Announcements
— 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…
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…
MAXONA is Developing MAX-001 as a Non-Opioid, Non-NSAID Solid Oral Prescription Therapy for the Treatment of Acute and Chronic Pain and Potential Additional Indications MAX-001 is a Proprietary Optimized Extended Release Form of Nefopam Nefopam is a New Molecular Entity (NME) in the U.S. with a Well Documented Safety and Efficacy Profile in Treating Acute…
Half of planned clinical sites will be activated this month; more than 20 patients have been pre-identified across participating centers Company to hold Type D meeting with FDA to discuss a potential registrational pathway through the addition of Part B to the existing REO 033 trial design Part B will be a randomized study designed…
At RDE of 32 mg QD, encouraging monotherapy responses with 57% uORR in 2L+ KRAS G12X pancreatic cancer in U.S. trial and median relative dose intensity of 100% Monotherapy has been generally well-tolerated at RDEs Promising combination potential, including no DLTs, encouraging safety data, and clearance of first dose escalation combination cohort of ERAS-0015 (16…