Multikine's Impressive Clinical Data Attracts Top Oncology Expert Giovanni Selvaggi to CEL-SCI

CEL-SCI Corporation (NYSE American: CVM) has secured a significant strategic addition to its leadership team as Dr. Giovanni Selvaggi, a renowned oncology specialist with a track record of bringing multiple cancer therapies to market, has joined the company as Clinical Advisor. His arrival comes at a critical juncture as CEL-SCI prepares to launch its confirmatory Registration Study for Multikine.

The Clinical Promise Behind the Appointment

The timing of Dr. Selvaggi’s involvement underscores the strength of Multikine’s clinical profile. This investigational immunotherapy has demonstrated striking efficacy in treating newly diagnosed head and neck cancer patients. In a pre-surgical setting, Multikine achieved a 5-year survival rate of 73% compared to just 45% in the control group—representing a statistically significant reduction in 5-year mortality risk of 50% (hazard ratio = 0.35, p = 0.0015).

These results are based on robust data collected from 750 patients who have received Multikine treatment. Importantly, the safety profile remained consistent with standard care protocols, with no unexpected adverse signals detected. This combination of efficacy and tolerability convinced the FDA to green-light a focused 212-patient confirmatory Registration Study targeting newly diagnosed advanced primary head and neck cancer patients with specific biomarker characteristics.

Why Multikine Represents a Category Innovation

Multikine operates on a fundamentally different principle than existing head and neck cancer treatments. As a pre-surgical immunotherapy that activates the body’s own immune response when it remains intact and capable, Multikine addresses a critical treatment gap. Head and neck cancer patients currently have no approved therapeutic options before standard surgical intervention and radiation therapy, making Multikine the first-in-class agent filling this void.

The drug is essentially a synthetic version of pro-inflammatory cytokine responses that naturally occur in the human body—engineered to empower immune cells to recognize and attack tumor cells at the earliest intervention point.

The Expert Behind the Mission

Dr. Selvaggi brings decades of oncology expertise to this endeavor. His career trajectory demonstrates consistent success in translating promising research into approved medications. He played instrumental roles in the successful development and regulatory approval of several landmark therapies:

• Ceritinib (Zykadia) for ALK-translocated non-small cell lung cancer at Novartis
• Nivolumab (Opdivo) for third-line small cell lung cancer at Bristol-Myers Squibb, where he led immunotherapy programs in thoracic malignancies

Before his private sector career, Dr. Selvaggi served as a thoracic oncology physician at the University Hospital in Torino, Italy, where he accumulated 20 years of clinical experience with lung cancer and mesothelioma patients across multiple clinical trials. His medical degree comes from the University of Torino School of Medicine.

Currently, Dr. Selvaggi holds the position of Chief Medical Officer at Xcovery Holdings, managing an active FDA New Drug Application for ensartinib, an ALK-targeted therapy for lung cancer. He also provides clinical consultation to Tubulis GmBH on early-stage drug programs and advises Alira Health on clinical strategy matters.

A Shared Vision for Patient Impact

In his new role, Dr. Selvaggi expressed strong enthusiasm for Multikine’s potential: “Multikine represents a truly first-in-class immunotherapy that has already demonstrated meaningful and durable survival benefits in a carefully selected patient population with newly diagnosed head and neck cancer. The strategic importance of intervening early in the cancer treatment journey cannot be overstated—particularly when existing treatment options fail to address the pre-surgical window. The expedited registrational pathway agreed upon with regulatory authorities offers a genuine path toward bringing curative options to these patients.”

CEL-SCI CEO Geert Kersten welcomed the addition: “Dr. Selvaggi’s passion for oncology drug development and his proven success in navigating complex late-stage clinical programs, regulatory interactions, and approval processes will prove invaluable as we execute this confirmatory study. The clinical data supporting Multikine is exceptionally strong, and having his expertise guide us through this pivotal phase significantly enhances our prospects for success.”

The Patient Population and Trial Design

CEL-SCI’s narrowly focused registration strategy reflects a precision medicine approach. The 212-patient study will enroll newly diagnosed advanced head and neck cancer patients meeting specific criteria: no lymph node involvement (confirmed via PET imaging) and low PD-L1 tumor expression (determined through biopsy analysis). This patient stratification represents over 100,000 patients annually—establishing a substantial addressable market for this orphan indication.

Multikine carries FDA Orphan Drug designation for neoadjuvant treatment of head and neck squamous cell carcinoma, positioning it to address a significant unmet clinical need with strong regulatory support.

About CEL-SCI Corporation

CEL-SCI’s core principle centers on immune system optimization at the point when it remains most capable. Multikine (Leukocyte Interleukin, Injection) operationalizes this philosophy by activating immune responses before standard treatment protocols compromise immune function. With operations based in Vienna, Virginia and the Baltimore, Maryland region, CEL-SCI continues advancing this differentiated approach to early-stage cancer intervention.