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Clinical Trial News

FDA Approves Vostally Oral Solution, First Liquid Ramipril Formulation for Hypertension Treatment

Drug Approval
  • The FDA approved Vostally (ramipril) oral solution on July 23, 2025, marking the first liquid formulation of this ACE inhibitor for adults with hypertension who have difficulty swallowing tablets.
  • The once-daily oral liquid is indicated for treating hypertension, reducing cardiovascular risk in high-risk patients over 55, and managing post-myocardial infarction heart failure.
  • Rosemont Pharmaceuticals developed this formulation to address treatment barriers for patients unable to swallow traditional solid dosage forms.
  • The approval expands treatment options in the hypertension market, with the product expected to become available later in 2025.

MaxCyte Partners with Anocca to Advance TCR-T Cell Therapy Manufacturing Using Non-Viral Gene Editing Platform

Gene Editing
  • MaxCyte has signed a Strategic Platform License Agreement with Anocca AB to support the scalable development and manufacturing of TCR-T cell therapies using Flow Electroporation technology.
  • Anocca will deploy MaxCyte's ExPERT platform for non-viral gene editing workflows across its therapeutic pipeline, including a lead program targeting mutant KRAS-driven advanced pancreatic cancer.
  • The partnership provides Anocca with non-exclusive research, clinical and commercial rights to MaxCyte's technology platform, while MaxCyte receives annual licensing fees and program-related revenue.
  • Anocca recently received GMP compliance certification and manufacturing license from Swedish regulators for its cell therapy production facility.

mRNA Therapy Reactivates Developmental Gene to Repair Heart Damage After Heart Attack

  • Researchers at Temple University developed a novel mRNA therapy that delivers the PSAT1 gene to stimulate heart muscle repair and improve cardiac function following heart attack.
  • The treatment showed striking results in mice, with robust increases in cardiomyocyte proliferation, reduced tissue scarring, improved blood vessel formation, and significantly enhanced heart function and survival.
  • PSAT1 activates the serine synthesis pathway, reducing oxidative stress and DNA damage while promoting nuclear translocation of β-catenin for cell cycle re-entry in cardiomyocytes.
  • The modRNA technology provides a flexible platform for gene delivery with high specificity and limited side effects, without integrating into the genome like viral therapies.

Radius Pharmaceuticals Secures Patent Victory for TYMLOS Osteoporosis Treatment Through 2038

  • The U.S. District Court for the District of Massachusetts ruled in favor of Radius Pharmaceuticals and Ipsen in a patent infringement case against Orbicular Pharmaceutical Technologies for their proposed generic TYMLOS product.
  • The court upheld the validity of all five TYMLOS patents asserted, with the latest patent protection extending through April 30, 2038.
  • TYMLOS (abaloparatide) is an FDA-approved parathyroid hormone related peptide for treating postmenopausal women and men with osteoporosis at high risk for fracture.
  • The favorable ruling reinforces the strength of the TYMLOS patent portfolio and represents an important commercial victory for Radius in protecting their bone health franchise.

Genvira and Labskin Secure £1.2 Million UK-Canada Grant for Melanoma Immunotherapy Development

  • Genvira Biosciences and Labskin Limited have received £1.2 million ($2.0 million) in funding through the Canada-UK Biomanufacturing of Biologics and Advanced Therapies program to develop novel melanoma immunotherapies.
  • The collaboration will combine Labskin's 3D human skin modeling expertise with Genvira's viral vector platforms and NRC's mRNA technologies to create targeted cancer vaccines for malignant melanoma.
  • The project addresses a significant unmet medical need, as malignant melanoma affects an estimated 330,000 new patients annually with 60,000 deaths worldwide.
  • The partnership aims to establish scalable production processes and quality control assays that could accelerate future cancer therapeutic development.

UCLA Scientists Achieve First-in-Human Reprogramming of Stem Cells to Generate Renewable Cancer-Fighting T Cells

CAR-T
  • UCLA researchers successfully demonstrated the first-in-human reprogramming of blood-forming stem cells to continuously produce cancer-targeting T cells in a groundbreaking clinical trial.
  • The approach creates an "internal factory" that generates tumor-targeting immune cells over time, potentially offering longer-lasting protection against cancer recurrence.
  • One patient with aggressive sarcoma showed tumor regression and maintained detectable levels of engineered immune cells for months following treatment.
  • The therapy targets NY-ESO-1, a cancer-testis antigen found in approximately 80% of synovial sarcomas but rarely in healthy adult tissues.

Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR After a Myeloablative Conditioning Regimen to Treat Patients With Advanced Cancer

NCT03240861TerminatedPhase 1
Jonsson Comprehensive Cancer Center
Posted 7/26/2017

Immunophotonics Completes Phase 1b/2a Trial of IP-001 Immunotherapy for Advanced Solid Tumors

  • Immunophotonics has completed treatment of the last patient in its 41-patient INJECTABL-1 Phase 1b/2a trial evaluating IP-001 for advanced solid tumors across three cancer types.
  • The multicenter trial tested IP-001, a proprietary glycan polymer designed to transform tumor ablation into personalized systemic cancer immunotherapies by retaining tumor antigens and activating immune responses.
  • IP-001 is administered by injection into the ablation zone following tumor destruction, aiming to enable systemic tumor surveillance and reduce recurrence after standard ablation therapy.
  • The company reports early positive signals and has expanded clinical collaborations to further assess the novel therapy's efficacy in addressing unmet medical needs.

Serina Therapeutics Advances Once-Weekly Injectable VMAT2 Inhibitor for Tardive Dyskinesia Treatment

  • Serina Therapeutics announced the advancement of SER-270 (POZ-VMAT2i), a novel once-weekly subcutaneous VMAT2 inhibitor designed to address medication adherence challenges in tardive dyskinesia patients.
  • The drug candidate targets underserved patient populations including those non-compliant with daily oral medications, institutionalized patients, and individuals with swallowing difficulties.
  • The U.S. tardive dyskinesia market exceeded $3.7 billion in 2024 and is projected to reach $5.4 billion by 2030, despite fewer than 30% of patients being diagnosed.
  • Serina plans to explore POZ-VMAT2i development for Huntington's disease chorea as a secondary indication, leveraging advantages for patients with swallowing difficulties.

FDA Approves Leqvio as First-Line Monotherapy for Cholesterol Management

Drug Approval
  • The FDA has approved an updated label for Novartis' Leqvio (inclisiran) allowing its use as monotherapy alongside diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemia.
  • The approval removes the previous requirement for Leqvio to be used in combination with statin therapy, positioning it as a first-line treatment option.
  • Up to 80% of atherosclerotic cardiovascular disease patients in the US fail to reach guideline-recommended LDL cholesterol targets below 70 mg/dL.
  • Leqvio's twice-yearly dosing schedule administered by healthcare providers is designed to improve patient adherence and long-term cholesterol management.

Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.

NCT05763875CompletedPhase 3
Novartis Pharmaceuticals
Posted 3/15/2023

A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)

NCT04929249CompletedPhase 3
Novartis Pharmaceuticals
Posted 6/25/2021

Vir Biotechnology's Dual-Masked T-Cell Engagers Show Promise in Solid Tumors and mCRPC

  • Vir Biotechnology's VIR-5818 and VIR-5500, dual-masked T-cell engagers, demonstrate encouraging preliminary safety and efficacy in Phase 1 trials.
  • VIR-5818 targets HER2-expressing solid tumors, showing dose-dependent tumor shrinkage in heavily pretreated patients, including those with colorectal cancer.
  • VIR-5500 targets PSMA in metastatic castration-resistant prostate cancer (mCRPC), with dose escalation ongoing and early clinical response signals observed.
  • The PRO-XTEN masking technology aims to selectively activate TCEs in the tumor microenvironment, potentially mitigating toxicity to healthy cells.

To Access the Safety and Effects of Intravenous Administration of AMX-818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

NCT05356741RecruitingPhase 1
Vir Biotechnology, Inc.
Posted 4/13/2022

Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

NCT06960395RecruitingPhase 1
Vir Biotechnology, Inc.
Posted 7/22/2025

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