Candel Therapeutics Highlights Promising Results in Oncology Trials

Candel Therapeutics Highlights Promising Results in Oncology Trials

NEEDHAM, Mass. -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical firm dedicated to developing innovative immunotherapies for cancer, has made significant strides in its recent clinical trials and financial performance. As the Company approaches the submission of its Biologics License Application (BLA) for CAN-2409, a therapy designed for localized prostate cancer, the latest developments illustrate both progress and potential for patients in need.

Significant Trials and Clinical Updates

Recently, Candel announced the acceptance of an oral presentation showcasing the encouraging results from a phase 3 clinical trial of CAN-2409 in the treatment of localized prostate cancer at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting. This pivotal research highlights CAN-2409’s effectiveness in reducing the risk of prostate cancer recurrence, aligning with the primary endpoint established with the FDA.

Positive Outcomes in Prostate Cancer

In addition to the positive phase 3 results, Candel is on target to file its BLA submission for CAN-2409 by the fourth quarter of 2026. This pathway, designed under a Special Protocol Assessment, allows Candel to leverage preliminary findings to advance regulatory approval. The promising outcomes could lead to new treatment options for patients diagnosed with intermediate-to-high risk prostate cancer.

Advancements in Lung and Pancreatic Cancer

Furthermore, Candel's research into CAN-2409 has shown impressive potential in patients with advanced non-small cell lung cancer (NSCLC) and borderline resectable pancreatic adenocarcinoma (PDAC). The Company reported a notable median overall survival (mOS) benefit in both conditions, suggesting that CAN-2409 may serve as a transformative option for patients resistant to standard therapies.

Recent Collaborations and Future Directions

March 2025 saw Candel enter a strategic collaboration with IDEA Pharma to support the commercialization of CAN-2409. This partnership aims to enhance Candel's development strategy with extensive commercial expertise in oncology, which is vital as the Company prepares for the broader marketing of its lead asset.

Insights from Key FDA Designations

Both fast-track and orphan drug designations for CAN-2409 in treating localized prostate cancer and PDAC signify Candel’s commitment to addressing high unmet needs in oncology. The validation from the FDA underscores the potential impact of this candidate, excitingly poised to improve outcomes in difficult-to-treat cancers.

Financial Performance Overview

For the first quarter of 2025, Candel reported a notable net income of $7.4 million, a significant turnaround from a net loss of $8.2 million in the previous year. This improvement mainly results from changes in the fair value of the Company's liabilities, providing a strong financial foundation as Candel advances its clinical programs.

Resource Allocation for Growth

Research and development costs slightly decreased year over year to $4.0 million, reflecting an emphasis on efficiency as Candel navigates its development pipeline. The Company also maintained sufficient cash reserves of $92.2 million, expected to fund ongoing operations into early 2027, allowing ample time to pursue its BLA submission and further trial results.

About CAN-2409

CAN-2409, Candel’s leading therapeutic candidate, is designed as a multimodal biological immunotherapy offering a sophisticated approach to cancer treatment by targeting tumors while building a systemic immune response. This investigational agent aims to not only treat localized tumors effectively but also induce activity against distant metastases, paving the way for broader oncological benefits.

With Candel’s continued efforts to innovate and enhance cancer therapies, CAN-2409 symbolizes hope for many cancer patients looking for new solutions in their fight against this disease.

Frequently Asked Questions

What is CAN-2409?

CAN-2409 is Candel Therapeutics' lead candidate, an investigational immunotherapy aimed at treating various cancers, particularly localized prostate cancer and advanced cancers such as NSCLC and PDAC.

What recent results did Candel report?

Candel reported positive outcomes from clinical trials of CAN-2409, including significant improvements in median overall survival for patients receiving the treatment in trials for prostate cancer, NSCLC, and PDAC.

What are the upcoming milestones for Candel?

Candel plans to submit a Biologics License Application (BLA) for CAN-2409 in prostate cancer by the end of 2026, with ongoing trials expected to yield further data throughout 2025.

How has Candel's financial performance been?

Candel reported a net income of $7.4 million in Q1 2025, a notable improvement compared to a net loss in the previous year. The Company has a strong cash position to support ongoing operations.

What strategic partnerships does Candel have?

Candel has partnered with IDEA Pharma to enhance its commercialization efforts for CAN-2409, leveraging their expertise in bringing oncology treatments to market.

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