Four Triangle pharmaceutical companies have shared in good news in recent days.
Here’s a recap:
Durham clinical stage company Argos Therapeutics closed a $29.8 million second tranche of its private placement funding, two days after the company was added to the Russell 2000 index. Argos also got word in mid-June that an independent data monitoring committee had given the company the go-ahead to continue its phase three clinical trial on its lead therapy for metastatic renal cell carcinoma. That signals the treatment platform is not causing serious side effects in volunteers receiving it.
Durham’s BioCryst Pharmaceuticals took another step closer to collecting on a $39.5 million contract with the National Institute of Allergy and Infectious Diseases (NIAID) to develop its BCX4430 as a treatment for hemorrhagic fever viral infections such as Ebola.
The most recent tranche of $5.5 million brought the company’s total on the contract to $35.4 million.
BioCryst is also testing BCX4430 as a treatment for filoviruses, under a potential $36.2 million contract with the Biomedical Advanced Research and Development Authority. The company says nonclinical studies have shown “survival benefits” from BCX4430 against Ebola, Marburg, Yellow Fever and Zika viruses.
Then another Chapel Hill clinical-stage developer of infection-fighters, Cempra, caught the “good-news” bug when the U.S. Food and Drug Administration accepted for review two formulations of its lead compound. The New Drug Applications for its antibacterial Solithera, both intravenous and oral, were accepted by the FDA for treating community-acquired bacterial pneumonia.
“The FDA’s acceptance of our two NDA filings brings us one step closer to the potential approval by the end of 2016 and U.S. commercial launch of Solithera,” said Prabhavathi Fernandes, Ph.D., president and CEO of Cempra.
“If approved, Solithera would be a significant milestone in the treatment of CABP, as bacterial resistance to older treatments has continued to rise. The FDA will convene a meeting of the Antimicrobial Drugs Advisory Committee for Solithera prior to its action on the applications.”
The FDA move comes on the heels of Cempra’s successful filing of a marketing authorization application with the European Medicines Agency for the same drug in the same formulations.
Meanwhile, another young oncology player, Chapel Hill’s G1 Therapeutics, closed on the final $3 million in a $50 million funding round.
G1, spun out of the University of North Carolina at Chapel Hill, was bootstrapped with $500,000 in loans from the North Carolina Biotechnology Center in 2011 and 2012.
(C) N.C. Biotechnology Center