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Clinical Trial News

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.

HARMONi-3

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

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

Vera Therapeutics' Atacicept Achieves 46% Protein Reduction in Phase 3 IgA Nephropathy Trial

Drug Approval
  • Vera Therapeutics' atacicept demonstrated a statistically significant 46% reduction in proteinuria in patients with IgA nephropathy, exceeding the 35% reduction seen in Phase 2 trials.
  • The positive ORIGIN 3 Phase 3 results drove Vera's stock price up over 65% in pre-market trading, with the company planning FDA submission in Q4 2025.
  • Atacicept faces competition from Otsuka Holdings' sibeprenlimab, which has already filed for FDA approval and may reach market 6-9 months earlier than Vera's drug.
  • IgA nephropathy affects up to 50% of patients who may progress to end-stage kidney disease, representing a significant unmet medical need in nephrology.

Viatris Reports Positive Phase 3 Results for MR-142 in Treating Night Vision Disturbances After Refractive Surgery

  • Viatris announced positive top-line results from the Phase 3 LYNX-2 trial of MR-142, achieving its primary endpoint of ≥15-letter gain in mesopic low contrast distance visual acuity compared to placebo.
  • The study demonstrated patient-reported functional benefits in treating chronic night driving impairment in keratorefractive patients, addressing a condition with no current FDA-approved therapies.
  • MR-142 showed no evidence of tachyphylaxis over the 6-week study period and maintained a consistent safety profile with previous trials.
  • The FDA has granted Fast Track designation to MR-142, potentially accelerating development and review for this unmet medical need affecting millions of patients worldwide.

A Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment

NCT06400511Active, Not RecruitingPhase 3
Famy Life Sciences, a Viatris Company
Posted 4/22/2024

Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances

NCT06349759Active, Not RecruitingPhase 3
Ocuphire Pharma, Inc.
Posted 4/1/2024

Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia

NCT06542497Active, Not RecruitingPhase 3
Ocuphire Pharma, Inc.
Posted 8/15/2024

Defence Therapeutics Establishes First U.S. Laboratory in Boston-Cambridge to Advance ADC Technology

  • Defence Therapeutics has opened its first U.S. laboratory at Cambridge Scientific Labs in Watertown, marking the company's initial physical presence in the United States.
  • The new facility will focus on developing and optimizing the company's proprietary Accum® technology for next-generation antibody-drug conjugates (ADCs).
  • The Boston-Cambridge location provides access to top-tier scientific resources and collaboration opportunities within one of the world's foremost biotech clusters.
  • The laboratory serves as a short-term base while Defence Therapeutics evaluates options for a long-term facility in the region.

NICE Recommends Eli Lilly's Mirikizumab for Crohn's Disease Treatment Following Positive Phase 3 Trial Results

Drug ApprovalMonoclonal Antibody
  • The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending mirikizumab (Omvoh) for adults with moderately to severely active Crohn's disease who have not responded to or cannot tolerate previous biological treatments.
  • Phase 3 VIVID-1 trial results demonstrated that 45% of mirikizumab-treated patients achieved clinical remission at one year compared to 20% on placebo, with 38% showing visible intestinal healing versus 9% on placebo.
  • The recommendation comes less than two months after UK regulatory approval, with the treatment targeting interleukin-23p19 protein to reduce gastrointestinal inflammation in patients with this lifelong condition affecting over 200,000 people in the UK.

Relay Therapeutics Reports Sustained Efficacy for RLY-2608 in PI3Kα-Mutated Breast Cancer at ASCO 2025

Precision Medicine
  • Relay Therapeutics presented updated interim data for RLY-2608 plus fulvestrant showing consistent median progression-free survival of 11.0 months in second-line patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer.
  • The first-in-human ReDiscover study enrolled 118 patients, with RLY-2608 demonstrating a favorable tolerability profile including 92% median dose intensity and only 36% experiencing Grade 3 treatment-related adverse events.
  • The company plans to initiate the pivotal Phase 3 ReDiscover-2 trial in mid-2025, marking the first mutant-selective PI3Kα inhibitor to advance to Phase 3 testing.
  • RLY-2608 represents a novel allosteric, pan-mutant, and isoform-selective approach to PI3Kα inhibition, potentially addressing over 300,000 patients annually in the United States.

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

NCT06982521RecruitingPhase 3
Relay Therapeutics, Inc.
Posted 8/26/2025

Terumo Neuro Launches SOFIA Flow 88 Neurovascular Aspiration Catheter in EMEA Markets

  • Terumo Neuro announced the commercial availability of the SOFIA Flow 88 neurovascular aspiration catheter in Europe, Middle East, and Africa markets, expanding their stroke treatment portfolio.
  • The new large-bore catheter features an 0.088-inch inner diameter with proprietary engineering enhancements designed for reliable trackability, proximal stability, and vessel-friendly flexibility.
  • The launch builds on the proven clinical performance of the SOFIA catheter line, which has supported more than 500,000 procedures across 170 countries over the past decade.
  • Clinical evidence from the SOFAST registry and SESAME trial evaluating the SOFIA Plus 6F as a first-line approach demonstrated strong results across speed, efficacy, safety and overall clinical outcomes.

MHRA Approves Serplulimab as First Anti-PD-1 Therapy for Small Cell Lung Cancer in UK

Monoclonal AntibodyDrug ApprovalOncology
  • The UK's Medicines and Healthcare products Regulatory Agency approved serplulimab (Hetronifly) as the first anti-PD-1 monoclonal antibody for treating extensive-stage small cell lung cancer.
  • Clinical trial data showed patients receiving serplulimab with chemotherapy lived an average of 15.4 months compared to 10.9 months with chemotherapy alone.
  • The approval provides a new treatment option for an aggressive cancer type that accounts for 10-15% of lung cancer cases and typically has poor prognosis.
  • Serplulimab is administered intravenously every three weeks in combination with carboplatin and etoposide chemotherapy for first-line treatment.

A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

NCT04063163Unknown StatusPhase 3
Shanghai Henlius Biotech
Posted 9/12/2019

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