With completion of a $120 million series B financing, Affinivax Inc. said it's poised to advance several new vaccine candidates for hospital-associated infections into the clinic even as its partner, Astellas Pharma Inc., carries its lead pneumococcal vaccine candidate, ASP-3772, through an upcoming phase III program.
LONDON – A veteran of the European vaccines industry has brought together three companies in three countries, in what is described as an ultra-fast-track COVID-19 vaccine development program. From a standing start less than three months ago, the three biotechs, Reithera Srl in Rome, Leukocare AG in Munich, Germany, and Univercells SA in Brussels, Belgium, have advanced to GMP manufacturing, with first-in-human studies due to start in June.
BEIJING – Nanobody startup Sysvax Inc., with its R&D center in Beijing and manufacturing facilities in Zhongshan, is developing a recombinant protein vaccine and a nanobody therapeutic for COVID-19, while trying to extend the half-life of potential COVID-19 treatments with its expertise in this smallest possible antibody format.
Looking ahead to COVID-19 strategies, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said vaccine studies might be done not in clinics but in the streets. “By definition, we’re probably not going to be able to vaccinate everyone simultaneously,” he noted.
LONDON – Researchers at the Jenner Institute in Oxford have given an inside view of how they are accelerating clinical development of a COVID-19 vaccine and at the same time putting in place commercial manufacturing for when phase III efficacy data are available, expected in August or September.
“Vaccines, obviously, are the ultimate solution for pandemics,” Rino Rappuoli told BioWorld. They have, he added, “already eliminated a lot of pandemic threats – smallpox, influenza, poliomyelitis.”
DUBLIN – Sanofi SA and Glaxosmithkline plc are lending their considerable weight to the urgent global effort to develop a vaccine for COVID-19 by teaming up to develop an adjuvanted recombinant subunit vaccine that will employ technologies from each company. Paris-based Sanofi is contributing its recombinant spike protein antigen and its baculovirus expression system, which is also the basis of its U.S.-licensed influenza vaccine Flublok. London-based GSK is contributing its pandemic adjuvant technology.
LONDON – Companies represented in the expert group brought together by the World Health Organization (WHO) to work on the development of COVID-19 vaccines have signed a pledge to strengthen collaboration and sharing of data.
“Vaccines, obviously, are the ultimate solution for pandemics,” Rino Rappuoli told BioWorld. They have, he added, “already eliminated a lot of pandemic threats – smallpox, influenza, poliomyelitis.” And the road to normalcy from the current pandemic, or any pandemic, is likely to be open only once there is a vaccine.
DUBLIN – The EMA has activated a COVID-19 task force to coordinate and accelerate the European regulatory response to the pandemic. The task force is intended to take a lead role in shaping the development, authorization and post-approval surveillance of drugs and vaccines for treating or preventing COVID-19 infection.