VIENNA, Va. - In a significant development for cancer treatment, the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recently raised concerns over the use of certain immune checkpoint inhibitors in patients with low PD-L1 expression. The ODAC's analysis, which took place on September 27, 2024, concluded with a majority vote against the risk-benefit profile of these drugs in various cancers, highlighting the lack of demonstrated benefit and potential for unnecessary toxicities and financial burdens for patients.
Checkpoint inhibitors, a class of drugs that includes the widely used Keytruda and Opdivo, represent a substantial portion of the cancer treatment market. However, the ODAC's findings suggest that their use may not be appropriate for all patients, particularly those with low PD-L1 expression levels.
In contrast, CEL-SCI Corporation's immunotherapy Multikine (Leukocyte Interleukin, Injection) has shown a survival benefit and favorable safety profile in a randomized controlled Phase 3 study of treatment-naive resectable locally advanced head and neck cancer patients with low PD-L1 expression. This positions Multikine as a potential game-changer in the treatment of this patient population, which represents about 70% of head and neck cancer cases.
CEL-SCI's CEO, Geert Kersten, stated that the company has identified low PD-L1 expression as a predictive biomarker and will use it as a selection criterion for their upcoming FDA confirmatory Registration Study of Multikine. The study aims to enroll 212 patients and will target newly diagnosed locally advanced primary head and neck cancer patients with no lymph node involvement and low PD-L1 tumor expression.
The recent ODAC meeting's outcomes may influence the future labeling and use of checkpoint inhibitors, potentially paving the way for alternative treatments like Multikine. CEL-SCI believes that Multikine, which has been dosed in over 740 patients and received Orphan Drug designation from the FDA, could serve a significant role in cancer treatment, both as a standalone therapy and in combination with existing checkpoint inhibitors.
This news is based on a press release statement from CEL-SCI Corporation and represents a potential shift in the landscape of cancer therapy, particularly for patients with low and negative PD-L1 expression.
In other recent news, CEL-SCI Corporation has made significant strides in the development of its investigational cancer treatment, Multikine. The company presented new data from its completed Phase 3 study, indicating a substantial increase in the 5-year survival rate for a specific patient group with head and neck cancer. Furthermore, the FDA has greenlit an upcoming confirmatory Registration Study, which will focus on this patient population.
In addition, CEL-SCI has received a pediatric study waiver for Multikine from the UK's Healthcare Products Regulatory Agency, eliminating the need for trials in patients under 18 as part of the UK marketing approval process. The company also announced a public offering of 10,845,000 shares, priced at $1.00 each, with projected gross proceeds of $10.8 million, which will be used for the development of Multikine and general corporate needs.
Finally, the company reported positive outcomes from a comprehensive bias analysis for its Phase 3 study of Multikine, supporting its clinical effect in extending patient survival. These developments are recent and it is important to note that Multikine is still under investigation, and its safety and efficacy have not yet been established for any use.
InvestingPro Insights
As CEL-SCI Corporation (CVM) positions itself at the forefront of a potential shift in cancer treatment, investors should be aware of some key financial metrics and insights provided by InvestingPro.
According to InvestingPro data, CEL-SCI's financial performance has been challenging. The company reported a gross profit of -$18.95 million and an operating income of -$27.7 million over the last twelve months as of Q3 2024. These figures align with an InvestingPro Tip indicating that the company "suffers from weak gross profit margins" and is "not profitable over the last twelve months."
Despite the promising developments with Multikine, CEL-SCI's stock performance has been underwhelming. InvestingPro data shows a 1-month price total return of -16.67% and a year-to-date return of -66.91%. This performance is reflected in the InvestingPro Tip stating that the "stock has fared poorly over the last month."
It's worth noting that analysts have set a fair value target of $7 for CVM stock, which may suggest potential upside if the company's Multikine therapy gains traction. However, investors should approach with caution, as another InvestingPro Tip warns that "net income is expected to drop this year" and "analysts do not anticipate the company will be profitable this year."
For a more comprehensive analysis, InvestingPro offers additional tips and insights that could be valuable for investors considering CEL-SCI's potential in the changing landscape of cancer treatment. There are 5 more InvestingPro Tips available for CVM, providing a deeper understanding of the company's financial health and market position.
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