SUZHOU, China – Chinese CAR T therapy developers from early to IPO-ready-stage are confident that they can create a strong presence in the global scene with their innovations, and they are also making strategies that will work best for their home market.
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.
DUBLIN – Tolerogenixx GmbH is on track to move its cell-based immune tolerance induction therapy for kidney transplant recipients into a 200-patient phase IIb trial, following the publication of promising data from a phase Ib trial, in 10 patients, in which all participants had a successful transplant at one-year follow-up.
Keen to address a rare vision-limiting disorder endured by nearly 1.9 million people globally, ophthalmology specialist Santen Pharmaceutical Co. Ltd. has negotiated a $252 million ex-U.S. licensing deal for Jcyte Inc.'s Jcell, a human retinal progenitor cell therapy initially aimed at treating retinitis pigmentosa.
LONDON – These are hardly times for a fanfare, but this month saw the unveiling of a new name in bioprocessing, following the formal closing of the $21.4 billion sale of GE Healthcare’s Life Sciences to Danaher Corp. The business, now renamed Cytiva, has turnover of $3.3 billion, nearly 7,000 employees and operations in 40 countries. More than 75% of FDA-approved biologic drugs use its products in their manufacture.
Fate Therapeutics Inc. inked a multiyear, global collaboration worth up to $3 billion with Janssen Biotech Inc., which calls for the latter to contribute antigen binding domains for up to four tumor-associated targets.
Cambridge, Mass.-based Elevatebio LLC has triple-pronged plans for its $170 million series B round, which the company said will be directed toward manufacturing cell and gene therapies, enabling new technology platforms, and pursuing therapeutics.
Investigators at Stanford University Medical Center have treated the first patient in a pivotal phase III study of Abeona Therapeutics Inc.'s EB-101, an autologous cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). The trial, delayed by an FDA clinical hold placed in September 2019, has now resumed, with the majority of its 15 expected participants pre-screened.
Immatics Biotechnologies GmbH, of Tuebingen, Germany, and Arya Sciences Acquisition Corp. plan to merge as Immatics NV. Immatics will receive gross proceeds of up to $252 million at closing, which is expected in the second quarter of 2020.
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. plans to evaluate its allogeneic mesenchymal stem cell (MSC) candidate, remestemcel-L, in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19) in the U.S., Australia, China and Europe.