On November 28, 2023 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported a strategic restructuring to focus on continuation and expansion of development of CAN-3110 as well as the enLIGHTEN Discovery Platform, while reducing the Company’s workforce and expenses associated with enabling commercial readiness of CAN-2409 (Press release, Candel Therapeutics, NOV 28, 2023, View Source [SID1234638017]). The Company expects to present initial activity and biomarker data for repeated injections of CAN-3110 in recurrent high-grade glioma in the second half of 2024 and new data for the second drug candidate based on the enLIGHTEN Discovery Platform in Q3 2024. The Company plans to continue to collect clinical data for key readouts for CAN-2409 in non-small cell lung cancer (NSCLC), with topline overall survival data of the open label phase 2 clinical trial expected in Q2 2024; pancreatic cancer, with an update on overall survival based on an interim analysis of the randomized, open label clinical trial in Q2 2024; and prostate cancer, with topline data for both fully enrolled randomized, blinded, placebo-controlled phase 2 and phase 3 clinical trials in Q4 2024.

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Based on the encouraging clinical activity data for CAN-2409, the large number of patients that might benefit from this treatment, and the investments needed for commercialization, the Company plans to explore the right partnering opportunities for the future development of this asset.

To focus on delivering on the value-creating catalysts in 2024, on November 28, 2023, Candel implemented a reduction in its workforce of approximately 50%. The Company estimates that it will incur a one-time restructuring charge of approximately $0.7 million in the fourth quarter of 2023 related to severance and healthcare and related benefits for terminated employees. Candel expects that the reduction in workforce, coupled with the reduced operating costs, will enable the Company’s existing cash resources to fund its revised operating plan into the fourth quarter of 2024, enabling the achievement of key catalysts next year.

"This decision, unfortunately, impacts our workforce," said Paul Peter Tak, MD PhD FMedSci, President and CEO of Candel. "I want to express my sincere gratitude for the very important work and valuable contributions of our departing employees. They have done amazing work advancing the pipeline and developing our investigational medicines. In the current market, we need to remain laser focused on delivering on our value-creating inflections points, while managing our expenditures. We have proof of mechanism and proof of concept in each indication that we are currently pursuing, and the value created in the past years will be leveraged in the multiple data readouts planned for 2024."

About the enLIGHTEN Discovery Platform

Candel’s enLIGHTEN Discovery Platform is a systematic, iterative herpes simplex virus (HSV)-based discovery platform leveraging human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors. In October 2022, the Company announced a discovery collaboration with the University of Pennsylvania Center for Cellular Immunotherapies to identify how viral immunotherapy could enhance the efficacy of CAR-T cell therapy in solid tumors. The enLIGHTEN Discovery Platform is designed to deconvolute the complexity of the tumor microenvironment to identify druggable properties that correlate with clinical outcomes. These discoveries are rapidly translated into optimized multi-gene payloads of tumor modulators that are tailored for specific indications, disease stage, and rationally designed therapeutic combinations. During the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2023 Annual Meeting and the International Oncolytic Virus Conference in November 2023, Candel presented encouraging data on the discovery pipeline, demonstrating the effects of Alpha 201-macro-1, an investigational locally delivered biological oncolytic therapeutic designed to interfere with the CD47/SIRP1a pathway, in a mouse model of breast cancer.

About CAN-3110

CAN-3110 is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate designed with dual activity for oncolysis and immune activation in a single therapeutic. Its activity is conditional to the expression of Nestin in cancer cells. CAN-3110 is being evaluated in a phase 1 investigator-sponsored clinical trial in patients with recurrent HGG. Earlier this month, the Company announced that Nature published results from this clinical trial. CAN-3110 was well tolerated with no dose-limiting toxicity reported and CAN-3110 plus prodrug was associated with improved survival. Positive HSV-1 serology was a predictor of response and was associated with improved survival. Increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after treatment were also associated with improved survival. In the clinical trial, the investigators observed a nearly doubling of the expected median overall survival after a single CAN-3110 injection, compared to historical reports of less than 6 to 9 months in this therapy-resistant condition. By comparison, survival in the anti-HSV1 positive patients treated with CAN-3110 was over 14 months. The Company and academic collaborators are currently evaluating the effects of multiple CAN-3110 injections in recurrent HGG, supported by the Break Through Cancer foundation, and expect initial results in H2 2024.

Candel will also initiate IND-enabling work in a second indication characterized by Nestin expression.

About CAN-2409

CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational off-the-shelf replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the disease. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ vaccination against a variety of tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, more than 950 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in NSCLC, borderline resectable pancreatic cancer, and localized, non-metastatic prostate cancer in ongoing clinical trials.