Clinical Trial News
Advancements in Minimal Residual Disease Assessment Transforming Myeloma Treatment
• Novel agents have shifted myeloma treatment, enabling minimal residual disease (MRD) negativity across the disease spectrum, improving patient outcomes.
• Next-generation flow and sequencing technologies offer real-time clinical tools for sensitive MRD detection in bone marrow samples.
• Liquid biopsy-based assays, particularly mass spectrometry, are progressing towards clinical use, enhancing MRD assessment with accessible, repeatable measurements.
• Ongoing clinical trials are defining the role of MRD testing in routine clinical practice, potentially informing treatment decisions and drug approvals.
AbbVie and Calico Extend Collaboration to Combat Age-Related Diseases
• AbbVie and Calico have extended their collaboration for the second time, focusing on discovering and developing therapies for age-related diseases like neurodegeneration and cancer.
• The collaboration has produced over 20 early-stage programs and advanced three targets into clinical trials, including PTPN2 inhibitors for immuno-oncology.
• AbbVie and Calico will each contribute an additional $500 million to the collaboration, extending research and early development until 2025 and Phase 2a trials through 2030.
• The partnership leverages Calico's research capabilities and AbbVie's development expertise to address unmet needs in aging and related diseases.
FDA Approves Shingrix for Shingles Prevention in Immunocompromised Adults
The US Food and Drug Administration (FDA) has approved Shingrix, a non-live, recombinant subunit vaccine, for the prevention of shingles in adults aged 18 years and older who are at increased risk due to immunodeficiency or immunosuppression. This approval expands the vaccine's use beyond its initial approval for adults 50 years and older, offering protection to a broader population at risk of shingles and its complications.
ByHeart Secures $90M Series B Funding After Successful Infant Formula Clinical Trial
• ByHeart secured $90 million in Series B funding to launch its infant formula and advance its pipeline of mom and baby products.
• The company's clinical trial with 311 babies met all endpoints, a key step for FDA submission and market entry.
• ByHeart's trial included a breastfed reference arm, providing additional data to enhance infant nutrition science.
• The funding will support ByHeart's mission to modernize infant nourishment with high-quality, transparent ingredients.
Patient-Centric Approach Could Transform Unsustainable Oncology R&D Landscape
• Oncology R&D costs have doubled since 2003, with failure rates reaching 90% and development timelines stagnating at 12 years, signaling an urgent need for innovation in the drug development process.
• Traditional pharmaceutical R&D methodologies are proving unsustainable, leading to increased drug prices and limited treatment access amid rising chronic disease burden in an aging population.
• Patient engagement in clinical trials shows promise as a cost-effective solution, with evidence suggesting deeper collaboration between drug developers, regulators, and patient associations could significantly improve R&D outcomes.
EU Clinical Trial Regulation Mandates Posting of Interim Results, Raising Transparency Standards
• The EU Clinical Trials Regulation will require sponsors to disclose interim clinical trial results, marking a significant shift in transparency.
• This new regulation mandates the posting of interim analysis results within specified timelines, impacting clinical operations and data management.
• Automation of data collection and reporting is crucial for ensuring compliance with the new EU transparency requirements.
• Sponsors must update their Clinical Trial Management Systems (CTMS) and workflows to capture interim analysis dates and facilitate timely posting.
Psilera Partners with Worldwide for Accelerated Clinical Development of DMT Patch
Psilera Inc. has partnered with Worldwide Clinical Trials to expedite the pre-IND filing for its DMT patch, aiming for Phase 1b clinical trials in 2022 to test safety and efficacy in humans.
FDA Lifts Partial Clinical Hold on RVU120 Trial in AML and MDS
• The FDA has lifted a partial clinical hold on the phase 1b trial of RVU120 (SEL120) in relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
• The trial will resume enrollment with a revised protocol, starting with a 75-mg dose of RVU120 every other day, following recommendations from the FDA to improve patient safety.
• Preliminary data from the trial presented at EHA 2021 showed some patients achieved stable disease, erythroid response, or complete response, with no dose-limiting toxicities reported.
• RVU120, a novel CDK8/CDK19 kinase inhibitor, has demonstrated significant activity in preclinical AML models, supporting its continued evaluation in this patient population.
Highlighted Clinical Trials:
Ryvu Therapeutics SA
Posted 9/4/2019
Breakthrough in Long COVID Detection: Blood Test Could Be Available Within 6-12 Months
• Imperial College London researchers have identified distinctive autoimmune antibodies in long COVID patients' blood, paving the way for a diagnostic test within 6-12 months.
• The study revealed unique antibody patterns in long COVID sufferers that attack healthy tissues, distinguishing them from fully recovered COVID-19 patients.
• With UK COVID-19 cases potentially reaching 100,000 per day, experts warn that 10-20% of infections could result in long COVID, despite vaccination efforts.
CDK4/6 Inhibitors Show Potential in HR+/HER2- Early Breast Cancer Adjuvant Therapy
• Meta-analysis of three trials (N=12,647) suggests adjuvant CDK4/6 inhibitors with endocrine therapy (ET) may prolong invasive disease-free survival (IDFS) in HR+/HER2- early breast cancer (EBC).
• Patients with N2/N3 nodal status showed statistically significant survival benefit from the combination of CDK4/6 inhibitors and ET, with a hazard ratio of 0.83 (95% CI 0.71–0.97, p = 0.02).
• The combination therapy was associated with a higher risk of grade 3/4 adverse events (AEs) and increased treatment discontinuation due to AEs compared to standard ET alone.
• Trial sequential analysis indicates that more trials are needed to establish firm evidence for the overall favorable effect of adjuvant CDK4/6 inhibitors with ET in HR+/HER2- EBC.
Highlighted Clinical Trials:
Eli Lilly and Company
Posted 7/12/2017
Novartis Pharmaceuticals
Posted 12/7/2018
German Breast Group
Posted 10/30/2013
ETOP IBCSG Partners Foundation
Posted 8/27/2019
Alliance Foundation Trials, LLC.
Posted 8/1/2015