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.
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New Delhi, India, 19th March 2026, ZEX PR WIRE — As emotional disconnection quietly replaces overt conflict in many modern relationships, PsychiCare, a global online therapy platform, has introduced the CARE Model for Relationship Healing, a structured counselling framework designed to help couples reconnect in an increasingly digital and emotionally overloaded world.
While popular relationship advice often focuses on surface-level communication tips, therapists at PsychiCare observed that many couples struggle not because they lack love, but because they lack emotional safety, awareness of triggers, and effective repair skills. The CARE Model addresses these deeper layers through a step-by-step therapeutic approach.
“Many couples today are not constantly fighting; they are simply drifting apart,” said Aakanksha Kapoor, Founder of PsychiCare. “They live together, share responsibilities, and function as a team, yet feel emotionally alone. The CARE Model was developed to help couples move from silent distance back to meaningful connection.”
What Is the CARE Model?
The CARE Model provides a clear roadmap for rebuilding relationship health:
C — Communication Reset
Helping partners relearn healthy communication patterns that reduce defensiveness and escalation.
A — Accountability & Awareness
Supporting individuals in recognising personal triggers, behavioural patterns, and shared responsibility in conflicts.
R — Repair & Reconnection
Introducing practical techniques to restore emotional safety, rebuild trust, and repair past hurts.
E — Emotional Growth
Fostering long-term relational maturity, resilience, and deeper intimacy beyond crisis resolution.
“Most couples are not lacking effort; they are lacking a roadmap,” Kapoor explained. “Without structure, partners keep repeating the same arguments, misunderstandings, and emotional shutdowns. The CARE Model gives them a clear path forward.”
Addressing a Modern Relationship Crisis
Relationship experts note a growing trend of “low-conflict disconnection,” where couples argue less but also feel less close. Increased screen time, work stress, long-distance dynamics, and post-pandemic lifestyle shifts have contributed to reduced emotional availability between partners.
“Digital communication has made staying in touch easier but connecting deeply harder,” Kapoor added. “Couples often communicate logistics efficiently but avoid vulnerable conversations. Over time, this creates emotional numbness rather than explosive conflict.”
PsychiCare reports rising demand for online marriage counselling from couples across India, the UK, North America, the Middle East, and other regions, particularly among dual-career partners, long-distance couples, and those balancing parenting with professional pressures.
Beyond Crisis Intervention
While therapy has traditionally been associated with severe relationship problems, PsychiCare emphasises that structured counselling can also serve as preventive care.
“Couples no longer want to wait until the relationship is breaking down,” Kapoor said. “Many seek guidance earlier, to strengthen emotional intimacy and communication before resentment accumulates.”
The CARE Model is used within PsychiCare’s online counselling sessions as well as workshops and educational initiatives aimed at promoting healthier relationship skills.
A Structured Approach to Healing
In addition to the CARE Model, PsychiCare has developed complementary frameworks for specific relationship challenges, including trust rebuilding after betrayal, conflict management, and emotional reconnection for long-distance partners.
By offering structured models rather than generic advice, the organisation aims to make therapy more accessible, understandable, and results-oriented for modern couples worldwide.
“Our goal is not just to resolve conflict, but to help couples build emotionally resilient relationships that can withstand life’s pressures,” Kapoor noted.
About PsychiCare
PsychiCare is an international online mental health platform providing counselling services for individuals, couples, and families. Its team includes licensed therapists with experience across diverse cultural contexts, offering support for relationship issues, anxiety, depression, parenting challenges, and personal growth.
Through secure virtual sessions, PsychiCare enables clients worldwide to access professional support from the comfort of their homes.
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PsychiCare Communications Team
Website: https://psychicare.com
Email: info@psychicare.com
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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
DemanPlay Surpasses 200,000 Discord Community Members, Expanding Its Chinese Gaming Community Ecosystem in NA
United States, 19th Mar 2026DemanPlay, a Chinese gaming community in NA, announced that as of March 15, 2026, the total number of members across its Discord communities has officially surpassed 200,000, marking a major milestone in its long-term growth.
According to the platform’s latest internal data, approximately 30% of its community users are located in Canada and 62% are based in the United States, based on IP address distribution across its online community. The remaining users mainly come from regions including Europe and Australia. The platform continues to grow steadily, adding around 3,500 new users per month and attracting Chinese-speaking gamers from across Canada and the U.S.
As its community continues to expand, DemanPlay has further strengthened its presence in gaming social networking, team matchmaking, interactive companionship services, and diversified online entertainment. Since its founding in 2018, DemanPlay has operated steadily for eight years, gradually building a mature and scalable community ecosystem.
One of DemanPlay’s core strengths is its response efficiency. Based on internal platform data, the average response time from a user placing an order to someone accepting it is under five seconds across all supported game categories. This reflects the platform’s continued advantage in both activity level and matchmaking speed.
In addition to fast response and matchmaking, DemanPlay has established a unified recharge and account system that allows users to recharge once and use their balance across multiple services within the community. These services include, but are not limited to, account rentals, in-game item trading, and other interactive gaming-related services. The platform also operates an automated after-sales system and 24/7 customer support, providing users with a stable and efficient service experience.
At present, DemanPlay’s main community covers multiple popular game sections, including:
- League of Legends
- VALORANT
- CS2
- PUBG
In addition, the platform also operates a dedicated Delta Force international server community, further meeting the social and matchmaking needs of different player groups.
Beyond gaming itself, DemanPlay continues to expand its community content ecosystem with a range of lifestyle and interest-based sections, including player selfie sharing, job information exchange, astrology discussions, and car and model collecting. These features help users build more authentic and engaging connections outside of gaming.
In terms of service coverage, DemanPlay currently supports multiple popular titles and interactive entertainment categories, including but not limited to:
- League of Legends (NA)
- VALORANT (NA)
- CS2 (NA)
- Delta Force (CN and International)
- Teamfight Tactics (NA)
- Overwatch 2 (NA)
- APEX Legends (NA)
The platform also offers entertainment-based interactive services such as music request sessions, Werewolf-style social games, and Goose Goose Duck, creating a more diversified online entertainment experience for users.
Beyond community operations and service infrastructure, DemanPlay’s North American team Deman Esport has also delivered strong competitive results. In 2024, Deman Esport won the championship in the North America Grand Final of the Naraka: Bladepoint Koi Cup, demonstrating the competitive strength of both its player community and team structure.
Ria Li said that reaching 200,000 users is not only a milestone for the community, but also a reflection of the growing demand among Chinese gamers in North America for high-quality online gaming communities and interactive services.
Daniel Hu said the platform will continue to improve its technical capabilities and user service systems while expanding into more game categories and community interaction scenarios.
Aaron Wan said DemanPlay will continue to strengthen its brand presence and community-building capabilities, with the goal of creating a more welcoming, active, and engaging environment for Chinese gamers across North America.
As one of the important Chinese online gaming communities in North America, DemanPlay will continue to invest in community experience, service efficiency, and content expansion, providing a richer, faster, and more interactive entertainment environment for gamers across the region.
Media Contact
Organization: Demanplay
Contact Person: Aaron Wan
Website: http://demanplay.com/
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The post DemanPlay Surpasses 200,000 Discord Community Members, Expanding Its Chinese Gaming Community Ecosystem in NA 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.
Press Release
Pioneering Psychedelic Harm Reduction: Mushrooms.support Bridges the Gap Between Colorado’s Legal Reforms and Evidence-Based Psilocybin and DMT Education
DENVER, COLORADO – March 18, 2026 – As Colorado continues to lead the nation in progressive psychedelic legislation under the Natural Medicine Health Act (NMHA), a groundbreaking Denver-based platform is setting the global standard for safety, education, and integration. Mushrooms.support, operating under Lyman Support Centers LLC, has officially announced the expansion of its comprehensive ecosystem dedicated to harm reduction, non-commercial gifting, and guided support for adults exploring the therapeutic benefits of psilocybin and dimethyltryptamine (DMT).
Following the historic voter approval of Proposition 122 and subsequent SB23-290 refinements, Colorado decriminalized the personal use, possession, and sharing of natural medicines for adults over 21. Navigating this new legal landscape, Mushrooms.support emerges as a vital community hub. Operating strictly within the non-commercial parameters of the law, the platform facilitates the free gifting of psilocybin and DMT while offering paid, professionally guided harm reduction sessions ranging from an accessible $10 to $200. This model ensures that life-changing mental health support and safety are accessible to all demographics, effectively removing the financial barriers often associated with psychedelic-assisted care.
The Scientific Foundation of Therapeutic Psychedelics The platform’s mission is deeply rooted in cutting-edge clinical research. Recent phase III trials and landmark studies from institutions like Johns Hopkins University have demonstrated the profound efficacy of psilocybin in treating Major Depressive Disorder (MDD), Treatment-Resistant Depression (TRD), and end-of-life existential anxiety.
By acting as a serotonin 5-HT2A receptor agonist, psilocybin promotes neuroplasticity, helping to rewire maladaptive thought patterns. Similarly, emerging research highlights endogenous DMT’s potential as a rapid-acting antidepressant and neuroprotectant. Mushrooms.support translates this complex science into actionable guidance for individuals dealing with PTSD, OCD, cluster headaches, and substance use disorders.
Award-Winning Harm Reduction Principles Recognized as the “Psychedelic Cup 2025 Winner” and awarded “Most Homogeneous” for its consistent quality and safety standards, Mushrooms.support distinguishes itself through five core principles of harm reduction:
1. Rigorous Testing: Ensuring the purity and safety of natural medicines.
2. Comprehensive Education: Providing transparent data on physiological effects and risks.
3. Set and Setting Preparation: Guiding users to create optimal environments for psychological safety.
4. On-Site Guided Support: Offering trained presence during the experience.
5. Post-Experience Integration: Helping users process and apply their insights for long-term personal growth.
Trained ambassadors and medical referrals are available to ensure that every individual’s journey is safe and therapeutically beneficial. The platform also strictly educates on contraindications, prominently warning against the risks of serotonin syndrome for individuals on specific medications or those with underlying cardiovascular or psychotic conditions.
“Decriminalization is only the first step; the true evolution of mental health care requires a solid foundation of safety, education, and community support,” says Darren Lyman, founder of Mushrooms.support and author of foundational texts on psychedelic integration. “Our goal is to transform Colorado’s legal framework into a scientifically grounded, accessible public health strategy. We are providing the essential resources—from microdosing guides to post-session integration—so individuals can explore these powerful natural medicines without fear or stigma.”
A Comprehensive Community Ecosystem Beyond one-on-one support, the Denver facility (located at 800 W. 8th Ave #110) and its digital platform offer an expansive library of resources. Users can access microdosing protocols, integration workbooks, specialized PDF drink recipes, chocolate formulations, and connections to trusted community growers and wellness products like Epic Balms.
As the psychedelic renaissance accelerates in 2026, Mushrooms.support stands at the forefront of the movement, ensuring that the integration of psilocybin and DMT into mainstream wellness is conducted ethically, safely, and equitably.
For more information, to access harm reduction resources, or to schedule a session, visit Website.
About Mushrooms.support
Mushrooms.support is a Denver-based educational and harm reduction platform operating under the Colorado Natural Medicine Health Act. Founded by Darren Lyman and managed by Lyman Support Centers LLC, the center provides non-commercial gifting of natural medicines alongside expert-guided support, integration services, and scientific resources for adults 21 and older. Operations run Tuesday through Saturday from 2:00 PM to 6:45 PM.
Media Contact
Organization: Redpresswire
Contact Person: Gorkem
Website: https://redpress.net
Email: Send Email
Contact Number: +905451552424
Address:Suite 10560 5 Brayford Square
City: London
Country:United Kingdom
Release id:42791
Disclaimer: This press release is for informational purposes only. Statements regarding therapeutic effects of psilocybin and DMT are based on research and do not constitute medical advice. Individuals should consult qualified healthcare professionals before using these substances.
The post Pioneering Psychedelic Harm Reduction: Mushrooms.support Bridges the Gap Between Colorado’s Legal Reforms and Evidence-Based Psilocybin and DMT Education 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
About Author
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.
PsychiCare Introduces the CARE Model for Relationship Healing in the Digital Age
DemanPlay Surpasses 200,000 Discord Community Members, Expanding Its Chinese Gaming Community Ecosystem in NA
Pioneering Psychedelic Harm Reduction: Mushrooms.support Bridges the Gap Between Colorado’s Legal Reforms and Evidence-Based Psilocybin and DMT Education
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