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Clinical Trial News

Parse Biosciences Wins Patent Invalidation Case Against 10x Genomics in Single Cell Sequencing Dispute

  • The District Court for the District of Delaware granted Parse Biosciences' Motion for Summary Judgment, invalidating Scale Biosciences' (now 10x Genomics) patent 11,634,752 for lack of written description and enablement.
  • Parse Biosciences, which has raised over $100 million in capital and serves over 3,000 customers worldwide, provides accessible single cell sequencing solutions that have enabled discoveries in cancer treatment and other therapeutic areas.
  • The company's technology portfolio includes Evercode Whole Transcriptome, Evercode TCR, Evercode BCR, CRISPR Detect, and Gene Select platforms for single cell analysis.
  • This legal victory strengthens Parse's position in the competitive single cell sequencing market, where their technology has contributed to groundbreaking research in stem cell therapy, tissue repair, and immune system studies.

Nurix Therapeutics Advances Bexobrutideg Toward Pivotal CLL Trials with Strong Phase 1 Data

  • Nurix Therapeutics announced plans to initiate pivotal trials for bexobrutideg in relapsed/refractory chronic lymphocytic leukemia patients in the second half of 2025, including both accelerated approval and confirmatory Phase 3 studies.
  • Phase 1a data presented at SOHO 2025 demonstrated bexobrutideg achieved an 80.9% objective response rate in 47 CLL patients, with rapid responses and durable activity across high-risk subgroups including those with TP53, PLCG2, and BTK mutations.
  • The BTK degrader showed strong efficacy in Waldenström macroglobulinemia with an 84.2% response rate in 19 patients, while maintaining a favorable safety profile with no dose-limiting toxicities or atrial fibrillation events.
  • Nurix reported $428.8 million in cash and marketable securities, providing financial runway as research and development expenses increased to $86.1 million in Q3 2025 to support accelerated clinical development.

A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies

NCT04830137RecruitingPhase 1
Nurix Therapeutics, Inc.
Posted 5/5/2021

A Study of NX-1607 in Adults With Advanced Malignancies

NCT05107674RecruitingPhase 1
Nurix Therapeutics, Inc.
Posted 9/29/2021

A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies

NCT05131022RecruitingPhase 1
Nurix Therapeutics, Inc.
Posted 4/13/2022

Cabaletta Bio's CAR-T Therapy Shows Promise Without Preconditioning in Pemphigus Vulgaris Trial

CAR-T
  • Cabaletta Bio's rese-cel CAR-T therapy achieved complete B cell depletion and meaningful clinical responses in pemphigus vulgaris patients without requiring preconditioning chemotherapy.
  • Two of three patients experienced near-complete resolution of clinical symptoms, with all patients remaining off immunomodulators since treatment infusion.
  • The simplified no-preconditioning regimen could expand treatment access while maintaining similar CAR-T cell expansion compared to over 30 patients who received preconditioning in other trials.
  • Results support continued exploration of the approach in pemphigus vulgaris and potential evaluation in other autoimmune diseases within the RESET program.

Phase 2 Trial of Inhaled IL-15 Immunotherapy Halted After Worse Outcomes in Canine Osteosarcoma

Oncology
  • A multicenter phase 2 trial testing inhaled recombinant human IL-15 combined with amputation and chemotherapy in dogs with osteosarcoma was halted for futility after showing statistically inferior survival outcomes compared to historical controls.
  • The study aimed to reduce metastatic failure rates from 40% to 20% but unexpectedly found worse disease-free survival and overall survival in the treatment group.
  • Immune correlative analyses revealed significant decreases in cytotoxicity after surgery and chemotherapy, with inflammatory cytokines like IL-6 increasing post-treatment and correlating with reduced immune function.
  • The findings have important implications for immunotherapy strategies combining surgery and chemotherapy, suggesting potential negative interactions between these treatment modalities.

Novel RAS-PI3K Inhibitor Enters Clinical Trials, Targeting Cancer Growth Without Metabolic Side Effects

Targeted Therapy
  • Researchers at the Francis Crick Institute and Vividion Therapeutics have developed compounds that selectively block the interaction between cancer-driving RAS protein and PI3K enzyme while preserving normal cellular functions.
  • The lead compound demonstrated tumor growth suppression in mouse models of RAS-mutated lung cancer and HER2-driven tumors without causing hyperglycemia, a common side effect of traditional PI3K inhibitors.
  • The investigational drug has entered Phase 1 clinical trials to evaluate safety and efficacy in patients with RAS or HER2 mutations, potentially offering treatment for approximately 20% of all cancers.
  • Combination therapy studies showed enhanced and longer-lasting tumor suppression compared to single-agent treatments, suggesting potential for multi-modal therapeutic approaches.

Lexaria Bioscience Expands Drug Delivery Platform Development with $4M Funding and Strategic Advisory Partnership

  • Lexaria Bioscience has engaged a global life science business development advisory firm to identify collaborative opportunities for its DehydraTECH drug delivery platform across pharmaceutical and biotechnology sectors.
  • The company secured $4.0 million in equity financing to fund expanded R&D programs through 2026, with existing operations previously funded only through end of 2025.
  • Four new patents were awarded covering therapeutic applications in diabetes, hypertension, seizure disorders, and antiviral treatments, adding to the company's portfolio of 54 granted patents.
  • Phase 1b Australian study results for GLP-1 sector applications are expected to demonstrate patient safety and efficacy of DehydraTECH-processed drugs.

Orexa's ORE-001 Shows Significant Promise in Preventing Post-Operative Ileus in Phase 2 Trial

  • Orexa B.V. reported positive interim results from its Phase 2 trial of ORE-001 for preventing post-operative ileus in patients undergoing major abdominal surgery.
  • The study demonstrated that patients receiving ORE-001 consumed 63% more food post-operatively, experienced first stool approximately one day earlier, and showed reduced gastrointestinal dysfunction from 21% to 6%.
  • Based on the promising results, Orexa will conclude the current Phase 2A trial ahead of schedule and begin preparations for Phase 2B/3 studies.
  • The treatment also significantly reduced extended hospitalizations due to adverse events from 31% to 7%, potentially offering substantial healthcare cost savings.

Telomir-1 Demonstrates Selective Killing of Triple-Negative Breast Cancer Cells Through Iron-Dependent Mechanism

OncologyTargeted Therapy
  • Telomir Pharmaceuticals reports that Telomir-1 significantly reduces viability of aggressive triple-negative breast cancer cells through dose-dependent iron regulation mechanisms.
  • Laboratory studies demonstrate the compound shuts down cellular energy pathways and mitochondrial function, with effects reversible upon iron supplementation.
  • The discovery exploits metabolic vulnerabilities unique to aggressive cancer cells while potentially sparing healthy tissue that manages iron differently.
  • Telomir plans to expand testing to additional cancer types and conduct animal studies in preparation for IND submission.

Delhi High Court Clears Path for Generic Risdiplam Launch, Enabling 97% Price Reduction for Rare Disease Treatment

Rare Disease
  • The Delhi High Court dismissed Roche's appeal against Natco Pharma, allowing the launch of a generic version of risdiplam for spinal muscular atrophy treatment.
  • Natco's generic version will be priced at ₹15,900 per bottle compared to Roche's ₹6.2 lakh, representing a 97% price reduction for this life-saving medication.
  • The ruling prioritizes public health access over patent protection, potentially enabling more patients to benefit from government support under India's National Policy for Rare Diseases.
  • Roche expressed disappointment with the decision and emphasized the importance of intellectual property protection for pharmaceutical innovation in India.

Milestone Pharmaceuticals to Present Etripamil PSVT Data at AHA Scientific Sessions 2025

  • Milestone Pharmaceuticals will present poster data on etripamil's efficacy, safety, and tolerability for self-administered treatment of paroxysmal supraventricular tachycardia at AHA Scientific Sessions 2025.
  • The presentation will combine results from multiple clinical trials examining etripamil's performance in treating acute PSVT episodes.
  • The company has recently submitted a New Drug Application to the FDA for etripamil as a treatment for PSVT, an abnormal heart rhythm condition.
  • Dr. James Ip from Weill Cornell Medicine will present the combined clinical trial data on November 10, 2025, in New Orleans.

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