Beijing Institute of Biotechnology

The inhaled vaccine is based on the same technology used while researching an inhaled tuberculosis vaccine and its injectable Covid-19 vaccine. Credit: Mockup Graphics / Unsplash. Chinese company CanSino Biologics is set to commence clinical trials of a Covid-19 vaccine that can be administered through inhalation. CNBC reported that, in collaboration with the Beijing Institute of Biotechnology (BIB), CanSinoBIO is developing the inhalation vaccine. The news channel quoted CanSino Biologics co-founder and chief executive Xuefeng Yu as saying that an inhaled vaccine could be more effective compared to injected ones as SARS-COV-2 enters the human body through the airways. Yu added that, theoretically, an inhaled vaccine can activate antibodies or T cells in the airways and offer extra protection. In the event of protection layer failure and the entry of the virus deep into the body, other parts of the immune system could still work against the virus. The inhaled vaccine is based on the same technology used by the company while researching an inhaled tuberculosis vaccine and its injectable Covid-19 vaccine. The company’s injectable Adenovirus Type 5 Vector vaccine (Ad5-nCoV) is already approved for use in China and many other countries. According to interim data from Phase III clinical trials outside the country, the vaccine demonstrated 68.83% effectiveness in preventing symptomatic Covid-19 two weeks after one injection with the rate falling to 65.28% after four weeks, reported Reuters. Chinese regulators had granted permission to conduct the first trial of a nasal spray vaccine developed by scientists at Hong Kong University (HKU), Xiamen University (XMUM), and Beijing Wantai Biological Pharmacy Enterprise last September. In January, Indian drug regulator CDSCO’s subject expert committee recommended granting permission for conducting Phase I clinical trial of Bharat Biotech’s intranasal Covid-19 vaccine (BBV154). In March, Hong Kong University concluded the Phase I/II trial of the vaccine in China and is currently enrolling participants for a second Phase I trial in Hong Kong, China. During the same period, the University of Oxford announced the launch of a study analysing the delivery of the ChAdOx1 nCoV-19 coronavirus vaccine using a nasal spray. It is based on the Covid-19 vaccine developed in collaboration with AstraZeneca. Recently, the efficacy rates of Chinese Covid-19 vaccines were found to be lesser than vaccines of Pfizer-BioNTech and Moderna. The Chinese Center for Disease Control director had noted that the Chinese vaccines do not have great protection rates and they intend to administer people with different shots to increase the efficacy of the vaccines. Separately, Chinese researchers are conducting a trial by mixing Covid-19 vaccines developed by CanSinoBIO and a unit of Chongqing Zhifei Biological Products, the news agency reported. This trial, which is progressing in the eastern city of Nanjing, will enrol 120 subjects.

A few companies shared some big Phase III results this week. Here’s a look. CanSino’s COVID-19 Trial Continues CanSino Biologics received positive top-line interim safety and efficacy news on its Phase III for its one-dose COVID-19 vaccine, topping a raft of upbeat late-stage news from Global Blood Therapeutics, Travere Therapeutics and NeurMedix. CanSino will complete the Phase III trial for its human adenovirus 5-based COVID-19 vaccine after getting positive top-line interim data with no serious adverse events from an independent review, according to Chinese media reports. The vaccine, Ad5-nCoV, has been tested in 40,000 across clinical sites in Russia, Mexico, Pakistan, Argentina and Chile. The company expects to receive complete interim results this week. Efficacy data has not yet been released, but CanSino announced in November it had sold 35 million doses to Mexico. Ad5-bCoV was developed in conjunction with the Beijing Institute of Biotechnology (BIB), part of China’s Academy of Military Medical Sciences. Phase II data was published in The Lancet in July. High-Dose Oxbryta Improves Leg Ulcers in Sickle Cell Patients Tested A post-hoc study of Phase III results showed high doses of Oxbryta improved or resolved leg ulcers in 13 out of 14 sickle cell disease patients receiving 900 mg or 1500 mg after 72 weeks, compared with 63% in a placebo group. The findings were published last week by Global Blood Therapeutics and its academic collaborators in American Journal of Hematology. By some estimates, leg ulcers occur in 14-18% of sickle cell disease patients, particularly in patients with severe hemolytic anemia. Oxbryta was approved in the U.S. in 2019 to treat sickle cell disease in patients 12 or older, and is currently in Phase III testing in children as young as 2. Global Blood Therapeutics is seeking European Medicines Agency (EMA) approval to market Oxbryta for hemolytic anemia in sickle cell disease in patients and last week the EMA completed its review. The European Commission will announce an approval decision by early April. Sparsentan Hits Endpoint in Focal Segmental Glomerulosclerosis Trial A Phase III study of patients taking sparsentan for the kidney scarring disease focal segmental glomerulosclerosis showed a statistically significant partial response at 36 weeks, according to a statement by Travere Therapeutics. There are no approved therapies for focal segmental glomerulosclerosis, a progressive disorder which can lead to end-stage kidney disease. Based on the data, Travere aims to work with regulators to determine the next steps. Upon completion of the current Phase III DUPLEX study, the primary endpoint will be estimated glomerular filtration rate, a measure of kidney function, for the 371 enrolled patients over 108 weeks of treatment. Patients are receiving either sparsentan or an active control, irbesartan. NeurMedix to Launch Alzheimer’s Phase III Trial in May NeurMedix will launch a Phase III trial of its insulin-sensitizing small molecule NE3107 in Alzheimer’s disease patients in May, following U.S. Food and Drug Administration’s (FDA) authorization this week. The therapeutic approach has been developed after a growing body of evidence has linked the neurological disease with insulin-resistant type 2 diabetes. Novo Nordisk previously launched a Phase IIb clinical trial of its diabetes drug Victoza for Alzheimer’s disease. Most Read Today