Biotheryx, Inc., a California-based biopharmaceutical company discovering and developing a portfolio of protein degraders with a focus on validated targets in cancer and inflammatory diseases, announced on Wednesday that the first patient has been dosed in its Phase 1 clinical trial evaluating BTX-9341.
BTX-9341, an investigational oral and bifunctional degrader of cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6), is being evaluated in the trial as a monotherapy and in combination with fulvestrant, for patients with advanced and/or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have previously received CDK4/6 inhibitor therapy either in the adjuvant or metastatic setting.
The Phase 1 clinical trial will begin with dose escalation of BTX-9341 as a monotherapy, followed by a combination with fulvestrant and will conclude with dose expansion of BTX-9341 in combination with fulvestrant. The trial will assess safety, tolerability, pharmacokinetic and pharmacodynamic activity of BTX-9341 as a monotherapy and in combination with fulvestrant. Once the recommended Phase 2 dose of the combination has been determined, there will be a formal evaluation of efficacy in an expansion cohort.
Nektar Therapeutics showcases rezpegaldesleukin at EADV 2024
Priovant Therapeutics enrols first patients in brepocitinib CLARITY study
Kine Sciences reports first patient dosed in KINE-101 Phase 1b/2a clinical study
Johnson & Johnson receives approval from FDA for TREMFYA (guselkumab)
Pfizer names new Regional President for Middle East, Russia and Africa
GSK's Nucala approved in Japan for chronic rhinosinusitis with nasal polyps
RedHill Biopharma's Opaganib receives US FDA orphan-drug designation
Lipella launches OLP Patient Registry to advance research
Talphera enrols first subject in NEPHRO CRRT study
Pfizer reports positive results for ABRYSVO RSV vaccine in immunocompromised adults
Cantargia reports positive CAN10 trial data
Quoin Pharmaceuticals to study QRX003 for Peeling Skin Syndrome
Dragonfly Therapeutics names new chief financial officer
Formosa Pharmaceuticals secures exclusive Canadian licensing deal with Apotex
Bio-Techne invests in Spear Bio to boost ultra-sensitive immunoassay development