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Clinical Trial News

Cardio-Oncology: Balancing Breast Cancer Treatment with Heart Health

  • Breast cancer treatments like doxorubicin and trastuzumab can impair heart function, leading to complications like heart failure, necessitating careful cardiovascular monitoring.
  • Shared risk factors between breast cancer and heart disease, including age, obesity, and lifestyle, highlight the importance of preventative measures for both conditions.
  • Cardio-oncology emerges as a specialty to integrate cardiac care with cancer treatment, emphasizing multidisciplinary approaches to minimize cardiac risks during cancer therapy.
  • Research indicates that lifestyle interventions, such as regular exercise, and medications like statins may protect heart health during breast cancer treatment, improving overall outcomes.

UCB Announces U.S. FDA Approvals for BIMZELX® (bimekizumab-bkzx) for the Treatment of Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis

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.

Seagen Secures $2.6B Deal with RemeGen for Novel HER2-Targeting Cancer Drug

• Seagen has acquired ex-Asian rights to RemeGen's disitamab vedotin for $200 million upfront, with potential payments of $2.4 billion, targeting HER2-positive cancers including breast, bladder, and gastric tumors.
• The antibody-drug conjugate has already received conditional approval in China for HER2-positive gastric cancer and breakthrough designation from FDA for bladder cancer.
• The deal positions Seagen to compete with established HER2-targeting ADCs like AstraZeneca/Daiichi Sankyo's Enhertu and Roche's Kadcyla, while focusing initially on distinct market segments.

Amazon Invests $14.7 Million in Proteome Analysis Company Nautilus Biotechnology

Drug DiscoveryPrecision Medicine
  • Amazon disclosed a $14.7 million investment in Nautilus Biotechnology, a pre-revenue company developing proteome measurement technology for drug discovery and clinical diagnostics.
  • Nautilus has built a prototype device that aims to measure more than 95% of the human proteome, compared to current mass spectrometers that only capture a small percentage of proteins.
  • The investment represents Amazon's continued expansion into healthcare following its $753 million PillPack acquisition and development of Amazon Care telehealth services.
  • Nautilus expects its first revenue in 2022 and has partnered with Roche-owned Genentech to use its proteome analysis system for research applications.

Triple Immunotherapy Eradicates Pancreatic Tumors in Mice, Clinical Trials Expected

  • A novel triple-drug immunotherapy combination has demonstrated the ability to eliminate pancreatic tumors in mice, offering a promising new approach for this deadly disease.
  • The therapy combines inhibitors of PD-1 and TIGIT with a CD40 agonist antibody to rejuvenate exhausted T cells and stimulate an immune attack on tumor cells.
  • Analysis of human pancreatic tumors revealed high expression of CD155, which activates the TIGIT receptor on T cells, leading to T cell exhaustion and suppressed immune response.
  • Clinical trials are expected to begin later this year to evaluate the triple combination in pancreatic cancer patients, potentially offering a new treatment option.

Luye Pharma's Next-Generation VMAT2 Inhibitor LY03015 to Begin Clinical Trials in the U.S.

Luye Pharma Group has announced the submission of an investigational new drug application for its next-generation VMAT2 inhibitor, LY03015, in the U.S., with Phase I clinical trials expected to start soon. LY03015 is designed for treating tardive dyskinesia (TD) and Huntington's disease (HD), offering potential improvements over current treatments in terms of efficacy, safety, and pharmacokinetic properties.

FDA Grants First-Ever Breakthrough Device Status to Digital Therapeutic for Heart Failure Management

• Biofourmis' BiovitalsHF becomes the first digital therapeutic to receive FDA breakthrough device designation, marking a significant milestone in digital health innovation for heart failure treatment.
• The prescription digital therapeutic uses wearable sensors and algorithms to optimize guideline-directed medical therapy for patients with heart failure with reduced ejection fraction (HFrEF).
• Clinical data demonstrates BiovitalsHF improves medication adherence and health outcomes, addressing a critical need as less than 1% of heart failure patients currently receive optimal drug dosing.

Ascentage Pharma Announces Milestone Payment from UNITY Biotechnology for Senolytic Drug Candidate UBX1325

Ascentage Pharma has announced a milestone payment from UNITY Biotechnology following encouraging Phase I clinical study results for UBX1325, a senolytic drug candidate targeting advanced vascular eye diseases. The drug, developed from Ascentage Pharma's licensed compound BM-962, has shown rapid improvement in patients with diabetic macular edema or wet age-related macular degeneration, leading to the initiation of a Phase IIa clinical study.

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.

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