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Clinical Trial News

HIV Drugs Show Promise as First Prophylactic Treatment for HTLV-1 Virus in Landmark Australian Study

  • Australian researchers have identified the first potential prophylactic treatment for HTLV-1, a neglected virus affecting 10 million people globally, using existing HIV antivirals tenofovir and dolutegravir in humanized mouse models.
  • The study marks the first time any research group has successfully suppressed HTLV-1 transmission in a living organism, with both drugs showing powerful suppression against international and Australian virus strains.
  • Combination therapy using HIV antivirals with MCL-1 protein inhibitors demonstrated the ability to selectively kill HTLV-1-infected cells, suggesting a potential curative strategy for established infections.
  • The research team is now in discussions with pharmaceutical companies to include HTLV-1 patients in ongoing HIV drug clinical trials, potentially leading to the first approved pre-exposure prophylaxis for this life-threatening virus.

DualityBio's HER3-Targeting ADC DB-1310 Receives FDA Fast Track Designation for EGFR-Mutant Lung Cancer

  • DualityBio's next-generation HER3-targeting antibody-drug conjugate DB-1310 has received FDA Fast Track Designation for treating advanced nonsquamous non-small cell lung cancer with EGFR mutations.
  • The designation specifically covers patients with EGFR exon 19 deletion or L858R mutation who have progressed after treatment with third-generation EGFR tyrosine kinase inhibitors and platinum-based chemotherapy.
  • Phase I/IIa clinical trial data presented at ASCO 2025 demonstrated encouraging efficacy and manageable safety profile in patients with advanced solid tumors who had failed standard therapies.
  • DB-1310 is developed using DualityBio's proprietary DITAC platform and has shown robust synergistic tumor suppression activity in preclinical combination studies with EGFR TKIs.

A Study of DB-1310 in Advanced/Metastatic Solid Tumors

NCT05785741RecruitingPhase 1
DualityBio Inc.
Posted 4/10/2023

AstraZeneca Announces $50 Billion US Investment Plan with Virginia Manufacturing Hub for Weight Management and Metabolic Drugs

  • AstraZeneca announces a $50 billion investment in the United States by 2030, with Virginia selected as the site for the company's largest single manufacturing facility investment globally.
  • The new multi-billion dollar Virginia facility will produce drug substances for AstraZeneca's weight management and metabolic portfolio, including oral GLP-1, baxdrostat, oral PCSK9, and combination small molecule products.
  • The investment is expected to create tens of thousands of highly skilled direct and indirect jobs across the country and support AstraZeneca's ambition to reach $80 billion in revenue by 2030.
  • The comprehensive investment plan includes expansion of R&D facilities in Maryland and Massachusetts, next-generation manufacturing sites for cell therapy, and continuous manufacturing expansion across multiple states.

CASI Pharmaceuticals Names David Cory CEO to Advance Anti-CD38 Antibody CID-103 Program

Monoclonal AntibodyLeadership Change
  • CASI Pharmaceuticals appointed industry veteran David Cory as CEO to lead the U.S. operations and focus on advancing CID-103, a potential best-in-class anti-CD38 monoclonal antibody.
  • CID-103 is currently dosing patients in a multi-center Phase 1/2 study for chronic immune thrombocytopenia (ITP) and has an IND application filed for renal allograft antibody-mediated rejection.
  • Cory brings over 30 years of biotech experience, having raised over $1 billion in capital markets and led multiple company exits totaling approximately $9 billion in acquisitions.
  • The leadership change positions CASI to concentrate resources on maximizing the therapeutic potential of CD38 targeting for organ transplant rejection and autoimmune diseases.

FDA Clears Takeda's HyHub Devices to Streamline At-Home HYQVIA Immunoglobulin Therapy

Drug Approval
  • The FDA has granted 510(k) clearance to Takeda's HyHub and HyHub Duo devices, which enable needle-free transfer of HYQVIA's dual-vial components for patients aged 17 and older.
  • The devices reduce preparation steps by up to 50% compared to traditional pooling bag methods and minimize the need for ancillary supplies during infusion preparation.
  • HYQVIA is approved for treating primary immunodeficiency in adults and children as young as two, and as maintenance therapy for chronic inflammatory demyelinating polyneuropathy in adults.
  • The devices will be available at no additional cost to patients starting in the second half of fiscal year 2025, with a CE Mark application under review in the European Union.

A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

NCT02549170CompletedPhase 3
Baxalta now part of Shire
Posted 12/15/2015

Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP

NCT02955355CompletedPhase 3
Baxalta now part of Shire
Posted 11/14/2016

Livzon's Dual-Target IL-17A/F Antibody LZM012 Outperforms Secukinumab in Phase III Psoriasis Trial

Monoclonal Antibody
  • Livzon Pharmaceutical's LZM012, the first domestic dual-target IL-17A/F monoclonal antibody, achieved superior efficacy compared to Secukinumab in a Phase III trial for moderate to severe plaque psoriasis.
  • The study demonstrated LZM012's 49.5% PASI 100 response rate at week 12 versus 40.2% for Secukinumab, with faster onset of action and sustained benefits through 52 weeks.
  • LZM012 showed good overall safety profile with adverse event rates comparable to the control group, and Livzon has submitted pre-market communication to China's NMPA for regulatory approval.

FDA Expert Panel Debates SSRI Safety During Pregnancy Amid Calls for Stronger Warnings

  • An FDA expert panel convened to evaluate the risks and benefits of SSRI antidepressants during pregnancy, with experts presenting conflicting evidence on fetal safety and maternal mental health outcomes.
  • Panel members highlighted that SSRI use during pregnancy has been linked to adverse fetal outcomes including increased risks of spontaneous abortion, congenital malformations, and neurodevelopmental issues ranging from 10% to 87% depending on the outcome.
  • Several experts called for stronger FDA warning labels, noting that current labeling inadequately informs patients about risks to fetal brain development and withdrawal challenges.
  • Mental health advocates emphasized that untreated perinatal depression affects 20% of pregnant women and poses significant risks including preterm delivery, maternal suicide, and poor prenatal care adherence.

AusperBio Receives China CDE Clearance for Phase III Trial of Hepatitis B Antisense Therapy AHB-137

  • AusperBio received China Center for Drug Evaluation clearance to initiate a Phase III clinical trial for AHB-137, a novel antisense oligonucleotide therapy targeting chronic hepatitis B functional cure.
  • The Phase III trial will evaluate 24-week treatment with AHB-137 (300 mg) in HBeAg-negative chronic hepatitis B patients receiving stable nucleos(t)ide analogue therapy.
  • AHB-137 previously received Breakthrough Therapy Designation from China CDE in July 2024, recognizing its potential to significantly improve treatment outcomes compared to existing therapies.
  • Chronic hepatitis B affects an estimated 290 million people globally, including approximately 75 million in China, with functional cure remaining rare despite available treatments.

Nestmedic Partners with Curavit for U.S. Clinical Trial of AI-Enabled Prenatal Monitoring Device

AIFDA Approval
  • Nestmedic S.A. has selected Curavit Clinical Research to lead the U.S. clinical trial of PregnaOne, an AI-enabled remote prenatal monitoring solution designed to provide continuous insight into fetal and maternal well-being.
  • The FDA-required Non-Significant Risk study will enroll 50 expectant mothers across multiple U.S. sites over 11 months to evaluate the safety and effectiveness of home-based prenatal monitoring.
  • The trial aims to generate foundational evidence to support future regulatory approval in the U.S., with Curavit managing all aspects including IRB submissions, site selection, data management, and clinical study reporting.

Nanogel-Armed CAR-T Cells Achieve 83.2% Tumor Inhibition Rate in Solid Tumor Model

CAR-T
  • Researchers from Changchun Institute of Applied Chemistry developed hyaluronidase-loaded nanogels (H-NGs) conjugated to CAR-T cells to overcome the dense extracellular matrix barrier that limits CAR-T cell infiltration in solid tumors.
  • The engineered H-NG CAR-T cells achieved an 83.2% tumor inhibition rate in the Raji solid tumor model, significantly outperforming free nanogels or unconjugated CAR-T cells.
  • The nanogels use thioketal linkers that respond to high reactive oxygen species levels in the tumor microenvironment, enabling precise release of hyaluronidase to degrade tumor stroma.
  • This dual-mechanism approach combines CAR-T cell trafficking capabilities with targeted enzyme delivery to enhance immune cell penetration and reduce immunosuppressive tumor microenvironment.

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