Regarding the interim look
question, see the highlighted bit in the quote below from the recent 10-Q:
"We are pursuing post-transplant AML as the lead indication for our
MultiTAA program. Our MultiTAA therapy has been well tolerated in an ongoing
Phase 1/2 clinical trial conducted by our strategic partner Baylor College of
Medicine, or BCM. As reported in March 2019, eleven of the thirteen patients in
the adjuvant disease setting dosed with our MultiTAA therapy after receiving an
allogeneic stem cell transplant survived, ranging from 6 weeks to 2.5 years post-infusion,
with nine of these remaining patients in continuing complete remission.
Survival of the six patients with active disease ranged from 4 to 21 months, as
compared to a historical survival rate of approximately 4.5 months for patients
who receive the standard of care post-transplant. We have submitted an
investigational new drug, or IND, application to the United States Food and
Drug Administration, or the FDA to initiate a Phase 2 clinical trial in
post-allogeneic hematopoietic stem cell transplant patients with AML in both
the adjuvant and active disease setting, which
may become pivotal pending the results of the interim analysis. The dose
administered in this multicenter trial is the current maximum tolerated dose
from the Phase 1/2 trial. In the adjuvant setting, patients will be randomized
to either MultiTAA therapy at approximately 90 days post-transplant versus
standard of care observation, while the active disease patients will receive
MultiTAA T cells at the time of relapse post-transplant as part of a single-arm
group."