Currently in preclinical development, Cel-Sci Corporation’s therapeutic vaccine, Cel-4000, targets the 25-40% of patients with rheumatoid arthritis (RA) who are not responsive to existing medication.
The company received an $1.5m (€1.34m) grant from the Small Business Technology Transfer (SBIR/STTR) Program and will be featured under NIH sponsorship in the Convention’s Innovation Zone, an exhibit space for SBIR/STTR awardees.
Cel-4000 is based on the company’s Leaps platform technology, which has been shown to preferentially direct the immune response to a cellular, humoral or mixed pathway.
According to the company, Leaps can be utilized in diseases for which antigenic epitope sequences have already been identified, such as a number of infectious diseases, some cancers, autoimmune diseases, allergic asthma and allergy, and select CNS diseases.
“Cel-4000 differentiates itself from other RA products because it re-programs or redirects the aberrant cells and the inflammatory immune response causing the damage and pain in the joints, involving several inflammatory cytokines,” a spokesperson from Cel-Sci told us.
He added that the cost of Cel-4000 manufacturing is much lower than the cost of manufacturing current biologics and biosimilars available on the market.
Geert Kersten, the company’s CEO, said Leaps is expected to benefit from the visibility it will receive from potential development partners and investors at the BIO Convention.
Previous development approaches commercialization
The company has already developed Multikine (leukocyte interleukin, injection), a cancer immunotherapy treatment designed to help the immune system detect and attack the tumor while it is still intact, which could ‘provide the greatest possible impact on survival’.
Multikine, which is currently under Phase III clinical trials, has received orphan drug designation from the FDA for the neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck.
During the clinical studies, which are the world's largest Phase III studies for head and neck cancer, newly diagnosed patients are treated with Multikine before standard treatment, which involves surgery, chemotherapy and/or radiation.
