Earlier this month, an update on phase I/IIa data rolled out from Rockville, Md.-based Regenxbio Inc. with RGX-314 for age-related wet macular degeneration (AMD). The company has a pivotal program in subretinal delivery of the compound set to start by the end of this year, and questions about routes of administration – always an issue in AMD – continue to simmer.
HONG KONG – Following FDA approval of its IND, Israel-based Kahr Medical Ltd. is set to start a phase I/II trial of lead product DSP-107, a second-generation CD47- and 41BB-targeting compound. The move puts Kahr among a number of companies working on drugs against checkpoint molecule CD47.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Algernon, Azurrx, Bio-Path, Cerecor, Debiopharm, Gyroscope, Novo Nordisk, Treadwell, Viela.
HONG KONG – Singapore-based Tessa Therapeutics Pte. Ltd. released the results of two investigator-initiated phase I/II trials that found its autologous CD30 CAR T-cell therapy TT-11 showed a high rate of durable complete responses and a favorable safety profile in patients with relapsed/refractory Hodgkin lymphoma.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Azurrx, Blade, Boehringer, Botanix, Eloxx, Epirium, Nektar, Sapience, Vaccibody, VBL.
HONG KONG – Osaka, Japan-based Ono Pharmaceutical Co. Ltd. has obtained positive top-line data in its phase III study of a combination of Opdivo (nivolumab, Bristol Myers Squibb Co.) and bevacizumab in lung cancer patients.
Israeli startup Bluewind Medical Ltd. has begun enrolling patients at U.S. sites in a pivotal trial of its Renova Istim implantable tibial neuromodulation system for the treatment of overactive bladder.
An interim analysis from Fulcrum Therapeutics Inc.’s phase II study of losmapimod for treating facioscapulohumeral muscular dystrophy (FSHD) produced data that pleased the CEO and displeased investors.
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