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Clinical Trial News

Pfizer and BioNTech Submit EMA Application for Updated COVID-19 Vaccine Targeting LP.8.1 Strain for 2025-2026 Season

  • Pfizer and BioNTech have submitted a regulatory application to the European Medicines Agency for approval of their updated COMIRNATY COVID-19 vaccine targeting the LP.8.1 strain for the 2025-2026 season.
  • The submission follows the EMA's Emergency Task Force recommendation to update COVID-19 vaccine composition to target the LP.8.1 strain for the upcoming season.
  • The companies have not disclosed information regarding target age groups or whether clinical studies will be conducted for the updated vaccine formulation.
  • COMIRNATY currently holds standard marketing authorization in the EU for individuals from 6 months of age, with multiple adapted vaccines already approved for various SARS-CoV-2 variants.

A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Adults, Including Those at Higher Risk of Severe COVID-19

NCT07069309RecruitingNot Applicable
BioNTech SE
Posted 7/8/2025

Ibudilast Fails to Show Efficacy for Alcohol Use Disorder in Phase 2 Trial, But Shows Promise for Women

  • A UCLA clinical trial found that ibudilast, an asthma drug approved in Japan, was no more effective than placebo for treating alcohol use disorder in most patients.
  • Women taking ibudilast showed significantly greater reductions in drinks per drinking day compared to placebo, suggesting potential gender-specific therapeutic benefits.
  • Participants with higher baseline depression levels responded better to placebo than ibudilast, indicating that mood disorders may influence treatment outcomes.
  • The study highlights the complex role of inflammation and immune responses in alcohol use disorder treatment, supporting continued research into personalized approaches.

Ibudilast for the Treatment of Alcohol Use Disorder

NCT03594435CompletedPhase 2
University of California, Los Angeles
Posted 10/1/2018

Vistagen Advances Fasedienol Phase 3 Program for Social Anxiety Disorder with Q4 2025 Data Readout

  • Vistagen's PALISADE-3 Phase 3 trial evaluating fasedienol nasal spray for acute treatment of social anxiety disorder remains on track for topline data in Q4 2025.
  • The investigational pherine nasal spray represents a potential first-in-class treatment with a novel mechanism targeting olfactory-amygdala neural circuits without systemic absorption.
  • Social anxiety disorder affects over 30 million adults in the U.S., with a mean duration of about 20 years and significant impact on daily functioning and quality of life.
  • Successful results from either PALISADE-3 or PALISADE-4, combined with positive PALISADE-2 data, could support a New Drug Application submission to the FDA.

Breakthrough Immunotherapy Response in Rare Lung Adenosquamous Carcinoma with Multiple Driver Mutations

Precision Medicine
  • A 63-year-old patient with advanced lung adenosquamous carcinoma harboring concurrent KRAS G12C, BRAF, PIK3CA, and FLT1 mutations achieved complete remission with tislelizumab plus chemotherapy, maintaining progression-free survival exceeding 46.5 months.
  • This represents the first documented case of such exceptional response in molecularly complex adenosquamous carcinoma, challenging conventional assumptions about multiple driver mutations and immune resistance.
  • The patient's tumor demonstrated PD-L1 positivity (18.11%) and low tumor mutational burden (3.7 muts/Mb), suggesting that biomarker-guided immunotherapy may overcome therapeutic limitations in this aggressive malignancy.
  • Literature review reveals that adenosquamous carcinoma patients typically achieve median progression-free survival of 5.7-14 months with conventional therapy, making this 46.5-month response unprecedented in the field.

Ferroptosis Emerges as Novel Therapeutic Target in Cancer Treatment and Immunotherapy

  • Ferroptosis, a novel form of programmed cell death discovered in 2012, is characterized by iron-dependent lipid peroxidation and shows significant potential as a cancer therapeutic target, particularly in tumors with RAS mutations.
  • Key regulatory pathways include the GPX4 pathway, FSP1-CoQ10 pathway, and complex interactions between iron metabolism, lipid metabolism, and amino acid metabolism that control ferroptosis sensitivity in cancer cells.
  • Ferroptosis demonstrates promising synergistic effects with cancer immunotherapy by enhancing tumor immunogenicity and promoting immune cell infiltration, with several drugs already showing dual ferroptosis-inducing and immunomodulatory properties.
  • Novel nanomedicines and combination therapies targeting ferroptosis pathways are emerging as innovative treatment strategies, though clinical translation remains challenging and requires further investigation.

ImmunAbs Receives FDA Clearance for Phase 2 Trial of IM-101 Complement Inhibitor in Myasthenia Gravis

Monoclonal AntibodyFDA ApprovalRare Disease
  • ImmunAbs Inc. announced FDA clearance of its IND application to initiate a Phase 2 clinical trial evaluating IM-101, a novel complement C5 inhibitor, for treating Myasthenia Gravis.
  • The multicenter, randomized, double-blind, placebo-controlled study will enroll up to 90 patients to assess monthly IM-101 dosing effectiveness and safety.
  • IM-101 demonstrated excellent safety profile in Phase 1 trials with no dose-limiting toxicity and superior efficacy in complement inhibition compared to existing treatments.
  • The company believes comprehensive inhibition of both classical and alternative complement pathways is essential for achieving deeper therapeutic responses in MG patients.

ALNEO Trial Demonstrates Promising Perioperative Alectinib Activity in Stage III ALK-Positive NSCLC

Targeted Therapy
  • The phase II ALNEO trial achieved its primary endpoint, demonstrating a 46% major pathological response rate with neoadjuvant alectinib in 33 patients with potentially resectable stage III ALK-positive NSCLC.
  • Among 28 patients who underwent surgery, 86% achieved R0 resection with no residual microscopic tumor, and 48% experienced nodal downstaging following neoadjuvant treatment.
  • This represents the first prospective trial evaluating targeted therapy in the perioperative setting for locally advanced ALK-positive NSCLC, offering a potential alternative to cytotoxic chemotherapy.
  • Treatment was well-tolerated with only 9% of patients experiencing grade 3 or higher adverse events during neoadjuvant therapy and no grade 4/5 treatment-related serious adverse events observed.

Alectinib in Neo-adjuvant Treatment of Stage III NSCLC

NCT05015010Active, Not RecruitingPhase 2
Gruppo Oncologico Italiano di Ricerca Clinica
Posted 5/20/2021

BeOne Medicines Reports Promising Early Data for Two Novel Breast Cancer Therapies at ASCO 2025

Oncology
  • BeOne Medicines presented first clinical data for two investigational breast cancer therapies at ASCO 2025, marking a pivotal milestone for the company's emerging oncology pipeline.
  • The B7-H4-targeting ADC BG-C9074 demonstrated a 16.1% confirmed overall response rate and 73.2% disease control rate in heavily pretreated patients with advanced solid tumors.
  • The CDK2 inhibitor BG-68501 showed manageable safety profiles in HR+/HER2- breast cancer patients with prior CDK4/6 inhibitor exposure, supporting continued development.
  • Both therapies exhibited favorable tolerability with no treatment-related deaths, positioning them as potential next-line options for addressing critical gaps in breast cancer treatment.

A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors

NCT06257264RecruitingPhase 1
BeiGene
Posted 3/11/2024

Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

NCT06233942RecruitingPhase 1
BeiGene
Posted 4/12/2024

KalVista's Sebetralstat Halts Hereditary Angioedema Attacks in Median 19.8 Minutes Across Clinical Trials

Rare Disease
  • KalVista Pharmaceuticals reported that sebetralstat, an investigational oral plasma kallikrein inhibitor, halted hereditary angioedema attack progression in a median time of 19.8 minutes across both KONFIDENT and KONFIDENT-S trials.
  • The drug demonstrated rapid efficacy in treating severe mucosal attacks, with patients achieving symptom relief in 1.3 hours for both abdominal and laryngeal attacks, and 96% of attacks resolved without requiring additional doses.
  • Clinical data showed sebetralstat effectively treated 76 severe or very severe HAE attacks that had progressed after delayed treatment, delivering symptom relief in a median of 1.36 hours.
  • The oral formulation represents a potential breakthrough as the first oral on-demand HAE treatment, with regulatory review ongoing and a FDA PDUFA goal date of June 17, 2025.

Bristol Myers Squibb Partners with BioNTech in $11.1 Billion Deal for Dual-Target Cancer Immunotherapy

Oncology
  • Bristol Myers Squibb will pay BioNTech $1.5 billion upfront plus $2 billion in anniversary payments through 2028 for a 50% partnership in BNT327, a bispecific antibody targeting both PD-L1 and VEGF proteins.
  • BNT327 represents a new class of cancer immunotherapies that simultaneously targets two of the most important cancer drug targets, following the success of ivonescimab which outperformed Keytruda in Phase 3 lung cancer trials.
  • The experimental drug is currently in Phase 3 trials for both small cell and non-small cell lung cancer, with a third late-stage trial in triple-negative breast cancer planned to start by year-end.
  • This partnership positions Bristol Myers to compete in the emerging bispecific antibody race alongside Pfizer, Merck, Akeso, and Summit Therapeutics in what could become a foundational immuno-oncology treatment approach.

Safety and Effectiveness of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

NCT06712355Active, Not RecruitingPhase 3
BioNTech SE
Posted 2/3/2025

HARMONi-3

2024-513087-26-00RecruitingPhase 3
Summit Therapeutics Inc.

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