NEEDHAM, Mass. - Candel Therapeutics, Inc. (NASDAQ: CADL), a clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CAN-3110, its investigational therapy for recurrent high-grade glioma (rHGG). This move could result in seven years of marketing exclusivity in the U.S. if CAN-3110 is approved.
The FDA's recognition comes after CAN-3110, a novel oncolytic viral immunotherapy, showed promise in early clinical trials. Published results in Nature indicated that a single dose of CAN-3110 extended survival in patients with rHGG, a particularly aggressive brain cancer. The therapy is currently in a phase 1b multi-institutional clinical trial.
CAN-3110's dual mechanism of action, combining oncolysis and immune activation, has been highlighted as a potential new approach to treating rHGG. The Orphan Drug Designation follows a previously granted Fast Track Designation by the FDA for the same treatment.
The company's commitment to advancing CAN-3110 is further reflected in the upcoming presentation of phase 1b data at the 2024 ASCO Annual Meeting on Saturday, June 1. The data will focus on the feasibility and safety of multiple doses of CAN-3110 in patients with rHGG.
CAN-3110 has been well tolerated in clinical trials, with no dose-limiting toxicity reported. Median overall survival after a single injection showed a significant increase compared to existing treatments. The ongoing trial, supported by the Break Through Cancer Foundation, is also examining the effects of multiple injections of the therapy.
This development is part of Candel's broader efforts in creating multimodal biological immunotherapies for cancer treatment. The company also has other product candidates in clinical trials targeting different types of cancer, including non-small cell lung cancer and prostate cancer.
The FDA's Orphan Drug Designation is intended to facilitate drug development for rare diseases affecting fewer than 200,000 people in the U.S. It offers financial incentives and the potential for marketing exclusivity to encourage the development of new therapies.
The information in this article is based on a press release statement from Candel Therapeutics.
InvestingPro Insights
Amidst the promising developments at Candel Therapeutics, Inc. (NASDAQ: CADL), investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, Candel Therapeutics currently has a market capitalization of $261.46 million. Despite the recent volatility, the company's stock has experienced a substantial return over the last six months, with a price total return of 877.75%. This impressive growth trajectory is further evidenced by a year-to-date price total return of 497.96%.
However, it is important to note that Candel Therapeutics is operating with a negative gross profit margin, as indicated by a gross profit of -$23.98 million over the last twelve months as of Q1 2024. Furthermore, the company is not expected to be profitable this year, with analysts anticipating continued challenges in achieving profitability. This is reflected in the negative P/E ratio of -6.7, suggesting that investors are pricing in the earnings challenges ahead.
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