Daily Top News – June 24, 2020

June 24, 2020

lacutamab (IPH4102) / Innate
U.S. FOOD AND DRUG ADMINISTRATION LIFTS PARTIAL CLINICAL HOLD ON LACUTAMAB TELLOMAK TRIAL IN ADVANCED T-CELL LYMPHOMAS (Innate Pharma Press Release) – Jun 24, 2020 – “Innate Pharma SA…announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on the lacutamab TELLOMAK Phase II clinical trial, evaluating the efficacy and safety of lacutamab (formerly IPH4102) in patients with advanced T-cell lymphomas…The Company can now resume recruitment of new patients in the US with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) who have received at least two prior systemic therapies….The Company expects to start sharing data from the TELLOMAK trial for mycosis fungoides in 2021 and Sézary syndrome in 2022.”

 

Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi; Coronavirus Vaccine / Sanofi, GSK; Coronavirus Vaccine / Sanofi, Translate Bio
Sanofi’s virtual R&D Day event to highlight capabilities, platforms, and expertise in disease pathways to deliver potentially transformative treatments to patients (GlobeNewswire) – Jun 24, 2020 – “Sanofi transforms R&D to drive productivity….This includes an integrated development organization…resulted in rapid initiation of clinical trials such as the studies evaluating Kevzara® (sarilumab) as a potential COVID-19 therapeutic….A recombinant protein-based​ vaccine approach (baculovirus), in collaboration with GSK….Sanofi expects a Phase 1/2 study to start in September and at the earliest, full approval by the first half of 2021….A messenger RNA (mRNA) candidate in collaboration with Translate Bio….Sanofi expects a Phase 1 study to start by the end of the year, and, if data is positive, an approval at the earliest in the second half of 2021​.”

 

Nidlegy (darleukin/fibromun) / Philogen
Philogen Received Combination Pack Approval for Nidlegy (PRNewswire) – Jun 24, 2020 – “EMA’s CHMP expressed a favorable opinion to the request of a combination pack for the to-be-marketed pharmaceutical form of NidlegyTM, a combination of the active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF). NidlegyTM is being developed as a neoadjuvant intralesional treatment for resectable Stage III melanoma patients and in locally advanced, not metastatic nonmelanoma skin cancers. NidlegyTM combination pack has now received confirmation of eligibility to the centralized procedure for submission of an application for a Union Marketing Authorisation under Article 3(1) – Indent 1 – Biotech medicinal product of Regulation (EC) No 726/2004.”

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