Press Release
Theriva Biologics Receives Fast Track Designation From FDA For VCN-01 For Treating Metastatic Pancreatic Cancer
–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
Benzinga
COMTEX_453481266/2655/2024-06-07T08:44:04
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Press Release
WHY VANESSA HUDGENS CHOSE AMAZON’S EKOUAER OVER LUXURY LABELS — AND WHAT IT REVEALS ABOUT FASHION’S NEW ERA
New York, US / Timesnewswire / October 2, 2026 – For decades, A-list celebrity endorsements followed a predictable blueprint: high fashion, multi-million-dollar haute couture deals, and unattainable luxury. But this fall, Hollywood star Vanessa Hudgens is continuing her game-changing fashion narrative with Amazon’s sleepwear and loungewear giant, EKOUAER.
First announced as an official EKOUAER Brand Friend earlier this July, Hudgens’ collaboration with the brand hits a major crescendo this October as EKOUAER celebrates its 11th Anniversary. Rather than aligned with exclusive runaway brands, Hudgens has embraced the ultimate daily wardrobe staple used by millions of everyday women across America.
“Becoming a mom has definitely made me appreciate versatility even more,” says Vanessa Hudgens. “I want pieces that are comfortable and easy for everyday life, but that I can dress up and still feel really good in.”
As EKOUAER marks its 11-year milestone, the timing coincides with October’s major Amazon shopping moment, proving that “everyday comfort” is officially beating traditional luxury status symbols. The star’s fall favorites spotlight pieces engineered for multi-scenario living, including the viral Ekouaer Satin Pajamas Set with Bow Tie Front and and the versatile, ultra-cozy Ekouaer 2-Piece Pleated Lounge & Sweater Set. “For me, it’s about finding that sweet spot where you feel comfortable but still put together,” Hudgens adds. “I love being able to take the same piece and completely change the feeling of it depending on how I style it.”
As EKOUAER kicks off its 11th Anniversary celebrations, the alliance redefines modern celebrity style: luxury isn’t about the price tag—it’s about effortless comfort.
EKOUAER
Dana Li
New York, US
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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.
Press Release
From One Store to 400 Daily Orders: 70-Year-Old Lalit Kumar Takes Natural Spices Online Across UAE
The Indian-born businessman has lived and worked in the UAE since 1983. Now 70, he has taken a single grocery store online, and it handles around 400 orders a day.
Dubai, Al Nahda 1, United Arab Emirates, 2nd Oct 2026 – When shipments were getting stuck and many small shops decided to sit tight, Lalit Kumar did the opposite. At 70, the owner of Natural Spices and Foodstuff Trading LLC moved his grocery business online. Today it delivers to customers in every emirate.
He started with one retail outlet and five staff. The business now handles about 400 orders a day through its own website, NaturalSpicesUAE.com, and through the UAE’s major online marketplaces. It sells spices, herbs, Indian groceries, snacks, dry fruits and other daily essentials.
Forty Years in the UAE
Mr. Kumar came to the UAE from India in 1983. Since then he has run businesses in electronics, transport, and oil and gas, and now in foodstuff. He says each one prepared him for the next. Electronics taught him how customers think. Transport taught him about timing. Oil and gas taught him patience.
“I came here as a young man and this country gave me a chance. It gave my family a home. I have never taken that for granted, and everything I build here is my way of saying thank you.”
— Lalit Kumar, Owner, Natural Spices and Foodstuff Trading LLC
Moving When Others Waited
The shift online came at a hard time for retail. Deliveries were running late, costs were going up and fewer people were walking into shops. Mr. Kumar decided not to wait it out.
With his team of five, he set up online ordering, reorganised the stock and worked out packing and delivery, all from the same store they were already running. The website went live, the products went onto the marketplaces, and orders started coming in from across the country.
“I have seen this market go up and down many times since 1983. If you stop every time things get difficult, you will never move. At my age people expect me to slow down. I would rather see what comes next.”
— Lalit Kumar
Still in the Store Every Day
Orders now go out to Abu Dhabi, Dubai, Sharjah, Ajman, Umm Al Quwain, Ras Al Khaimah and Fujairah. Customers say they come back for the range, the fair prices and delivery they can count on.
Growth hasn’t pulled Mr. Kumar away from the business. He is in the store every day. He talks to customers himself, bargains with suppliers and makes the big decisions. His staff say he has more energy than most of them, and he still knows many of his regulars by name.
“A customer is a person, not an order number. Whether they walk into the shop or order from Fujairah, they should get the same respect and the same fair price. That is how I have always worked. A website doesn’t change that.”
— Lalit Kumar
Looking Ahead
Over the coming months, the company plans to add more products, grow its marketplace presence and improve delivery across the UAE.
“I have been building businesses in this country for more than forty years, and I still feel like I’m starting out. As long as I have the energy, I’ll keep going, for my customers, my team and for the UAE.”
— Lalit Kumar
About Natural Spices and Foodstuff Trading LLC
Natural Spices and Foodstuff Trading LLC is a UAE-based grocery and foodstuff company serving customers through its retail outlet, its e-commerce platform NaturalSpicesUAE.com and leading online marketplaces across the United Arab Emirates. The company offers spices, herbs, Indian grocery products, snacks, dry fruits and other food essentials. It is owned and led by Lalit Kumar, who has been in business in the UAE since 1983 across the electronics, transport, oil and gas, and foodstuff sectors.
Media Contact
Organization: Natural Spices and Foodstuff Trading LLC
Contact Person: Lalit Kumar Kundani
Website: https://naturalspicesuae.com/
Email: Send Email
Contact Number: +971529941656
Address: Al Bannai Building, Shop 1, Al Amman Street, Al Nahda 1, Dubai, UAE
City: Dubai
State: Al Nahda 1
Country: United Arab Emirates
Release id: 45332
The post From One Store to 400 Daily Orders: 70-Year-Old Lalit Kumar Takes Natural Spices Online Across UAE 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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Press Release
Memito Opens Token Sale on Ethereum With Formula-Based Pricing and Multi-Network Payments
Memito, a community meme token on Ethereum, has opened a token sale on memito.org. The price is calculated by a formula in the verified smart contract, and the sale accepts five assets on Ethereum, a bridge from five networks and a wide range of wallets.
Canada, 2nd Oct 2026 – Memito (MEMITO), a community meme token on Ethereum, has opened its public token sale at memito.org, making participation available worldwide in 24 languages, with five payment assets, a built-in bridge from five networks and support for seven popular wallets. The sale is run directly by the token’s smart contract, which is published and verified on Etherscan.
Formula-based pricing set in the contract
Instead of fixed sale rounds, the token price is calculated by a formula written into the smart contract. The formula starts at 0.00000018585 USD per token and adjusts the price according to the total amount raised in the sale. Before confirming a transaction, each participant is shown the calculated quote for the selected amount. Tokens are transferred to the participant’s wallet within the same on-chain transaction, so there is no separate claim step. Trading of the token has not opened, and no date has been set.
Payment options across networks
The sale accepts ETH, USDT, USDC, DAI and WBTC on Ethereum, with individual transactions from about 1 USD to 10,000 USD. For users whose funds are held on BNB Chain, Arbitrum, Base, Polygon or Optimism, the website integrates the third-party LI.FI bridge, which can move funds to ETH on Ethereum and shows the route fees before signing. The website is available in 24 languages.
The sale page supports MetaMask, Trust Wallet, OKX Wallet, Bitget Wallet, Binance Wallet and Bybit Wallet (via WalletConnect), as well as other WalletConnect-compatible wallets, on desktop and mobile devices.
“Memito started as a meme, but we are building it as a community first,” the Memito team said. “We wanted anyone, from any network and in their own language, to be able to join from day one, with the rules of the sale written openly into the contract. The community on X and Telegram is where we share every next step.”
Token details
The token contract address is 0xe02AD79732658a2ec2C85Ecd15De5E08A311373C. Maximum supply is 420,690,000,000,000 MEMITO. When trading opens, the final supply is allocated as follows: 60% to buyers, referrals and the liquidity pool, 10% to a reserve, 15% to the founder share held in the project’s Ecosystem Wallet and 15% to the treasury. The deploying wallet received no tokens at launch.
About Memito
Memito (MEMITO) is a community meme token (ERC-20) on Ethereum, distributed through a formula-priced token sale on memito.org. More information is available on the project website and on its X and Telegram channels.
The token sale is open now at memito.org, where participants can review the contract details and the current quote before taking part.
Website: memito.org | X: @MEMITO_COIN | Telegram: t.me/memito_coin
Disclaimer: This press release is provided for information purposes only and is not investment advice. Crypto-assets carry risk, including the loss of funds. Readers should do their own research.
Media Contact
Organization: Memito
Contact Person: Memito Team
Website: https://memito.org
Email: Send Email
Country: Canada
Release id: 49614
The post Memito Opens Token Sale on Ethereum With Formula-Based Pricing and Multi-Network Payments 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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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.
WHY VANESSA HUDGENS CHOSE AMAZON’S EKOUAER OVER LUXURY LABELS — AND WHAT IT REVEALS ABOUT FASHION’S NEW ERA
From One Store to 400 Daily Orders: 70-Year-Old Lalit Kumar Takes Natural Spices Online Across UAE
Memito Opens Token Sale on Ethereum With Formula-Based Pricing and Multi-Network Payments
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