BEIJING – CAR T-cell therapeutics developer Carsgen Therapeutics Co. Ltd., of Shanghai, won IND clearance from the FDA for its first-in-class CT-041 for advanced gastric and pancreatic cancers. The company said it is the first claudin18.2 (CLDN18.2)-targeted CAR T-cell therapy cleared for clinical trials in the world.
Transmedics Group Inc. reported a proposed public offering of $60 million of its shares of common stock (NASDAQ:TMDX). The Andover, Mass.-based company expects to grant underwriters a 30-day purchase option for additional shares of its common stock up to 15% of the number of shares sold in the offering. J.P. Morgan and Morgan Stanley are jointly managing the proposed offering with Canaccord Genuity acting as lead manager.
Argenx SE’s later-stage effort with antibody fragment efgartigimod in generalized myasthenia gravis (gMG) was designed with guidance from the phase II trial that showed 75% of patients had a durable response of at least six weeks.
Navidea Biopharmaceuticals Inc. CEO Jed Latkin said positive findings from the second interim analysis of the phase IIb study called NAV3-31 “were certainly better than what we were looking for” and will “make our partnering discussions a lot more interesting.”
LONDON – Human challenge specialist Open Orphan plc has raised £12 million (US$14.6 million) in a placing to accelerate development of COVID-19 challenge study models, to meet demand from vaccines and therapeutics developers worldwide.
HONG KONG – A researcher at Israel’s Ben-Gurion University of the Negev (BGU) has developed a test that identifies those carrying the COVID-19 virus in less than a minute. And it is both affordable and works with greater than 90% accuracy to boot.
Shares of Entera Bio Ltd. (NASDAQ:ENTX), a lightly traded Israeli drug delivery specialist, fell 27% on May 21 after the company said an ongoing phase II trial of its oral parathyroid hormone (PTH) candidate in osteoporosis patients found the two lowest doses tested demonstrated "suboptimal increases" in P1NP, an important biomarker of bone formation.