Gene therapy specialist Uniqure N.V. said Tuesday that, with confidence inspired by new 52-week data on its investigational hemophilia B therapy, etranacogene dezaparvovec, it plans to submit a BLA for the program with partner CSL Behring LLC in first quarter of 2022. Uniqure meanwhile has moved to acquire Corlieve Therapeutics SAS and its lead program to treat temporal lobe epilepsy, the most common form of focal epilepsy. The acquisition, worth up to €250 million (US$297.3 million) for Corlieve, includes €46.3 million cash up front.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, Anavex, Cytodyn, Cytomx, Innovent, Medicinova, Moleculin, Oyster Point, Redhill, Spruce, Tarsus, Theravance.
Shares of Vir Biotechnology Inc. (NASDAQ:VIR) and Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) each rose modestly on June 21 as both delivered positive updates on their COVID-19 programs. Vir and its partner, Glaxosmithkline plc, shared final clinical data confirming the efficacy of their monoclonal antibody therapy, sotrovimab, following an FDA emergency use authorization for the therapy last month. Cumberland announced five case studies in which its antibiotic, Vibativ (telavancin), successfully treated hospital-acquired and ventilator-associated bacterial pneumonia in COVID-19 patients.
Jacobio Pharmaceuticals Group Co. Ltd. has received a milestone payment of $20 million from Abbvie Inc. for dosing the first two patients in the U.S. for a global phase I/IIa study of SHP2 inhibitor JAB-3312 in combination with PD-1 antibody pembrolizumab and MEK inhibitor binimetinib, taking another step forward in the global SHP2 race.
Tarsus Pharmaceuticals Inc. announced results from a pivotal trial of its therapy for Demodex blepharitis, which could lead to an FDA filing to treat the common eye disease for which there are no FDA-approved medications.
Immvira Group Co. presented positive phase I data for MVR-T3011 as an intratumoral administration (MVR-T3011 IT) at the 2021 American Society of Clinical Oncology annual meeting this month, drawing attention to oncolytic viruses developed by Chinese scientists.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biogen, Curevac, Harbour, Kancera, Pfizer, Qpex, Satsuma, Targovax, Tarsus, Viking.
Artios Pharma Ltd. plans to begin the first clinical trials of a POLQ inhibitor class cancer drug later this year. There are a handful of companies working on POLQ inhibitor drugs, the name of the gene that encodes the enzyme DNA polymerase theta, but it looks like Artios has taken a head start following the publication of the supportive study in Nature Communications.
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