Glioblastoma drug to enter clinic, EHA presentations, clinical hold lifted, and more..
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CLINICAL TRIAL NEWS
Praxis Precision Medicines
Announced the outcomes from a recent end-of-Phase 2 meeting with the FDA regarding plans to advance ulixacaltamide into Phase 3 for essential tremor (ET).
VBI Vaccines
Announced that an abstract highlighting T-cell responses and durability of immune responses following vaccination with VBI’s 3-antigen hepatitis B (HBV) vaccine, PreHevbrio™, has been accepted for poster presentation at The International Liver Congress™ 2023 (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), taking place June 21-24.
Enanta Pharmaceuticals
Announced that preclinical data from Enanta’s out-licensing portfolio has been accepted for a poster presentation at the European Association for the Study of the Liver (EASL) International Liver Congress 2023. In the poster, Enanta’s HSD17B13 inhibitors were evaluated in a mouse model of autoimmune hepatitis for anti-inflammatory and hepatoprotective effects.
TransCode Therapeutics
Reports positive preclinical results with its lead candidate, TTX-MC138, in Glioblastoma. Study provides support for further evaluation of TransCode’s lead therapeutic candidate, TTX-MC138, in clinical trials.
ImmunoGen
Announced updated data from an interim analysis of the Phase 2 CADENZA trial of pivekimab sunirine (pivekimab) in patients with frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN). The data will be presented in an oral session on Sunday, June 11 at the European Hematology Association (EHA) 2023 Congress.
REGULATORY NEWS
CRISPR Therapeutics
Announced that the FDA has accepted the Biologics License Applications (BLAs) for the investigational treatment exagamglogene autotemcel (exa-cel) for severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The PDUFA target date is 12/8/23.
Innate Pharma
Announced the FDA has granted Fast Track Designation for SAR’579 / IPH6101 for the treatment of hematological malignancies. SAR’579, platform lead asset, is a trifunctional anti-CD123 NKp46×CD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi, now under development by partner Sanofi.
Rocket Pharmaceuticals
Announced that the FDA has granted Fast Track and Orphan Drug designations to RP-A601, the Company’s gene therapy candidate for the treatment of plakophilin-2 related arrhythmogenic cardiomyopathy (PKP2-ACM).RP-A601 is Rocket’s adeno-associated virus (AAV.rh74)-based gene therapy for PKP2-ACM, an inherited heart disease.
Foghorn Therapeutics
Announced that the FDA has lifted the clinical hold on the Phase 1 monotherapy dose escalation study of FHD-286 in acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). Foghorn plans to commence a Phase 1 study of FHD-286 in combination with decitabine or cytarabine in relapsed and/or refractory AML patients in the third quarter of 2023.
COLLABORATION NEWS
NRx Pharmaceuticals
NRx Pharmaceuticals, Lotus Pharmaceuticals, and Alvogen to collaborate on the further development and commercialization of NRX-101 for suicidal treatment-resistant bipolar depression (S-TRBD) for global markets.
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