CEL-SCI Corporation (NYSE American: CVM) recently announced its financial results for the fiscal year ended September 30, 2022, along with several noteworthy clinical and corporate developments. The Vienna, Virginia-based company highlighted highlights such as positive clinical findings and strategic partnerships that are helping to propel its mission of bringing innovative treatments to those who need them.
Clinical and Corporate Developments:
CEL-SCI is gearing up to make a big splash in the medical industry by submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of its innovative treatment, Multikine®* (Leukocyte Interleukin, Injection). If approved, this revolutionary therapy could be used to treat advanced primary head and neck cancer patients. With the entire fiscal year 2022 dedicated to this cause, CEL-SCI is one step closer to making this life-saving therapy available to those in need.
For those suffering from recurrent squamous cell carcinoma of the head and neck (SCCHN), there is a new hope in Multikine. This revolutionary drug therapy from Merck and Bristol Myers Squibb (BMS) is the first of its kind to show a substantial survival benefit in a Phase 3 trial; it is prescribed to newly-diagnosed patients following initial diagnosis and is given prior to surgery. This is a game-changer for those with SCCHN, providing an alternative to current therapies which are only used as a last resort after treatments have failed or for those who cannot undergo surgery.
CEL-SCI’s groundbreaking immunotherapy treatment, Multikine, has been proven to provide significant benefits to patients with head and neck cancer. In a pivotal Phase 3 clinical trial, patients receiving Multikine in addition to surgery and radiotherapy had a 46.5 month median overall survival improvement – nearly four years – and a 62.7% survival rate after 5 years, compared to 48.6% in the control group. Additionally, 5 patients saw their tumors completely disappear in just 3 weeks before surgery, and tumor shrinkage was seen in nearly 1 in 6 patients, leading to a threefold decrease in the death rate. The results of the clinical trial have been presented at prestigious cancer conferences such as ASCO and ESMO, and have been published on www.clinicaltrials.gov. CEL-SCI has also completed the construction of a dedicated manufacturing facility to ensure its compliance with FDA GMP and European regulations. With $22.7 million in cash and cash equivalents, CEL-SCI is well-positioned to continue to develop and commercialize Multikine.
CEL-SCI is proud to have achieved a major breakthrough in the treatment of advanced primary head and neck cancer: successful neoadjuvant immunotherapy. Despite the success of Keytruda and Opdivo, this achievement is unprecedented, and the last FDA approval for this disease was decades ago. Our Phase 3 study, which enrolled 928 patients and produced an extensive amount of data, has shown a very large improvement in survival. However, due to our lack of resources, our progress towards submitting a BLA has been slower than larger companies. Still, our tenacity has paid off and we are looking forward to a year of positive activity and progress as we strive to bring Multikine to market and meet the severe unmet medical need of these patients.
About CEL-SCI Corporation
CEL-SCI is pioneering a unique approach to cancer treatment with their investigational product Multikine (Leukocyte Interleukin, Injection) – a therapy that has received FDA Orphan Drug designation for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck. In their Phase 3 study, CEL-SCI studied patients with newly diagnosed, locally advanced primary squamous cell carcinoma of the head and neck who received Multikine before surgery, radiotherapy or chemotherapy – treatments which are currently standard of care for these patients. This groundbreaking study is the largest Phase 3 study in the world for the treatment of locally advanced primary head and neck cancer, and CEL-SCI believes that boosting the immune system while it is still intact can provide the greatest possible impact on survival.
CEL-SCI, a company with operations in Vienna, Virginia, and near/in Baltimore, Maryland, started a Phase 3 study in 2011 with the aim of testing the efficacy of Multikine in helping the immune system target tumors. After enrolling 928 patients in September 2016, the study required the company to wait until 298 deaths had occurred among the two main comparator groups to test for an overall survival benefit.
CEL-SCI is pleased to announce the terms and expected closing of its offering, which could provide the necessary capital to further its mission of developing safe and effective treatments. However, there are risks and uncertainties that could prevent the Company from achieving its objectives, including the inability to duplicate successful clinical results, the timely development of products, obtaining necessary regulatory approvals, and difficulties in manufacturing. CEL-SCI is committed to doing its best to overcome these challenges in order to make its treatments available to those in need.