News & Updates
Why Speed Matters Every day a study remains in startup mode represents lost opportunity. Sponsors face pressure to activate sites faster, begin enrollment sooner, reach milestones more quickly, and control operational costs. Technology implementation can significantly influence these timelines. Traditional EDC Challenges Many EDC implementations require extensive customization and lengthy configuration cycles. Common challenges include…
Modern Trials Depend on Imaging Data Medical imaging plays a critical role across numerous therapeutic areas, including oncology, neurology, cardiology, inflammatory diseases, and rare disease research. As imaging endpoints become more prevalent, organizations must manage increasing volumes of DICOM files, metadata, image reviews, adjudication workflows, and regulatory requirements. Many organizations still handle imaging separately from…
— FDA clearance of the IND, together with the previously cleared CTA, establishes a global Phase 1/2 clinical program for PM577a — — PM577a targets the H1069Q mutation in the ATP7B gene, the most prevalent WD-causing allele in North America and Europe — — Initial clinical data expected in 2027 — Excerpt from the Press…
Excerpt from the Press Release: PHILADELPHIA — (JULY 23, 2026) — Scientists at The Wistar Institute have identified a new mechanism behind the chemotherapy resistance that makes ovarian cancer so lethal. In a new study, funded by top cancer research foundations and published in The Journal for ImmunoTherapy of Cancer, the researchers showed that chemotherapy…
The Growing Complexity of Clinical Trial Data Clinical trials are becoming increasingly complex. Modern studies often collect data from numerous sources, including investigator sites, laboratories, patient-reported outcomes, randomization systems, and medical imaging procedures. While advancements in technology have improved the ability to capture and manage large amounts of data, many organizations still struggle with fragmented…
Excerpt from the Press Release: EMERYVILLE, Calif.–(BUSINESS WIRE)–Estrella Immunopharma, Inc. (NASDAQ: ESLA) (“Estrella” or the “Company”), a clinical-stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, today announced that the first patient has been successfully dosed in the dose-expansion phase of its ongoing STARLIGHT-1 Phase I/II clinical trial…
RT-114 achieved systemic exposure greater than 150% relative to a matched 12mg subcutaneous dose of PG-102 No adverse events attributed to RaniPill Capsule; treatment-related adverse events were mild and consistent with the GLP-1/GLP-2 agonist class of therapeutics Phase 1a study expanded with an additional cohort to further define the oral-to-subcutaneous pharmacokinetic relationship ahead of a…
ALLO-316 Achieved a 31% Confirmed Response Rate with the Recommended Phase 2 Regimen in Patients with Stage IV Renal Cell Carcinoma (RCC) with High CD70 Expression Safety Profile was Manageable with Proactive Diagnostic and Management Strategies Effective in Mitigating IEC-HSALLO-316 Demonstrated Robust Expansion and Tumor Infiltration Following Standard Lymphodepletion, Validating the Dagger® Technology as a…
Treatment with investigational DNASE1L3 analog NTR-441, which degrades neutrophil extracellular traps (NETs), resulted in rapid clinical improvement in a patient with treatment-refractory SLE Results provide first human proof-of-concept that enzymatic NET degradation may address a key driver of disease activity in SLE, with broader implications for other NET-driven autoimmune and inflammatory diseases Observations from this single-patient…
Independent CRO Successfully Reproduces ERNA-101 Combination Data in Larger Preclinical Study, Significantly Strengthening Confidence as Company Advances Toward IND ERNA-101 Plus Anti-PD-1 Achieved Complete Tumor Clearance and Long-Term Survival in Two-Thirds of Treated Animals While No Complete Responses Were Observed in Any Monotherapy or Control Group IND Submission Planned for Q3 2026 with First-in-Human Phase…
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