Join us for an exclusive and deeply insightful conversation with Geert Kersten, Chief Executive Officer of CEL-SCI Corporation (NYSEAMERICAN: CVM). In this feature interview for Global Market Bulletin TV, Mr. Kersten discusses the scientific, regulatory, and clinical milestones surrounding Multikine, CEL-SCI’s pioneering cancer immunotherapy candidate, and outlines the company’s path toward FDA approval. With decades of research behind it and new regulatory momentum emerging, Multikine has the potential to reshape the treatment landscape for head and neck cancer patients worldwide.
Mr. Kersten begins by describing what makes Multikine such a groundbreaking innovation. Unlike traditional cancer treatments that attempt to destroy tumor cells directly, Multikine is designed to strengthen the patient’s own immune system before it is weakened by surgery, radiation, or chemotherapy. By activating the immune response at the earliest and most critical moment of treatment, Multikine aims to give patients a stronger, more durable chance of survival. This foundational concept, Kersten explains, represents a new paradigm in oncology—one in which strengthening the body’s defenses may offer greater benefit than simply attacking the tumor itself.
The interview explores the extensive clinical foundation that supports Multikine, including CEL-SCI’s large global Phase 3 trial. Kersten highlights that the company received approvals from twenty-four international regulatory agencies to conduct that pivotal study, including authorities in the United States, Canada, France, and the United Kingdom. More importantly, the trial revealed a profound clinical insight: certain patients—specifically those with no lymph node involvement and low PD-L1 tumor expression—experienced a substantial survival advantage when treated with Multikine. Among this defined population, long-term survival rates significantly exceeded those of patients receiving the current Standard of Care alone.
Kersten recounts the company’s recent meeting with the U.S. Food and Drug Administration, a crucial milestone in Multikine’s development. He explains the challenges of demonstrating clinical significance in oncology and the rigorous data required to prove that Multikine’s survival benefit is consistent, meaningful, and reproducible. According to Kersten, the FDA’s agreement to CEL-SCI’s patient selection criteria and its authorization to conduct a confirmatory Registration Study marks a major turning point for the company. This study, designed around a carefully defined patient population, is intended to validate the Phase 3 results and ultimately support a future Biologics License Application.
The conversation also explores what differentiates the upcoming Registration Study from the earlier Phase 3 trial. Kersten emphasizes that the new study is smaller, more focused, and optimized for precision, enrolling 212 newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement, as confirmed via PET scan, and with low PD-L1 expression determined through biopsy. This group represents a significant global patient population—more than 100,000 individuals annually—and the trial aims to replicate the strong survival outcomes seen in the earlier Phase 3 subset.
Kersten speaks passionately about the survival benefit Multikine has already demonstrated. In its target population, Multikine achieved a 73 percent five-year survival rate, compared to just 45 percent among those receiving standard therapy alone. If confirmed, this improvement could establish Multikine as a new Standard of Care and mark one of the most meaningful advancements in head and neck cancer treatment in decades.
The interview concludes with a forward-looking discussion on the future of Multikine and CEL-SCI’s broader research ambitions. Kersten outlines plans to explore Multikine’s potential use in other cancers and to investigate whether combining Multikine with emerging immunotherapies or targeted agents could produce enhanced results. He also offers a heartfelt message to patients, caregivers, and shareholders, emphasizing the company’s determination to complete the confirmatory study, obtain regulatory approval, and bring this long-awaited therapy to those who need it most.
For investors and medical professionals alike, this conversation offers a rare and comprehensive window into a first-in-class immunotherapy program approaching its most important milestone yet.
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About CEL-SCI Corporation (NYSEAMERICAN: CVM)
CEL-SCI Corporation is a clinical-stage biotechnology company focused on developing innovative immunotherapies that strengthen the body’s natural defenses before they are compromised by conventional cancer treatments. The company’s flagship therapy, Multikine (Leukocyte Interleukin, Injection), is designed as a first-line immunotherapy administered prior to surgery and radiation or chemotherapy. It has been dosed in more than 750 patients and has received Orphan Drug designation from the U.S. Food and Drug Administration for the neoadjuvant treatment of squamous cell carcinoma of the head and neck.
Multikine has demonstrated a compelling survival benefit in its target patient population, achieving a 73 percent five-year survival rate compared to 45 percent with the current Standard of Care. Based on these results, the FDA has approved CEL-SCI’s patient selection criteria and authorized the company to conduct a focused confirmatory Registration Study enrolling 212 patients worldwide. CEL-SCI operates in Vienna, Virginia, and in the Baltimore, Maryland area, and remains committed to advancing immunotherapy research that has the potential to improve outcomes for patients across multiple cancer types.
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