Candel Therapeutics, a leading clinical-stage biopharmaceutical company specializing in the development of multimodal biological immunotherapies for cancer, announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for the company’s groundbreaking adenovirus asset, CAN-2409, in combination with the prodrug valacyclovir, aimed at enhancing overall survival rates in pancreatic ductal adenocarcinoma (PDAC) patients.
The announcement prompted a notable surge in Candel Therapeutics’ stock, which opened Tuesday’s trading at $1.35, a substantial increase from the previous day’s closing at $0.86.
At the time of this publication, Candel Therapeutics Inc stock (CADL) has witnessed a surge.
Candel Therapeutics Inc
Current Price: $1.21
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Expressing enthusiasm, Paul Peter Tak, MD, PhD, FMedSci, President, and CEO of Candel, remarked, “We are pleased with the FDA’s decision to grant Fast Track Designation for CAN-2409 in pancreatic cancer. This milestone follows our first interim data report from the randomized phase 2 clinical trial in patients with borderline resectable PDAC.”
Candel’s ongoing clinical trial has demonstrated promising results, indicating prolonged and sustained survival among patients who received experimental treatment with CAN-2409, particularly when compared to real-world data on patients undergoing radiotherapy. The company is on schedule to unveil updated overall survival data from the interim analysis in the second quarter of 2024.
In November 2023, Candel presented compelling overall survival and immunological biomarker data from an interim analysis of its phase 2 clinical trial. The trial evaluated CAN-2409 in conjunction with the prodrug and standard of care neoadjuvant chemoradiation, followed by resection for borderline resectable non-metastatic PDAC. The findings, disclosed at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, showcased an estimated survival rate of 71.4% at both 24 and 36 months for patients receiving 2 or 3 injections of the CAN-2409 plus prodrug regimen, coupled with standard of care chemoradiation before surgery.
In stark contrast, patients treated solely with standard of care chemoradiation before surgery exhibited a mere 16.7% estimated survival rate at both 24 and 36 months. The data strongly supports the potential efficacy of CAN-2409 in improving patient outcomes.
Notably, the immunological changes observed in resected pancreatic tissue following CAN-2409 administration suggested the investigational treatment’s ability to activate a robust immunologic antitumoral response in this traditionally “cold” tumor.
Candel Therapeutics acknowledges the pivotal role played by patients, caregivers, investigators, and clinical sites in advancing the clinical trial. The company remains dedicated to furthering its mission of delivering innovative and effective cancer therapies, with a commitment to releasing comprehensive updates on overall survival data in the coming months.
As Candel Therapeutics continues its pioneering work in the field of pancreatic cancer treatment, the Fast Track Designation by FDA underscores the significance and potential impact of CAN-2409 in reshaping the landscape of PDAC therapy. Investors and the medical community alike eagerly anticipate further developments as Candel progresses towards its goal of improving the lives of cancer patients through cutting-edge immunotherapies.
