TPI Composites files for Chapter 11 bankruptcy, plans delisting from Nasdaq
NEEDHAM, Mass. - Candel Therapeutics, Inc. (NASDAQ: CADL), a biopharmaceutical company whose stock has surged over 450% in the past year according to InvestingPro data, reported final survival data from a phase 2a clinical trial of their experimental treatment CAN-2409 for patients with advanced non-small cell lung cancer (NSCLC) who have not responded to immune checkpoint inhibitor (ICI) therapy. The results indicated a median overall survival (mOS) of 24.5 months in patients who received two courses of CAN-2409, surpassing the mOS of 9.8-11.8 months typically seen with standard docetaxel chemotherapy.
The trial included 46 evaluable patients with stage III/IV NSCLC, with 90% having stage IV disease upon enrollment. A significant portion (37%) of patients with progressive disease despite ICI treatment were still alive more than two years post-CAN-2409 administration as of March 3, 2025. The company maintains a strong financial position, with InvestingPro analysis showing more cash than debt on its balance sheet and a healthy current ratio of 2.77x. Additionally, approximately two-thirds of patients with metastatic disease experienced regression in both injected and uninjected lesions, suggesting a systemic immune response.
The study, led by Charu Aggarwal, MD, MPH, from the University of Pennsylvania’s Perelman School of Medicine, highlighted the treatment’s potential, particularly for those with non-squamous NSCLC, who showed a mOS of 25.4 months. The safety profile of CAN-2409 remained generally favorable, with no new safety signals identified during the extended follow-up period.
Candel Therapeutics plans to further develop CAN-2409, including preparations for a future clinical trial that may be registrational for NSCLC patients with non-squamous histology. The FDA has granted Fast Track Designation for CAN-2409 plus valacyclovir in combination with ICI treatment for stage III/IV NSCLC patients resistant to first-line PD-(L)1 inhibitor therapy.
CAN-2409 is designed to deliver the herpes simplex virus thymidine kinase gene to a patient’s specific tumor, inducing an individualized systemic immune response. With more than 1,000 patients dosed to date, CAN-2409 has shown a favorable tolerability profile, supporting its potential combination with other therapeutic strategies.
This press release statement provides a glimpse into the promising results of CAN-2409 in treating advanced NSCLC, potentially offering a new treatment avenue for patients with limited options after ICI therapy failure. Analysts maintain an optimistic outlook, with price targets ranging from $15 to $25 per share. InvestingPro analysis suggests the stock is currently undervalued, with 6 additional exclusive ProTips available to subscribers, offering deeper insights into CADL’s investment potential.
In other recent news, Candel Therapeutics has reported significant progress in its clinical trials, particularly with its lead asset, CAN-2409. The Phase 3 study for prostate cancer showed a statistically significant improvement in disease-free survival, while the Phase 2 trial for pancreatic ductal adenocarcinoma revealed a marked increase in median overall survival compared to standard care. These promising results have led H.C. Wainwright to maintain a Buy rating on Candel Therapeutics, with a price target of $19.00, expressing confidence in the company’s therapeutic pipeline.
Additionally, Citi has initiated coverage of Candel Therapeutics with a Buy rating and a $25.00 price target, citing the potential of CAN-2409 to significantly extend median disease-free survival in localized prostate cancer. Candel is preparing for a Biologics License Application for CAN-2409, expected in the fourth quarter of 2026, as the company continues to advance its commercialization strategy. The recent strategic partnership with IDEA Pharma aims to enhance the commercial strategy for CAN-2409, particularly after its promising Phase 3 results.
Candel’s broader pipeline includes CAN-3110, currently in a Phase 1b trial for high-grade glioma, with updates expected in late 2025. The company’s innovative approach to cancer treatment has earned it Fast Track and Orphan Drug Designations from the FDA for various indications. These developments underscore Candel Therapeutics’ commitment to advancing cancer immunotherapies and its potential for growth in the biotech sector.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.