On April 4, 2024, Candel Therapeutics, Inc. (the “Company”) issued a press release announcing positive interim data from its randomized phase 2 clinical trial of CAN-2409 in non-metastatic pancreatic cancer.
A copy of the full press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.
On April 4, 2024, the Company announced positive interim data from its randomized phase 2 clinical trial of CAN-2409 in non-metastatic pancreatic cancer (as of a March 29, 2024 data cut-off):
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Prolonged and sustained survival was observed after experimental treatment with CAN-2409 in patients with borderline resectable pancreatic ductal adenocarcinoma (“PDAC”) (n=13)
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Estimated median overall survival was 28.8 months in the CAN-2409 group versus only 12.5 months in the control group.
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At 24 months, a survival rate of 71.4% was observed in CAN-2409 treated patients, after standard of care (“SoC”) chemoradiation and prior to surgery, versus only 16.7% in the control group. At 36 months, a survival rate of 47.6% was estimated in patients who received CAN-2409, together with SoC chemoradiation prior to surgery, versus only 16.7% in the control group.
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Importantly, 4 out of 7 patients who received CAN-2409 were still alive at the time of data cut-off, with 2 patients surviving more than 50.0 months from enrollment. Only 1 out of 6 patients, randomized to control SoC chemotherapy, remained alive at data cut-off (alive at 50.6 months).
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Previous analysis of blood and resected tumors showed consistent and robust activation of the immune response after experimental treatment with CAN-2409
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In pancreatic tissue of patients treated with CAN-2409 plus prodrug together with SoC (but not SoC alone), dense aggregates of CD8+ granzyme B positive cytotoxic tumor infiltrating lymphocytes, dendritic cells, and B cells were observed in the tumor microenvironment.
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Increased levels of soluble granzymes B and H, as well as pro-inflammatory cytokines, including IFN-γ, were observed in peripheral blood after CAN-2409 administration, but not after SoC.
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CAN-2409 continued to be associated with a favorable safety/tolerability profile
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Addition of CAN-2409 regimen to SoC was generally well tolerated, with no dose-limiting toxicities, including no cases of pancreatitis.
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