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Clinical Trial News

Toripalimab Emerges as Preferred PD-1 Inhibitor for Metastatic Nasopharyngeal Carcinoma Despite Access Challenges

CAR-TTargeted Therapy
  • Toripalimab has received NCCN category 1 recommendation for nasopharyngeal carcinoma based on positive phase 3 data in both first-line and second-line settings, unlike pembrolizumab which showed negative results in the KEYNOTE-122 trial.
  • Clinical practitioners report easier insurance coverage for pembrolizumab compared to toripalimab, leading many to use pembrolizumab off-label in combination with chemotherapy despite inferior clinical evidence.
  • PD-1 inhibitors combined with chemotherapy represent the established standard of care for systemic recurrent nasopharyngeal carcinoma, with EBV levels serving as useful biomarkers for monitoring treatment efficacy.
  • Future treatment approaches may focus on novel combinations including CAR-T cell therapy, tumor-infiltrating lymphocytes, and targeted therapies like EGFR inhibitors to improve outcomes while reducing toxicity.

The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer

NCT03581786CompletedPhase 3
Shanghai Junshi Bioscience Co., Ltd.
Posted 10/18/2018

Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)

NCT02611960CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 4/18/2016

PD-1 Blockade Combined With De-intensified Chemoradiotherapy Sparing Concurrent Cisplatin in Nasopharyngeal Carcinoma

NCT04907370Active, Not RecruitingPhase 3
Sun Yat-sen University
Posted 8/1/2021

Monopar Therapeutics Launches FDA-Authorized Expanded Access Program for uPAR-Targeted Radiopharmaceuticals in Advanced Cancers

Targeted Therapy
  • Monopar Therapeutics and EDNOC have received FDA authorization for an expanded access program providing MNPR-101-Zr imaging agent and MNPR-101-Lu therapeutic agent to patients with advanced solid tumors.
  • The program targets aggressive cancers including triple-negative breast, pancreatic, and colorectal cancers through selective targeting of the urokinase plasminogen activator receptor (uPAR).
  • EDNOC in Houston, Texas serves as the treatment center and is among the first private outpatient facilities designated as a Radiopharmaceutical Therapy Center of Excellence by SNMMI.
  • The expanded access program follows the initiation of Phase 1 clinical trials in Australia and represents continued progress in Monopar's radiopharmaceutical pipeline development.

MNPR-101-PCTA-177Lu Expanded Access Program (EAP) for Patients With Solid Tumor Cancer

NCT06980519available
Monopar Therapeutics

MNPR-101-DFO*-89Zr Expanded Access Program (EAP) for Patients With Solid Tumor Cancer

NCT06980506available
Monopar Therapeutics

Molecular Partners Reports Promising Response Rates with Optimized MP0533 Dosing in Relapsed/Refractory AML

  • Molecular Partners' tetraspecific T-cell engager MP0533 achieved over 30% response rate in relapsed/refractory AML patients using an accelerated dosing regimen in cohort 8.
  • One patient maintained a complete response beyond 6 months, demonstrating potential for durable clinical benefit with the optimized treatment protocol.
  • The company is advancing to cohort 9 with further dosing improvements and plans combination studies with azacitidine/venetoclax based on encouraging antitumor activity.
  • Data presented at EHA 2025 support continued dose optimization to maximize therapeutic exposure and clinical responses in this difficult-to-treat patient population.

Skin Biopsy Test Detects Neurodegenerative Biomarker in 75% of REM Sleep Disorder Patients

  • The Syn-One Test successfully detected phosphorylated alpha-synuclein in skin biopsies of 75% of patients with idiopathic REM sleep behavior disorder, closely mirroring the 73.5% conversion rate to neurodegenerative diseases within 12 years.
  • The NIH-sponsored Syn-Sleep Study enrolled 80 participants across 11 U.S. sites, with P-SYN positive individuals tending to be older and having longer duration of symptoms compared to negative participants.
  • This minimally invasive diagnostic approach could enable early detection of synucleinopathies like Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy up to a decade before clinical symptoms emerge.
  • The test's ability to distinguish patients with underlying alpha-synuclein pathology from those with other causes of RBD could guide prognosis and facilitate enrollment in disease prevention trials.

Olaparib-Temozolomide Combination Fails to Improve Outcomes in Advanced Uterine Leiomyosarcoma

  • The phase 2/3 Alliance A092104 trial evaluating olaparib plus temozolomide in advanced uterine leiomyosarcoma failed to meet its primary progression-free survival endpoint compared to standard care.
  • The combination showed a median PFS of 3.2 months versus 5.5 months with investigator's choice of pazopanib or trabectedin, leading to early trial closure for futility.
  • Despite promising early-phase data, the study highlights the challenge of demonstrating superiority over existing therapies in this rare cancer population.
  • The trial will be closed on October 1, 2025, with researchers emphasizing the need to better identify which patients might benefit from molecularly targeted approaches.

Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working

NCT05432791Active, Not RecruitingPhase 2
National Cancer Institute (NCI)
Posted 3/30/2023

Moderna Seeks External Partners to Fund Late-Stage Vaccine Trials for Latent Virus Programs

  • Moderna is actively seeking partnerships with pharmaceutical companies and financial firms to fund late-stage trials for its latent virus vaccine portfolio, including programs targeting Epstein-Barr virus, herpes simplex virus, and varicella-zoster virus.
  • The company has paused internal spending on these programs and aims to advance them to Phase 3 trials without additional capital expenditure, leveraging existing manufacturing capacity.
  • This strategic financing approach follows Moderna's earlier collaboration model with Blackstone on flu vaccine development and supports the company's goal to return to profitability by 2028.
  • Despite having over $8.5 billion in cash reserves, Moderna prioritizes capital efficiency and securing optimal partnership structures over speed in deal-making.

University at Buffalo Develops Novel Non-Opioid Molecule for Long-Lasting Chronic Pain Relief

  • University at Buffalo researchers have developed a lipidated peptide molecule that provides chronic pain relief for up to three weeks with a single local injection, targeting the Magi-1/NaV1.8 protein interaction.
  • The novel approach disrupts the scaffolding protein Magi-1's interaction with pain-transmitting NaV1.8 ion channels, causing channel degradation and blocking pain transmission without affecting touch sensation.
  • Preclinical studies published in the journal Pain demonstrate the molecule's effectiveness in both animal models and human pain neurons, with the research team now seeking partners for clinical trials.
  • The development represents a significant advancement in non-opioid pain management, supported by NIH's HEAL Initiative and being commercialized through startup company Channavix Therapeutics LLC.

Ryght AI Secures $3M Seed Funding and Expands Academic Partnerships to Accelerate Clinical Trial Site Selection

AI
  • Ryght AI raised $3 million in seed funding led by Foothill Ventures to advance its AI-powered clinical trial platform that creates digital twins of over 100,000 research sites worldwide.
  • The company announced new partnerships with academic medical centers including Emory University, West Virginia University, and West Clinic, joining previously established collaborations with USC Keck School of Medicine and Medical College of Wisconsin.
  • Ryght AI's platform addresses critical industry inefficiencies where sponsors spend up to $50,000 activating a single site and $50,000-$500,000 enrolling each patient, with 55% of trials failing due to poor site feasibility.
  • The AI-driven solution reduces traditional feasibility timelines from several months to less than three weeks through automated workflows and real-time site performance data.

Sandoz Completes $11.2 Billion Spin-Off from Novartis, Becomes Independent Generics Leader

  • Sandoz successfully separated from Novartis and began trading independently on the SIX Swiss Exchange at CHF 24 per share, valuing the company at approximately $11.2 billion.
  • The newly independent company reported strong financial performance with $4.8 billion in first-half sales, up 8% at constant currencies, and operating profit of $1 billion.
  • Sandoz management expects to add $3 billion in annual sales from new product launches, primarily biosimilars and complex generics, following the separation.
  • The spin-off allows Novartis to focus entirely on innovative medicines while positioning Sandoz as a global leader in generics and biosimilars serving 500 million patients worldwide.

FDA Accepts Tamarack Biotics' UV Light Milk Treatment Technology as Safe Alternative to Traditional Pasteurization

FDA Approval
  • Tamarack Biotics secured FDA acceptance for its TruActive® UV light-based milk treatment process, marking the first scientifically verified safe raw milk equivalent in the dairy industry.
  • The innovative technology eliminates harmful pathogens while preserving bioactive compounds like enzymes and immunity-supporting proteins that are typically destroyed by heat-based pasteurization.
  • A UC Davis clinical trial demonstrated that milk protein concentrate treated with TruActive® restored immune function in aging populations, while European studies showed raw milk consumption protected children from allergies.
  • The FDA approval initially covers powdered dairy ingredients, with liquid raw milk treatment expected as early as 2027.

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