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By Jeremy Golden, Benzinga

Among brain tumors, high-grade gliomas are the most frequently diagnosed and fatal. Most of the patients with high-grade glioma will have glioblastoma, a more aggressive form of the cancer. The global burden of high-grade gliomas, which have a median overall survival of less than 15 months, cannot be understated, especially given the lack of available treatments to date. The unmet need is even greater in patients with recurrent high-grade glioma, where the expected median overall survival is less than 6 to 9 months.

A leader in the development of therapies to treat this field of rare tumors, clinical-stage biopharmaceutical company Candel Therapeutics, Inc. (NASDAQ: CADL), is developing CAN-3110 – a first-in-class drug candidate – to help patients combat these deadly tumors.

Candel Therapeutics leverages the ability of viral gene constructs to activate cancer-killing mechanisms, exposing multiple tumor antigens and inhibiting the immunosuppressive tumor microenvironment. The company reports that this tactic has been shown to produce an individualized immune response specific to the patient and their cancer.

The company’s viral immunotherapy approach utilizes intratumoral administration of genetically engineered viruses to selectively induce tumor cell death. This elicits an innate and adaptive systemic immune response against the injected tumor and uninjected distant metastases. Best of all, local delivery enables Candel to achieve these results while aiming to minimize systemic toxicity.

The lead product candidate in Candel Therapeutics’ HSV platform, CAN-3110, is a replication-competent herpes simplex virus-1 (HSV-1) engineered to enhance the selective killing of cancer cells while sparing healthy neighboring cells. Designed with dual activity for oncolysis and immune activation in a single therapeutic, CAN-3110’s activity is designed to be conditional to the expression of Nestin in cancer cells.

CAN-3110 is being evaluated in a phase 1b investigator-sponsored clinical trial in patients with recurrent high-grade glioma. The results from this ongoing clinical trial were recently published in Nature.

Investigators discovered that the drug candidate was well tolerated with no dose-limiting toxicity reported, and CAN-3110 was associated with improved survival. Pre-existing anti-HSV-1 immunity increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after treatment were all associated with improved survival.

“Single-timepoint intralesional injection of rHGG with CAN-3110 enriches the tumor microenvironment with tumor infiltrating lymphocytes, inducing defined changes in peripheral and tumor T cell repertoires and tumor transcriptomic signatures,” investigators wrote in the report. “These changes are particularly evident in patients who are seropositive for HSV1 and are associated with improved survival in this otherwise therapy-refractory cancer. These findings therefore provide human immunological and biological evidence supporting the ability of CAN-3110 to convert the immunosuppressive one immunosuppressive tumor microenvironment characteristic of many solid cancers into a one that is more favorable to immunologic rejection of the tumor.”

In the CAN-3110 clinical trial, Candel Therapeutics reports that a near-doubling of the expected median overall survival was observed after a single CAN-3110 injection, compared to historical reports of less than 6 to 9 months in this therapy-resistant condition.

The company’s scientists and academic collaborators are currently evaluating the effects of multiple CAN-3110 injections in recurrent high-grade glioma, supported by the Break Through Cancer Foundation. Fresh off receiving FDA Fast Track Designation for the treatment of recurrent high-grade glioma, Candel Therapeutics plans to announce a data readout for the multiple injection cohort in CAN-3110’s phase 1 trial in 2H 2024. They expect initial results in the second half of 2024.

How Does CAN-3110 Work?

The off-the-shelf drug candidate is engineered for selective replication by placing ICP34.5 – the gene controlling HSV replication – under the control of the Nestin promoter. Nestin is highly expressed in high-grade glioma cells but absent in healthy adult brain cells, which could explain why dose-limiting toxicity was not observed in a study of a single injection of CAN-3110 into the brain tumor in patients with recurrent high-grade glioma.

Nestin expression has also been detected in aggressive tumors other than high-grade glioma, broadening the potential reach of CAN-3110 into other indications outside the brain – creating a future pipeline-in-a-product.

For more information on Candel Therapeutics, visit candeltx.com.

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, Candel’s 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 management’s 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 Company’s 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 Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s SEC filings, including the Company’s 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 Company’s 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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Contact Details

Aljanae Reynolds

+1 617-916-5445

areynolds@wheelhouselsa.com

Company Website

https://www.candeltx.com/

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