Clinical Trial News

NCI's SeroNet studies COVID-19 immune responses, finding neutralizing antibodies last months post-infection or vaccination. Research suggests booster shots may be needed, with ongoing studies to determine protective antibody levels. Cancer patients may have weaker vaccine responses. T cells also play a role in immunity. Vaccines offer some protection against variants, though less against Delta. Serology studies help understand pandemic spread and disparities. SeroNet also explores social science to address vaccine hesitancy.

Breast cancer and heart disease are interconnected, sharing risk factors and treatment impacts. Treatments like doxorubicin and radiation can harm heart health, making cardiovascular disease a leading cause of death among breast cancer survivors. The American Heart Association emphasizes the need for multidisciplinary care, leading to the emergence of cardio-oncology. Lifestyle choices and monitoring heart health during treatment are crucial. A clinical trial is exploring statins' role in protecting heart function during chemotherapy. Exercise is recommended to improve survival and reduce heart injury risk.

UCB has received U.S. FDA approval for BIMZELX® (bimekizumab-bkzx) to treat adults with active psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS). BIMZELX is the first IL-17A and IL-17F inhibitor approved in the U.S. for these conditions, supported by Phase 3 studies showing significant improvements in symptoms.

MIT researchers developed a new immunotherapy strategy combining three drugs to boost the immune system against pancreatic cancer, showing promise in eliminating tumors in mice. The therapy targets the CD155/TIGIT axis, alongside PD-1 inhibition and CD40 agonist antibodies, leading to significant tumor shrinkage. Clinical trials are expected to begin later this year.

Advances in minimal residual disease (MRD) assessment technologies, including next-generation flow and sequencing, have revolutionized multiple myeloma treatment, enabling MRD negativity across the disease spectrum. These developments, alongside emerging liquid biopsy-based assays, are enhancing real-time clinical care and informing treatment strategies. Regulatory progress and clinical trials are further validating MRD's role as a surrogate endpoint, promising improved patient outcomes and novel therapeutic approvals.

AbbVie and Calico Life Sciences extend their collaboration to 2025, focusing on age-related diseases like neurodegeneration and cancer. Since 2014, they've developed over 20 early-stage programs, advancing three targets to clinical trials. Both will contribute an additional $500 million, sharing costs and profits equally.

ByHeart, a baby nutrition company, secured $90M in Series B funding, following a $70M Series A in April 2020, to launch its innovative infant formula after completing a significant clinical trial. The company aims to modernize baby nutrition with products based on advanced nutrition science and breast milk research, challenging the traditional infant formula market dominated by three companies. ByHeart's approach includes owning the entire manufacturing process and conducting comprehensive clinical trials, setting a new standard in the industry.

Starting January 2022, European regulations will mandate sponsors to publish interim clinical trial results, enhancing transparency. This requires capturing and reporting interim analysis dates accurately, with phase 1 results due within 30 months and later phases within 12 months post-analysis. Automation in data management and reporting is crucial for compliance.

The FDA lifted a partial clinical hold on a phase 1b trial for RVU120 in AML and MDS patients, following a serious adverse event. Enrollment resumes with a revised 75-mg dose protocol. RVU120, a CDK8/CDK19 inhibitor, showed promise in preclinical models. The trial aims to assess safety, efficacy, and pharmacokinetics, with initial data indicating varied patient responses.

Adjuvant CDK4/6 inhibitors with ET showed potential in prolonging IDFS for HR+/HER2- EBC, especially in N2/N3 patients, but with higher grade 3/4 AEs and treatment discontinuation risks. Evidence remains inconclusive, necessitating further trials for validation.