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Clinical Trial News

TransMedics Receives FDA Approval for Largest Heart Transplant Preservation Trial

FDA Approval
  • TransMedics received FDA conditional approval for its Investigational Device Exemption to initiate the Next-Generation OCS ENHANCE Heart trial, marking a significant regulatory milestone.
  • The two-part ENHANCE trial will exceed 650 patients and aims to demonstrate superiority of OCS Heart perfusion over static cold storage methods in donation after brain death cases.
  • The company plans to initiate both the ENHANCE Heart and DENOVO Lung trials in Q4 2025, positioning these studies as major catalysts for clinical adoption throughout 2026.
  • TransMedics believes this will constitute the largest heart preservation for transplant trial ever conducted worldwide, addressing critical unmet needs in cardiothoracic transplantation.

INmune Bio's INKmune Therapy Meets Primary Endpoints in Phase 1/2 Prostate Cancer Trial

Oncology
  • INmune Bio's phase 1/2 CaRe PC trial of INKmune therapy in metastatic castration-resistant prostate cancer has successfully met both primary and secondary endpoints, demonstrating favorable safety and tolerability across all three dose levels.
  • The NK cell-priming therapy showed greatest biomarker improvements in patients with low baseline NK cell activation, helping define the target population for future trials.
  • Individual tumor lesions were observed reducing in size or completely disappearing in some patients during treatment, suggesting direct anti-tumor effects.
  • The company plans to advance to a randomized phase 2b trial in patients with less severe disease to enable more robust measurement of clinical benefits.

Study of INKmune in Patients With mCRPC (CaRe Prostate)

NCT06056791RecruitingPhase 1
Inmune Bio, Inc.
Posted 11/30/2023

Davion Healthcare Files for NASDAQ Direct Listing to Advance Non-Invasive Medical Technologies

  • Davion Healthcare Plc, an Irish medical technology company, has filed a Form F-1 registration statement with the SEC for a proposed direct listing on NASDAQ under ticker symbol "DAVI."
  • The company specializes in non-invasive diagnostic and monitoring solutions, including its flagship BreastCheck home test for breast anomalies.
  • The direct listing will not involve raising new capital but aims to enhance shareholder liquidity and provide broader access to U.S. investors.
  • The registration statement has been filed but is not yet effective, and the company cannot sell shares until SEC approval is obtained.

Medicus Pharma and HelixNano Partner to Develop Needle-Free, Heat-Stable mRNA Vaccines

  • Medicus Pharma and HelixNano have signed a non-binding memorandum of understanding to develop thermostable mRNA vaccines that eliminate cold-chain storage requirements.
  • The partnership combines HelixNano's mRNA vaccine platform with Medicus's dissolvable microneedle array technology to create needle-free vaccine delivery.
  • The companies plan to conduct preliminary research with the University of Pittsburgh before potentially forming a joint venture for co-development and commercialization.
  • Initial work will focus on producing clinical-grade vaccine patches for a Phase 1 bridging study comparing traditional injection with microneedle patch delivery of HelixNano's HN-0001 vaccine candidate.

Atavistik Bio Doses First Patient in Phase 1 Trial of ATV-1601 for AKT1 E17K-Mutant Solid Tumors

  • Atavistik Bio has dosed the first patient in a Phase 1 clinical trial of ATV-1601, a first-in-class selective allosteric inhibitor targeting AKT1 E17K-mutant solid tumors.
  • The AKT1 E17K mutation affects over 40,000 cancer patients annually in the United States, with highest prevalence in breast, endometrial, and prostate cancers.
  • ATV-1601 demonstrated superior target engagement, efficacy, and tolerability compared to pan-AKT inhibitors in preclinical studies, potentially addressing limitations of current therapies.
  • The open-label Phase 1a/1b study will evaluate ATV-1601 as monotherapy and in combination with fulvestrant for hormone receptor-positive breast cancer patients.

A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations

NCT07038369Not Yet RecruitingPhase 1
Atavistik Bio, Inc
Posted 7/1/2025

Chocolate Compound Theobromine Combined with Arainosine Outperforms Tamiflu Against Drug-Resistant Flu Strains

  • A novel drug combination of Theobromine (found in chocolate) and Arainosine demonstrated superior effectiveness against influenza compared to Tamiflu in a study published in PNAS.
  • The combination therapy targets the M2 ion channel in influenza viruses, effectively neutralizing drug-resistant strains including bird flu and swine flu variants.
  • Researchers at Hebrew University of Jerusalem tested the combination in both cell cultures and animal trials, showing dramatic improvements over Oseltamivir treatment.
  • The breakthrough approach could potentially address the growing challenge of antiviral resistance and prepare for future pandemic threats.

Microbiotica Completes Enrollment in Phase 1b Trial of MB310 for Ulcerative Colitis

  • Microbiotica has completed patient recruitment for its COMPOSER-1 Phase 1b trial, enrolling 29 adults with ulcerative colitis across five European countries.
  • The randomized, placebo-controlled study is evaluating MB310, an oral live biotherapeutic containing eight bacterial strains designed to induce long-term remission without immunosuppression.
  • Initial results from the 12-week treatment period followed by 12-week observation are expected by the end of 2025.
  • MB310 was developed based on analysis of faecal microbiota transplant data and acts through three mechanisms targeting ulcerative colitis pathology.

A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis

NCT06582264Active, Not RecruitingPhase 1
Microbiotica Ltd
Posted 9/27/2024

Certara's Simcyp Simulator Becomes First PBPK Modeling Platform to Receive EMA Qualification for EU Regulatory Submissions

  • Certara's Simcyp Simulator has become the first and only PBPK modeling platform to receive formal qualification from the European Medicines Agency for regulatory submissions across the EU.
  • The qualification allows sponsors to use Simcyp simulations to assess drug-drug interaction risk in regulatory submissions without re-establishing the platform's credibility for specified scenarios.
  • The qualification covers three contexts of use spanning six CYP enzymes and two inhibition mechanisms, potentially reducing the number of required clinical DDI studies.
  • This milestone represents a significant advancement in model-informed drug development as regulators increasingly prioritize biosimulation approaches to accelerate drug development.

Raytone Biotech Doses First Patient with Novel Tacrolimus Plug for Dry Eye Disease

  • Raytone Biotech successfully dosed the first patient with RTP-008, a bioabsorbable tacrolimus lacrimal canaliculus plug, in Q2 2025 at Beijing Tongren Hospital.
  • The novel therapy combines physical tear retention through hydrogel plug occlusion with sustained anti-inflammatory tacrolimus release for moderate-to-severe dry eye disease.
  • Current dry eye treatments require multiple daily topical agents leading to poor compliance and a "remission-relapse vicious cycle" that RTP-008 aims to break.
  • The first enrolled patient with moderate-to-severe dry eye disease tolerated the procedure well with no significant adverse reactions observed.

Anbogen Receives FDA Clearance for Phase 1/2 Trial of ABT-301 Triplet Therapy in Metastatic Colorectal Cancer

FDA Approval
  • Anbogen Therapeutics received FDA approval for its Investigational New Drug application to initiate a Phase 1/2 clinical trial of ABT-301 combined with tislelizumab and bevacizumab for metastatic colorectal cancer patients.
  • The open-label, multi-center international study will enroll 66 patients with proficient mismatch repair or non-microsatellite instability-high metastatic colorectal cancer in Taiwan and Australia.
  • ABT-301 is an oral HDAC1/2/3 inhibitor that converts "cold tumors" into "hot tumors" by promoting CD8+ T cell infiltration and enhancing immune checkpoint inhibitor efficacy.
  • The therapy targets approximately 95% of metastatic colorectal cancer patients who respond poorly to current immunotherapies, representing a potential $9 billion market opportunity.

Dose-Seeking Study of MPT0E028 in Subjects With Advanced Solid Malignancies Without Standard Treatment

NCT02350868CompletedPhase 1
Taipei Medical University
Posted 4/24/2015

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