Candel Lights Up Investors' Portfolio With 830% Gain

(RTTNews) - Shares of Candel Therapeutics Inc. (CADL) have gained more than 830% in the past 2 months, thanks to the substantial progress achieved across its clinical programs.

The company has two clinical stage multimodal biological immunotherapy platforms - one based on genetically modified adenovirus gene constructs and the other based on genetically modified herpes simplex virus (HSV) gene constructs.

The lead product candidate from the adenovirus platform is CAN-2409, being explored in the indications of non-small cell lung cancer borderline resectable Pancreatic Ductal Adenocarcinoma, and localized, non-metastatic prostate cancer.

Ongoing Trials & Updates

-- A phase II trial of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection for borderline resectable pancreatic ductal adenocarcinoma (PDAC) is underway.

In April of this year, the company announced encouraging interim data from the PDAC trial. These findings revealed notable improvements in the estimated median overall survival, with 28.8 months following experimental treatment with CAN-2409 versus only 12.5 months in control group in borderline resectable pancreatic ductal adenorcarcinoma.

Moreover, at 24 months, survival rate was 71.4% in CAN-2409 treated PDAC patients versus 16.7% in the control group after chemoradiation. At 36 months, estimated survival was 47.6% in the CAN-2409 group versus 16.7% in the control group.

-- In the indication of non-small cell lung cancer, a phase II trial is evaluating CAN-2409 plus valacyclovir and continued immune checkpoint inhibitor (ICI) treatment in patients with non-resectable, stage III/IV non-small cell lung cancer (NSCLC), who have an inadequate response to front line anti-PD(L)1 therapy.

The company announced promising initial survival data from the non-small cell lung cancer trial last September.

Among the 40 evaluable patients in cohorts 1 and 2 of the study, 15 non-small cell lung cancer patients have survived for at least 12 months. Out of these 15 patients, ten have surpassed the 18-month mark, with 70% still alive during the latest follow-up. Additionally, four patients have exceeded 24 months of overall survival, all of whom were alive at the most recent follow-up. The longest overall survival among these four patients reached 31.7 months by the data cutoff on August 1, 2023. It should be noted that these patients historically have had an expected median overall survival of 10-13 months.

-- In the indication of prostate cancer, CAN-2409 is under two trials - a phase III trial in localized intermediate/high-risk prostate cancer and a phase II trial in low-to-intermediate-risk, localized, non-metastatic prostate cancer.

Next in the pipeline is CAN-3110, which is the lead product candidate from the HSV platform. This compound is currently in an ongoing investigator-sponsored phase Ib clinical trial in recurrent high-grade glioma.

Based on findings disclosed from this trial last year, the median overall survival (mOS) after a single CAN-3110 injection was roughly 12 months in patients with recurrent high-grade glioma compared to historical reports of less than 6 to 9 months in this therapy-resistant condition.

Anticipated Milestones

-- Phase II topline overall survival data for CAN-2409 in non-small cell lung cancer to be presented at ASCO on June 3, 2024. -- Updated Phase Ib data for CAN-3110 in recurrent high-grade glioma is expected in H2 2024. -- Phase II topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer is anticipated in Q4 2024. -- Phase III topline disease-free survival data for CAN-2409 in localized intermediate/high-risk prostate cancer is also expected in Q4 2024.

Cash Position

The company ended March 31, 2024, with cash and cash equivalents of $25.7 million, which is expected to be sufficient to fund its current operating plan into the fourth quarter of 2024.

Candel Therapeutics made its debut on the Nasdaq Global Select Market on July 27, 2021, offering its shares at a price of $8 each.

The stock has traded in a range $0.66 to $14.28 in the last 1 year. The stock closed yesterday's trading at $14, up 30.84%.