It’s back to the drawing broad for Vertex Pharmaceuticals Inc. and its efforts to develop treatments for the rare disease alpha-1-antritrypsin deficiency (AATD), after its VX-864 produced disappointing results in a phase II trial.
New phase III data on Novan Inc.'s molluscum contagiosum candidate showed it cleared all lesions associated with the highly contagious viral skin infection in 32.4% of trial participants who received it vs. 19.7% provided a placebo. Paired with what company President and CEO Paula Brown Stafford called "strong safety," the result gives the company's team confidence as it moves toward an NDA submission for the topical antiviral, SB-206, she said.
Navigation Sciences Inc. has enrolled the initial patient in the first-in-human clinical feasibility trial of the Navisci system designed for surgeons to be able to remove probable early-stage lung tumors in minimally invasive surgery, integrating augmented reality (AR) and advanced software with surgical instruments.
Bristol-Myers Squibb Co. has released top-line phase III results from its CAR T therapy Breyanzi (lisocabtagene maraleucel) that could support its use earlier in patients with refractory large B-cell lymphoma, outperforming standard stem cell transplant therapy.
Phase II data from Iovance Biotherapeutics Inc. in advanced melanoma at the recent meeting of the American Society of Clinical Oncology turned up an important relationship between previous anti-PD-1 therapy exposure and the durability of treatment response. Findings added weight to the idea that tumor-infiltrating lymphocytes (TILs) should be deployed earlier in therapy.
With Pharmabcine Inc.’s anti-angiogenic antibody TTAC-0001 (olinvacimab) already in testing against recurrent glioblastoma multiforme (GBM) and metastatic triple negative breast cancer, CEO Jin-San Yoo is now giving serious thought to starting trials to test it in children with brain tumors. Plans to begin four additional trials between the end of 2021 and the beginning of 2022 are also underway.
Byondis BV is gearing up for a U.S. filing of an antibody-drug conjugate (ADCs) in advanced HER2-positive breast cancer, but CEO Marco Timmers has grand plans to partner up with big pharma and expand into other diseases.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ananda, Asklepios, Avadel, Bluerock, Chinook, Effector, Icosavax, Incarda, India Globalization, Nanology, Nascent, Noveome, Noxxon, Synaptogenix, Virios.