Candel Therapeutics’ Phase II trial has seen its immunotherapy candidate elicit a median overall survival (OS) of 31.4 months in patients with non-metastatic pancreatic ductal adenocarcinoma (PDAC).
Final data from the randomised control trial of CAN-2409 (NCT02446093) saw three of the seven patients dosed with CAN-2409 still alive at the end of the trial, with survival of 66.0, 63.6 and 35.8 months after enrolment compared to an average of 12.5 months in the control group.
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Additionally, these three patients, in contrast to patients in the control arm, saw some disease recurrence but responded to salvage chemotherapy and experienced extended post-progression survival at the time of the data cutoff.
Investors do not seem convinced by the data, however, with the company’s stock dropping by more than 20% after the market opening this morning (25 February).
The Phase II trial examined CAN-2409 in combination with Glaxo Smith Kline’s (GSK’s) Valtrex (valacyclovir) alongside the current standard-of-care (SOC) chemoradiation therapy in patients with borderline resectable PDAC.
Candel’s chief medical officer, Garrett Nichols, said: “Pancreatic cancer remains one of the most difficult to treat diseases.
“Patients with borderline resectable PDAC often have undetectable metastases that are not cleared with the current standard of care neoadjuvant chemoradiation and surgery. CAN-2409 is a first-in-class multimodal immunotherapy candidate designed for in situ vaccination against the patient’s tumour, which offers the potential to control this disease and to prolong survival, thus improving outcomes following this dismal prognosis.”
Paul Peter Tak, president of Candel, said: “The notable benefits observed with CAN-2409 in this clinical trial, including evidence of a long tail of survival, highlights the transformative potential of this biological multimodal immunotherapy in difficult-to-treat cancers.
“The data presented today support the potential of CAN-2409 across various solid tumours, by showing its potential to alter the balance between the pancreatic tumour and the anti-tumour immune response, even in patients with residual tumour, improving long-term survival in a subset of the patients.”
Previously CAN-2409 (aglatimagene besadenovec), was granted orphan drug designation by the US Food and Drug Administration (FDA) in combination with Valtrex for the treatment of PDAC. CAN-2409 is an adenoviral replication-defective engineered gene construct encoding the thymidine kinase gene derived from inactivated herpes simplex virus (HSV) to directly deliver a gene to cancer cells. This is followed by an anti-herpetic therapy with Valtrex (valacyclovir), killing the cells containing the gene.
Currently, Candel also is evaluating CAN-2409 in non-small cell lung cancer (NSCLC), and localised, non-metastatic prostate cancer. A Phase III trial of the therapy in prostate cancer met its primary endpoint, the company announced in December 2024, sending the company’s stock flying by 174%.
Research by GlobalData estimates that the market for PDAC therapies stood at approximately $29.7bn, with that figure predicted to rise to $38bn by the end of 2030. Of 2024 sales, more than $29.4bn of that was brought in by Merck’s blockbuster drug Keytruda.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the field of pancreatic cancer therapies, the Paul-Ehrlich-Institute (PEI) in Germany has granted approval to continue subject enrolment in cohort 5 of Oncolytics Biotech’s GOBLET trial. Meanwhile, US-based biopharma, Actuate Therapeutics’s elraglusib reduced the risk of death by 37% in a Phase I/II metastatic pancreatic cancer trial.
