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Clinical Trial News

Incannex Healthcare Forms Joint Venture with Mind Medicine Australia to Launch Psychedelic Therapy Clinic in Melbourne

  • Incannex Healthcare has entered a 50:50 joint venture with Mind Medicine Australia to launch a psychedelic-assisted therapies clinic in Melbourne, targeting PTSD and treatment-resistant depression.
  • The new entity, Mind Medicine Australia Clinics, will provide integrated services including clinical operations, governance, medicine supply, and clinician training to expand treatment access.
  • The updated clinic model is expected to reduce costs and more than triple service capacity, with patient intake beginning shortly in response to strong early demand.
  • Mind Medicine Australia successfully led the world's first regulatory rescheduling of psilocybin and MDMA for controlled clinical use in Australia in 2023.

NMDP ACCESS Trial Shows Mismatched Donors Expand Stem Cell Transplant Access for Blood Cancer Patients

  • The ACCESS Phase II trial demonstrated that mismatched unrelated donors can safely provide stem cell transplants with one-year overall survival rates of 83.8% for myeloablative and 78.6% for reduced-intensity conditioning.
  • Results showed no significant difference in overall survival between patients with 7/8 HLA-matched donors and those with fewer matches, expanding donor eligibility for blood cancer patients.
  • The study enrolled 145 adult patients across 21 U.S. transplant centers, with 59% from underrepresented racial or ethnic groups, addressing historical disparities in donor availability.
  • Low rates of severe graft-versus-host disease were observed, with grade III-IV acute GVHD occurring in only 8-10% of patients at six months.

Lung Cancer Research Foundation and Boehringer Ingelheim Launch $2.25 Million Initiative to Target HER2-Mutant Lung Cancer

Targeted Therapy
  • The Lung Cancer Research Foundation and Boehringer Ingelheim announced a $2.25 million research collaboration to advance understanding and treatment of HER2-mutant lung cancer through two new funding mechanisms.
  • The initiative includes a $1.5 million Team Science Award and $750,000 in Early Career Investigator Awards, addressing the critical need for novel therapeutic approaches in HER2-driven lung cancers.
  • HER2 mutations occur in up to 4% of non-small cell lung cancer cases, with current treatments not being curative and resistance invariably developing despite recent FDA approval of trastuzumab deruxtecan.
  • The collaboration aims to accelerate scientific discovery by supporting team-based research approaches and early career investigators, with proposal submissions due by July 29, 2025.

EarlyHealth Group Acquires Turkish Pharmaceutical Distributor Corena in $100M Life Sciences Expansion

  • EarlyHealth Group acquired Corena Ecza Deposu, Turkey's leading pharmaceutical distributor, to strengthen its position as one of the largest life sciences service providers in the country.
  • The acquisition supports EarlyHealth Group's $100 million portfolio strategy aimed at globalizing the Turkish pharmaceutical environment and reducing import dependency.
  • The partnership will accelerate government-led export initiatives, strengthen academic-industry collaborations, and advance Turkey's role in clinical research and pharmaceutical innovation.
  • The ceremonial signing took place in Dubai under the presence of Turkish and UAE diplomatic officials, highlighting strategic cooperation between the two nations.

Tislelizumab Shows Promise as Adjuvant Therapy for High-Risk Hepatocellular Carcinoma Patients

Monoclonal Antibody
  • A multicenter retrospective study of 108 patients demonstrated that tislelizumab, with or without tyrosine kinase inhibitors, significantly extended recurrence-free survival in high-risk hepatocellular carcinoma patients after curative resection.
  • Patients receiving adjuvant therapy for at least 6 months showed significantly longer recurrence-free survival compared to those treated for less than 6 months, with RFS rates of 89.8%, 71.3%, and 59.3% at 6, 12, and 24 months respectively.
  • Combination therapy with TKIs did not provide additional survival benefit over tislelizumab monotherapy but resulted in significantly higher rates of grade 3 or higher treatment-related adverse events (38.5% vs 18.6%).
  • The findings suggest tislelizumab monotherapy may be the optimal adjuvant approach for preventing HCC recurrence, balancing efficacy with acceptable toxicity profiles.

Adjuvant Immune Checkpoint Inhibitors in Postoperative Hepatocellular Carcinoma

NCT05221398Completed
Guangxi Medical University
Posted 3/3/2019

Microbot Medical Secures China Patent for LIBERTY Robotic System Ahead of Q3 2025 US Launch

  • Microbot Medical received a patent from China's National Intellectual Property Administration covering robotic manipulation of surgical tool handles for its LIBERTY Endovascular Robotic System.
  • The company's intellectual property portfolio now includes nine patents granted globally and 59 patent applications pending, strengthening its competitive position in endovascular robotics.
  • Microbot is preparing for the anticipated Q3 2025 commercial launch of the LIBERTY system in the US market, pending FDA 510(k) clearance.
  • The global market opportunity includes over two million peripheral endovascular procedures performed annually in the US and approximately 2.9 million in China.

Iovance CFO Resigns Amid Amtagvi Launch Struggles and Securities Fraud Investigation

Leadership Change
  • Iovance Biotherapeutics CFO Jean-Marc Bellemin resigned effective July 10, 2025, following significant commercial setbacks for the company's melanoma treatment Amtagvi.
  • The company's first-quarter Amtagvi sales substantially underperformed Wall Street expectations, leading to revised revenue projections and a UBS downgrade.
  • Iovance faces a securities fraud class action lawsuit alleging misrepresentation of authorized treatment center operations and patient treatment timelines.
  • The company's stock plummeted over 44% from $3.17 to $1.75 per share following disclosure of poor Q1 results and operational challenges.

University of Georgia Develops First Broad-Spectrum Fungal Vaccine, Enters Clinical Trials

  • University of Georgia researchers have developed NXT-2, a vaccine that successfully protects against the three most common fungal pathogens responsible for over 80% of fatal fungal infections.
  • The vaccine demonstrated efficacy in treating vaginal yeast infections in mice and has shown broad cross-protective immunity across multiple animal models including nonhuman primates.
  • Clinical trials will begin with women suffering from recurrent yeast infections, a condition affecting hundreds of millions globally and costing billions in healthcare expenses annually.
  • If successful, this would be the first vaccine to prevent pathogenic fungal infections, addressing the growing threat of antifungal drug resistance identified by the World Health Organization.

Canada Outpaces OECD Countries in New Medicine Launches Despite Rising Treatment Costs

Drug Approval
  • Canada launched more new medicines than the median for OECD countries in 2022-2023, according to the PMPRB's 9th annual Meds Entry Watch report.
  • Most new medicines entering the Canadian market carry high treatment costs exceeding $10,000 per year or $5,000 per 28-day cycle for oncology treatments.
  • Specialty medicines including biologics, orphan drugs, and cancer treatments represent a growing share of the new drug landscape in Canada.
  • The report analyzed 48 medicines receiving first-time market approval in 2022 and provided preliminary analysis of 63 medicines approved in 2023.

BioAegis Therapeutics Receives FDA Fast Track Designation for Novel ARDS Treatment

  • BioAegis Therapeutics has received FDA Fast Track designation for recombinant human plasma gelsolin (rhu-pGSN), a novel immune modulator for treating acute respiratory distress syndrome (ARDS).
  • The designation enables expedited regulatory review and highlights the therapeutic promise of rhu-pGSN for a condition affecting over 500,000 patients annually in the U.S. with a 40% mortality rate.
  • A global Phase 2b clinical trial with 600 patients is currently underway to evaluate the efficacy and safety of rhu-pGSN in moderate to severe ARDS.
  • Gelsolin represents a unique therapeutic approach that rebalances dysfunctional inflammation without suppressing immune function, addressing a critical unmet medical need in ARDS treatment.

A WORLD-WIDE CLINICAL STUDY TO FIND OUT IF INTRAVENOUS RECOMBINANT HUMAN PLASMA GELSOLIN IS SAFE AND IS BENEFICIAL FOR TREATING ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) CAUSED BY PNEUMONIA OR OTHER INFECTIONS

2023-510109-16-00RecruitingPhase 2
Bioaegis Therapeutics Inc.
Posted 10/3/2024

Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers

NCT06216366Active, Not RecruitingPhase 2
BioAegis Therapeutics Inc.
Posted 8/15/2025

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