Candel Therapeutics Announces Late-Breaking Oral Presentation at SITC Annual Meeting with Data on CAN-2409 in Combination with Nivolumab in a Phase 1 Mechanistic Clinical Trial in Patients With High-Grade Glioma

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Therapeutic Candel

  • The combination of nivolumab and CAN-2409 administered during neurosurgery was generally well tolerated, with no significant additional toxicity compared to standard of care

  • Systemic immune activation was observed in peripheral blood after CAN-2409/valacyclovir administration prior to nivolumab treatment

  • The median overall survival (mOS) of patients with a methylated MGMT promoter was 30.6 months for those undergoing gross total resection (GTR) and 12.6 months for those undergoing subtotal resection (STR). For patients with an unmethylated MGMT promoter, the mOS was 13.2 months and 15.9 months, respectively.

NEEDHAM, Mass., Nov. 11, 2022 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Nasdaq: CADL), a clinical-stage biopharmaceutical company developing novel viral immunotherapies, today announced the presentation of late-breaking data of a Phase 1 mechanistic treatment clinical trial of CAN-2409, Candel’s lead viral immunotherapy in development, in combination with nivolumab and the standard treatment in patients with high-grade glioma. The data was presented at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) today in Boston.

In the trial of 35 evaluable patients, extensive biomarker analyzes demonstrated that the combination of CAN-2409 and nivolumab resulted in a statistically significant expansion of activated CD4+ and CD8+ T cells, as well as a decrease in markers of depletion of effector cells. Proteomic analysis by OLINK revealed an increase in pro-inflammatory cytokines, including interferon-gamma, chemokines CXCL9/10 and CXCL11, MCP-1, MCP-3, and granzyme A. Systemic immune activation was observed after the single administration of CAN-2409, before the start of nivolumab (week 3 post-treatment). The median overall survival (mOS) for patients with a methylated MGMT promoter was 30.6 months for those who underwent gross total resection (GTR) (n=10) and 12.6 months for those who underwent subtotal resection (STR) (n = 5). The mOS for patients with unmethylated MGMT was 13.2 months (GTR) (n=16) and 15.9 months (STR) (n=4), respectively.

“We are encouraged to see strong systemic immune activation after a single administration of CAN-2409 to the resection bed during neurosurgical tumor removal combined with nivolumab therapy in one of the most treatment-resistant cancers. , high-grade glioma, which is characterized by a highly immunosuppressive microenvironment,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel Therapeutics. “The data support potential therapeutic synergies between CAN-2409 in combination with immune checkpoint inhibitors in various solid tumors.”

The details of the oral presentation at the SITC are as follows:

Title of the oral presentation: First Efficacy and Multi-Omic Analysis Data from Phase 1 Clinical Trial of Viral Oncolytic Immunotherapy with CAN-2409 + Valacyclovir in Combination with Nivolumab and Standard Therapy in Newly Diagnosed High-Grade Glioma

  • Presenter: Patrick Y. Wen, MD, director, Cancer for Neuro-Oncology, Dana-Farber Cancer Institute; Professor, Neurology, Harvard Medical School; Principal Investigator for Candel Therapeutics

  • Abstract session: Late 204

  • Session date and time: Friday, November 11, 2022 at 11:25 a.m. ET

  • Location: Lobby B2, Omni Boston Hotel, Boston, MA or virtual

For more information about the clinical trial, please visit: https://www.clinicaltrials.gov/ct2/show/NCT03576612?term=candel&draw=3

About CAN-2409

CAN-2409, Candel’s most advanced viral immunotherapy candidate, is a replication-defective adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. Intratumoral administration results in the release of tumor-specific neoantigens into the microenvironment. At the same time, adenoviral capsid protein serotype 5 induces a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a specific CD8+ T cell-mediated response against the injected tumor and non-injected distant metastases for broad anti-tumor activity. Due to its versatility, CAN-2409 has the potential to treat a wide range of solid tumors. Monotherapy activity as well as combined activity with radiotherapy, surgery, chemotherapy and standard immune checkpoint inhibitors have already been demonstrated in several preclinical and clinical settings. In addition, CAN-2409 exhibits a favorable tolerance profile; over 950 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without undue concern for overlapping adverse events. Currently, Candel is also evaluating the effects of CAN-2409 treatment in non-small cell lung cancer, pancreatic cancer, and localized non-metastatic prostate cancer in ongoing clinical trials.

About Candel Therapeutics

Candel is a clinical-stage biopharmaceutical company focused on helping patients fight cancer through viral immunotherapies. Candel-modified viruses are designed to induce immunogenic cell death by direct viral cytotoxicity in cancer cells, thereby releasing tumor neoantigens while creating a pro-inflammatory microenvironment at the injection site. Candel has established two viral immunotherapy platforms based on novel genetically engineered adenoviruses and HSV constructs, respectively. CAN-2409 is the lead product candidate of the adenovirus platform and CAN-3110 is the lead product candidate of the HSV platform. Candel’s enLIGHTEN™ Discovery Platform is the first systematic and iterative HSV-based discovery platform leveraging human biology and advanced analytics to create novel viral immunotherapies for solid tumors.

For more information about Candel, visit: www.candeltx.com

Forward-looking statements

This press release contains certain information that contains “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 progress of development programs, including key milestones in reading data; expectations regarding the therapeutic benefit of its programs; and expectations regarding the cash trail and expenditures. The words “may”, “will”, “could”, “should”, “should”, “expect”, “plan”, “anticipate”, “intend”, “believe”, ” estimate”, “predict”, “project”, “potential”, “continuing”, “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. All forward-looking statements contained in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and factors that may cause actual events or results to differ. differ materially from those expressed or implied by any forward-looking statement. the statements contained in this press release, including, without limitation, risks and uncertainties relating to the timing and progress of development programs; expectations regarding the therapeutic benefit of the Company’s programs; the Company’s ability to effectively discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval for product candidates; the Company’s ability to retain 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 filings with the SEC, including the registration statement of the Company on Form S-1, the Company’s Quarterly Report on Form 10-Q filed on November 10, 2022, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which such statements may be based, or which may affect the likelihood that actual results will differ from those listed. in forward-looking statements. All forward-looking statements contained in this press release represent the views of the Company only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

Media Contact
Cassidy McClain
Account director
Evoke Canale
Cassidy.McClain@evokegroup.com
(619) 694-6291

Contact Investor
Sylvia Wheeler
Director
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com

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