Johnson & Johnson has selected a lead COVID-19 vaccine candidate from the constructs it has been working on since January. Moreover, the company has expanded its existing partnership with its Janssen division and the Biomedical Advanced Research and Development Authority (BARDA). The company is also rapidly scaling up its manufacturing capacity with the aim of providing global supply of more than one billion doses of a vaccine. Johnson and Johnson expected to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorisation in early 2021. Find the right vaccine candidate Johnson & Johnson began efforts in January 2020, as soon as the novel coronavirus became available, to research potential vaccine candidates. Research teams at Janssen, in collaboration with Beth Israel Deaconess Medical Centre, part of Harvard Medical School, constructed and tested multiple vaccine candidates using the Janssen AdVac technology. Through collaborations with scientists at multiple academic institutions, the vaccine constructs were then tested to identify those with the most promise in producing an immune response in preclinical testing. Based on this work, Johnson & Johnson has identified a led COVID-19 vaccine candidate (with two back-ups), which will progress into the first manufacturing steps. Under an accelerated timeline, the Company is aiming to initiate a Phase 1 clinical study in September 2020, with clinical data on safety and efficacy expected to be available by the end of the year. This could allow vaccine availability for emergency use in early 2021. For comparison, the typical vaccine development process involves a number of different research stages, spanning 5 to 7 years, before a candidate is even considered for approval.
Jonathan Rigby has been appointed CEO of Immune Regulation, a London-based clinical stage biotech focussed on for inflammatory and immunological diseases. Based in the US, Mr Rigby, who also joins the Board of Directors, brings decades of pharma, biotech and drug delivery technology experience. In 2011, he became the CEO of SteadyMed Therapeutics and focused the company on the development of drug device combination products to treat Pulmonary Hypertension. He led the company through a Nasdaq listing in 2015 and a public-to-public company sale to United Therapeutics in late 2018. In 2006 he cofounded Zogenix, a specialty pharmaceutical company now focused on the development and commercialisation of drug products to treat rare diseases and was instrumental in its listing on Nasdaq in 2010. Earlier in his career, he held commercial and business development positions of increasing responsibility at large pharmaceutical companies including Merck and Bristol Myers Squibb and Profile Therapeutics (now Phillips Medical). He replaces outgoing Chief Executive Richard Nagle, who has led the business since 2017. Immune Regulation Chairman, Dr Dominik Escher, said that Mr Rigby is “the ideal candidate to lead the next stage of clinical development of our two key therapies in immune system resetting”. Mr Rigby said: “The Company has first-in-class immune-resetting therapies with a broad potential to treat autoimmune diseases. For example, IRL201805 and IRL201104 have shown considerable efficacy in preclinical and human clinical studies in rheumatoid arthritis and asthma / severe allergy respectively. “We are also in the early stages of assessing the potential of IRL1104 to reduce lung inflammation which may be a consequence in patients infected by the COVID-19 virus.”
Some COVID-19 patients still have coronavirus after symptoms disappeared, according to a new study. Researchers found that half of the patients they tested for mild COVID-19 infection still have coronavirus for up to eight days after symptoms disappeared. In the research letter, Lixin Xie, Lokesh Sharma, and co-authors report on a study of 16 patients with COVID-19, who were treated and released from the Treatment Centre of PLA General Hospital in Beijing between January 28 and Feb. 9, 2020. Researchers collected samples from throat swabs taken from all patients on alternate days and analysed. Patients were discharged after their recovery and confirmation of negative viral status by at least two consecutive polymerase chain reaction (PCR) tests. “The most significant finding from our study is that half of the patients kept shedding the virus even after resolution of their symptoms,” said co-lead author Dr. Sharma, instructor of medicine, Section of Pulmonary, Critical Care & Sleep Medicine, Department of Medicine, Yale School of Medicine. “More severe infections may have even longer shedding times.” The primary symptoms in these patients included fever, cough, pain in the pharynx (pharyngalgia) and difficult or laboured breathing (dyspnea). Patients were treated with a range of medications. The time from infection to onset of symptoms (incubation period) was five days among all but one patient. The average duration of symptoms was eight days, while the length of time patients remained contagious after the end of their symptoms ranged from one to eight days. Two patients had diabetes and one had tuberculosis, neither of which affected the timing of the course of COVID-19 infection. “If you had mild respiratory symptoms from COVID-19 and were staying at home so as not to infect people, extend your quarantine for another two weeks after recovery to ensure that you don’t infect other people,” recommended corresponding author Lixin Xie, professor, College of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital, Beijing. The authors had a special message for the medical community: “COVID-19 patients can be infectious even after their symptomatic recovery, so treat the asymptomatic/recently recovered patients as carefully as symptomatic patients.” The researchers emphasised that all of these patients had milder infections and recovered from the disease, and that the study looked at a small number of patients. They noted that it is unclear whether similar results would hold true for more vulnerable patients such as the elderly, those with suppressed immune systems and patients on immunosuppressive therapies. “Further studies are needed to investigate if the real-time PCR-detected virus is capable of transmission in the later stages of COVID-19 infection,” Dr Xie added.