Press Release
Candel Therapeutics (NASDAQ: CADL) Reports Positive Data From Phase 2 Trial Of CAN-2409 In Borderline Resectable Pancreatic Cancer
–News Direct–
By Jeremy Golden, Benzinga

Clinical-stage biopharmaceutical company Candel Therapeutics, Inc. (NASDAQ: CADL) reported updated survival data from its randomized phase 2 clinical trial of CAN-2409 in borderline resectable pancreatic cancer. Pancreatic cancer is the fourth leading cause of cancer-related death in the U.S. The disease accounts for approximately 3% of all cancers, with an estimated 64,050 patients diagnosed in 2023.
The randomized, controlled clinical trial is specifically looking into the safety and efficacy of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection if possible in borderline resectable pancreatic ductal adenocarcinoma (PDAC).
Very encouraging results were recently reported by the Needham, Massachusetts-based company.
Patients reached an estimated median overall survival of 28.8 months after experimental treatment with CAN-2409 versus only 12.5 months in the control group in PDAC. At 24 months, the survival rate was 71.4% in CAN-2409 treated patients compared to only 16.7% in the control group after chemoradiation. Thus, prolonged and sustained survival was observed after experimental treatment with CAN-2409 in patients with borderline resectable PDAC. Importantly, 4 out of 7 patients who received CAN-2409 were still alive at the time of data cut-off, with 2 patients surviving more than 50.0 months from enrollment. Only 1 out of 6 patients in the randomized control SoC chemotherapy group remained alive at the data cut-off (50.6 months).
No new safety signals were observed, providing further support that multiple injections of CAN-2409 are generally well tolerated. Additionally, there were no dose-limiting toxicities or cases of pancreatitis reported.
Previous analysis of resected tumors showed dense aggregates of immune cells including CD8+, cytotoxic tumor-infiltrating lymphocytes and dendritic cells in PDAC tissue after CAN-2409 administration. This reinforces the potential of CAN-2409 to activate a robust antitumoral immune response in patients with cancer also in cold, immunosuppressive tumors like PDAC.
Given the frequent recurrence and short survival with SoC chemotherapy for non-metastatic PDAC, effective new treatment options are urgently needed, said Garrett Nichols, MD, MS, Chief Medical Officer of Candel. We are very encouraged by the improved survival associated with CAN-2409, which has been shown to be durable after prolonged follow-up based on the updated data in this randomized clinical trial. CAN-2409 was generally well tolerated without significant additional local or systemic toxicity when added to SoC chemoradiation.
Candels most advanced viral immunotherapy candidate, CAN-2409, is an investigational off-the-shelf, replication-defective adenovirus designed to induce an individualized, systemic immune response against the tumor. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. More than 1,000 patients have been dosed with CAN-2409 to date, with a favorable reported tolerability profile and proof of concept in each indication that the company is currently pursuing.
CAN-2409 is injected directly into the tumor or target tissue using a localized injection method that is akin to the standard approach for in situ vaccination to elicit an immune response against the injected tumor and uninjected metastases.
Long-term survival data in PDAC was recently updated with eight months of further follow-up since the first analysis was presented at the 2023 Society for Immunotherapy (SITC) Annual Meeting. Based on the data presented at SITC, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to Candel Therapeutics for CAN-2409 in combination with valacyclovir for the treatment of patients with PDAC in December 2023. More recently, the FDA also granted Orphan Drug Designation.
The failure of conventional immunotherapy to improve outcomes in pancreatic cancer is attributed to the highly immunosuppressive tumor microenvironment, which is largely devoid of immune cells, said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. The immunological changes induced by CAN-2409, evident in the pancreatic tissue and the peripheral blood after administration, suggest that CAN-2409 is able to change the balance between the tumor and the patients anti-tumor immune response, which can convert progressive cancer into a chronic disease associated with improved survival.
Featured photo by National Cancer Institute on Unsplash.
Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent high-grade glioma (HGG). Finally, Candels enLIGHTEN Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.
This article includes certain disclosures that contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, including the timing and availability of additional data, key data readout milestones, including CAN-3110 in HGG; expectations regarding the potential benefits conferred by Fast Track Designation; expectations regarding the therapeutic benefit of its programs, including the potential for its programs to extend patient survival; and expectations regarding cash runway and expenditures. The words may, will, could, would, should, expect, plan, anticipate, intend, believe, estimate, predict, project, potential, continue, target and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on managements current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Companys programs; that final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Companys ability to efficiently discover and develop product candidates; the Companys ability to obtain and maintain regulatory approval of product candidates; the Companys ability to maintain its intellectual property; the implementation of the Companys business model, and strategic plans for the Companys business and product candidates, and other risks identified in the Companys SEC filings, including the Companys most recent Quarterly Report on Form 10-Q filed with the SEC, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Companys views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice.
Contact Details
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View source version on newsdirect.com: https://newsdirect.com/news/candel-therapeutics-nasdaq-cadl-reports-positive-data-from-phase-2-trial-of-can-2409-in-borderline-resectable-pancreatic-cancer-425692953
Candel Therapeutics
COMTEX_453283087/2655/2024-06-03T08:31:08
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Press Release
Bell Buckle Holdings Acquires MORE and Appoints New Interim CEO
Las Vegas, NV, 28th April 2025, ZEX PR WIRE, Bell Buckle Holdings Inc. (OTCMarkets: BLLB) today announced a transformative shift in its strategic direction, positioning the company at the forefront of the digital asset economy. As part of this strategic realignment, BLLB has divested its interest in Green Mantis, LLC and will no longer pursue its previous focus on soil remediation. Moving forward, the company will operate as a digital asset holding company and incubator, bridging the gap between traditional finance and the rapidly evolving cryptocurrency market.
Acquisition of MORE Management, LLC
BLLB has acquired 100% of the assets of MORE Management, LLC. Founded in 2016, MORE (www.morebrand.co) was an early pioneer in the crypto lifestyle sector, gaining global recognition for its innovative use of the MORE token, launched in 2017, as a payment and membership instrument.
MORE now operates in exclusive nightlife venues in Las Vegas and Los Angeles, and hosts pop-up events, private dinners, Super Bowl and EDC parties, concierge services, and high-profile activations.
Through this acquisition, BLLB now owns MORE’s intellectual property, social media accounts, membership roster, and 10,000,000 MORE tokens. The MORE token is currently available directly from the company, with plans to pursue additional exchange listings immediately. Proceeds from token sales are retained by BLLB.
MORE’s hotel partners have included premier brands such as MGM Grand, Resorts World, Sahara Hotel, and Graduate Hotels.
To facilitate the transaction, 40 million restricted shares were issued to outgoing management. These shares are subject to a twelve-month restriction. Control shares have been transferred to entities associated with MORE Management. The company’s overall capital structure remains relatively unchanged.
Creator Economy and AI Integration
Since its inception, MORE has cultivated relationships with creators, talent agencies, DJs, influencers, and celebrities. The company is now expanding its focus by integrating AI services with its creator economy platform, enhancing product offerings in alignment with emerging trends at the intersection of digital assets, AI, and social media.
Building a Diverse Cryptocurrency Portfolio
BLLB intends to establish a portfolio of leading digital assets, including Bitcoin, Ethereum, Solana, Ripple, Trump, Dogecoin, and BNB. In addition, the company is exploring opportunities in special situations such as meme coin launches, with the goal of maximizing shareholder value. MORE’s network of venues and events will provide added utility and brand activation opportunities for various cryptocurrencies.
Tokenization of Real-World Assets
Leveraging the MORE acquisition as a strategic foundation, BLLB plans to partner with businesses seeking to tokenize real-world assets, including real estate, fine art, season tickets, royalties, collectibles, and other tangible assets. This strategy underscores BLLB’s commitment to innovation in bridging traditional and digital finance.
Leadership and Strategic Initiatives
Peter Klamka, a seasoned executive with extensive expertise in traditional finance, digital assets, and AI, has been appointed interim CEO. Under Mr. Klamka’s leadership, BLLB will provide updates in the near term on several initiatives, including:
– Capital structure refinement and share reduction programs
– Addressing potential 3(a)(10) dilution concerns
– Expansion of venue partnerships
– Development of an advisory board and board of directors
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements regarding Bell Buckle Holdings Inc.’s (“BLLB”) future plans, objectives, strategies, expectations, intentions, and projections, are forward-looking statements. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements.
Factors that could cause or contribute to such differences include, but are not limited to, risks related to the development and implementation of BLLB’s business strategies, risks associated with cryptocurrency market volatility, regulatory changes, technological changes, market conditions, competitive factors, and other risks described in BLLB’s filings with OTCMarkets and other regulatory bodies.
BLLB undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.
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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
Navigating Larger Markets: Dee Agarwal’s Checklist Before Scaling Up
Dee Agarwal shares a 10-step checklist for scaling into larger markets, emphasizing market research, financial health, scalable operations, strong teams, tech adoption, risk mitigation, customer experience, tailored marketing, and performance tracking.
Atlanta, GA, 28th April 2025, ZEX PR WIRE, Scaling up a business to enter larger markets can be a thrilling yet challenging endeavor. Dee Agarwal, a seasoned founder known for his strategic acumen and innovative approach, shares his essential checklist to ensure a smooth transition and sustained growth.
1. Assess Market Potential
Before diving into a larger market, it’s crucial to thoroughly understand its potential. Dee Agarwal emphasizes the importance of comprehensive market research.
“Understanding the market dynamics, consumer behavior, and competitive landscape is the first step,” Dee Agarwal explains. “Without this knowledge, you’re essentially flying blind.”
2. Evaluate Financial Health
Scaling up requires significant financial resources and investments. Dee Agarwal suggests conducting a detailed financial assessment to ensure the business can support the expansion.
“You need to have a clear picture of your current financial standing,” says Dee Agarwal. “Evaluate your cash flow and profit margins, and ensure you have enough capital or access to funding to sustain the growth phase.”
3. Strengthen Your Core Operations
Before expanding, it’s vital to have the robust internal processes and operations necessary to fuel the growth.
“Your core operations should be scalable,” Dee Agarwal advises. “This means having efficient systems in place that can handle increased demand without compromising on quality or customer satisfaction.”
4. Develop a Scalable Business Model
A scalable business model is essential for successful expansion. Dee Agarwal points out that businesses need to ensure their model can be replicated in different markets.
“A business model that works in a small market might not be suitable for a larger one,” Dee Agarwal notes. “Adaptability and flexibility are key. You need to be ready to pivot your model to meet the demands of new markets.”
5. Build a Strong Team
A strong, cohesive team is the backbone of any successful expansion. Dee Agarwal stresses the importance of having the right talent in place.
“Scaling up requires a team that is not only skilled but also aligned with your vision,” he says. “Invest in hiring, training, and retaining top talent that understand the market you are looking to enter and are willing to take accountability.”
6. Leverage Technology
Technology and automation can significantly streamline the scaling process. Dee Agarwal encourages businesses to embrace digital tools and platforms that enhance efficiency and productivity.
“From CRM systems to data analytics and automation, technology can provide valuable insights and improve operational efficiency,” Dee Agarwal explains. “It’s an investment that pays off in the long run.”
7. Mitigate Risks
Entering a new market comes with its own set of risks. Dee Agarwal advises businesses to have a robust risk management strategy in place that takes into account business and market vulnerabilities and potential scenarios.
“Identify potential risks and develop strategies to mitigate them,” Dee Agarwal says. “Whether it’s regulatory challenges, supply chain issues, or market volatility, being prepared can save you a lot of headaches down the road.”
8. Focus on Customer Experience
Customer experience should remain a top priority, regardless of the market size. Dee Agarwal highlights the importance of maintaining high standards of customer service.
“Your customers are your biggest advocates,” Dee Agarwal states. “Delivering exceptional service and creating positive experiences will help you build a loyal customer base and drive growth. Build raving fans at every instance by obsessing over your customers.”
9. Adapt Your Marketing Strategy
Dee Agarwal believes that a tailored marketing strategy is crucial for capturing the attention of a larger audience.
“Your marketing efforts need to resonate with the new market demographics,” Agarwal advises. “Invest in market-specific campaigns, leverage local influencers, and utilize ROAS-driven amplification to reach a broader audience on UGC.”
10. Monitor and Evaluate Performance
Finally, continuous monitoring and evaluation of your core KPIs are essential to ensure the success of your expansion efforts. Remember, what gets measured gets done.
“Regularly track your performance metrics,” Dee Agarwal recommends. “Analyze what’s working and what’s not, and be ready to make necessary adjustments. Scaling up is an ongoing process of learning and improvement.”
Dee Agarwal Final Thoughts on Scaling
Scaling up to larger markets can propel your business to new heights, but it requires careful planning and execution. By taking cues from Dee Agarwal’s checklist, businesses can navigate the complexities of expansion and position themselves for sustained success.
“Scaling up is not just about growing bigger; it’s about growing better,” Dee Agarwal concludes. “With the right strategy and mindset, you can achieve remarkable growth and make a significant impact in larger markets and with customers.”
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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
Eric Banoun Investments Eyes AI Startups in Defence and Cyber Security

Israel, 28th Apr 2025 – The AI in startups has been booming. With artificial intelligence (AI) chatbots using natural language processing to create humanlike conversational dialogue, leading a wide revolution for many industries. AI is now everywhere and will continue to evolve fast opening new opportunities.
Eric Banoun Investments is now seeking entrepreneurs experimenting in the security space with AI. A fresh fund has been prepared focusing on solving large, pressing problems through innovation and technology.
Speaking to the media, Eric Banoun said: “The fund looks to attract its first set of startups by May and the initial rounds will be expected to close in June. We want to assist startups in a manner that they can multiply their success rate by ten folds and really create an impact in the security industry, creating massive impact to the cyber space”
Eric Banoun in the past has been a senior executive with a global track record in leading large-scale sales initiatives. As Global VP of Sales at NICE Systems, drove major projects and market growth worldwide. Co-founded Circles Technologies (acquired in 2014), and held VP roles at ECI Telecom and Orckit, expanding sales in Asia and globally. Early career included work with Boeing’s Interior Crashworthiness Division, partnering with leading airlines.
Eric now has a team which evaluates the startups and is now well-positioned to handle larger volume deals. They want to make this fund more accessible and inclusive for founders with a vision to improve security and defence.
Apply for investment through the website: https://ericbanoun.com/apply/
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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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