Conf call:
Pre Spy
"So on the next slide, how we're progressing in breast cancer is we've had very productive conversations with the pre-spy network, and they are going to take on Part 1 of our Phase II study, which as the FDA requested is a dose escalation, confirming safety, PK, the DNA and the PD-L1 Per the Pre spy network, they are extending the patient population from TNBC to include all HER2-negative patients with breast cancer. And we're fortunate to have Dr. Paul Polman from MD Anderson, who will serve as the principal investigator for that project. Those contracts and budgets have been negotiated, and they have suggested that their start-up time can be measured in weeks to a few months
I SPY 2.2
Trial site
https://clinicaltrials.gov/study/NCT01042379
"At the same time, we are then going to be following up with a contribution of components study, which will adaptively demonstrate the additive benefit of including a checkpoint inhibitor with leronlimab as part of a Phase II/III study".
(Up to 120 patients )
Tnbc Eap - Conf call. (Don't know why font got bigger)
"This was initially imagined as a way to sort of quickly and prospectively confirm the PD-L1 induction we were seeing with leronlimab that some potential industry partners had asked to see.
And that is still the case that in the EAP program, we will be measuring PD-L1 at baseline and then at month 1, 2 and 3, and we'll report on that later.
Pre Spy
"So on the next slide, how we're progressing in breast cancer is we've had very productive conversations with the pre-spy network, and they are going to take on Part 1 of our Phase II study, which as the FDA requested is a dose escalation, confirming safety, PK, the DNA and the PD-L1 Per the Pre spy network, they are extending the patient population from TNBC to include all HER2-negative patients with breast cancer. And we're fortunate to have Dr. Paul Polman from MD Anderson, who will serve as the principal investigator for that project. Those contracts and budgets have been negotiated, and they have suggested that their start-up time can be measured in weeks to a few months
I SPY 2.2
Trial site
https://clinicaltrials.gov/study/NCT01042379
"At the same time, we are then going to be following up with a contribution of components study, which will adaptively demonstrate the additive benefit of including a checkpoint inhibitor with leronlimab as part of a Phase II/III study".
(Up to 120 patients )
Tnbc Eap - Conf call. (Don't know why font got bigger)
"This was initially imagined as a way to sort of quickly and prospectively confirm the PD-L1 induction we were seeing with leronlimab that some potential industry partners had asked to see.
And that is still the case that in the EAP program, we will be measuring PD-L1 at baseline and then at month 1, 2 and 3, and we'll report on that later.
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