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Clinical Trial News

CytoMed Therapeutics Advances Novel CAR Gamma Delta T Cell Therapy to Phase I Dose Level 2

CAR-T
  • CytoMed Therapeutics successfully completed dose level 1 of its first-in-human Phase I ANGELICA trial for CTM-N2D therapy in four late-stage cancer patients.
  • The company's novel allogeneic CAR gamma delta T cell therapy targets NKG2DL antigens commonly present in many cancers without requiring donor-patient compatibility matching.
  • CTM-N2D represents a significant advancement over conventional CAR-T therapies by using donor-derived gamma delta T cells rather than patient-derived cells.
  • The trial is scheduled to advance to dose level 2 in the third quarter of 2025, evaluating safety and tolerability in advanced solid and hematological malignancies.

Allogeneic NKG2DL-targeting CAR γδ T Cells (CTM-N2D) in Advanced Cancers (ANGELICA)

NCT05302037RecruitingPhase 1
CytoMed Therapeutics Pte Ltd
Posted 11/19/2024

ProMIS Neurosciences Receives FDA Fast Track Designation for Alzheimer's Drug PMN310

Precision Medicine
  • ProMIS Neurosciences received FDA Fast Track designation for PMN310, a therapeutic candidate targeting Alzheimer's disease, driving stock prices up 177% in pre-market trading.
  • The company's PMN310 is currently in Phase 1b trials evaluating safety, tolerability, and pharmacokinetics in early Alzheimer's patients, with interim results expected in Q2 2026.
  • Wall Street analysts maintain a Moderate Buy rating with an average price target of $3.50, representing potential 695% upside from current levels.
  • Trading volume surged to over 79 million shares compared to the three-month daily average of 3.5 million shares following the FDA announcement.

Epirium Bio Completes First-in-Human Trial of Novel Oral Sarcopenia Treatment MF-300

  • Epirium Bio has completed dosing in its Phase 1 trial of MF-300, a first-in-class oral 15-PGDH enzyme inhibitor for treating sarcopenia, with preliminary data showing only mild to moderate adverse events.
  • The randomized, double-blind, placebo-controlled trial assessed safety, tolerability, pharmacokinetics and pharmacodynamics of MF-300 in healthy adults, with no severe adverse events or early discontinuations reported.
  • MF-300 works by inhibiting 15-PGDH enzyme to increase prostaglandin E2 levels in aged muscle, potentially improving muscle quality and function in sarcopenia patients.
  • The company plans to share topline results later this quarter and commence Phase 2 safety and efficacy trials in sarcopenia patients by mid-2026.

MedGenome Secures $47.5 Million Series E Funding to Expand Genomic Diagnostics Access Across India

Precision Medicine
  • Bengaluru-based MedGenome raised $47.5 million in Series E funding co-led by Maj Invest and existing investor Novo Holdings to expand genomic diagnostics access.
  • The funding will enable broader access to genomics and integrated diagnostics solutions across India and other emerging markets.
  • MedGenome aims to reduce India's disease burden through early detection and targeted disease management using affordable genetic diagnostics tools.
  • The investment reflects growing adoption of genomics in personalized and preventive healthcare across emerging economies.

DiaMedica Therapeutics Secures $30.1 Million to Advance DM199 for Preeclampsia and Fetal Growth Restriction

  • DiaMedica Therapeutics raised $30.1 million in a private placement led by current investors to fund operations for more than two years.
  • The funding will support submission of an investigational new drug application in the United States for preeclampsia and fetal growth restriction.
  • The company plans to conduct a Phase 2b study to further evaluate DM199 in both indications, pending IND approval.
  • DM199 represents the most advanced clinical program targeting preeclampsia and fetal growth restriction, conditions with no approved treatment options.

Lantern Pharma Secures European Patent for AI-Developed Cancer Therapy LP-284

AIOncology
  • Lantern Pharma received European Patent Office allowance for LP-284, a next-generation acylfulvene targeting relapsed or refractory non-Hodgkin's lymphoma with patent exclusivity through early 2039.
  • The AI-developed drug candidate achieved clinical trial readiness in under three years at approximately $1.5-2.0 million cost and is currently in Phase 1 trials for aggressive NHL subtypes.
  • LP-284 has earned FDA Orphan Drug Designations for mantle cell lymphoma and high-grade B-cell lymphomas, addressing a $4 billion annual global blood cancer market.
  • The European patent strengthens Lantern's global intellectual property portfolio alongside existing patents in the US, Japan, India, and Mexico, positioning LP-284 for worldwide commercialization.

Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients with Relapsed or Refractory Lymphomas and Solid Tumors

NCT06132503RecruitingPhase 1
Lantern Pharma Inc.
Posted 1/3/2023

MVP Health Care Partners with Renalytix to Expand Access to AI-Powered Kidney Disease Testing

AIPrecision MedicineFDA Approval
  • MVP Health Care and Renalytix announced a partnership to expand access to the FDA-approved kidneyintelX.dkd test for patients with type 2 diabetes and chronic kidney disease.
  • The collaboration aims to identify patients at higher risk for progressive kidney function decline earlier, enabling more targeted therapeutic interventions and personalized care plans.
  • The test will be available to all MVP customers in New York, including Medicare and Medicaid beneficiaries, and is recommended by KDIGO clinical guidelines.
  • Renalytix reports measurable improvements in patient outcomes and quality metrics, including HEDIS measures for blood pressure and HbA1c control in high-risk populations where the test is implemented.

Korro Bio Receives EMA Orphan Drug Designation for RNA Editing Therapy KRRO-110 in Alpha-1 Antitrypsin Deficiency

Rare Disease
  • Korro Bio has received orphan drug designation from the European Medicines Agency for KRRO-110, an investigational RNA editing therapy for Alpha-1 Antitrypsin Deficiency (AATD).
  • The designation follows a similar FDA orphan drug designation granted in March 2025, highlighting the urgent medical need for innovative treatments in this rare genetic disorder.
  • KRRO-110 is currently being evaluated in the Phase 1/2a REWRITE clinical study with interim data expected in the second half of 2025.
  • The therapy represents the first RNA editing oligonucleotide from Korro's proprietary OPERA platform, designed to restore normal protein function by editing defective RNA.

A Phase 1/2a, Single- and Multiple-dose Escalation Study of KRRO-110

NCT06677307RecruitingPhase 1
Korro Bio, Inc.
Posted 1/13/2025

RedHill Biopharma Receives FDA Approval for Groundbreaking MAP-Targeted Crohn's Disease Study

FDA ApprovalOrphan Drug
  • RedHill Biopharma received positive FDA feedback for the first-ever clinical study targeting Mycobacterium avium subspecies paratuberculosis (MAP) infected Crohn's disease patients with RHB-204.
  • The novel Phase 2 study will test MAP as a root cause of Crohn's disease, potentially making RHB-204 a paradigm-shifting therapy treating both the suspected cause and symptoms.
  • RHB-204 is supported by positive Phase 3 data from RHB-104 showing 64% improvement in efficacy and offers a 40% pill burden reduction with patent protection through 2041.
  • The Crohn's disease market is expected to grow from $13.6 billion in 2024 to over $19 billion by 2033, presenting significant commercial potential for new therapies.

Cerus Corporation Secures $7.2M DoD Contract Amendment to Advance Trauma Hemorrhage Treatment

  • Cerus Corporation received an additional $7.2 million contract amendment from the U.S. Department of Defense to develop lyophilized INTERCEPT Fibrinogen Complex for treating trauma-related bleeding.
  • The funding will support CRYO-FIRST, a 320-patient randomized study comparing pre-thawed IFC to conventional cryoprecipitated antihemophilic factor in trauma-associated hemorrhagic shock patients.
  • This award adds to approximately $18 million already provided under Cerus' DoD contract to develop room-temperature, shelf-stable fibrinogen products for military and civilian trauma care.
  • Initial patient enrollment for the CRYO-FIRST study is targeted for the first half of 2026, with the goal of improving early fibrinogen treatment in trauma patients.

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