After 35 years operating without a commercial product, one may question what sort of successful business could sustain. However, those with knowledge of the biotechnology sector understand that things take time. One biotech company that knows this best is Vienna, Virginia based CEL-SCI.

CEL-SCI Corporation (NYSE American: CVM) is a biotechnology company that was formed in 1983 and is involved in the research and development of immunotherapy products for the treatment of cancer, autoimmune and infectious diseases. The Company's core capabilities include: drug discovery, research, development and manufacturing of complex biological substances.

From the earliest days, CEL-SCI has held a unique vision to change the way cancer is treated. The organization strives to develop novel immune-based therapies that have the potential to utilize the body’s own immune defense system. One of the possibilities and goals of this approach is the minimization of toxicity to normal cells and the body’s organ systems.

A CEO Who Knows and Cares

Geert Kersten is approaching 25 years in his role with CEL-SCI taking the helm as CEO back in 1995. CEL-SCI began with a very basic yet radical idea, the treatment of cancer patients is completely inadequate.

Mr. Kersten has been with the company since 1987 in its earliest days of inception and has been regularly involved on a daily basis with the pioneering field of cancer immunotherapy for over two decades. As CEO he has successfully steered CEL-SCI through many changes and challenging cycles in the biotechnology industry over the past two decades. Simply put, Geert Kersten is not just a CEO who cares about his company, he cares about helping others. “This is about helping people…. At CEL-SCI I often say that we don’t have to talk about money, we don’t need to cheapen any of this,” says the CEO. “Every day above ground is a gift.” It sounds very simple when spoken, but it carries an incredibly impactful message.

In addition to his knowledge and expertise in the cancer immunotherapy sector, Mr. Kersten has a deep understanding of finance and law. This perspective offers him a unique vision on how he believes the company’s Multikine product will change cancer treatment as a whole in the future. Prior to his beginning at CEL-SCI, Mr. Kersten worked at the law firm of Finley & Kumble and worked at Source Capital, an investment banking firm located in McLean, VA. In addition, Mr. Kersten is the inventor of a patent on the potential use of Multikine in managing cholesterol.


CEL-SCI’s core beliefs are the basis of the company’s research and development.

Those core beliefs are that our own immune systems are continuously working to fight cancer but a weakened immune system increases the susceptibility to disease. CEL-SCI also feels innovation is critical. New and innovative therapies have the potential to meet unmet medical needs rather than minor innovations to existing therapies or ‘me-too’ products.

Multikine ® (Leukocyte Interleukin, Injection) is CEL-SCI ’s lead investigational therapy that is currently being developed as a potential therapeutic agent directed at enabling the immune system to use the body’s own anti-tumor immune response. Multikine is being developed as a first-line therapy for cancer meaning that it is being studied for use before a patient receives any other therapy for their advanced primary head and neck cancer.

The hope of Multikine is to demonstrate an investigational therapy that helps to make a patient’s initial course of treatment more successful. Multikine is intended to be administered to the cancerous tumor locally ahead of any surgery, chemotherapy or radiation treatment. The goal of this is to help boost the immune system and signal the immune system recognize and kill micrometastases that often cause cancer recurrence.

“Where I am from in Germany, we are raised with a more holistic approach. When you go back 30 years, Americans did not think holistically when this began,” says Kersten. “In our earliest days, we were thought of as being crazy, now it seems like we may have been right all along.”

The CEO and the CEL-SCI team collectively believe that the body has the ability to regulate our health. The potential to enhance a weakened immune system is the first step in fighting cancer.

Phase III Clinical Trial

Multikine has successfully enrolled the largest head and neck cancer study to ever be completed in head and neck cancer encompassing 24 total countries including the United States. The total number of newly diagnosed and not yet treated head and neck cancer patients is nine hundred twenty-eight (928).

Approximately 135 patients were enrolled in the study from 2011 to 2013, 195 enrolled in 2014, 340 in 2015, and the final group of 260 in 2016. The study protocol assumed an overall survival rate of about 55% at 3 years for the SOC treatment group alone.

All patients who completed Multikine treatment continue to be followed for protocol-specific outcomes in accordance with the Study Protocol. The final patients were enrolled in September of 2016 and the Phase 3 trial recently concluded when CEL-SCI announced on May 4, 2020 that the 298th event had occurred, ending the nearly 10-year Phase III trial of Multikine.

CEL-SCI’s Phase 3 study was the largest Phase 3 study in the world for the treatment of head and neck cancer. To prove an overall survival benefit, the study required CEL-SCI to wait until 298 events occurred among the two main comparator groups.

In one sense, all CEL-SCI could do is wait. Wait and witness the positive results and benefits that Multikine is having in those cancer patients that enrolled in the Phase III trial. That is not at all what the team is doing however. While the final patient was enrolled in the study in September 2016, much like they have done since their founding over 35 years ago the CEL-SCI team continues to research, develop and study all they can to improve their products, healthcare and the lives of patients.

What’s Ahead

CEL-SCI Corporation continue their biotechnology operations as they await the results of the Phase III Trial. CEL-SCI remains actively engaged in the research and development of immunotherapy products for the treatment of cancer, autoimmune, and infectious diseases.

The final analysis of the trial results are soon to be performed and CEL-SCI will remain blinded to the study results throughout this process. CEL-SCI will be advised of the results when the analysis is completed and the study results will be announced to the public and investors at that time.

“This has always been a company of the little people, and I am sorry to say that you and I may be little people, but we have thousands and thousands of little people helping us,” says Kersten as he ponders what is ahead for CEL-SCI. “By the way, remember that is also the definition of a revolution. You will never find a groundbreaking idea that changes the world originating in a large company, it always comes from the little people willing to take a chance.”

It should be noted that the last FDA approval for advanced primary head and neck cancer was over 50 years ago. Head and neck cancer is huge, about 6% of all cancers, and the current treatment involves horrible surgeries and side effects. CEL-SCI currently has orphan drug status for this disease. If Multikine is shown to increase survival when added to this standard of care, one could well imagine that Multikine should become part of the new standard of care.