Candel soars on updated survival data for pancreatic cancer vaccine

04 Apr 2024
firstwordpharma.com
Clinical ResultPhase 2VaccineFast TrackImmunotherapy
After interim survival data prompted the FDA to bestow fast-track designation upon Candel Therapeutics’ experimental cancer vaccine late last year, longer-term results released Thursday suggested that its benefit is more than double that of standard treatment. Shares of the biotech shot up more than 280% on the data.
The Phase II trial randomised seven patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) to receive Candel’s viral immunotherapy CAN-2409, and six to receive standard-of-care chemotherapy.
CAN-2409 led to an estimated median overall survival (OS) of 28.8 months, versus an OS of 12.5 months for the control group.
Additionally, four of the PDAC patients who received CAN-2409 were alive at the data cut-off of March 29, with two of those surviving for more than 50 months since enrollment. Only one patient in the comparator group remained alive at data cut-off.
The latest readout builds on interim results released in November. Candel presented 24-month data at the Society for Immunotherapy (SITC) annual meeting showing that CAN-2409-treated patients had a survival rate of 71.4%, compared with 16.7% for those who received standard-of-care chemotherapy.
Candel shared updated 36-month survival data on Thursday, with an estimated rate of 47.6% for the CAN-2409 group, versus 16.7% for control. Additionally, no dose-limiting toxicities or cases of pancreatitis were observed in the CAN-2409 arm.
CAN-2409 is an off-the-shelf immunotherapy that uses an adenovirus vector to deliver the herpes simplex virus (HSV) thymidine kinase gene to a patient’s tumour. When co-administered with valacyclovir, the HSV kinase converts the oral antiviral into a form that is toxic to nearby cancer cells, causing immunogenic cell death and the release of tumour-specific antigens that are then recognised by the immune system. Because the adenovirus itself provokes an inflammatory immune response – which can now recognise the tumour’s neoantigens – a patient is essentially “vaccinated” against the tumour and any distant metastases.
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