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Clinical Trial News

Vir Biotechnology Licenses Masked T-Cell Engagers from Sanofi to Expand Oncology Pipeline

  • Vir Biotechnology has finalized an exclusive worldwide license agreement with Sanofi, enhancing its oncology and infectious disease drug discovery.
  • The agreement brings three clinical-stage masked T-cell engagers (TCEs) into Vir's pipeline, targeting HER2, PSMA, and EGFR-expressing tumors.
  • Vir gains exclusive access to Sanofi's PRO-XTEN masking platform, designed to improve the therapeutic index of TCEs by selectively activating them in the tumor microenvironment.
  • Key Sanofi employees with expertise in TCEs and the PRO-XTEN platform will join Vir, bolstering the company's development capabilities.

Nivolumab Plus Chemotherapy Shows QOL Benefits and High Response in Urothelial Cancer Subsets

  • The CheckMate 901 trial showed nivolumab plus chemotherapy maintained quality of life (QOL) compared to chemotherapy alone in urothelial carcinoma patients.
  • A subset analysis of CheckMate 901 revealed a high complete response rate (63%) in patients with lymph node-only metastatic urothelial cancer treated with nivolumab plus chemotherapy.
  • Early data on sacituzumab govitecan plus ipilimumab and nivolumab showed promising response rates but was halted due to unexpected immune myocarditis.
  • The combination of antibody-drug conjugates and immune checkpoint inhibitors remains a promising strategy but requires careful management of toxicities.

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer

NCT03036098Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 3/24/2017

Combination of Ipi/Nivo Plus Sacituzumab Govitecan in Metastatic Cisplatin Ineligible Urothelial Carcinoma Patients

NCT04863885Active, Not RecruitingPhase 1
H. Lee Moffitt Cancer Center and Research Institute
Posted 4/30/2021

Pembrolizumab Plus Chemoradiotherapy Improves PFS in East Asian Cervical Cancer Patients

  • In East Asian patients with high-risk, locally advanced cervical cancer, pembrolizumab plus concurrent chemoradiotherapy (CCRT) significantly improved progression-free survival (PFS).
  • At 24 months, the PFS rate in the pembrolizumab plus CCRT arm was 77.6% compared to 59.8% in the placebo plus CCRT arm, demonstrating a substantial difference.
  • The safety profile of pembrolizumab plus CCRT in the East Asian subgroup was manageable and consistent with the overall study population, supporting its potential use.
  • These findings suggest pembrolizumab plus CCRT could be a new treatment option for this patient population, particularly relevant given the high incidence of cervical cancer in East Asia.

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)

NCT04221945Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/12/2020

FDA Advisory Committee to Review Elamipretide for Barth Syndrome

  • The FDA's Cardiovascular and Renal Drugs Advisory Committee will review elamipretide for Barth syndrome on October 10, 2024.
  • Elamipretide, a first-in-class mitochondria-targeted therapeutic, is under review as a potential treatment for this ultra-rare genetic condition.
  • The FDA has granted priority review to the NDA for elamipretide, with a PDUFA action date set for January 29, 2025.
  • Barth syndrome affects approximately 150 individuals in the U.S. and is associated with reduced life expectancy, with no current FDA-approved therapies.

BAY 2927088 Demonstrates Promising Activity in HER2-Mutant NSCLC

  • BAY 2927088, a novel oral TKI, showed a 72.1% objective response rate in pretreated HER2-mutant NSCLC patients in the SOHO-01 trial.
  • The disease control rate with BAY 2927088 was 83.7%, with a median duration of response of 8.7 months and progression-free survival of 7.5 months.
  • A subgroup analysis revealed a 90% objective response rate in patients with YVMA insertion mutations, a common and difficult-to-treat HER2 mutation.
  • The most common treatment-related adverse event was diarrhea, with a low discontinuation rate of 6.8% observed in the study cohort.

First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)

NCT05099172Active, Not RecruitingPhase 1
Bayer
Posted 10/25/2021

A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

NCT06452277RecruitingPhase 3
Bayer
Posted 8/28/2024

Servier and Clariness Collaborate on Phase II Trial for Sjögren's Syndrome Drug

  • Servier and Clariness are collaborating on a Phase II trial to develop a novel biological therapy for primary Sjögren's syndrome, an autoimmune disease affecting salivary and lacrimal glands.
  • The investigational drug uses an antibody to suppress inflammatory processes associated with Sjögren's syndrome, addressing the unmet need for targeted treatments.
  • Clariness is supporting Servier's digital patient recruitment efforts in Germany through the ClinLife portal to accelerate enrollment in the Phase II study.
  • Current treatments for Sjögren's syndrome primarily focus on symptomatic relief, highlighting the potential impact of a targeted therapy under development.

Semaglutide Linked to Reduced COVID-19 and Cardiovascular Deaths in SELECT Trial

  • Semaglutide significantly reduced overall mortality by 19% in overweight or obese patients with heart disease compared to placebo.
  • Cardiovascular deaths were 15% lower in the semaglutide group, highlighting the drug's potential cardioprotective effects.
  • The study surprisingly found a 23% reduction in deaths from non-cardiovascular causes, including COVID-19-related deaths, with semaglutide.
  • Further research is needed to understand the mechanisms behind semaglutide's benefits beyond weight loss, especially regarding infection-related mortality.

Agenus Faces Class Action Lawsuit Over Botensilimab and Balstilimab Claims

  • Agenus Inc. is facing a class action lawsuit on behalf of investors who purchased securities between January 23, 2023, and July 17, 2024.
  • The lawsuit alleges that Agenus made misleading statements about the effectiveness of botensilimab and balstilimab combination therapy.
  • The FDA's feedback against using trial results for accelerated approval of the combination therapy in colorectal cancer led to a significant stock drop.
  • Investors have until November 5, 2024, to file a lead plaintiff motion in the class action lawsuit.

Olezarsen Shows Promise in Reducing High Triglycerides in New Study

  • A recent study reveals that olezarsen, an investigational drug, significantly reduces triglyceride levels by up to 50% in patients with hypertriglyceridemia.
  • The research indicates that olezarsen not only lowers triglycerides but also reduces other key indicators of cardiovascular risk, offering a potential new treatment avenue.
  • Current treatment options for high triglycerides are limited, making olezarsen a promising candidate for addressing this unmet medical need and preventing severe complications.
  • Olezarsen's efficacy could provide a substantial improvement over existing medications, which have a limited impact on lowering triglyceride levels effectively.

Psilera's PSIL-006 Shows Promise in Treating Frontotemporal Dementia Without Hallucinogenic Effects

  • Psilera's PSIL-006, a psilocybin-based drug, has demonstrated a strong safety profile in preclinical studies, marking a key milestone in dementia treatment.
  • The drug is designed to avoid inducing hallucinogenic effects, potentially enabling more reliable double-blind trials and safer administration for patients.
  • PSIL-006 has shown promising improvements in memory, sleep, and learning in models mimicking frontotemporal dementia (FTD), which currently lacks FDA-approved treatments.
  • The development of non-psychedelic therapies like PSIL-006 could significantly impact mental health and dementia care, offering more accessible treatment options.

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