FDA Orphan Designation provides CAN-3110 certain developmental financial incentives, with potential for up to 7 years of marketing exclusivity in the United States, if approved CAN-3110 phase 1b data on the feasibility and safety of multiple doses of CAN-3110 will be featured in poster presentation at 2024 ASCO Annual Meeting NEEDHAM, Mass., May 30, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing mult ...

Core Insights - Candel Therapeutics is focused on developing two novel therapeutics, CAN-2409 and CAN-3110, for various cancer indications [1] - The company has seen a significant stock price increase of 430.6% year-to-date, driven by positive clinical updates for CAN-2409 [2] Product Development - CAN-2409 is an investigational adenovirus immunotherapy candidate being studied in mid to late-stage trials for prostate cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer [1] - CAN-3110 is an HSV-1-based immunotherapy candidate currently in an early-stage study for recurrent high-grade glioma (HGG) [2] Clinical Trial Results - Positive interim data from a phase II study showed that CAN-2409 combined with valacyclovir and standard of care led to a median overall survival of 28.8 months in borderline resectable pancreatic ductal adenocarcinoma (PDAC) patients, compared to 12.5 months in the control group [4] - The survival rate for patients treated with CAN-2409 was 71.4% at 24 months and 47.6% at 36 months, significantly higher than the control group's rates of 16.7% [5] Regulatory Designations - The FDA granted orphan drug designation to CAN-2409 for PDAC, enhancing its market exclusivity potential [8] - CAN-2409 also received Fast Track designation from the FDA, which expedites its development timeline due to the unmet medical need [10] Future Expectations - Candel is evaluating CAN-2409 for newly diagnosed localized prostate cancer and expects to report top-line data from these studies in Q4 2024, which could serve as a significant catalyst for the stock [11]

Image Source: Zacks Investment Research Apart from NSCLC, CAN-2409 is also being developed for several cancer indications, including pancreatic ductal adenocarcinoma (PDAC) and prostate cancer. Last month, CADL announced positive interim data from the phase II study evaluating CAN-2409 plus valacyclovir, together with SoC chemoradiation, followed by resection for borderline resectable PDAC. The updated interim data from the ongoing phase II study showed that experimental treatment with CAN-2409 led to notab ...

A live webcast will be available by selecting Events and Presentations, under the News & Events tab, in the Investors section on Candeltx.com. A replay of the webcast will be archived for up to 90 days following the session date. NEEDHAM, Mass., May 20, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (NASDAQ:CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced it will be hosting ...

NEEDHAM, Mass., May 20, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced it will be hosting a webcasted R&D breakfast panel featuring prominent scientific and medical thought leaders to discuss topline overall survival data from its phase 2 clinical trial of CAN-2409, its multimodal biological immunotherapy candidate, ...

i The accompanying notes are an integral part of these condensed consolidated financial statements. | --- | --- | --- | --- | --- | --- | |-------------------------------------------------------------------|-------|------------------------------|-------|-------|--------| | Assets | | MARCH 31, 2024 (Unaudited) | | 2023 | | | Current assets: | | | | | | | Cash and cash equivalents | $ | 25,713 | $ | | 35,413 | | Prepaid expenses and other current assets | | 1,423 | | | 1,384 | | Total current assets | | 27,1 ...

▪ Received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for CAN-2409 for the treatment of pancreatic cancer. ▪ Received Fast Track Designation from the FDA for CAN-3110 for the treatment of patients with rHGG to improve OS. ▪ Presented preclinical data at the AACR Annual Meeting unveiling the second candidate from the enLIGHTEN™ Discovery Platform, a first-in-class multimodal immunotherapy candidate to induce tertiary lymphoid structures (TLS), being developed as a novel therapeu ...

NEEDHAM, Mass., May 14, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (NASDAQ:CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update. Program Updates CAN-2409 – Pancreatic Cancer In early April, announced positive updated survival data, from the ongoing randomized phase 2 clinical trial ...

KanawatTH/iStock via Getty Images Candel Therapeutics, Inc. (NASDAQ:CADL) was able to report positive interim results from its phase 2 randomized study using CAN-2409 plus valacyclovir [prodrug] together with standard of care [SOC] chemoradiation, following by resection in patients with borderline respectable pancreatic ductal adenocarcinoma [PDAC]. Not only that, but it also achieved Orphan Drug Designation [ODD] of CAN-2409 for the treatment of this patient population. Both of these events have led to ...

Candel Therapeutics, Inc. (CADL) announced that the FDA has granted orphan drug designation to its lead investigational adenovirus immunotherapy candidate, CAN-2409, for the treatment of pancreatic ductal adenocarcinoma (PDAC). Shares of the company rallied 42.8% on Apr 12, following the news.The FDA grants the orphan drug designation to support the development of medicines for rare disorders that affect fewer than 200,000 patients in the United States. The orphan drug designation will grant Candel market e ...