On November 9, 2023 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing viral immunotherapies to help patients fight cancer, reported financial results for the third quarter ended September 30, 2023, and provided a corporate update (Press release, Candel Therapeutics, NOV 9, 2023, View Source [SID1234637356]).

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"Candel has made very significant progress with our viral immunotherapy platforms and oncology-focused pipeline," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "We are encouraged by the recent clinical and biomarker data for CAN-2409 in NSCLC and pancreatic cancer, and CAN-3110 in recurrent HGG. The quality of the science was recently validated by a publication in Nature. Our off-the-shelf investigational medicines are designed to elicit individualized, systemic anti-tumor immune responses and, to date, have shown promise for extended survival beyond historical rates, along with a generally favorable safety and tolerability profile. We observed markedly increased immune cell infiltration in immunosuppressive tumors and systemic immune activation after experimental treatment with both CAN-2409 and CAN-3110."

"We look forward to multiple anticipated data readouts in 2024, including topline overall survival data from the phase 2 clinical trial of CAN-2409 in NSCLC in Q2 2024, topline progression-free survival data from the randomized phase 2 study of CAN-2409 vs. active surveillance alone in early localized prostate cancer, and topline disease-free survival data from the randomized phase 3 clinical trial of CAN-2409 in intermediate to high risk localized prostate cancer in Q4 2024, in addition to the first data on multiple injections of CAN-3110 in recurrent HGG in the second half of 2024," Dr. Tak concluded.

Third Quarter 2023 & Recent Highlights

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Program Updates:
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CAN-2409 – Non-Small Cell Lung Cancer (NSCLC)
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Initial data from the phase 2 NSCLC clinical trial suggested promising extension of overall survival, consistent with an increased tail on the maturing survival curve in patients whose disease progressed despite receiving anti-PD(L)1 treatment (Cohort 2).
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Data showed 93% of patients with long survival (≥12 months) were low or negative for PD-(L)1 expression, which supports the potential of CAN-2409 to convert patients unresponsive to immune checkpoint inhibitor treatment into long-term survivors.
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Robust activation of the immune system and immunological correlations between early changes in key effector immune populations after CAN-2409 treatment and survival suggested the potential to use early biological readouts as predictors of clinical response.
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CAN-3110 – Recurrent High-Grade Glioma (HGG)
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Nature published results from the phase 1 investigator-sponsored clinical trial of CAN-3110 in 41 patients with recurrent HGG.
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New findings demonstrated that the proposed dual mechanism of CAN-3110 to trigger potent oncolysis and immune activation may be further enhanced in the presence of pre-existing antibodies to HSV (herpes simplex virus)-1.Median overall survival (mOS) of 14.2 months was observed in the patients with antibodies to HSV-1 virus (66%), present either at baseline or developed after CAN-3110 treatment.

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As of the data cut-off of April 20, 2023, data support the continued tolerability of a single injection of CAN-3110 in recurrent HGG with no dose-limiting toxicity and observed nearly doubling of the expected mOS in 50 patients (Arm A and B).
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The observed increase in diversity of the T-cell receptor repertoire associated with improved survival after a single injection, suggests that CAN-3110 can induce a broad and diverse immune response against HSV-1 and against the newly released tumor antigens.
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Arm C, supported by the Break Through Cancer Foundation, is currently evaluating the effects of repeat dosing of CAN-3110 (up to six injections over four months).
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CAN-2409 – Pancreatic Cancer
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Positive overall survival and immunological biomarker data were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting for 2023, based on an interim analysis of the ongoing, randomized, phase 2 clinical trial of CAN-2409 plus prodrug together with SoC chemoradiation followed by resection for borderline resectable non-metastatic pancreatic ductal adenocarcinoma (PDAC) as of the August 21, 2023 data cutoff date.
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An estimated survival rate of 71.4% at 36 months was observed in patients who received 2 or 3 injections of CAN-2409 regimen together with SoC chemoradiation prior to surgery, versus only 16.7% estimated survival at 36 months with SoC chemoradiation prior to surgery.
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Patients whose cancer progressed showed an altered disease course after salvage chemotherapy with improved CA19-9 levels (biomarker of tumor burden) and ongoing survival. Similar responses were not observed in the control arm.
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Biomarker analysis demonstrated dense aggregates of immune cells that included CD8 positive granzyme B positive cytotoxic T cells, dendritic cells, and B cells in PDAC tissue resections obtained after CAN-2409 treatment, which confirmed activation of a robust antitumoral immune response.
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enLIGHTEN Discovery Platform
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Presented the first experimental agent from the enLIGHTEN Discovery Platform, Alpha-201-macro1, during SITC (Free SITC Whitepaper). This new agent is an investigational viral immunotherapy that is designed to interfere with the CD47/ SIRPα pathway and activate innate immune surveillance. Results demonstrated monotherapy activity

following local administration in a preclinical model of breast cancer.
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Additional preclinical data presented at SITC (Free SITC Whitepaper) confirmed the capability of the enLIGHTEN Advanced Analytics suite to predict optimal gene payload combinations to arm viral vectors, that enable the design of potential combination therapeutics to overcome tumor resistance especially in cancers resistant to immune checkpoint inhibitor treatment.
Anticipated Milestones

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Expect to report topline overall survival data on the phase 2 clinical trial of CAN-2409 plus valacyclovir combined with continued PD-(L)1 targeting agents in patients whose disease progresses despite receiving anti-PD-(L)1 treatment with late-stage NSCLC (Cohort 2) in Q2 2024.
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Expect to report topline disease-free survival data on the fully enrolled, pivotal, placebo-controlled, randomized phase 3 clinical trial of CAN-2409 in combination with valacyclovir in localized intermediate/high-risk prostate cancer in Q4 2024.
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Expect to report topline progression-free survival data on the fully enrolled, placebo-controlled, randomized phase 2 clinical trial of CAN-2409 in patients with low-to-intermediate-risk, localized, non-metastatic prostate cancer in Q4 2024.
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Expect to report clinical and immunological biomarker data in patients with recurrent HGG enrolled into Arm C, evaluating repeat dosing regimen of CAN-3110 in 2H 2024.

Financial Results for the Quarter Ended September 30, 2023

Research and Development Service Revenue, related party: Research and development service revenue, related party, was $0 for the third quarter of 2023 compared to $31,000 for the third quarter of 2022, as the amortizable $1.0 million up-front license fee that Candel received in 2014 and 2015 from Ventagen LLC was fully recognized as of December 2022.

Research and Development Expenses: Research and development expenses were $5.8 million for the third quarter of 2023 compared to $5.4 million for the third quarter of 2022. The increase was primarily due to manufacturing and regulatory activities in support of the Company’s CAN-2409 programs. Research and development expenses included non-cash stock compensation expense of $0.3 million for both the third quarter of 2023 and the third quarter of 2022.

General and Administrative Expenses: General and administrative expenses were $3.0 million for the third quarter of 2023 compared to $3.5 million for the third quarter of 2022. The decrease was primarily due to lower professional service and consulting expenses, recruiting and insurance costs. General and administrative expenses included non-cash stock compensation expense of $0.4 million for both the third quarter of 2023 and the third quarter of 2022.

Net Loss: Net loss for the third quarter of 2023 was $8.4 million compared to a net loss of $8.7 million for the third quarter of 2022, and included net other income of $0.4 million and $0.2 million, respectively, primarily related to the change in the fair value of the Company’s warrant liability.

Cash Position: Cash and cash equivalents as of September 30, 2023 were $43.0 million. The Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the second quarter of 2024.