Replies to post #207376 on Biotech Values

[dewophile]

yeah I think it's more likely to be the payload too. Abbvie licensed it as well but I don't think they have any ADCs w this new payload in the clinic yet (and they now have their own ADC tech through stemcentrx)
happy holidays genisi

[camacho]

sgen- trying to make heads and tails out of it:

fda fully holds: the transplant trial.

partial hold: combo with hma and combo with 7+3

yet

allows the p3 cascade to continue (knock on wood).

what is the rational here?

[DewDiligence]

SGEN—FDA lifts clinical hold on phase-1 trials in AML:

http://finance.yahoo.com/news/fda-lifts-clinical-hold-seattle-114500739.html

Seattle Genetics will resume two phase 1 trials of vadastuximab talirine. The first is combination treatment with standard of care, or 7+3, chemotherapy in newly diagnosed younger AML patients and the second is monotherapy and combination treatment with hypomethylating agents in both newly diagnosed and relapsed AML patients.

Seattle Genetics will not resume the phase 1/2 trial of vadastuximab talirine monotherapy in pre- and post-allogeneic transplant AML patients given the challenges of developing therapies in this specific setting.

The company’s randomized global phase 3 CASCADE trial in frontline older AML and phase 1/2 trial in frontline MDS were not placed on clinical hold and have continued to enroll patients. Planned studies include a randomized phase 2 trial of vadastuximab talirine in combination with 7+3 chemotherapy in frontline younger AML patients. Going forward, additional risk mitigation measures will be implemented in all vadastuximab talirine studies, including revised eligibility criteria and stopping rules for veno-occlusive disease (VOD).