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Clinical Trial News

Teva and Fosun Pharma Form Strategic Partnership for Novel Anti-PD1-IL2 Cancer Immunotherapy TEV-56278

Oncology
  • Teva Pharmaceutical and Fosun Pharma announced a strategic partnership to develop TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy currently in Phase 1 trials for various cancers including melanoma.
  • Under the agreement, Fosun Pharma receives exclusive rights to develop, manufacture and commercialize TEV-56278 in China, Hong Kong, Macau, Taiwan and select Southeast Asian countries while Teva retains global rights elsewhere.
  • TEV-56278 represents a novel cancer immunotherapy approach designed to selectively deliver IL-2 to PD-1+ T cells within tumors, potentially amplifying anti-tumor activity while minimizing systemic toxicities.
  • Preclinical data has demonstrated tumor regression, enhanced T-cell infiltration, and durable immune memory, with the therapy being evaluated both as monotherapy and in combination with pembrolizumab.

Debiopharm Initiates First-in-Human Trial of CD37-Targeted ADC Debio 1562M for Relapsed/Refractory AML

Monoclonal AntibodyOncologyTargeted Therapy
  • Debiopharm has dosed the first patient in a Phase 1/2 trial of Debio 1562M, a first-in-class CD37-targeted antibody-drug conjugate for relapsed/refractory acute myeloid leukemia patients.
  • The compound utilizes Debiopharm's proprietary Trifecta approach, combining naratuximab antibody, MultiLink™ linker technology, and a microtubule inhibitor payload to target CD37 antigens on leukemic cells.
  • AML represents a significant unmet medical need with only 32% five-year overall survival and median survival as low as 7 months in certain populations.
  • Preclinical studies demonstrated Debio 1562M showed anti-leukemic activity across all AML subtypes and superior activity compared to current standard-of-care therapies.

A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)

NCT06969430RecruitingPhase 1
Debiopharm International SA
Posted 5/30/2025

AbbVie's VERONA Trial for High-Risk Myelodysplastic Syndrome Fails to Meet Primary Survival Endpoint

  • AbbVie's Phase 3 VERONA trial evaluating venetoclax plus azacitidine in newly diagnosed higher-risk myelodysplastic syndrome failed to meet its primary endpoint of overall survival with a hazard ratio of 0.908 and p-value of 0.3772.
  • The global randomized controlled trial compared venetoclax in combination with azacitidine versus azacitidine plus placebo, with no new safety signals observed during the study.
  • The negative results do not impact venetoclax's current approved indications for chronic lymphocytic leukemia, small lymphocytic lymphoma, and acute myeloid leukemia in elderly patients or those unsuitable for standard chemotherapy.
  • Full trial results will be presented at a future medical congress or publication, with participating patients being informed by their treating physicians about the study outcomes.

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

NCT06012240Active, Not RecruitingPhase 3
AbbVie
Posted 10/11/2023

A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

NCT02942290Active, Not RecruitingPhase 1
AbbVie
Posted 1/12/2017

Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome

NCT04401748Active, Not RecruitingPhase 3
AbbVie
Posted 9/10/2020

Penumbra Completes Enrollment in Landmark STORM-PE Trial Testing Thrombectomy for Pulmonary Embolism

  • Penumbra has completed enrollment of 100 patients in the pivotal STORM-PE randomized controlled trial, comparing computer assisted vacuum thrombectomy plus anticoagulation versus anticoagulation alone for acute intermediate-high risk pulmonary embolism.
  • The first-of-its-kind trial aims to provide level 1 clinical evidence on whether endovascular therapy with CAVT is superior to medical therapy alone for this critically ill patient population.
  • Pulmonary embolism affects an estimated 900,000 Americans annually and can be life-threatening, with 10-30 percent of individuals dying within one month of diagnosis.
  • The trial results will inform treatment guidelines for intermediate-high risk PE patients, where current treatment strategies are not well defined despite the condition being a leading cause of cardiovascular morbidity and mortality.

Comparison of Two Pulmonary Embolism Treatments

NCT05684796Active, Not RecruitingNot Applicable
Penumbra Inc.
Posted 11/27/2023

Innovative Molecules Completes Phase 1b Enrollment for Novel HSV Inhibitor IM-250

  • Innovative Molecules GmbH has completed enrollment in the Phase 1b portion of its clinical trial evaluating IM-250, a next-generation helicase-primase inhibitor for recurrent genital herpes.
  • The placebo-controlled study assesses safety, efficacy, and pharmacokinetics of once-weekly oral dosing in patients with recurrent genital herpes.
  • IM-250 represents potential innovation in a market that has seen little therapeutic advancement in over four decades.
  • Topline results from the Phase 1b portion are expected in the second half of 2025.

Xlife Sciences Expands Asian Footprint Through Strategic Partnerships in Digital Health and Precision Oncology

AI
  • Xlife Sciences AG has signed strategic partnerships with Korean companies Huraypositive Corp. and OncoMASTER Inc. to accelerate digital health and precision oncology innovation across Asia.
  • The collaboration leverages OncoMASTER's AI-powered platform built on clinical data from over 10,000 advanced cancer patients, representing the largest such dataset in Asia.
  • The partnership aims to bridge academic innovation with clinical translation while enabling Korean companies to access European commercialization opportunities through Xlife Sciences' network.
  • This marks a significant expansion of Xlife Sciences' international presence, focusing on personalized healthcare solutions and AI-driven cancer treatment prediction technologies.

Neurizon's NUZ-001 Demonstrates Neuroprotective Effects in Huntington's Disease Zebrafish Model

  • NUZ-001 and its active metabolite NUZ-001 Sulfone showed significant neuroprotective effects in a zebrafish model of Huntington's disease, preventing developmental abnormalities and neuronal cell death.
  • Treatment with both compounds rescued key biomarkers including BDNF expression and haemoglobin production following huntingtin protein knockdown in the disease model.
  • The findings strengthen NUZ-001's potential as a platform therapy for multiple neurodegenerative diseases beyond its current ALS development program.
  • Neurizon plans to advance additional preclinical studies in mammalian models of Huntington's disease to further validate the therapeutic potential.

uBriGene Launches GMP-Compliant iPSC Banks to Accelerate Cell Therapy Development

  • uBriGene Biosciences has launched fully characterized, ready-to-use induced pluripotent stem cell (iPSC) banks developed using proprietary RNA-LNP reprogramming technology to support clinical applications worldwide.
  • The iPSC banks are generated in GMP-compliant cleanrooms using healthy donor fibroblasts from the USA and undergo rigorous quality control testing to confirm genomic stability and pluripotency markers.
  • According to Dr. Xiulian Sun, CTO and Founder at uBriGene, these banks can save clients 1-2 years and reduce uncertainty associated with donor cell sourcing and reprogramming processes.
  • The banks are available in both research-use only and GMP-compliant formats, with additional gene editing services offered for disease modeling and therapeutic development customization.

Quiver Bioscience Names Co-Founder Graham Dempsey CEO to Advance Nav1.7-Targeting ASO for Chronic Pain

Leadership Change
  • Quiver Bioscience appointed co-founder Graham Dempsey, PhD as CEO to lead the company's transition from discovery platform to clinical-stage therapeutics development.
  • The company's lead antisense oligonucleotide targeting Nav1.7 for chronic neuropathic pain is approaching development candidate selection in 2025 with IND-enabling studies to follow.
  • Quiver is scaling its AI-driven CNS drug discovery platform while advancing a pipeline including a UBE3A-targeting ASO for chromosome 15q duplication syndrome.
  • The Nav1.7 ASO demonstrates efficacy in preclinical models with favorable CNS tolerability, potentially overcoming limitations of existing Nav-targeted small molecules.

Elite Pharmaceuticals Achieves Bioequivalence for Generic Anticoagulant in $27 Billion Market

FDA Approval
  • Elite Pharmaceuticals reported positive bioequivalence results for an undisclosed generic anticoagulant targeting a branded product with $27 billion in annual sales.
  • The crossover bioequivalence study in healthy subjects demonstrated that Elite's generic formulation is bioequivalent to the branded reference product.
  • The company is preparing to file an Abbreviated New Drug Application with the FDA, though commercialization depends on patent resolution and regulatory approval.
  • No generic competitor currently exists in this anticoagulant market, presenting a significant commercial opportunity for Elite upon successful market entry.

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