Latest From Mandy Jackson
Lead immuno-oncology asset NC318 targeting Siglec-15 showed encouraging early activity in patients refractory to PD-1/L1 inhibitors, but now Phase II plans are scuttled in lung and ovarian cancers.
A steady flow of venture capital into the medical device industry continued in the first half of 2020 despite the novel coronavirus pandemic. While Biopharma companies secured more than $7.5bn in private financings between January and June.
Poseida, Nkarta and Inventiva raised $224m, $252m and $107.7m, respectively. Also, Forbion raised €185m ($208m) of a new €250m fund and Blackstone closed the last $1.2bn of its $4.6bn fund for public and private company deals, and Ascendis led recent follow-ons with a $569.2m offering.
Some analysts see a 50-50 chance of US FDA approval despite the controversial dataset for the anti-amyloid antibody, but at least one expects an eventual CRL requesting a third Phase III trial.
A Phase I study for allogeneic therapy UCARTCS1A was put on clinical hold after a patient died. High dosing and double exposure to cyclophosphamide pre-conditioning may have played a role.
After accelerated approval in the US in April based on Phase II response rates, the company will seek full approval later this year based on a tripling of progression-free survival in a Phase III trial.