Clinical Trial News

FDA approves Ocrevus Zunovo, a subcutaneous formulation of Ocrevus for treating MS, covering relapsing forms and primary progressive MS. This new option allows for a 10-minute injection compared to the original's 2-4 hour IV infusion, potentially increasing accessibility. Based on OCARINA II trial data, both formulations showed similar efficacy and safety, with 92% of patients satisfied with the new subcutaneous method.

Sanofi ships BEYFORTUS doses to US healthcare providers and CDC for RSV prevention, ensuring access for eligible babies. A new FDA-approved filling line expands manufacturing capacity, with another line expected to boost supply for the 2024/2025 RSV season. BEYFORTUS is the first long-acting monoclonal antibody for RSV LRTD prevention in newborns and infants up to 24 months.

A multinational clinical trial, EASi-KIDNEY, will evaluate whether vicadrostat (BI 690517) combined with empagliflozin reduces CKD progression, heart failure hospitalization, or cardiovascular death. The trial, involving 11,000 participants across 15-20 countries, aims to provide robust evidence for new treatments. Initial results are expected by 2028/2029.

Velsera's tumor profiling tech integrated into Illumina's TruSight™ Oncology Comprehensive IVD report, enhancing personalized cancer treatment nationwide. Collaboration aims to advance diagnostics and make targeted therapeutics more accessible.

Novartis' Kisqali, combined with endocrine therapy, reduced breast cancer recurrence risk by 28.5% beyond the three-year treatment period. The company expects an FDA decision on approval this quarter.

5.8% of patients receiving CAR T-cell therapy developed second primary malignancies (SPMs), with hematologic malignancies, solid tumors, and nonmelanoma skin cancers being the most common subtypes. SPM risk factors include treatment setting, follow-up duration, and previous treatment lines.

INmune Bio Inc. is offering 2,341,260 shares of common stock and warrants to purchase up to 2,341,260 shares of common stock. The offering price per share of common stock and accompanying Warrant is $5.50 for Third-party investors and $6.50 for Insiders. The Warrants are exercisable beginning on March 16, 2025, at an exercise price of $6.40 per share, and will expire on March 16, 2030, unless accelerated. The net proceeds from this offering will be used for funding to complete the Phase 2 AD trial of XPro, initiate the Phase 2 trial of TRD, continue the INKmune programs, and for general corporate purposes, working capital, other R&D, and manufacturing.

Trishula Therapeutics reported positive Phase 1 results for TTX-030, an anti-CD39 antibody, in first-line metastatic pancreatic cancer patients, with strong median overall survival and marked benefit in HLA-DQhigh patients. The trial evaluated TTX-030 in combination with gemcitabine/nab-paclitaxel, with or without budigalimab, showing a 30% objective response rate and 19.1 months median overall survival. The treatment was well-tolerated, leading to the ongoing Phase 2 ELTIVATE study.

KEYNOTE-522 trial in early-stage TNBC showed neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab improved overall survival by 34% vs chemotherapy plus placebo, with 5-year OS rates of 86.6% and 81.7%, respectively.

Pfizer announced positive results for ponsegromab in a Phase 2 trial for treating cancer cachexia, with plans for late-stage trials next year. The drug showed improvements in body weight, muscle mass, quality of life, and physical function.