Lumicell Inc. sees a brighter future now that it has secured U.S. FDA approval for both its new drug application for Lumisight (pegulicianine) optical imaging agent and premarket approval for the Lumicell direct visualization system . The company markets the two together as the Lumisystem to detect and resect residual breast cancer. Newton, Mass.-based Lumicell expects the Lumisystem will be available in the fourth quarter of 2024, Lumicell President and Chief Operating Officer Howard Hechler told BioWorld.
Researchers from Astrazeneca plc reported preclinical data for AZD-8421, a selective cyclin-dependent kinase 2 (CDK2) inhibitor, currently being evaluated in early-phase clinical trials as a treatment for solid tumors.
Icecure Medical Ltd. submitted data to the U.S. FDA seeking de novo marketing authorization for its Prosense system to treat patients with early stage T1 invasive breast cancer in combination with adjuvant hormone therapy. Prosense is a minimally invasive cryoablation technology that freezes and destroys tumors, both malignant and benign.
Zinc transporter ZIP6, also known as LIV-1, is a transmembrane protein that is an interesting target for antibody-drug conjugate (ADC) therapy because of its higher expression in tumors and almost no expression in normal tissues.
Onkure Inc. has described phosphatidylinositol 3-kinase (PI3K) inhibitors reported to be useful for the treatment of cancer, congenital lipomatous overgrowth, vascular malformations, epidermal naevi and skeletal abnormalities and scoliosis (CLOVES syndrome), and PIK3CA-related overgrowth spectrum (PROS).
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. has described Toll-like receptor 7 (TLR7) and/or TLR8 agonists and their immunostimulatory antibody conjugates (ISACs) consisting of antibodies covalently linked to TLR7 and/or TLR8 agonists through cleavable or uncleavable linkers.
Chia Tai Tianqing Pharmaceutical Group Co. Ltd. has identified ubiquitin carboxyl-terminal hydrolase 1 (USP1) inhibitors reported to be useful for the treatment of cancer.
Pfizer Inc. has presented preclinical data on its first-in-class, selective cyclin-dependent kinase 4 (CDK4) inhibitor compound, PF-07220060, that has shown 20-fold and 4-fold increased selectivity for CDK4 vs. CDK6 compared to palbociclib and abemaciclib/ribociclib, respectively.
