A new step in the clinical development

Basel-based company NUCLIDIUM announced the imaging of the first patient in a Phase 1 clinical trial for its radiotracer, 61Cu-NuriPro, aimed at diagnosing and staging prostate cancer. The phase 1 clinical trial aims at evaluating the company’s radiotracer candidate as a safe and accurate diagnostic and disease-staging imaging agent in prostate cancer patients. 61Cu-NuriProTM, is the first candidate from the company’s innovative copper-based radiopharmaceutical pipeline to enter the clinic, (61Cu-NODAGA-PSMA I&T) is the diagnostic component of NUCLIDIUM’s NuriPro program, binding specifically to Prostate Specific Membrane Antigen (PSMA). PSMA has evolved as an established biomarker for the diagnosis, staging, and treatment of patients suffering from certain types of prostate cancer. The investigator-initiated, non-randomized phase 1 trial is being conducted at Hoag Memorial Hospital Presbyterian in Newport Beach, California.  The company’s theranostic counterpart, 67Cu-NuriPro (67Cu-NODAGA-PSMA I&T), for the treatment of patients with certain types of prostate cancer, is currently completing its preclinical program. A phase 1 clinical study is planned to start in 2025. 

Noema Pharma’s phase 2 study meets endpoints
Noema Pharma AG is a clinical-stage neuroscience-based company advancing a portfolio of transformative therapeutics utilizing first-in-disease approaches targeting neuroscience-based conditions with high unmet need. The company announced Phase 2a ALLEVIA-1 study with NOE-105 (gemlapodect) in patients with Tourette syndrome (TS) met its primary and all key secondary endpoints. Gemlapodect is a novel and first-in-class PDE10A inhibitor currently being studied to assess its potential to reduce vocal and motor tics in people with TS with an improved tolerability profile over current treatment options. The Phase 2a study, ALLEVIA-1 (NOE-TTS-211), was a multi-center, 12-week, open-label, single-arm monotherapy study which enrolled a total of 15 patients with TS with a mean age of 26.2 (+/- 8.7) years. Patients were treated with ascending doses of gemlapodect ranging from 2.5 to 15 mg once daily, with a target dose range of 10 to 15 mg per day. The ALLEVIA-1 study achieved its primary and secondary objectives. inlcuding ALLEVIA.1, Noema has four programs currently in active Phase 2 clinical trials evaluating pain in Trigeminal Neuralgia, seizures in Tuberous Sclerosis Complex, Tourette syndrome and vasomotor symptoms plus associated symptoms of menopause with readouts expected in 2025. 

Limmatech Valneva and LimmaTech awarded FDA Fast Track Designation
Valneva SE, a specialty vaccine company, and LimmaTech Biologics AG, a Swiss-based clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Shigella4V (S4V), the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech. In August 2024, Valneva entered into a strategic partnership and exclusive licensing agreement with LimmaTech2 for the development, manufacturing and commercialization of S4V. Following positive Phase 1/2 results earlier this year, LimmaTech will conduct a Phase 2 Controlled Human Infection Model study (CHIM) in the U.S. and a Phase 2 pediatric study in LMICs, both expected to begin before the end of 2024. Valneva will assume all further development, including CMC (chemistry, manufacturing, and controls) and regulatory activities, and be responsible for its commercialization worldwide, if approved. 

Fast Track designation is granted by the FDA to products under development that have the potential to treat serious conditions and fill an unmet medical need. It is designed to facilitate the clinical development and expedite the review of important new products with the intention to get them to the people who require them earlier.