Articles & Research from Venn Life Sciences

Proof of Pharmacology, Safety, and Pharmacokinetics of the Novel TRPA1 Antagonist BI 1839100: A Randomized, Placebo-Controlled, Parallel Group, First-In-Human Study in Healthy Male Participants

Publication: CTS – Clinical and Translational Science Co-Authored by: Yanick Botilde, Consultant Clinical Pharmacokinetics and Laure Viguerie, Clinical Consultant Pharmacokinetics Summary BI 1839100 is a selective TRPA1 antagonist being investigated for its potential in treating conditions involving TRPA1 activation, such as pain, skin, and lung...

A phase (Ph) 0/Ia study of brigimadlin concentration in brain tissue and a nonrandomized, open-label, dose escalation study of brigimadlin in combination with radiotherapy (RT) in patients (pts) with newly diagnosed glioblastoma (GBM).

MDM2 inhibits tumor suppressor p53. Brigimadlin, a potent MDM2–p53 antagonist, restores wild-type (wt) p53 function and has shown early efficacy in pts with solid tumors (LoRusso et al Cancer Disc 2023). GBM is an area of unmet need with 5-year survival <10%. In p53 wt...

A phase I dose escalation study of the LRP5 antagonist BI 905681 in patients with advanced and metastatic solid tumors

The Wnt pathway is involved in proliferation and tissue homeostasis. Aberrant activation promotes cancer cell proliferation and survival. Inhibition of the low-density lipoprotein receptor-related protein 5/6 (LRP5/6) coreceptors that regulate Wnt signaling could prevent cancer cell proliferation. BI 905681 is a novel LRP5 antagonist that...

HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors With HER2 Alterations: A Phase Ia Dose-Escalation Study

Human epidermal growth factor receptor 2 (HER2) alterations occur in many solid cancers, including non-small cell lung cancer (NSCLC). Beamion LUNG-1 (ClinicalTrials.gov identifier: NCT04886804) is assessing the safety/efficacy of zongertinib (BI 1810631), a novel HER2-selective tyrosine kinase inhibitor that spares epidermal growth factor receptor, in...

Safety, pharmacokinetics, and pharmacodynamics of AS-1763, a highly selective, orally bioavailable, non-covalent BTK inhibitor, in healthy volunteers (Abstract No. CT137)

Covalent Bruton’s tyrosine kinase (BTK) inhibitors such as ibrutinib are approved for treating patients with B-cell malignancies, but their long-term efficacy is limited due to their toxicity (i.e., on-target and off-target inhibition of kinases) and acquired resistance (i.e., BTK C481 mutation). AS-1763 is a potent,...

A phase0/1a study of BI907828 concentrations in brain tissue and a nonrandomized, open-label, dose escalation study of BI 907828 in combination with radiotherapy in patients with newly diagnosed glioblastoma (GBM) (Abstract# 404648)

Murine double minute 2 (MDM2) directly regulates the stability of the tumor suppressor p53, and dysregulation of this pathway can critically disrupt cellular response to genomic stress and lead to cell death. BI 907828 is a highly potent inhibitor of the MDM2-p53 interface that triggers...

7 Tips for Successful CDMO Selection

Selecting a Contract Development and Manufacturing Organization (CDMO) can be challenging, especially given today’s evolving geopolitical landscape. These seven tips can guide you toward a successful CDMO partnership. 1) Cost-effectiveness Conducting clinical trials in Asia often proves significantly more cost-effective when partnering with a local...

Regulatory Affairs

From the early phases of drug development through marketing authorization, efficient and effective regulatory interactions are essential to your progress and success. These exchanges will not only shape the advancement of your program but also the value of your assets and company.

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