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Clinical Trial News

Nucleus Genomics Launches First Genetic Optimization Software for IVF Embryo Selection

  • Nucleus Genomics has launched Nucleus Embryo, the world's first genetic optimization software that allows parents to analyze and compare up to 20 embryos across over 900 hereditary conditions and 40 additional analyses.
  • The software tests for genetic markers tied to cancers, chronic conditions, cognitive ability, mental health, appearance traits, and longevity, providing comprehensive genetic profiles to help parents select embryos with the lowest risk profiles.
  • The company has partnered with Genomic Prediction to widen access to the technology, reflecting a growing shift in how parents view genetics as a tool to give children the best possible start in life.
  • The launch raises ethical concerns about embryo selection based on genetic probabilities, with critics questioning the practice as potentially eugenic while supporters argue it extends health optimization principles to life's inception.

Machine Learning Model Outperforms Individual Biomarkers in Predicting Advanced Renal Cell Carcinoma Treatment Response

  • A machine learning-based approach integrating tumor and circulating biomarkers demonstrated superior predictive capability compared to individual biomarkers alone for patients with advanced renal cell carcinoma treated with nivolumab plus cabozantinib.
  • The multivariate model identified 10 predictive features across four biomarker categories, showing substantially improved outcome prediction compared to univariate analysis of six features with modest predictive ability.
  • Researchers analyzed over 4,000 measurements across 150 patients from the CheckMate 9ER trial, identifying circulating extracellular matrix proteins as novel biomarkers associated with treatment outcomes.
  • The findings provide a foundation for future integrative biomarker discovery in kidney cancer, addressing the current challenge that determinants of response and resistance to checkpoint inhibitors remain largely unknown.

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

NCT03141177Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 7/23/2017

RET Inhibitor Rechallenge Shows Promise in Pre-Treated NSCLC Patients After Toxicity-Related Discontinuation

Targeted TherapyOncology
  • Rechallenge with a different first-generation RET inhibitor after toxicity-related discontinuation achieved a 50% objective response rate and 9.89-month median progression-free survival in RET-rearranged NSCLC patients.
  • The retrospective multicenter study from the RET MAP registry demonstrated that switching to a different RET inhibitor of the same class remains effective after initial treatment discontinuation due to side effects.
  • RET inhibitor rechallenge after disease progression showed limited efficacy as monotherapy with only 18% response rate, though combination therapies targeting bypass resistance showed some promise.
  • The findings provide new evidence for treatment sequencing in RET-rearranged NSCLC, a rare subset affecting 1-2% of advanced lung cancer patients with limited therapeutic options.

Mycovia Pharmaceuticals Initiates Phase 2 Trial of Oteseconazole for Cryptococcal Meningitis

  • Mycovia Pharmaceuticals has enrolled the first participant in the PLATFORM-CM Phase 2 trial evaluating oteseconazole for cryptococcal meningitis treatment.
  • The open-label randomized trial will involve up to 200 participants across three sites in Uganda, comparing oteseconazole to standard WHO first-line therapy.
  • Cryptococcal meningitis causes an estimated 152,000 cases and 112,000 deaths annually, representing a critical unmet medical need particularly in HIV patients.
  • Preclinical studies demonstrate oteseconazole's potency against both fluconazole-sensitive and resistant Cryptococcus strains, targeting fungal CYP51 for cell wall integrity.

Toyobo and DMC Biotechnologies Partner to Develop Sustainable Chemical Intermediates Through Precision Fermentation

  • Toyobo Co., Ltd. and DMC Biotechnologies have signed a multi-year collaboration agreement to develop sustainable, fermentation-produced chemical intermediates for essential materials production.
  • The partnership combines DMC's proprietary Dynamic Metabolic Control™ technology with Toyobo's chemical synthesis and biotechnology expertise to create cost-effective bio-based chemical products.
  • The collaboration aims to address biomanufacturing's challenge of higher production costs compared to conventional chemical processes while reducing greenhouse gas emissions and fossil resource dependency.
  • Toyobo plans to utilize the optimized microorganisms and compounds as raw materials for its films and plastic products, supporting its Sustainable Vision 2030 goal of contributing to a decarbonized society.

Zigakibart Shows Sustained 60% Proteinuria Reduction in 100-Week IgA Nephropathy Study

Monoclonal Antibody
  • Zigakibart, an investigational anti-APRIL monoclonal antibody, demonstrated sustained efficacy with 60% proteinuria reduction from baseline at 100 weeks in IgA nephropathy patients.
  • Over half of patients (55%) achieved proteinuria below 500 mg/24h, with 31% reaching deeper remission below 300 mg/24h, while kidney function remained stable across all patient subgroups.
  • The treatment showed a reassuring safety profile with mostly mild to moderate adverse events and no treatment-related serious infections or discontinuations throughout the study period.
  • These represent the longest duration of kidney function stabilization reported for an anti-APRIL agent in IgA nephropathy, supporting zigakibart's potential as a disease-modifying therapy.

Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)

NCT03945318Active, Not RecruitingPhase 1
Novartis Pharmaceuticals
Posted 4/8/2019

A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy

NCT05174221Active, Not RecruitingPhase 1
Takeda
Posted 11/9/2022

A Study of Zigakibart in Adults With IgA Nephropathy

NCT05852938Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 7/6/2023

Stanford Researchers Develop Milli-Spinner Technology That Doubles Blood Clot Removal Effectiveness

  • Stanford University researchers have developed a breakthrough milli-spinner thrombectomy technology that shrinks blood clots to just 5% of their original volume through a unique rotating mechanism.
  • The new technique is more than twice as effective as current clot removal methods and addresses major limitations of existing treatments that often cause clot fragmentation.
  • The technology transforms clot microstructure by densifying fiber networks through shear force, causing clots to turn white as red blood cells are extracted from the fiber matrix.
  • Human trials are planned for next year, with the research published in Nature journal, potentially revolutionizing treatment for strokes, heart attacks, and other clot-related diseases.

AI Breakthrough Accelerates Protein Engineering for Next-Generation Therapeutics

AI
  • Scientists from the University of Sheffield and AstraZeneca developed MapDiff, an AI framework that outperforms existing methods for inverse protein folding, a critical process in designing therapeutic proteins.
  • A separate research team from Chongqing University and Zhejiang University created an AI tool that generated 7,245 new proteins designed to bind to targets like viruses and cancer markers.
  • These AI advances could significantly accelerate drug development timelines by reducing months of laboratory work to weeks while improving protein stability and functionality.
  • The breakthrough technologies complement existing tools like AlphaFold and could enable faster development of vaccines, gene therapies, and diagnostic tools.

Knight Therapeutics Acquires Sumitomo's Canadian Portfolio Including MYFEMBREE and ORGOVYX for C$25.4 Million

  • Knight Therapeutics has entered into exclusive licensing agreements with Sumitomo Pharma to commercialize MYFEMBREE, ORGOVYX, and vibegron in Canada for an upfront payment of C$25.4 million.
  • The acquired portfolio generated C$11.2 million in revenue for the year ended March 2025, with MYFEMBREE representing the first oral treatment for uterine fibroids and endometriosis in Canada.
  • The transaction aligns with Sumitomo's strategy to focus on U.S. operations and pipeline development in oncology, regenerative medicine, and cell therapy.
  • Knight expects the products to be highly synergistic with its existing Canadian women's health and urology portfolio, including IMVEXXY, BIJUVA, and TRELSTAR.

Highridge Medical Divests Bone Healing Division to Focus on Core Spine Technologies

  • Highridge Medical has completed the sale of its EBI Bone Healing Division to Avista Healthcare Partners as part of a strategic refocusing on core spine solutions.
  • The divested division specializes in non-invasive bone stimulation devices for spinal and orthopedic patients and will now operate as an independent company.
  • Highridge plans to use proceeds from the sale to drive long-term growth of its spine portfolio and accelerate innovation in surgical technologies.
  • The transaction allows H.I.G. Capital, Highridge's owner, to make significant investments in the company's core spine business where they see tremendous growth opportunities.

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