Shares of Candel Therapeutics Inc. (CADL) have surged by over 830% in the past two months due to significant progress in its clinical programs.
The company operates two clinical-stage multimodal biological immunotherapy platforms: one focused on genetically modified adenovirus gene constructs and the other on genetically modified herpes simplex virus (HSV) gene constructs.
The lead candidate from the adenovirus platform, CAN-2409, is being evaluated for non-small cell lung cancer, borderline resectable pancreatic ductal adenocarcinoma, and localized non-metastatic prostate cancer.
### Ongoing Trials & Updates
- **Pancreatic Ductal Adenocarcinoma (PDAC):**
A phase II trial is underway for CAN-2409 combined with valacyclovir (a prodrug) and standard-of-care chemoradiation, followed by resection for borderline resectable PDAC. Interim data, announced in April, showed an estimated median overall survival of 28.8 months for the experimental treatment group versus 12.5 months for the control group. At 24 months, survival rates were 71.4% in the CAN-2409 group compared to 16.7% in the control group, and at 36 months, estimated survival was 47.6% versus 16.7%.
- **Non-Small Cell Lung Cancer (NSCLC):**
A phase II trial of CAN-2409 combined with valacyclovir and continued immune checkpoint inhibitor (ICI) treatment is being assessed in patients with stage III/IV NSCLC who have inadequate responses to front-line anti-PD(L)1 therapy. Promising initial survival data from September indicates that out of 40 evaluable patients, 15 have survived at least 12 months, with 10 surpassing 18 months. Four patients exceeded 24 months of overall survival, with the longest being 31.7 months as of the data cut-off on August 1, 2023. Historically, these patients had a median overall survival of 10-13 months.
- **Prostate Cancer:**
CAN-2409 is being tested in two trials: a phase III trial for localized intermediate/high-risk prostate cancer and a phase II trial for low-to-intermediate-risk, localized, non-metastatic prostate cancer.
Next in the pipeline is **CAN-3110**, the lead candidate from the HSV platform, currently in a phase Ib clinical trial for recurrent high-grade glioma. Findings from last year’s trial indicated a median overall survival of approximately 12 months post a single CAN-3110 injection, compared to historical reports of less than 6 to 9 months for this therapy-resistant condition.
### Anticipated Milestones
- **June 3, 2024:** Phase II topline overall survival data for CAN-2409 in NSCLC to be presented at ASCO.
- **H2 2024:** Updated Phase Ib data for CAN-3110 in recurrent high-grade glioma expected.
- **Q4 2024:** Expected release of Phase II topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer.
- **Q4 2024:** Phase III topline disease-free survival data for CAN-2409 in localized intermediate/high-risk prostate cancer anticipated.
### Financial Position
As of March 31, 2024, the company reported cash and cash equivalents of $25.7 million, sufficient to fund current operations through the fourth quarter of 2024.
Candel Therapeutics debuted on the Nasdaq Global Select Market on July 27, 2021, with its shares priced at $8 each. Over the last year, the stock has ranged between $0.66 and $14.28, closing at $14 yesterday, up 30.84%.
