Thiogenesis Receives Confirmatory Guidance on IMPD for Pediatric MASH Phase 2a Clinical Trial in Europe and Core Patent Granted in EUJune 25, 2025 9:00 AM EDT | Source: Thiogenesis Therapeutics, Corp.San Diego, California--(Newsfile Corp. - June 25, 2025) - Thiogenesis Therapeutics, Inc. (TSXV: TTI) (OTCQX: TTIPF), a clinical-stage biopharmaceutical company developing next-generation thiol-based therapies for mitochondrial disease and pediatric metabolic conditions, today announced that the Co ...

Thiogenesis Announces Second Site Begins Enrolling in Phase 2 MELAS Clinical Trial and Provides UpdateJune 17, 2025 9:00 AM EDT | Source: Thiogenesis Therapeutics, Corp.San Diego, California--(Newsfile Corp. - June 17, 2025) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQX: TTIPF) ("Thiogenesis" or the "Company") a clinical-stage biopharmaceutical company developing sulfur-based therapeutics for serious pediatric and inherited mitochondrial diseases, today announced the recent activation o ...

Summary of Werewolf Therapeutics Conference Call Company Overview - Werewolf Therapeutics is a clinical stage biopharmaceutical company focused on developing conditionally activated biologics for cancer and other serious diseases. The company has engineered a pipeline of cytokine prodrugs, referred to as endokines, to address therapeutic index challenges associated with potent biologics [2][3] Core Programs - The lead endokine programs include: - WTX-124 (an interleukin-2 endokine) - WTX-330 (an interleukin-12 endokine) - The company has also developed T cell engagers called inducers, designed to address therapeutic index challenges of T cell engagers [3][19] Clinical Data and Efficacy - WTX-124 has completed dose escalation for both monotherapy and combination therapy with pembrolizumab, with a determined dose of 18 mg delivered IV every two weeks [5][6] - Expansion arms are open for indications including: - Cutaneous melanoma - Renal cell carcinoma - Cutaneous squamous cell carcinoma, where a patient achieved a complete response after failing standard treatment [6][7] - The company aims for an overall response rate above 20% for monotherapy and higher for combination therapy, with enrollment progressing well [11][12] Safety Profile - The safety profile of WTX-124 has shown no hallmark toxicities associated with high-dose IL-2, allowing for outpatient delivery to a broad patient population [9][10] Regulatory Pathway - The company plans to present data to the FDA in the coming quarters, seeking insights on both monotherapy and combination data for potential registration [13][14] Future Expectations - The company anticipates presenting updated interim data in Q4 2025, with a focus on both efficacy and safety metrics [9][22] - For WTX-330, the company has completed a first-in-human trial, showing a good safety profile and antitumor activity, with plans for further studies [16][17] Inducers Platform - The inducers platform aims to mask immune cell engagement to reduce cytokine release syndrome, enhancing the therapeutic index of T cell engagers [19][20] - The company plans to announce a development candidate for the inducers platform imminently [22] Conclusion - Werewolf Therapeutics is positioned for significant developments in the coming months, with a robust pipeline and promising clinical data that could lead to regulatory advancements and potential market opportunities [24][25]

Core Insights - Thiogenesis Therapeutics has initiated a Phase 2 clinical trial for TTI-0102, targeting the treatment of MELAS, an inherited mitochondrial disease [1][3] - The trial aims to assess the safety, tolerability, efficacy, and pharmacokinetics of TTI-0102 over a 6-month period, involving 12 patients [2][3] - TTI-0102 is designed to increase intracellular antioxidants and amino acids, addressing deficiencies in MELAS patients [3][8] Company Overview - Thiogenesis Therapeutics is a clinical-stage biotechnology company based in San Diego, focusing on developing disulfides that enhance intracellular antioxidant production [1][10] - The company is publicly traded on the TSX Venture Exchange and OTCQX, with a focus on treating serious pediatric diseases with unmet medical needs [10] Clinical Trial Details - The Phase 2 trial is a multi-country, multi-center study conducted in the Netherlands and France, with a randomized, double-blind, placebo-controlled design [2] - A total of 12 patients will be enrolled, with 8 receiving TTI-0102 and 4 receiving a placebo, followed by an interim analysis after 3 months [2] Disease Background - MELAS is characterized by symptoms such as seizures, muscle weakness, and fatigue, often presenting before the age of 20, and is caused by mitochondrial DNA mutations [4] - The disease affects approximately 4.1 per 100,000 of the population, making it one of the most prevalent inherited mitochondrial disorders [4] Product Information - TTI-0102 is an asymmetric disulfide and prodrug that acts as a precursor to cysteamine, aimed at restoring mitochondrial function by increasing levels of glutathione and taurine [8] - The prodrug formulation addresses limitations of first-generation thiol-based drugs, including short half-life and adverse side effects [8][9]