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NEEDHAM, Mass. - Candel Therapeutics, Inc. (NASDAQ:CADL), a biopharmaceutical company with a market capitalization of $267 million engaged in the development of biological immunotherapies for cancer treatment, has published results from a phase 1b clinical trial which suggest a favorable safety profile and potential survival benefits of their therapy for patients with high-grade glioma, a form of brain cancer. The findings, released in the journal Neuro-Oncology on March 22, 2025, come as the company’s stock has experienced significant volatility, with a 31% decline over the past week despite a remarkable 223% gain over the last year.InvestingPro analysis reveals that Candel maintains a strong liquidity position, with current assets exceeding short-term obligations by a ratio of 2.77, providing important financial flexibility for its ongoing research programs.
The trial investigated the safety and efficacy of combining CAN-2409, a biological agent, and nivolumab, an immunotherapy drug, with standard cancer care treatments. Of the 41 enrolled patients, 35 completed the regimen, which included neurosurgery, radiotherapy, and temozolomide chemotherapy.
The study showed that the combination therapy was generally well-tolerated and extended survival in a subset of patients who demonstrated immune activation. Notably, patients with methylated MGMT promoter who underwent complete tumor resection experienced a median overall survival of 30.6 months, significantly higher than the typical prognosis.
The research also highlighted the association between baseline immune cell composition in tumors and clinical outcomes. Higher levels of certain immune cells correlated with improved survival rates, while an increase in immunosuppressive monocytes was negatively associated with survival.
The treatment induced systemic immune activation, evidenced by changes in T cell populations and cytokine profiles. Additionally, increased T cell receptor diversity after treatment was linked to improved survival outcomes.
While Candel is not currently developing CAN-2409 for high-grade glioma, due to portfolio prioritization, the results support the potential of CAN-2409 as a therapy for various solid tumors. The company, which holds more cash than debt on its balance sheet according to InvestingPro data, is advancing late-stage development of CAN-2409 for localized prostate cancer, pancreatic ductal adenocarcinoma, and non-small cell lung cancer. Analysts maintain an optimistic outlook, with price targets ranging from $15 to $25 per share, suggesting significant potential upside from current levels.For investors seeking deeper insights into biotech valuations and growth potential, InvestingPro offers exclusive access to over 10 additional ProTips and comprehensive financial metrics that can help inform investment decisions in this volatile sector.
These results add to the body of evidence suggesting CAN-2409’s ability to induce an individualized immune response against cancer. The therapy has been administered to over 1,000 patients across various studies, with a generally favorable safety profile reported.
The data from this trial, based on a press release statement, contributes to the understanding of immunotherapy in the treatment of high-grade glioma and solid tumors, offering hope for improved survival for patients facing these aggressive cancers.
In other recent news, Candel Therapeutics has reported promising results from its phase 2a clinical trial of CAN-2409 for advanced non-small cell lung cancer (NSCLC). The trial revealed a median overall survival of 24.5 months for patients treated with CAN-2409, significantly surpassing the typical survival of 9.8-11.8 months with standard chemotherapy. Additionally, Candel has formed a strategic partnership with IDEA Pharma to enhance the commercial strategy for CAN-2409, especially after positive phase 3 results in prostate cancer. This partnership aims to support Candel’s preparations for a Biologics License Application for CAN-2409 in prostate cancer.
Furthermore, Candel reported extended survival data from its phase 2 trial for pancreatic ductal adenocarcinoma, with patients showing a median overall survival of 31.4 months compared to 12.5 months in the control group. Analysts at H.C. Wainwright have maintained a Buy rating for Candel Therapeutics, citing positive outcomes in prostate and pancreatic cancer trials. Citi also initiated coverage with a Buy rating and a $25 price target, highlighting the potential of CAN-2409 to significantly extend disease-free survival in prostate cancer.
Candel’s broader pipeline includes CAN-3110, currently in a phase 1b trial for high-grade glioma. The company is expected to reveal additional data in early 2025, which could serve as near-term catalysts. The strategic developments and promising clinical outcomes underscore Candel’s progress in advancing its cancer treatment portfolio.
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