17:41 , Jan 11, 2019 |  BC Week In Review  |  Clinical News

Autolus' dual targeting CAR T safe in Phase I/II data for hematological malignancies

Autolus Therapeutics plc (NASDAQ:AUTL) reported preliminary data from a pair of open-label, U.K. Phase I/II trials showing that AUTO3 had a manageable safety profile and led to responses among patients with hematological malignancies. AUTO3 comprises...
05:09 , Jan 5, 2019 |  BioCentury  |  Product Development

Bristol-Myers’ next phoenix act?

Bristol-Myers Squibb Co. will now be in the driver’s seat to monetize the assets gained from the myriad deals Celgene Corp. has forged. The pharma will need to mimic its history of using well-timed acquisitions...
19:07 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

Viela planning BLA submission for inebilizumab in rare CNS disorder

Viela Bio Inc. (Gaithersburg, Md.) said it will submit a BLA to FDA this half for inebilizumab (MEDI-551) to treat neuromyelitis optica spectrum disorder (NMOSD) after the compound met the primary endpoint in the Phase...
12:06 , Jan 3, 2019 |  BC Extra  |  Clinical News

Viela planning BLA submission for inebilizumab in rare CNS disorder

Viela Bio Inc. (Gaithersburg, Md.) said it will submit a BLA to FDA this half for inebilizumab (MEDI-551) to treat neuromyelitis optica spectrum disorder (NMOSD) after the compound met the primary endpoint in the Phase...
22:56 , Dec 28, 2018 |  BC Extra  |  Financial News

TCR2 seeks IPO as first program slated to enter clinic

Looking to bring at least one of its cell therapy programs to the clinic next year, TCR2 Therapeutics Inc. (Cambridge, Mass.) filed on Friday to raise $100 million in an IPO on NASDAQ. TCR2 is...
04:43 , Dec 15, 2018 |  BioCentury  |  Product Development

O’Day’s expansive task at Gilead

A fresh executive team and a track record of building deep portfolios could allow incoming Gilead Sciences Inc. chairman and CEO Daniel O’Day to do what his predecessors couldn’t: make Gilead a leader outside of...
20:23 , Dec 10, 2018 |  BC Extra  |  Company News

Veteran Roche cancer executive O'Day to lead Gilead

Daniel O’Day will inherit a pile of cash and a company that is looking beyond infectious disease to carve out its space in cancer and build on its newly acquired CAR T platform when he...
02:33 , Dec 8, 2018 |  BioCentury  |  Product Development

Intermittent move beyond Blincyto

A swath of data at ASH shows that companies have been able to move beyond the 28-day continuous dosing of Amgen Inc.’s first-generation BiTE, Blincyto, to build next-generation antibodies with more convenient, intermittent dosing and...
22:07 , Dec 3, 2018 |  BC Extra  |  Company News

NIH may give ElevateBio exclusive CAR T license

NIH's National Cancer Institute is considering granting ElevateBio LLC (Cambridge, Mass.) an exclusive license to develop an undisclosed CAR T therapy targeting FMS-like tyrosine kinase 3 (FLT3; CD135). In a Federal Registry notice , NIH...
03:50 , Dec 1, 2018 |  BioCentury  |  Product Development

Cell therapy momentum at ASH

This year’s American Society of Hematology (ASH) meeting will showcase a surge in clinical CAR T cell presentations. But gene therapies are not following the same trajectory, despite both modalities being fresh off their first...