The new era for CEL-SCI is here are it doubles down on a new approach for head and neck cancer
CEL-SCI (NYSE AMERICAN: CVM) believes Multikine could revolutionize the treatment of head and neck cancer. From early research conducted at the prestigious Max Plank Institute in Germany in the 1970s to a phase 3 clinical trial that lasted more than 10 years, and a lawsuit against a multi-billion-dollar company they won along the way — most CEOs would have given up. Not CEL-SCI CEO Geert Kersten. “Despite the formidable headwinds we’ve encountered over the years, we forge ahead in hopes to deliver a much-needed alternative for patients and their loved ones battling head and neck cancer,” says Mr. Kersten. “Based on the recent unblinding of our landmark Phase 3 trial, we have increased our commitment and investment to ensure the commercialization of Multikine.”
CEL-SCI’s founder, Maximilian de Clara, believed that the immune system played a pivotal role in fighting cancer. Considering that most new oncology therapies these days fall into the “immunotherapy” category, it seems that Mr. deClara’s belief has been validated. His investment in early research ultimately led to the discovery of Multikine. Multikine is a copy of the substances that regulate a healthy person’s immune system every day. Simply stated Multikine is believed to be more effective and less toxic than other head and neck cancer (HNC) therapies.
Head and neck cancer is a disease of extremely high unmet medical need. It has been more than 50 years since a new treatment option for newly diagnosed HNC has been commercialized. Approximately 890,000 new cases of HNC are diagnosed each year globally, of which approximately 65,000 are in the U.S. and 105,000 in Europe.
These grim statistics set the stage for CEL-SCI’s Phase 3 clinical trial with Multikine. This is the largest study in the world for these HNC patients and was launched in early 2011 and was fully enrolled with 928 patients in September 2016. The study treated newly diagnosed patients with advanced primary squamous cell carcinoma of the head and neck with Multikine first, BEFORE they received surgery and radiotherapy or surgery plus concurrent radiotherapy and chemotherapy (the current standard of care for these patients). This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. The idea is to conquer cancer at the beginning when patients still have the best chance of success.
To prove an overall survival benefit, the study required CEL-SCI to wait until at least 298 (deaths) events had occurred among the two main comparator groups. This study milestone occurred in late April 2020 and the database lock occurred in December 2020. The final results of the study were announced in June 2021.
The study produced a statistically significant 14.1% 5-year survival benefit in patients receiving surgery plus radiotherapy, representing 40% of the study population and an estimated 211,000 patients annually. Data from the successful treatment arm should be acceptable in seeking FDA approval. To be clear: the study showed excellent 5-year survival data with no safety issues for patients who the physicians selected to receive surgery and radiation. When the physicians elected to add chemotherapy, the chemotherapy killed the immune response from Multikine. There was no other way to conduct the study because the standard of care treatment includes chemotherapy for many patients.
“Our Phase 3 results showed a long-term 5-year overall survival (OS) benefit in this treatment arm that was robust and durable, with no safety issues, something not commonly seen with cancer drugs,” said Eyal Talor, Chief Scientific Officer, CEL-SCI. “In fact, the survival benefit increased over time and at 5-years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation), which is about a 29% improvement, control arm 48.6%, Multikine arm 62.7% survival.”
A New Era for CEL-SCI
According to CEL-SCI, these Phase 3 data validate Multikine’s efficacy and will be used as the basis of an official regulatory filing to the U.S. Food and Drug Administration. This work will require significant resources and time. In addition to the regulatory pathway for Multikine’s commercialization is the investment CEL-SCI is making in the technology and infrastructure required to manufacture Multikine.
CEL-SCI will use its recent funding round to build out the company and prepare for the commercialization of Multikine. CEL-SCI will allocate resources toward operations, particularly with strategic hires. In addition, the company is investing in its manufacturing facility and capacity for the development and distribution of Multikine. Funds will also be invested in the further development of Multikine for additional indications.