CAJICA, Colombia, and BEIJING – Last week Sinovac Biotech Ltd., of Beijing, announced the approval by Anvisa, the Brazilian health care surveillance agency, to start phase III trials to test the efficacy and safety of its inactivated COVID-19 vaccine being developed by Sinovac Life Sciences, a subsidiary of the Chinese company, in the Latin American country.
Although details are yet to come, Equillium Inc.’s chief medical officer, Krishna Polu, told BioWorld that the company will move “urgently and expeditiously” to set up another experiment testing itolizumab in COVID-19 now that Bangalore, India-based partner Biocon Ltd. has unveiled positive phase II results with the CD6-targeting agent. Shares of Equillium (NASDAQ:EQ) closed at $26.50, up $23.31, or 731%, after trading as high as $27.05. “We recognize we have to do a robust study,” said Bruce Steel, CEO of the La Jolla, Calif.-based firm. Talks with the FDA about design come next, but the clinical bid will “very likely include sites outside the U.S.,” where the need is high and where there is “somewhat less competition for patients,” he said.
BEIJING – Androgen receptor (AR) antagonist developer Kintor Pharmaceutical Ltd., of Suzhou, China, is going to provide its proxalutamide (GT-0918) to an ongoing clinical trial in male patients, led by U.S. firm Applied Biology Inc., in Brazil for COVID-19, after preliminary clinical research suggested a potential link between androgenetic alopecia and COVID-19 pathogenesis.
Bharat Biotech International Ltd. has successfully developed India’s first indigenous vaccine candidate for COVID-19 to enter human trials. Named Covaxin, the vaccine has been cleared by the Drug Controller General of India (DCGI) and Ministry of Health & Family Welfare for phase I and II trials after the company submitted positive preclinical study results regarding safety and immune response.
BEIJING – China this week approved both the country’s first mRNA vaccine candidate and its first recombinant protein subunit vaccine to begin clinical trials to fight COVID-19. China National Biotec Group (CNBG)’s vaccine is also entering phase III trials in Beijing, Wuhan and Abu Dhabi, the United Arab Emirates (UAE).
PERTH, Australia – Melbourne-based regenerative medicine company Cynata Therapeutics Ltd. is gearing up to take its Cymerus mesenchymal stem cell (MSC) product candidate, CYP-004, into a phase III trial in osteoarthritis.
BEIJING – Chinese state-backed vaccine developer China National Biotec Group (CNBG), of Beijing, said on June 16 that its inactivated COVID-19 vaccine candidate produced a seroconversion rate of up to 100% in a phase I/II trial that enrolled 1,120 healthy subjects.
BEIJING – Suzhou, China-based Ascentage Pharma Group Inc. said on June 22 that it is working with Astrazeneca plc’s hematology R&D unit, Acerta Pharma, to develop a combination therapy of its Bcl-2 inhibitor, APG-2575, with Acerta's BTK inhibitor, Calquence (acalabrutinib). The first patient has been dosed in the U.S.
HONG KONG – Astellas Pharma Inc. reported positive results from phase III of its DOLOMITES study comparing the efficacy and safety of roxadustat to that of darbepoetin alfa in treating anemia in nondialysis-dependent, stage 3 to 5 chronic kidney disease (CKD) patients.