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Clinical Trial News

Amgen's MariTide to Be Evaluated for Kidney Disease and Other Indications

  • Amgen is expanding the clinical development of its obesity drug MariTide (AMG 133) to include studies focused on kidney disease, driven by promising preclinical data.
  • The decision to explore MariTide's potential in kidney disease is based on the drug's mechanism of action, which targets both GLP-1 and GIP receptors.
  • Clinical trials are planned to assess MariTide's efficacy and safety in patients with specific kidney conditions, addressing a significant unmet medical need.
  • This strategic move reflects Amgen's broader approach to leverage its obesity portfolio for treating related metabolic and cardiovascular diseases.

Moleculin Biotech's STAT3 Inhibitor WP1066 Enters Phase 2 Trial for Glioblastoma

  • Moleculin Biotech initiates a Phase 2 trial of WP1066, a STAT3 inhibitor, combined with radiation for glioblastoma treatment at Northwestern University.
  • The trial (NU 21C06) is an open-label, multi-arm study focusing on newly diagnosed IDH wild-type, MGMT-unmethylated glioblastoma patients.
  • Primary outcome is progression-free survival, with secondary measures including tumor microenvironment analysis, addressing a critical unmet need.
  • Preclinical data showed WP1066 with radiation increased survival and induced anti-tumor immune responses, supporting the clinical trial's rationale.

WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

NCT05879250Active, Not RecruitingPhase 2
Northwestern University
Posted 5/22/2024

Agilent Launches Biopharma CDx Services Lab to Advance Precision Medicine

  • Agilent Technologies has launched its Biopharma CDx Services Lab (BCSL) in Carpinteria, California, after receiving necessary certifications.
  • The BCSL will support drug development from early clinical studies through regulatory approval, offering efficient companion diagnostic development.
  • The lab provides access to innovative technologies for biomarker assessment and high-quality assays for clinical trials, streamlining the path to FDA approval.
  • This launch strengthens Agilent's capabilities in the biopharma, clinical diagnostics, and precision medicine sectors, offering cost and time advantages.

Novel Immunotherapy Targeting Multiple Epitopes Shows Promise for Alzheimer's Treatment

• Researchers are developing a novel immunotherapy vaccine targeting multiple epitopes of amyloid-beta and tau proteins, key hallmarks of Alzheimer's disease. • Preclinical studies in mice genetically modified to develop Alzheimer's-like conditions showed fewer signs of brain damage and improved cognitive test performance. • The immunotherapy utilizes liposomes to deliver the vaccine and boost the immune response, aiming to clear plaques and tangles or slow their progression. • The research team is working towards establishing manufacturing standards and safety testing to potentially initiate human trials in the coming years.

Allogeneic NK Cell Therapy Shows Promise in Relapsed Neuroblastoma: Phase I Trial Results

  • A Phase I clinical trial evaluated the safety and efficacy of allogeneic natural killer (NK) cell therapy in children with relapsed or refractory neuroblastoma.
  • The study demonstrated that NK cell therapy is safe and feasible, with no dose-limiting toxicities observed across the tested dose range.
  • Preliminary efficacy signals were observed, including stable disease in some patients, warranting further investigation in larger trials.
  • This approach offers a potential new treatment option for high-risk neuroblastoma, addressing the need for more effective therapies.

Annexon's ANX007 Shows Promise in Protecting Vision in Geographic Atrophy

• Annexon will present Phase 2 ARCHER trial data on ANX007 for geographic atrophy (GA) at upcoming Retina Society and Euretina Congress meetings. • ANX007 demonstrated significant vision protection in standard and low light conditions, along with preservation of photoreceptors in the fovea. • The ARCHER II Phase 3 pivotal program is underway, with data expected in the second half of 2026, evaluating ANX007's potential to protect vision in GA. • ANX007 is a first-in-kind Fab designed to block C1q locally in the eye, potentially transforming the GA treatment landscape.

Replimune's RP1 Receives Positive FDA Feedback for Melanoma Treatment

• Replimune completed a successful pre-BLA meeting with the FDA for RP1 in anti-PD1 failed melanoma, supporting an accelerated approval pathway. • The IGNYTE clinical trial showed a 33% overall response rate when RP1 was combined with nivolumab in patients with advanced melanoma. • Replimune is on track to submit the BLA for RP1 in the second half of 2024, with the confirmatory IGNYTE-3 trial currently underway. • Data from the IGNYTE trial, including secondary endpoints, will be presented at the ESMO Annual Congress 2024, offering further insights.

VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)

NCT06264180RecruitingPhase 3
Replimune Inc.
Posted 7/11/2024

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

NCT03767348RecruitingPhase 2
Replimune Inc.
Posted 9/20/2017

FDA Lifts Clinical Hold on Rezolute's Ersodetug for Congenital Hyperinsulinism, Allowing US Trial Enrollment

• The FDA has lifted the partial clinical hold on Rezolute's ersodetug, clearing the way for U.S. patients to participate in the Phase 3 sunRIZE trial. • The decision was based on follow-up toxicology studies that found liver toxicity observed in earlier rat studies was strain-specific and not relevant to humans. • Rezolute plans to begin enrolling U.S. participants in early 2025, with topline data from the global sunRIZE study expected in the second half of 2025. • Ersodetug, a fully human monoclonal antibody, is being developed for congenital hyperinsulinism, a rare genetic disorder causing severe and continuous low blood sugar.

Medicenna Presents Preclinical Data on IL-2 Super-Antagonist MDNA209 and Anti-PD1-IL-2 BiSKIT MDNA113

  • Medicenna's MDNA209, an IL-2 super-antagonist, demonstrated a 400% increase in overall survival in an animal model of graft versus host disease (GvHD), suggesting potential in autoimmune disease treatment.
  • MDNA113, a tumor-targeted anti-PD1-IL-2 BiSKIT, showed enhanced efficacy in mice with IL-13Rα2-overexpressing tumors, indicating promise for treating immunologically 'cold' tumors like pancreatic and ovarian cancers.
  • The BiSKIT approach of MDNA113 allows for conditional activation in the tumor microenvironment, potentially improving safety and efficacy compared to traditional anti-PD1 therapies.
  • These preclinical findings validate Medicenna's IL-2 Superkine platform and its potential to develop transformative medicines for both cancer and autoimmune diseases.

Tonix Pharmaceuticals Presents Promising Data on Mpox Vaccine Candidate TNX-801

• Tonix Pharmaceuticals' TNX-801, a horsepox-based vaccine, demonstrates efficacy in protecting animals against lethal mpox challenge, supporting its potential as a single-dose mpox vaccine. • New data indicates improved tolerability of TNX-801 in immunocompromised animals, with no evidence of spread to blood or tissues, even at high doses, suggesting a favorable safety profile. • TNX-801's single-dose regimen and stability at standard temperatures offer advantages over existing mpox vaccines, potentially facilitating widespread use, especially in resource-limited settings. • Tonix's synthetic horsepox vaccine platform has been selected by NIH’s Project NextGen for clinical testing, highlighting its potential in combating emerging infectious diseases like COVID-19.

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