Geert Kersten on CEL-SCI’s Multikine and the Future of Immunotherapy – Exclusive Interview

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In this exclusive interview, host Allison Godlove sits down with CEL-SCI (NYSEAMERICAN: CVM) CEO Geert Kersten to delve into the company’s revolutionary lead drug candidate, Multikine. Discover the incredible journey from the completion of the Phase 3 Clinical Trial to the recent FDA approval for a confirmatory study.

Interview Highlights

Introduction to Multikine

Multikine, formally known as Leukocyte Interleukin Injection, is CEL-SCI’s pioneering immunotherapy designed as a first-line neoadjuvant treatment for patients with advanced primary squamous cell carcinoma of the head and neck (SCCHN). Unlike traditional therapies that target the tumor directly, Multikine aims to harness and amplify the body’s natural immune response against cancer cells. Administered prior to standard treatments such as surgery, radiation, or chemotherapy, Multikine seeks to bolster the immune system’s ability to combat tumors when it is most intact and responsive.

Understanding Multikine

Geert Kersten elucidates the unique mechanism of action of Multikine, distinguishing it from conventional cancer treatments. Comprising a defined mixture of 14 pro-inflammatory cytokines, including interleukins, interferons, chemokines, and colony-stimulating factors, Multikine is designed to simulate a healthy immune response. This combination is intended to exert a dual effect: directly targeting tumor cells and activating the immune system to mount an anti-tumor response. By initiating treatment before conventional therapies, Multikine aims to engage the immune system at its peak functionality, potentially leading to improved patient outcomes.

Key Findings from the Phase 3 Clinical Trial

The Phase 3 Clinical Trial for Multikine, one of the largest studies ever conducted in head and neck cancer, enrolled 928 patients across approximately 100 global centers. The trial evaluated the efficacy of Multikine administered prior to standard of care treatments. Topline results revealed that patients receiving the Multikine treatment regimen followed by surgery and radiotherapy experienced a 5-year overall survival benefit of 14.1% (62.7% treated vs. 48.6% control), surpassing the protocol’s required 10% improvement. The study also reported no significant safety issues associated with Multikine administration, underscoring its potential as a safe and effective addition to existing treatment protocols.

Defining the Target Patient Population

Through comprehensive analysis of the Phase 3 trial data, CEL-SCI identified a specific subset of patients who demonstrated the most pronounced benefit from Multikine therapy. This target population includes individuals with newly diagnosed advanced primary head and neck cancer who exhibit no lymph node involvement (N0), as determined by PET imaging, and low PD-L1 tumor expression, identified via biopsy. These criteria are grounded in Multikine’s mechanism of action, which is believed to be more effective in patients with intact local immune architecture and lower disease burden.

Criteria for Patient Selection in the Latest Study

Building upon insights from the initial trial, CEL-SCI has refined its patient selection criteria for the upcoming confirmatory Registration Study. The focus will be on enrolling patients who meet the N0 and low PD-L1 expression parameters. This strategic selection is based on the understanding that Multikine’s immunotherapeutic effects are optimized in patients whose immune systems are less compromised by disease progression. By targeting this group, the study aims to validate and potentially enhance the survival benefits observed in the previous trial.

Challenges and Breakthroughs with the FDA

Navigating the regulatory landscape presented both challenges and opportunities for CEL-SCI. Engaging in detailed discussions with the FDA, the company addressed concerns regarding study design and patient safety. The FDA’s subsequent approval for the 212-person confirmatory Registration Study signifies a pivotal breakthrough, reflecting confidence in Multikine’s safety profile and its potential efficacy in the defined patient population. This approval marks a significant milestone in bringing Multikine closer to clinical application.

Differences Between Phase 3 and Confirmatory Studies

The upcoming confirmatory study is designed to build upon the findings of the Phase 3 trial, with a more focused approach. While the Phase 3 study encompassed a broad patient population, the confirmatory study will concentrate exclusively on patients with no lymph node involvement and low PD-L1 tumor expression. This targeted approach aims to confirm the substantial survival benefits observed in this subgroup, thereby strengthening the evidence for Multikine’s efficacy in this specific cohort.

Survival Benefits of Multikine vs. Standard Care

Analysis of the Phase 3 trial data revealed that patients within the target population who received Multikine prior to standard treatment exhibited a 5-year survival rate of 73%, compared to 45% in the control group. This significant improvement underscores Multikine’s potential to enhance patient outcomes when integrated into the treatment regimen for head and neck cancer. The findings suggest that early immunotherapeutic intervention with Multikine may offer a substantial survival advantage over standard care alone.

Future Research and Potential Applications of Multikine

Looking ahead, CEL-SCI is committed to exploring the broader applicability of Multikine beyond head and neck cancer. Future research initiatives aim to investigate its potential in treating other cancer types and in combination with various therapies. By expanding the scope of Multikine’s application, CEL-SCI seeks to leverage its immunotherapeutic properties to benefit a wider patient population, potentially transforming the landscape of cancer treatment.

Message to Patients and Shareholders

In his concluding remarks, Geert Kersten extends heartfelt gratitude to patients and shareholders for their unwavering support and patience throughout Multikine’s development journey. He emphasizes CEL-SCI’s dedication to advancing innovative therapies that address unmet medical needs and improve patient outcomes. Kersten reaffirms the company’s mission to transform lives through groundbreaking science and compassionate care.

Watch the Full Interview

The full interview with Geert Kersten is now live on our platform. Click here to watch and gain deeper insights into how CEL-SCI and its innovative approach to immunotherapy are shaping the future of medicine.

Stay tuned for more expert interviews and updates from BioTech Health X as we continue to explore groundbreaking advancements in healthcare.

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