Cel Sci Corp (NYSE: CVM)

CEL-SCI Corporation (CVM) is a clinical-stage biotechnology company operating in the healthcare industry, specifically focused on researching and developing treatments for cancer and other diseases using the immune system. The company's main business activities involve the development of its lead investigational therapy, Multikine, an immunotherapy product candidate comprised of a patented defined mixture of 14 human natural cytokines.

Multikine is being developed as a potential therapeutic agent that harnesses the power of the immune system to produce an anti-tumor immune response. Data from CEL-SCI's clinical trials suggest that Multikine may help the immune system "see" the tumor and then attack it, enabling the body's own anti-tumor immune response to fight the tumor. The primary product candidate, Multikine, is an investigational therapy being developed for the treatment of squamous cell carcinoma of the head and neck (SCCHN), a type of cancer that affects the mouth, throat, and other areas of the head and neck. Multikine has been tested in a Phase III clinical trial, which demonstrated a statistically significant improvement in overall survival in patients with locally advanced primary SCCHN.

CEL-SCI's target population for Multikine is treatment-naive adult patients with resectable locally advanced primary SCCHN who have no nodal involvement (N0) and no extracapsular spread (ECS) as determined by PET-CT/MRI, and who have low tumor programmed death-ligand 1 (PD-L1) expression (defined as tumor proportion score (TPS) < 10). These patients can be readily identified upon diagnosis using tests that physicians routinely use in cancer screenings. The company's Phase III clinical trial demonstrated that Multikine caused tumors to reduce in size and/or caused the disease to "downstage" within just a few weeks of treatment before surgery. Importantly, patients with these reductions and/or downstages had their risk of death cut in half after five years of follow-up. The trial also showed that Multikine was well-tolerated, with no demonstrable safety signals or toxicities observed in about 750 Multikine-treated subjects across multiple clinical trials.

CEL-SCI's competitive advantages include its unique local administration of Multikine before surgery, which is believed to be more effective than systemic administration after surgery and radiation. Additionally, Multikine is designed to work best in patients with low PD-L1 expression, which is a different mechanism of action than checkpoint inhibitors like Keytruda and Opdivo, which work best in patients with high PD-L1 expression. The company's customers are primarily cancer patients and healthcare providers who treat cancer patients. CEL-SCI's products are designed to be used in conjunction with standard cancer treatments, such as surgery, radiation, and chemotherapy.

The company has a licensing agreement with Byron Biopharma LLC, under which CEL-SCI granted Byron an exclusive license to market and distribute Multikine in the Republic of South Africa, if approved. CEL-SCI also has a licensing agreement with Orient Europharma Co., Ltd., of Taiwan, which grants Orient Europharma the exclusive marketing and distribution rights to Multikine in several countries, if approved.

In addition to Multikine, CEL-SCI has a patent portfolio that covers its proprietary technologies, including Multikine and LEAPS, by multiple issued patents and pending patent applications in the United States and in key foreign markets. The company has also built a dedicated manufacturing facility to produce its investigational biological product candidate Multikine.