Former J&J Executive Herwig Janssen Appointed Chairman of Tryptamine Therapeutics as Company Advances Psilocin-Based Clinical Programs
• Tryptamine Therapeutics has appointed Herwig Janssen, a former Johnson & Johnson executive with 40+ years of pharmaceutical experience, as its new non-executive chairman effective May 12.
• The leadership change comes as Tryptamine prepares for pivotal clinical trials of TRP-8803, an IV-infused psilocin formulation being developed to treat binge eating disorder, fibromyalgia, and irritable bowel syndrome.
• Chris Ntoumenopoulos will transition from non-executive to executive director, strengthening the company's leadership team ahead of key clinical and commercial milestones in psychedelic-assisted therapeutics.
BlinkLab Initiates Major FDA Registration Study for Autism Diagnostic Platform
BlinkLab has launched a significant FDA registrational study for its Dx 1 platform, designed to aid in autism diagnosis. The study plans to recruit up to 1,100 children across multiple U.S. sites, with final results expected by the end of 2025 to support 510(k) FDA approval. The company has also partnered with Monash University for the MAGNET study to enhance its diagnostic capabilities for autism and ADHD.
ASX Biotech Shares Surge on Cancer Trial Progress, Diagnostic Milestones
• Race Oncology's stock jumped following the submission of a human ethics application for its RC220 Phase 1 solid tumour trial, with patient recruitment expected in Q1 2025.
• Inoviq Ltd. reported successful disease specificity testing for its neuCA15-3 blood test, showing high sensitivity and specificity in detecting breast cancer across all stages.
• Lumos Diagnostics Holdings Ltd. saw its shares rise after receiving approval for FebriDx reimbursement at US$41.38 per test by the United States Centers for Medicare and Medicaid Services.
Race Oncology's RC220 Phase 1 Trial Advances for Solid Tumors
• Race Oncology has submitted ethics and regulatory documents for a Phase 1 trial of RC220 with doxorubicin, targeting advanced solid tumors.
• The trial, expected to begin in Q1 2025, will assess the safety and tolerability of RC220 in combination with doxorubicin across multiple sites.
• The study includes two stages focusing on dose optimization, cardioprotective benefits, and anticancer efficacy of RC220.
• Race Oncology also reported $18.78 million in cash reserves, with significant investment in R&D and drug manufacturing.
Scancell's SCIB1 Melanoma Vaccine Shows Promise in Phase II Trial
• Scancell's SCIB1, a DNA-based cancer vaccine, is being evaluated in a Phase II trial in combination with nivolumab and ipilimumab for melanoma treatment.
• Early results from 25 patients showed an 84% disease control rate, with 80% remaining progression-free and 20% achieving a complete response.
• New data presented at the AACR IO conference provides insights into how SCIB1 activates immune T cells to fight melanoma, supporting its further development.
• The findings suggest SCIB1 could be a valuable new treatment option for advanced melanoma, especially when used with checkpoint inhibitors.
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