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Voyager Therapeutics Advances Multi-Modal Neurotherapeutics Pipeline with Novel NeuroShuttle Platform and TDP-43 Collaboration

Monoclonal Antibody
  • Voyager Therapeutics introduced its Voyager NeuroShuttle platform, a nonviral delivery system that demonstrated sustained brain expression over three weeks in murine studies, significantly longer than transferrin receptor shuttles.
  • The company entered a collaboration with Transition Bio to develop small molecules targeting TDP-43 for ALS and FTD, addressing a historically undruggable target found in over 90% of ALS cases.
  • Voyager's tau-targeting programs continue to advance with VY7523 anti-tau antibody in final MAD trial cohort and VY1706 gene therapy expected to enter clinical trials in 2026.
  • The company maintains a strong cash position of $229 million with runway extending into 2028, while R&D expenses increased to $35.9 million in Q3 2025 to support advancing clinical programs.

Akeso's AK135 Shows Promise for Chemotherapy-Induced Neuropathy in Preclinical Studies

Monoclonal Antibody
  • Akeso presented preclinical data for AK135, a novel IL-1RAP targeting antibody, at SITC 2025, demonstrating effective blockade of three key inflammatory pathways.
  • The antibody significantly alleviated neuropathic pain in a dose-dependent manner in chemotherapy-induced peripheral neuropathy mouse models while maintaining good tolerability.
  • AK135 is currently in Phase I clinical trials for treating CIPN, a prevalent side effect affecting 50-90% of chemotherapy patients with limited treatment options.
  • The drug candidate showed high binding affinity comparable to control antibody CAN04 and effectively reduced pro-inflammatory cytokine secretion in tumor cell models.

Innate Pharma Receives FDA Clearance for Phase 3 Trial of Lacutamab in Cutaneous T-Cell Lymphoma

Monoclonal Antibody
  • Innate Pharma announced FDA clearance to proceed with TELLOMAK 3, a confirmatory Phase 3 trial of lacutamab in patients with Sézary syndrome and Mycosis fungoides who failed prior systemic therapy.
  • The randomized, open-label study will compare lacutamab against standard treatments with progression-free survival as the primary endpoint, targeting trial initiation in H1 2026.
  • FDA provided encouraging feedback on a potential accelerated approval pathway for Sézary syndrome once the Phase 3 trial is underway, building on positive Phase 2 data.
  • Lacutamab is a first-in-class anti-KIR3DL2 antibody that has received multiple regulatory designations including Fast Track, PRIME, Orphan Drug, and Breakthrough Therapy status.

IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma

NCT03902184Active, Not RecruitingPhase 2
Innate Pharma
Posted 5/22/2019

Safety and Efficacy of Lacutamab in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma That Express KIR3DL2

NCT05321147CompletedPhase 1
Innate Pharma
Posted 3/17/2022

Sibeprenlimab Demonstrates 54% Proteinuria Reduction in Largest Phase 3 IgA Nephropathy Trial

Monoclonal Antibody
  • Sibeprenlimab achieved a 54.3% placebo-adjusted reduction in proteinuria at 12 months in the Phase 3 VISIONARY trial, the largest IgA nephropathy study conducted to date.
  • The APRIL inhibitor demonstrated favorable safety profile comparable to placebo while significantly reducing key disease biomarkers including galactose-deficient IgA1 and hematuria rates.
  • Otsuka Pharmaceutical received FDA Priority Review for sibeprenlimab with a target action date of November 28, 2025, potentially offering the first targeted therapy for this progressive kidney disease.
  • Treatment effects remained consistent across patient subgroups, including those on SGLT2 inhibitors, suggesting additional benefit beyond current standard of care.

Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)

NCT05248646Active, Not RecruitingPhase 3
Otsuka Pharmaceutical Development & Commercialization, Inc.
Posted 3/15/2022

Phase II Trial Shows Promise for Toripalimab-FLOT Combination in Gastric Cancer with Peritoneal Metastasis

Monoclonal Antibody
  • A phase II trial demonstrated that toripalimab combined with FLOT chemotherapy achieved a 25% R0 resection conversion rate in gastric cancer patients with peritoneal metastasis, a condition with historically poor prognosis.
  • The combination therapy resulted in a median overall survival of 10.8 months and progression-free survival of 6.5 months, with an objective response rate of 35% and disease control rate of 80%.
  • Grade 3-4 treatment-related adverse events occurred in 35% of patients, primarily neutropenia, while patients who underwent conversion surgery showed trends toward improved survival outcomes.
  • The study enrolled 20 patients with laparoscopically confirmed gastric adenocarcinoma and peritoneal metastasis, representing the first prospective trial evaluating this specific combination in this patient population.

FLOT Combined With PD-1 in the First-line Treatment of Patients With Advanced Gastric Cancer and Peritoneal Metastasis

NCT04886193Unknown StatusNot Applicable
Guangdong Provincial Hospital of Traditional Chinese Medicine
Posted 4/16/2021

Takeda's Mezagitamab Shows Sustained Kidney Protection 18 Months After Treatment in IgA Nephropathy

Monoclonal AntibodyOrphan Drug
  • Takeda's Phase 1b study demonstrates that mezagitamab (TAK-079) maintains stable kidney function in IgA nephropathy patients through Week 96, 18 months after the last dose.
  • The anti-CD38 monoclonal antibody sustained a 55.2% reduction in proteinuria and 50.1% reduction in Gd-IgA1 levels with no serious adverse events reported.
  • Mezagitamab has received FDA Breakthrough Therapy Designation for immune thrombocytopenia and EMA Orphan Drug Designation for IgA nephropathy.
  • Phase 3 trials are now enrolling patients for both primary IgA nephropathy and chronic immune thrombocytopenia indications.

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

NCT06722235RecruitingPhase 3
Takeda
Posted 2/27/2025

A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy

NCT05174221Active, Not RecruitingPhase 1
Takeda
Posted 11/9/2022

A Study of Mezagitamab in Adults With Primary IgA Nephropathy Kidney Condition

NCT06963827RecruitingNot Applicable
Takeda
Posted 7/15/2025

Pliant Therapeutics Reports Promising 50% Response Rate for PLN-101095 in Checkpoint-Resistant Solid Tumors

OncologyMonoclonal Antibody
  • Pliant Therapeutics completed enrollment of its Phase 1 trial for PLN-101095, an oral dual integrin inhibitor designed to overcome immune checkpoint resistance in solid tumors.
  • Interim data showed PLN-101095 achieved a 50% objective response rate in the third dose cohort and was well tolerated across all tested doses.
  • The company expects to report complete trial data including results from the two highest dose cohorts by the end of 2025.
  • Pliant reduced operating expenses by 54% year-over-year following discontinuation of the BEACON-IPF trial and strategic workforce restructuring.

Genmab Reports Strong Q3 2025 Results with Key Pipeline Advances and $8 Billion Merus Acquisition

Monoclonal AntibodyOncology
  • Genmab achieved 21% revenue growth to $2.66 billion in the first nine months of 2025, driven primarily by increased DARZALEX and Kesimpta royalties.
  • The FDA granted Breakthrough Therapy Designation to Rina-S for advanced endometrial cancer, while epcoritamab's Phase 3 trial met dual primary endpoints in follicular lymphoma.
  • The company announced an $8 billion all-cash acquisition of Merus to add petosemtamab, a late-stage asset with two BTDs, to its portfolio.
  • Operating profit increased significantly to $1.007 billion compared to $662 million in the same period last year, reflecting strong commercial execution.

Ianalumab-Ibrutinib Combination Enables Treatment-Free Periods for Chronic Lymphocytic Leukemia Patients

Monoclonal Antibody
  • A phase Ib clinical trial demonstrated that adding investigational antibody ianalumab to ibrutinib therapy allowed 17 out of 39 chronic lymphocytic leukemia patients to discontinue daily treatment for 12-24 months.
  • The combination achieved a 60% overall response rate and 43.6% of patients reached undetectable measurable residual disease, indicating deep remissions that could enable treatment-free intervals.
  • The therapy showed a favorable safety profile with no dose-limiting toxicities and lower infection rates compared to single-agent ibrutinib, potentially transforming CLL from lifelong to fixed-duration treatment.

VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

NCT03400176TerminatedPhase 1
Novartis Pharmaceuticals
Posted 4/9/2018

Nona Biosciences Expands CAR-T Partnership with Umoja Biopharma to Develop In Vivo Cell Therapies

CAR-TMonoclonal Antibody
  • Nona Biosciences and Umoja Biopharma have expanded their strategic collaboration through a new evaluation and license agreement to develop multiple in vivo CAR-T cell products.
  • The partnership combines Nona's proprietary HCAb Harbour Mice® and NonaCarFx™ platforms with Umoja's VivoVec™ platform to create next-generation cell therapies.
  • Under the agreement terms, Nona is eligible for upfront payments, option exercise fees, and milestone payments, while Umoja will handle product development and commercialization.
  • The collaboration builds on an initial partnership established in September 2024 and aims to transform patient access to innovative CAR-T cell therapies.

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