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Candel Therapeutics (NASDAQ: CADL) Lead Candidate CAN-2409 Combats Lung, Pancreatic And Prostate Cancers With Fast Track Designation For Three Cancers

Published

6 months ago

on

–News Direct–

By Jeremy Golden, Benzinga

Immunotherapy has transformed the way cancer is treated, but just 20% to 40% of patients typically respond to FDA-approved immune checkpoint inhibitor (ICI) treatments.

Poor ICI treatment response has been linked to the tumors ability to disguise antigen presentation and generate an immunosuppressive microenvironment. In addition, most conventional immunotherapies are not designed to educate the patients immune system on how to recognize a variety of tumor antigens and neoantigens.

Amid this landscape, a clinical-stage biopharmaceutical company has developed a new multimodal biological approach that leverages the ability of viral gene constructs to activate cancer-killing mechanisms, exposing multiple tumor antigens to the immune system, resulting in vaccination against the tumor while inhibiting the immunosuppressive tumor microenvironment.

Candel Therapeutics, Inc. (NASDAQ: CADL) is developing a product candidate that is being studied in lung, pancreatic and prostate cancers. 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 patients own tumor.

Part of the companys adenovirus platform, CAN-2409 is injected directly into the tumor or target tissue using a localized injection, akin to the standard approach for vaccination.

CAN-2409's adenoviral construct serves as a vector to transport the HSV-thymidine kinase gene into tumor cells at the site of injection. These tumor cells can then express HSV-thymidine kinase, which converts generic, FDA-approved anti-herpes drugs such as ganciclovir, acyclovir and valacyclovir into a toxic nucleotide analog that blocks DNA synthesis in dividing cells.

Cancer cells exposed to the toxic nucleotide analog in the tumor microenvironment have been observed to undergo immunogenic cell death. Simultaneously, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment, creating the optimal conditions to induce a specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad and systemic anti-tumor activity.

CAN-2409 is currently being studied in an open-label, phase 2 clinical trial in non-small cell lung cancer (NSCLC) and in randomized, controlled, blinded phase 2b and phase 3 clinical trials in prostate cancer. The company has recently released very encouraging data for CAN-2409s ability to improve overall survival in non-metastatic pancreatic cancer, with topline overall survival data in non-small cell lung cancer planned for this quarter (Q2 2024) and results from the prostate clinical trials later this year (Q4 2024).

When it comes to NSCLC, the company previously presented data from the phase 2 clinical trial in which patients received two administrations of CAN-2409 plus prodrug. Those patients demonstrated the following:

1) Increased infiltration of CD8+ cytotoxic T cells in the tumor microenvironment, systemic expansion of effector T cells and increased soluble granzyme B levels in peripheral blood;

2) Favorable changes in the trajectory of tumor progression;

3) Decreased tumor size of target lesions in most patients; and

4) Reduced size of uninjected tumor lesions.

The CAN-2409 immunotherapy antitumor strategy aims to increase the number of long survivors beyond 10 to 13 months.

As previous work has shown that progressive disease could be converted into stable disease in most patients with non-small cell lung cancer after CAN-2409 treatment, the hypothesis is that this will translate into improved survival.

When it comes to pancreatic cancer, the company reported notable improvements in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) after experimental treatment with CAN-2409. The estimated overall survival rate was 71.4% at 24 months in CAN-2409-treated patients versus only 16.7% in the control arm after chemoradiation.

In 2023, CAN-2409 received Fast Track Designation for both non-small cell lung cancer and pancreatic cancer, a validation from the FDA on its potential. CAN-2409 plus valacyclovir in combination with continued PD-1/PD-L1 agents is being evaluated in an ongoing, open-label phase 2 clinical trial in patients with late-stage NSCLC and an inadequate response to anti-PD(L)-1 therapy. In 2024, CAN-2409 also received Orphan Drug Designation from the FDA for CAN-2409 in borderline resectable pancreatic cancer.

In the upcoming year, Candel plans to announce data readouts for the following:

1) Phase 2 topline overall survival (OS) data for CAN-2409 in NSCLC, expected in Q2 2024;

2) Phase 2 topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer, expected in Q4 2024;

3) Phase 3 topline data for CAN-2409 in localized intermediate/high-risk prostate cancer, expected in Q4 2024.

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

Aljanae Reynolds

+1 617-916-5445

areynolds@wheelhouselsa.com

Company Website

https://www.candeltx.com/

View source version on newsdirect.com: https://newsdirect.com/news/candel-therapeutics-nasdaq-cadl-lead-candidate-can-2409-combats-lung-pancreatic-and-prostate-cancers-with-fast-track-designation-for-three-cancers-458506267

Candel Therapeutics

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UVKXE Releases Anti-Scam Guide, Enhancing User Security Protections

Published

20 hours ago

on

November 23, 2024

By

DENVER — Recently, the globally renowned cryptocurrency trading platform UVKXE has published its latest anti-scam guide to address the escalating threats of online scams, establishing a comprehensive protective barrier for users worldwide. The guide focuses on various scamming tactics prevalent in the cryptocurrency sector, highlighting what users should be aware of during transactions and asset management, while also providing effective preventive measures.

Kevin Anderson, CEO of UVKXE, noted: “As the cryptocurrency market continues to expand, more cybercriminals are turning their attention to cryptocurrency users, developing sophisticated scam techniques. As a well-known platform in the cryptocurrency trading field, UVKXE has a responsibility to help users identify and mitigate these potential risks. Through the release of this anti-scam guide, we aim to further enhance user awareness and safeguard their digital asset security.”

The guide outlines the common characteristics of these scams, such as phishing emails that typically use UVKXE or similar official-sounding names, along with forged logos and links, to deceive users into providing their login credentials and sensitive information. It also advises users to always choose official channels when downloading applications to avoid malicious software. Furthermore, UVKXE emphasizes that the platform will never proactively request users to provide sensitive information such as passwords or verification codes in any form.

In addition to the anti-scam guide, UVKXE will launch a series of interactive activities, utilizing community forums and video tutorials to educate users about safety knowledge and help them recognize and respond to potential threats. The UVKXE security team stated that these activities will not only provide real-time updates on scams but also offer users opportunities for direct communication and inquiries.

The investment in technology and education is reflected not only in the publication of the anti-scam guide but also in daily operations and maintenance. Kevin Anderson concluded: “Every protective measure and security technology implemented by UVKXE is designed to ensure the safety of user assets. In the future, we will continue to advance this mission, providing users with safer and more convenient cryptocurrency trading services.”

Media Contact:
Company Name: UVKXE CRYPTO TECH CO.,LTD.
Company website: https://www.uvkxe.co
Contact person’s full name: Mayang
Email id: mayang@uvkxe.co

Disclaimer: This content is provided by sponsor. The statements, views and opinions expressed in this column are solely those of the content provider. The information provided in this press release is not a solicitation for investment, nor is it intended as investment advice, financial advice, or trading advice. It is strongly recommended you practice due diligence, including consultation with a professional financial advisor, before investing in or trading cryptocurrency and securities. Please conduct your own research and invest at your own risk.

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Press Release

UVKXE Clarification Statement: A Legally Compliant Trading Platform with International Accreditation

Published

20 hours ago

on

November 23, 2024

By

DENVER — Recently, the Securities Commission Malaysia (SC) published a list on its official website of cryptocurrency trading platforms that have not met its local registration requirements, mentioning UVKXE. UVKXE takes this matter seriously and wishes to clarify its credentials and compliance status to its users.

Global Compliance Credentials of UVKXE

UVKXE is committed to operating under legal and compliant principles, upholding a user-first core value. The platform has obtained several certifications from international authoritative regulatory bodies, including but not limited to:

U.S. MSB License
UVKXE has obtained the MSB license issued by the U.S. FinCEN. This certification represents the highest recognition by the U.S. government for financial service institutions, ensuring that UVKXE can legally conduct cryptocurrency-related business.

U.S. SEC License
As one of the few cryptocurrency trading platforms registered with the U.S. Securities and Exchange Commission (SEC), UVKXE complies with securities and investment-related legal regulations, providing users with a safer and more transparent investment environment.

Background on the Malaysian Public List

The list published by the Securities Commission Malaysia mainly targets trading platforms that have not met local registration requirements, such as Binance and Bursa Malaysia, rather than denying the platform legality. UVKXE has obtained multiple authoritative licenses internationally, and its compliance is beyond doubt. UVKXE is in communication with relevant departments to understand local specific regulations and to advance the registration process, ensuring compliance with local market requirements.

Commitment to Legal Compliance and User-Centric Values

UVKXE will use this event as an opportunity to further enhance its global compliance framework, actively adapting to regulatory environments in various countries, and providing users with more professional and diversified financial services. We sincerely thank all users for their trust and support! UVKXE promises that no matter where it operates, the platform will always adhere to the core philosophy of “user-first”, moving together with global users towards a safer, more open, and transparent new era of the digital economy.

Media Contact:
Company Name: UVKXE CRYPTO TECH CO.,LTD.
Company website: https://www.uvkxe.co
Contact person’s full name: Mayang
Email id: mayang@uvkxe.co

Disclaimer: This content is provided by sponsor. The statements, views and opinions expressed in this column are solely those of the content provider. The information provided in this press release is not a solicitation for investment, nor is it intended as investment advice, financial advice, or trading advice. It is strongly recommended you practice due diligence, including consultation with a professional financial advisor, before investing in or trading cryptocurrency and securities. Please conduct your own research and invest at your own risk.

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Press Release

UVKXE Strengthens Security Strategy, Leading Innovations in Anti-Scam Technology for Crypto Platforms

Published

20 hours ago

on

November 23, 2024

By

DENVER — Recently, the globally recognized cryptocurrency trading platform UVKXE officially announced the completion of its latest security system upgrade. This upgrade significantly enhances the cybersecurity defenses of the platform and introduces cutting-edge anti-scam technologies. Through this technological update, UVKXE demonstrates its commitment to user asset security and proactive measures against potential future cyber threats.

Kevin Anderson, CEO of UVKXE, stated: “User trust is the foundation of UVKXE, and ensuring the security of user assets is always our top priority. This security system upgrade incorporates AI deep learning, real-time risk control, and efficient anomaly detection algorithms, aiming to create a safe and trustworthy trading environment for users. We will continue to optimize the security measures for user assets, ensuring that every user can trade confidently on UVKXE.”

The focus of this security system upgrade is primarily on anti-scam technologies. In response to the ever-evolving online threats and scam tactics in recent years, UVKXE has strengthened its multi-layered protective mechanisms, effectively enhancing the security and responsiveness of the system. The upgrade introduces AI-driven anti-scam technology, which intelligently analyzes user behavior through deep learning algorithms, allowing for rapid identification and isolation of suspected scamming activities. The AI anti-scam system can monitor and analyze large volumes of trading data in real time, immediately freezing any suspicious transactions or account activities to safeguard user assets.

Kevin Anderson further explained: “Traditional anti-scam methods often rely on post-event analysis, whereas the new system of UVKXE can identify risks promptly before incidents occur, taking immediate action to prevent losses.”

In terms of anomaly detection, the system of UVKXE combines the transaction histories, asset conditions, login locations, and other multidimensional data of users to accurately pinpoint potential security vulnerabilities. Through anomaly detection technology, each user login and transaction can be monitored in real time, with timely alerts prompting users to confirm actions, further enhancing the security of the platform.

Kevin Anderson concluded: “We hope every user can enjoy a secure trading experience on UVKXE. By continually optimizing our security strategies, we aim to provide a safer and more convenient cryptocurrency trading experience for our users.”

Media Contact:
Company Name: UVKXE CRYPTO TECH CO.,LTD.
Company website: https://www.uvkxe.co
Contact person’s full name: Mayang
Email id: mayang@uvkxe.co

Disclaimer: This content is provided by sponsor. The statements, views and opinions expressed in this column are solely those of the content provider. The information provided in this press release is not a solicitation for investment, nor is it intended as investment advice, financial advice, or trading advice. It is strongly recommended you practice due diligence, including consultation with a professional financial advisor, before investing in or trading cryptocurrency and securities. Please conduct your own research and invest at your own risk.

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Cloud PR Wire

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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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