Shares of Candel Therapeutics CADL surged 68.1% on Wednesday after the company reported superior efficacy of CAN-2409, an investigational adenovirus immunotherapy candidate, compared to standard of care (SOC) radiation therapy alone in a late-stage study to treat prostate cancer.

The phase III study enrolled intermediate-to-high-risk, localized prostate cancer patients who either received the combination therapy of CAN-2409+prodrug (valacyclovir)+SOC or SOC alone. The study met its primary endpoint, demonstrating statistically significant improvement in disease-free survival (DFS) in patients receiving the combo therapy compared to SOC alone.

Per Candel, in the United States, over 100,000 men are diagnosed annually with localized prostate cancer, with more than 50,000 receiving radiotherapy. Despite being the second leading cause of cancer death among men, there has been no major advancement in treatment for localized, non-metastatic cases in over 20 years. The addressable market for CAN-2409 in this area is valued at over $10 billion, representing a significant opportunity for Candel.

In the past three months, shares of Candel have gained 10.6% against the industry’s 8.9% fall.

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More on CADL’s Prostate Cancer Study Data

Candel reported that prostate cancer patients treated with the CAN-2409 combo therapy achieved a 14.5% relative improvement in DFS compared to the placebo control arm. A subsequent analysis of prostate-specific outcomes in the phase III study revealed a highly significant effect of CAN-2409 on prostate cancer-free survival. The treatment arm demonstrated a substantial increase in the proportion of patients achieving a prostate-specific antigen nadir, associated with better cancer control outcomes, compared to the placebo control arm (67.1% vs. 58.6%, respectively). Additionally, treatment with the combo therapy resulted in 80.4% pathological complete responses in the 2-year post-treatment biopsies compared to 63.6% observed in the control arm.

In the phase III prostate cancer study, CAN-2409 was overall well tolerated and demonstrated a safety profile consistent with previous studies. No new safety signals were identified. Adverse events related to treatment with the candidate were mostly mild to moderate in severity.

In the same press release, Candel reported top-line data from its phase II study evaluating CAN-2409 as a monotherapy in patients with low-to-intermediate risk localized prostate cancer undergoing active surveillance. Per the data readout, treatment with the candidate demonstrated numerical improvement in time to radical treatment and the percentage of patients achieving negative (prostate cancer-free) biopsies at 1-year post treatment. However, such improvements did not reach statistical significance.

CADL’s Next Steps in CAN-2409 Development

Based on the encouraging phase III and phase II study data, Candel plans to initiate discussions with the FDA regarding the regulatory pathway for CAN-2409 in intermediate-to-high-risk localized prostate cancer. Detailed results from both studies will be presented at a later medical conference.

Please note that the phase III study of CAN-2409 for the prostate cancer indication was conducted under a Special Protocol Assessment with the FDA. This means the study's safety and efficacy data can support a regulatory filing for the candidate for the same indication in the United States. Subject to approval, Candel believes that CAN-2409 has the potential to transform the treatment paradigm in prostate cancer. It will offer patients with localized disease an effective treatment option that may reduce the risk of disease recurrence.

Apart from the prostate cancer indication, Candel is also currently evaluating CAN-2409 in separate mid-stage studies for pancreatic and lung cancer indications. The company’s clinical pipeline comprises another candidate, CAN-3110, an HSV-1-based immunotherapy candidate, which is being evaluated for a brain cancer indication in an early-stage study.

Candel Therapeutics, Inc. Price and Consensus

Candel Therapeutics, Inc. price-consensus-chart | Candel Therapeutics, Inc. Quote

CADL’s Zacks Rank and Stocks to Consider

Candel currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the drug/biotech industry are Bristol Myers BMY, Pfizer PFE and Gilead Sciences GILD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, estimates for Bristol Myers’ 2024 earnings have increased from 75 cents to 91 cents per share. Estimates for 2025 earnings per share have increased from $7.05 to $7.19 in the same time frame. BMY shares have gained 15.3% in the past three months.

Bristol Myers’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 15.54%.

In the past 60 days, estimates for Pfizer’s 2024 earnings have risen from $2.66 to $2.92 per share. Estimates for 2025 earnings per share have increased from $2.86 to $2.94 in the same time frame. PFE shares have lost 13.8% in the past three months.

Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.

In the past 60 days, estimates for Gilead Sciences’ 2024 earnings have risen from $3.78 to $4.29 per share. Estimates for 2025 earnings per share have increased from $7.24 to $7.38 in the same time frame. GILD shares have risen 11.6% in the past three months.

Gilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.

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