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Clinical Trial News

Brenus Pharma and InSphero Develop Advanced 3D Tumor Models for Colorectal Cancer Immunotherapy Testing

  • Brenus Pharma and InSphero presented promising data at the European Association for Cancer Research 2025 congress confirming the use of 3D tumor spheroids for potency testing of STC-1010, their lead colorectal cancer immunotherapy candidate.
  • The collaboration developed vitrified 3D colorectal cancer spheroids using tumor cell lines co-cultured with fibroblasts, preserving tumor morphology and stromal integrity to better mimic in vivo human tumor conditions.
  • Previous studies demonstrated that STC-1010 antigens were effectively processed by dendritic cells, activating CD8+ T cells that induced apoptosis in both 2D and 3D colorectal cancer models while releasing anti-tumor cytokines.
  • The European-funded collaboration represents a significant advancement in translational immunotherapy development, enabling more realistic evaluation of therapeutic potential through scalable 3D tumor models.

Bionova Scientific Expands into Advanced Therapies with Third FlexFactory Platform Installation

Monoclonal Antibody
  • Bionova Scientific is installing its third FlexFactory manufacturing platform from Cytiva to enter the advanced therapy manufacturing space while maintaining its core monoclonal antibody business.
  • The CDMO will utilize Cytiva's Fast Trak process development services to accelerate entry into genomic medicines manufacturing, specifically plasmid DNA production.
  • The new FlexFactory platform offers reduced business risks, increased operational speed, and enhanced flexibility with built-in compliance features for regulatory adherence.
  • Bionova's new facility in The Woodlands, Texas celebrated its grand opening on May 29, 2025, with the FlexFactory delivery scheduled for Q3 2025.

Biomea Fusion's BMF-650 Demonstrates Significant Weight Loss in Primate Study, Advancing Toward Clinical Trials

  • Biomea Fusion's oral GLP-1 receptor agonist BMF-650 achieved 12% and 15% weight reduction in obese cynomolgus monkeys over 28 days at doses of 10 mg/kg and 30 mg/kg respectively.
  • The study showed dose-dependent appetite suppression with daily food intake reduced to 35g/day and 16g/day compared to 109g/day in control groups.
  • The company plans to file an Investigational New Drug application in the second half of 2025, with Phase I trials in obese volunteers anticipated for late 2025.
  • BMF-650 is designed as a next-generation oral small molecule with enhanced pharmacokinetic properties and improved bioavailability compared to injectable GLP-1 therapies.

PleoPharma's PP-01 Shows Significant Efficacy in Phase 2b Trial for Cannabis Withdrawal Syndrome

  • PleoPharma's PP-01, a dual-mechanism investigational agent containing nabilone and gabapentin, significantly reduced Cannabis Withdrawal Scores compared to placebo (P < 0.02) in a Phase 2b trial.
  • The treatment demonstrated 5-fold greater cannabis abstinence two weeks post-treatment compared to placebo in patients with Cannabis Use Disorder.
  • PP-01 has received FDA Fast Track designation and could become the first FDA-approved treatment for Cannabis Withdrawal Syndrome, addressing an unmet need for 19.2 million Americans with Cannabis Use Disorder.
  • The company is preparing to advance PP-01 into Phase 3 trials following these positive results from the CAN-002 study.

U.S. Pharmacopeia Recognizes Mass Photometry as Key Method for AAV Gene Therapy Quality Standards

  • The U.S. Pharmacopeia has officially recognized mass photometry as a key orthogonal method for characterizing adeno-associated virus (AAV) reference standards in gene therapy quality control.
  • Mass photometry is specifically referenced in the new USP general chapter <1067> as a recommended method capable of distinguishing between empty, full, and partially filled AAV capsids.
  • USP's new AAV8 reference standards were characterized using mass photometry alongside four other analytical methods in a comprehensive multi-laboratory study.
  • This recognition follows similar acknowledgment by the British Pharmacopeia in 2024, establishing mass photometry as an accepted analytical tool for AAV characterization.

KRAS G12C NSCLC Patients Face Limited CNS Treatment Options Despite 40% Brain Metastases Rate

Targeted Therapy
  • Central nervous system metastases affect approximately 40% of patients with KRAS G12C-positive non-small cell lung cancer, creating significant management challenges.
  • KRAS G12C inhibitors demonstrate 40% to 43% intracranial response rates in untreated brain metastases, but these rates remain below 50%.
  • Stereotactic radiosurgery often becomes the preferred approach for CNS lesions when systemic options are exhausted after platinum-based chemotherapy and immunotherapy.
  • KRAS G12C mutations represent 12% to 14% of all NSCLC diagnoses, with treatment decisions heavily dependent on PD-L1 expression levels.

Memo Therapeutics to Present Phase II Results for First-in-Class BK Polyomavirus Treatment at World Transplant Congress

Monoclonal Antibody
  • Memo Therapeutics will present interim Phase II results for potravitug, a monoclonal antibody targeting BK polyomavirus infection in kidney transplant recipients, at the World Transplant Congress in August 2025.
  • The SAFE KIDNEY II trial enrolled 95 patients across 22 U.S. sites to evaluate potravitug's efficacy against BKPyV infection, which affects up to 50% of kidney transplant recipients.
  • Potravitug represents a potential first-in-class therapy for BKV infection, addressing a significant unmet medical need with no currently approved treatment options available.
  • The drug received FDA fast-track designation in May 2023, recognizing the high medical need in this indication with market potential estimated at up to $2 billion annually.

Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients

NCT05769582CompletedPhase 2
Memo Therapeutics AG
Posted 4/10/2023

Assess Safety, Tolerability and Pharmacokinetics of AntiBKV in Healthy Adult Volunteers.

NCT05358106CompletedPhase 1
Memo Therapeutics AG
Posted 5/9/2022

DOE Supplies Accelerator-Produced Actinium-225 for First-Ever U.S. Cancer Therapy Clinical Trial

Targeted Therapy
  • The U.S. Department of Energy's Isotope Program will supply accelerator-produced actinium-225 to a U.S. company for the first clinical trial using this radioisotope for cancer therapy.
  • The clinical trial is scheduled to begin in summer 2025 and represents a significant milestone in radiopharmaceutical development by opening a new pipeline for this lifesaving isotope.
  • DOE has established a scalable production method using particle accelerators at Brookhaven National Laboratory and Los Alamos National Laboratory to address the current shortage of Ac-225.
  • This marks the transition from years of preclinical research and animal studies to the first human patient care application of accelerator-produced Ac-225.

Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.

NCT06590857RecruitingPhase 1
RayzeBio, Inc.
Posted 7/19/2024

Synfini and O2nix Bio Partner to Develop AI-Driven Cancer Metastasis Therapies Targeting FTSJ1

  • Synfini Inc. and O2nix Bio announced a strategic collaboration to develop novel drug candidates targeting FTSJ1, a tRNA-modifying enzyme implicated in metastatic cancer cell survival.
  • The partnership combines O2nix Bio's expertise in RNA epitranscriptomics and metastasis biology with Synfini's AI Cloud Foundry platform to accelerate drug discovery.
  • The collaboration aims to address cancer metastasis, which is responsible for over 90% of cancer-related deaths and remains largely untreatable by current therapies.
  • This marks O2nix Bio's first commercial drug discovery initiative as an independent entity, building on foundational research published in Nature Cancer.

FDA Cancels Advisory Committee Meeting for Capricor's Duchenne Therapy Amid Leadership Shake-up

  • The FDA's Center for Biologics Evaluation and Research director Vinay Prasad unilaterally canceled an advisory committee meeting for Capricor Therapeutics' Duchenne muscular dystrophy cell therapy due to skepticism about the treatment.
  • The cancellation occurred immediately before the ouster of Nicole Verdun, the FDA's chief regulator of cell and gene therapies, who had originally scheduled the meeting.
  • Capricor shares plummeted 40% to $7.22 following news of the canceled advisory committee meeting and regulatory uncertainty.
  • Long-standing tensions over Verdun's management style may have contributed to her placement on administrative leave, raising questions about the precise reasons for the leadership change.

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