- Tiziana Life Sciences reported clinical results from the second patient with Secondary Progressive Multiple Sclerosis (SPMS) in the ongoing study as part of an expanded access program.
- These results confirm the previously reported data from the first SPMS patient after three months of treatment of the first SPMS patient.
- The treatment with foralumab, a fully human anti-CD3 monoclonal antibody, was well-tolerated and improved clinical and PET imaging analyses.
- After three months of treatment with intranasal foralumab, the patient showed improvement as measured by PET imaging and neurologic examination.
- Approximately 10-30% reduction in PET signal was seen across brain regions in the second SPMS patient, comparable to the PET changes seen in the first SPMS patient.
- Clinically, the Timed 25-Foot Walk test and neurologic exam were also improved.
- The FDA has now allowed Tiziana to treat an additional eight SPMS patients.
- Although the original dosing regimen with intranasal therapy with foralumab will remain the same (50 mcg), the revised regimen has a dose escalation of up to 100 mcg (MWF), an option to improve clinical benefit.
- SELLAS Life Sciences Group Inc announced updated data from a Phase 1 clinical trial of galinpepimut-S (GPS), combined with Bristol-Myers Squibb Co's nivolumab (Opdivo) in with malignant pleural mesothelioma (MPM).
- The trial included patients who were either refractory or relapsed after at least one line of the standard of care therapy.
- Data from eight patients enrolled in the study have been analyzed, with final data in the clinical trial expected by the end of 2022.
- Median overall survival (OS) was 40.9 weeks (9.4 months) for all eight patients and 45.7 weeks (10.5 months) in patients who received the combination therapy (seven out of eight patients).
- The median progression-free survival (PFS) was 11.1 weeks for all eight patients and 11.9 weeks for the combination therapy patients.
- The safety profile of the GPS-nivolumab combination was similar to that seen with nivolumab alone, with the addition of only low-grade, temporary local reactions at the GPS injection site.
- No Grade 3/4 toxicities were observed for GPS, and there were no dose-limiting toxicities.
