Vaccinex, Inc. recently announced positive results for a multi center, randomized, double-blinded, placebo-controlled phase 1 clinical trial that evaluated single ascending-dose tolerability and safety in an experimental treatment for Multiple Sclerosis (MS) adult patients.
The researchers enrolled 50 MS patients in one of five study groups (1, 3, 6, 10, and 20 mg/kg) to assess the tolerability and safety of the new compound VX15/2503 that was IV-administered in a single dose.
VX15/2503 is a first in class, monoclonal antibody that Vaccinex discovered, characterized, and examined in Multiple Sclerosis and Huntington’s Disease preclinical models.
Results from the study revealed the drug is well tolerated at doses of up to 20 mg per kg. The results also showed no major adverse effects during treatment with no maximum tolerated dose (MTD) determined and no dose-limiting toxicities (DLTs).
After a preliminary analysis, researchers determined that the half-life of a single drug dose is between 21 and 23 days at the dose level of 20 mg/ per kg, and that saturation of the specific SEMA4D drug-target receptor persisted for about 155 days. The company is planning to publish these preliminary results in a peer-reviewed journal.
Vaccinex will begin a new phase 2 study during the first half of 2015, to test the efficacy of its VX15/2503 antibody in patients with Huntington’s Disease. The company is actively working in discovering and developing human therapeutic monoclonal antibody solutions for cancer treatment. Vaccinex is also committed to advancing therapeutic solutions for neurodegenerative diseases, such as multiple sclerosis and Huntington’s Disease.
The company’s proprietary ActivMAb Antibody Discovery Technology includes a mammalian cell-based antibody selection and is part of Vaccinex’s antibody pipeline. The system combines the benefits of a fast and precise selection through virus panning and cell sorting all in one single technology, with key selection of antibodies that are efficiently expressed and stable in mammalian cells.