Feb. 11 Product Development Quick Takes: J&J gets BARDA funding for COVID-19 vaccine; plus Novartis-Incyte, LogicBio and Elicio-Natera
BARDA to support Janssen COVID-19 vaccine R&D
Johnson & Johnson (NYSE:JNJ) announced a collaboration with HHS that will speed development of a clinical COVID-19 (2019-nCoV) vaccine by its Janssen Pharmaceutical unit. The Biomedical Advanced Research and Development Authority (BARDA) and Janssen will share R&D costs to bring the program -- which will use the AdVac and PER.C6 technologies Janssen applied to its Ebola vaccine program -- into Phase I testing, and Janssen will scale up associated production and manufacturing capacities in parallel. The agency has the option to provide additional funding for a “promising candidate.”
Priority Review for capmatinib for NSCLC
FDA has accepted and granted Priority Review to an NDA for non-small cell lung cancer candidate capmatinib from Incyte (NASDAQ:INCY) and Novartis AG (NYSE:NVS; SIX:NOVN). Capmatinib is in line to become the first approved therapy to specifically target advanced lung cancer with a c-MET exon 14-skipping mutation, a type of lung cancer with a particularly poor prognosis, according to Incyte.
FDA hold sinks LogicBio shares
LogicBio Therapeutics Inc. (NASDAQ:LOGC) fell $3.34 (32%) to $7.11 Tuesday after FDA placed a clinical hold on its IND for a Phase I/II trial of LB-001 to treat methylmalonic acidemia (MMA) pending resolution of undisclosed clinical and non-clinical questions.
Elicio, Natera partner on blood test for pancreatic cancer vaccine study
Elicio Therapeutics will use Signatera, a circulating tumor DNA test from Natera Inc. (NASDAQ:NTRA), to select eligible patients for a Phase I/II of ELI-002 in patients with pancreatic ductal adenocarcinoma. Signatera will also be used to monitor and assess the percentage of patients in the trial who achieve clearance of molecular residual disease. Elicio plans to submit an IND for the K-Ras-driven cancer vaccine in 1H20.
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c-MET (MET; HGFR) - c-Met receptor tyrosine kinase