HONG KONG – Shanghai-based I-Mab Biopharma Co. Ltd. expects to begin clinical trials for the world’s first and only claudin18.2 and 4-1BB bispecific program in a year. "We expect the trial to start in U.S. in the [middle of] next year. We will then expand the trial to China afterwards as planned," Joan Shen, CEO of I-Mab, told BioWorld.

An editorial yesterday in The New England Journal of Medicine (NEJM) marveled that “the world has now witnessed the compression of six years of work into six months,” and went on to ask the question that’s on everyone’s pandemic-wrenched mind: “Can the vaccine multiverse do it again, leading to a reality of a safe, efficacious COVID-19 vaccine for the most vulnerable in the next six [months]?”

HONG KONG – Osaka, Japan-based Shionogi & Co Ltd. continues to make global inroads with its influenza treatment, Xofluza (baloxavir marboxil), submitting supplemental new drug applications in Japan and Taiwan for a post-exposure prophylaxis indication on the back of positive results from its phase III trials.

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.

Inmune Bio Inc. CEO Raymond Tesi told BioWorld his firm is taking an “oncology-style” approach to Alzheimer’s disease (AD) as the firm tests next-generation tumor necrosis factor (TNF) inhibitor XPro-1595 against neuroinflammation.

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.