CEL-SCI reports positive bias analysis for cancer drug

VIENNA, Va. – CEL-SCI Corporation (NYSE American: CVM) has announced the results of a comprehensive bias analysis for its Phase 3 study of Multikine, an investigational immunotherapy for head and neck cancer, showing promising outcomes. The analysis aimed to ensure the reliability and validity of the trial’s findings by evaluating potential sources of bias.

The study involved 923 patients with newly diagnosed resectable, locally advanced primary head and neck cancer. The bias analysis confirmed that there were no significant differences in demographics or baseline characteristics between the treatment and control groups, indicating no bias in favor of Multikine. The results are considered statistically significant and support the clinical effect of Multikine in extending patient survival.

CEL-SCI’s CEO, Geert Kersten, expressed confidence in the data, which suggests a 5-year survival rate of 73% for patients treated with Multikine compared to 45% in the control group. The company is preparing to submit this data to regulatory agencies, including the FDA, for a confirmatory registration study.

The upcoming study, agreed upon with the FDA, will enroll 212 patients fitting specific criteria: newly diagnosed with locally advanced primary head and neck cancer, no lymph node involvement, and low PD-L1 tumor expression. These criteria align with the target population that showed a notable survival benefit in the Phase 3 study.

Multikine has been administered to over 750 patients and has received Orphan Drug designation from the FDA for its use as a neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck.

The company, headquartered in Vienna, Virginia, with operations near Baltimore, Maryland, focuses on enhancing patient survival by boosting the immune system before it is compromised by disease or therapy.

The information in this article is based on a press release statement from CEL-SCI Corporation. It should be noted that Multikine is still under investigation and has not been approved for sale by the FDA or any other regulatory agency.

Its safety and efficacy have not yet been established for any use. The forward-looking statements in the press release are subject to various risks and uncertainties that could affect the company’s actual results.

InvestingPro Insights

CEL-SCI Corporation (NYSE American: CVM) has shared optimistic results from their Phase 3 study of Multikine, yet it’s important for investors to also consider the company’s financial health and market performance. Here are some critical insights based on recent data from InvestingPro:

InvestingPro Data:

• Gross Profit (last twelve months as of Q2 2024): -$19.98M

• Operating Income, Adjusted (last twelve months as of Q2 2024): -$29.21M

• 6 Month Price Total Return (as of mid-2024): -57.99%

These figures suggest that while the clinical development of Multikine may be progressing, the company is facing financial challenges, with significant losses in both gross profit and operating income over the last twelve months. Additionally, the stock price has experienced a substantial decline over the last six months, which could reflect investor concerns about the company’s profitability and future.

InvestingPro Tips:

1. CEL-SCI’s stock has taken a significant hit over the last week, with a -8.33% return, which may concern current and potential investors.

2. Analysts contributing to InvestingPro have raised concerns about the company’s weak gross profit margins and anticipate a drop in net income this year.

For investors interested in a deeper analysis, there are additional InvestingPro Tips available, offering a comprehensive look at CEL-SCI’s financials, market performance, and potential risks. To explore these insights, visit https://www.investing.com/pro/CVM and consider applying the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.

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