–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.

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