ACT Brief: Evaluating Evidence for Individualized Therapies, Clinical Trial Reporting Compliance, and TIL Therapy Merger

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In part two of her video interview, Mwango Kashoki, MD, MPH, senior vice president and global head of regulatory strategy at Parexel, broke down how FDA evaluates substantial evidence of effectiveness for individualized therapies in ultra-rare conditions. The determination depends on totality of mechanistic, biomarker, and clinical outcome data rather than trial numbers alone, fundamentally reshaping how sponsors design evidence generation strategies.
• The FDA contacted over 2,200 medical product companies reminding them of legal obligations to submit clinical trial results to ClinicalTrials.gov. The outreach covered more than 3,000 trials where required results had not been submitted, with nearly 30% of studies under mandatory reporting showing no submitted results. The agency noted that companies often suppress unfavorable results, creating publication bias and gaps in the public record affecting clinician and researcher assessments.
• Obsidian Therapeutics and Galera Therapeutics agreed to merge in an all-stock transaction backed by $350 million in new financing. The combined company will advance OBX-115, a next-generation TIL cell therapy for melanoma and lung cancer that eliminates high-dose IL-2 and surgical biopsies, with key Phase I lung cancer data expected in H1 2027 and melanoma registration data by year-end 2027.

That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.