NEEDHAM, Mass. - Candel Therapeutics, Inc. (NASDAQ: CADL), a biopharmaceutical company engaged in the development of cancer immunotherapies, has announced that its leading candidate, CAN-2409, received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
This designation follows recent phase 2 trial results showing that CAN-2409, in combination with standard care, significantly extended median overall survival in patients with borderline resectable pancreatic cancer. The trial data indicated a median overall survival of 28.8 months for patients treated with CAN-2409, compared to 12.5 months in the control group.
The Orphan Drug Designation is expected to provide Candel with development incentives and up to seven years of marketing exclusivity in the United States if CAN-2409 is approved for this indication. This status is granted to treatments for diseases affecting fewer than 200,000 people in the U.S.
CAN-2409 is an off-the-shelf adenovirus-based immunotherapy that aims to induce a systemic anti-tumor immune response. It has also been granted Fast Track Designation by the FDA for several indications, including treatment of stage III/IV non-small cell lung cancer resistant to first-line therapies and localized primary prostate cancer in combination with radiotherapy.
The treatment works by delivering a gene that converts a prodrug into a toxic metabolite, killing cancer cells and releasing antigens that activate the immune system. The therapy has been generally well tolerated in clinical trials, with no dose-limiting toxicities or cases of pancreatitis reported.
Candel's ongoing clinical trials are evaluating CAN-2409's efficacy in additional cancers, including non-small cell lung cancer and localized prostate cancer. The company is also conducting a pivotal phase 3 clinical trial in prostate cancer under a Special Protocol Assessment by the FDA.
Pancreatic cancer remains a challenging disease with a high mortality rate, emphasizing the need for new therapeutic options. The disease is the fourth leading cause of cancer-related death in the U.S., with an estimated 64,050 new cases and 50,550 deaths in 2023.
This article is based on a press release statement from Candel Therapeutics.
InvestingPro Insights
Candel Therapeutics, Inc. (NASDAQ: CADL) has been in the spotlight with its recent FDA Orphan Drug Designation for CAN-2409, which has shown promising results in extending median overall survival in pancreatic cancer patients. While the clinical advancements are encouraging, an analysis of the company's financial health and stock performance provides additional context for investors considering CADL.
According to real-time data from InvestingPro, Candel Therapeutics has a market capitalization of $149.67 million, which reflects the company's valuation in the biopharmaceutical market. Despite the positive news on the clinical front, the company's financial metrics indicate challenges. The P/E Ratio stands at -3.91, and when adjusted for the last twelve months as of Q4 2023, it deteriorates to -4.97, underscoring that the company is not currently profitable. Moreover, the Price / Book ratio is relatively high at 14.81, suggesting that the stock is trading at a premium compared to the company's book value.
InvestingPro Tips reveal that analysts do not expect Candel Therapeutics to be profitable this year, which aligns with the negative earnings metrics observed. Additionally, the stock's Relative Strength Index (RSI) suggests it is in overbought territory, hinting at potential pullbacks after recent price surges. Despite these concerns, the stock has seen a high return over the last year, with a 369.34% increase, and liquid assets exceeding short-term obligations, indicating some degree of financial stability.
For investors intrigued by Candel Therapeutics' potential in the biopharmaceutical space, especially considering its recent FDA designation, it may be worth noting that InvestingPro offers additional insights. There are 13 more InvestingPro Tips available that could help in making a more informed decision. To access these tips, visit https://www.investing.com/pro/CADL and consider using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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