity around it all become part of those early experiences.

Dr. Jennifer Creed, a practicing small-animal veterinarian and founder of Midwest Ragdolls in Elburn, Illinois, believes prospective owners should consider that part of a kitten’s background alongside questions about veterinary care and health.

“My kittens are raised by my family and me and are used to being around kids and dogs,” Creed says. “That is simply part of their normal environment from early on.”

For Creed, the point is not that early socialization can guarantee how a cat will behave as an adult. Every kitten is an individual, and many factors can influence temperament. Instead, she encourages families to ask a broader question when researching a breeder: What has everyday life actually looked like for this kitten?

What Does Socialization Mean for a Young Kitten?

Socialization is sometimes treated as a formal training program. In practice, many important experiences can happen through ordinary daily life.

A young kitten may hear people moving through a home, meet different family members, experience routine handling, or notice other animals nearby. These experiences introduce the kitten to situations it may encounter again after joining a new family.

At Midwest Ragdolls, the family-run structure means this exposure is built into the environment in which the kittens are raised. Creed has no employees at the cattery. Her children help with the kittens, and dogs are also part of the environment.

“Veterinary care is important, but raising an animal involves more than what happens during an examination,” Creed says. “You are also looking at the environment that animal experiences during an important period of its early life.”

Why Early Experiences and Temperament Are Not the Same Thing

Creed cautions against assuming that only early socialization creates a predictable personality.

Genetics, individual temperament, later experiences, and the environment in a new home can all shape how a cat behaves.

Ragdoll kittens are bred for a specific temperament. They are friendly , outgoing cats but the environment they are raised in is very important.

That distinction matters for families researching breeders. Statements about kittens being raised around children or other animals can provide useful information about their background, but they should not be interpreted as promises about future behavior.

For Creed, the more practical question is whether kittens have opportunities to experience normal interaction before they leave.

“You cannot promise that every kitten will respond to every situation in exactly the same way,” Creed says. “They have individual personalities. What you can do is start with a very social breed and  think carefully about the experiences they have while they are in your care.”

What Should Families Ask About a Kitten’s Early Environment?

When prospective owners speak with a breeder, Creed recommends learning about daily life rather than focusing only on a list of veterinary procedures.

Families can ask where the kittens are raised, who regularly interacts with them, whether they have experience around children or other animals, and what normal activity they encounter. They can also ask how much direct interaction the breeder has with the kittens.

Those questions can provide a more complete picture of the weeks before a kitten joins its new family.

This is particularly relevant because bringing a kitten home represents another major environmental change. New people, unfamiliar rooms, different sounds, and possibly other pets can all arrive at once.

Creed says families should expect adjustment to take time rather than assuming that a well-socialized kitten will immediately feel comfortable in every situation.

Socialization Continues After a Kitten Comes Home

The breeder is responsible for only the beginning of a kitten’s experiences. Once a kitten leaves, its new family must continue that process.

Creed encourages owners to allow kittens to become familiar with a new home gradually. Introductions to unfamiliar people, pets, rooms, and routines do not have to happen all at once. Paying attention to how an individual kitten responds can help families decide when to move forward and when to give the animal more time.

The same principle applies to children and other pets. A kitten having previous experience around children or dogs does not mean every future interaction will automatically be comfortable. New introductions still require supervision, patience, and attention to the animals involved.

That continuing process is one reason Creed believes prospective owners should think about socialization as more than something a breeder completes before a kitten goes home.

“The early weeks matter, but they are only the beginning,” Creed says. “Families continue building on those experiences once the kitten becomes part of their home.”

For Midwest Ragdolls, that beginning takes place within the Creed family’s own environment. More than three decades after the cattery was founded in 1993, kittens are still raised with direct family involvement and regular exposure to children and dogs.

The approach reflects a simple idea: veterinary care provides important information about a kitten’s health, while everyday experiences form another part of its early development. Families researching a kitten can benefit from asking about both.

About Midwest Ragdolls

Midwest Ragdolls is a family-run Ragdoll cattery based in Elburn, Illinois. Founded in 1993 by practicing small-animal veterinarian Dr. Jennifer Creed, Midwest Ragdolls raises purebred Ragdoll kittens for families primarily throughout the Midwest and across the United States.

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Scientology Mission of Shizuoka Marks First Anniversary at Foot of Mount Fuji

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One year after opening at the foot of Mount Fuji, the Church of Scientology Mission of Shizuoka marks its first anniversary on October 25, 2026, with courses, seminars and a public display in operation.

Shizuoka, Japan – October 16, 2026 – The Church of Scientology Mission of Shizuoka marks its first anniversary on October 25, 2026, completing one year of operation at its location on Road 75 in Shizuoka City, Japan. The anniversary is the Mission’s first annual milestone since it opened as an Ideal Scientology Mission in October 2025.

Shizuoka City is the capital of Shizuoka Prefecture, located on Honshu, the main island of Japan, between the Pacific coast and the slopes of Mount Fuji. The Mission serves residents of the city and the surrounding region, and is one of the Church of Scientology’s centers in Japan.

Over its first year, the Mission has operated as a center for the introductory services of the Scientology religion. These include Life Improvement Courses on everyday subjects such as marriage, parenting, personal motivation and goal setting; seminars on topics including personal efficiency and the fundamentals of Dianetics and Scientology; and auditing, the religion’s form of spiritual counseling. The Mission also maintains a Public Information Display with multimedia presentations on the beliefs and practices of the Scientology religion and on the life of its Founder. The display is open to visitors.

Scientology Missions are local centers of the Scientology religion that deliver its basic and introductory services. An Ideal Mission is one equipped to provide the full range of those services under one roof. The Shizuoka Mission opened on October 25, 2025, following a dedication ceremony attended by parishioners and guests from across Japan and from overseas, including Taiwan and Australia. The one-year mark follows the Mission’s first full annual cycle of courses, seminars and public access.

At the Mission’s dedication, the Executive Director said: “This Mission represents more than a building. It’s a new starting point.” One year later, the Mission is in regular operation, with courses, seminars and the Public Information Display open to residents of Shizuoka and the surrounding region.

The Church of Scientology Mission of Shizuoka is located on Road 75 in Shizuoka City, Shizuoka Prefecture, Japan. More information about the Scientology religion is available at scientology.org.

 

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