Thanks also Enjay for transcript. HH beat me to to EIND patient in mTNBC. But the other part I found compelling concerned mssCRC. 4 pretty nice things stand out.
- open label means real time PD-L1 monitoring
- 5th patient onboarding so DSMB monitoring board can open enrollment to 700mg thereafter potentially
- high prescribing clinic coming onboard and enrollment to accelerate
- Potential rollover allows patients with disease progression to continue LL after study further validating ICI combo
“ So let's take a look at our colorectal cancer study. It's a phase two study evaluating two doses [levels] of Leronlimab
00:07:19:17 - 00:07:48:15
in combination with other agents including bevacizumab. Participants, our CCR5 positive, micro satellite stable, relapsed refractory metastatic colorectal cancer. It's an open label study. It's randomized, with two arms, open label as I mentioned. So the open label part is important because it will allow us to view, PD-L1 data as we go along
00:07:48:18 - 00:08:19:11
and hopefully we'll see our mechanism of action, that positive PD-L1 positive, throughout the study. We currently have, four clinics that are up and running. The number of patients we have, we expect to enroll our fifth patient in the study this month. That's important and it's kind of a milestone because that allows the DSMB, the monitoring board, to meet and go over the safety
00:08:19:11 - 00:08:45:04
and we would imagine, open up the enrollment to the 700mg dose. I did mention the number of clinics. We did just, sign up a really high prescribing clinic. So I expect enrollment to really accelerate here as we as we move forward, they really have a backlog of patients, in sadly with colorectal cancer. So we're really excited to have them up and running.
00:08:45:07 - 00:08:54:12
And we expect to have the full 8 to 10, clinics up and running by the by the end of the year.
00:08:54:15 - 00:09:17:27
So the other important part is the rollover protocol, which we plan on putting in place. That will allow, ensure that CRC patients can continue Leronlimab treatment beyond the 48 weeks, and allow patients with disease progression the opportunity to receive Leronlimab in combination with an ICI. So that's really important.
00:09:17:28 - 00:09:34:23
That kind of tests our theory as well, that making these patients PD-L1 positive will be effective for ICI treatment.
00:09:34:25 - 00:10:01:06
So in this study, we believe the colorectal cancer trial will further establish Leronlimab, and put us in great shape to test patients in a registrational study next….
- open label means real time PD-L1 monitoring
- 5th patient onboarding so DSMB monitoring board can open enrollment to 700mg thereafter potentially
- high prescribing clinic coming onboard and enrollment to accelerate
- Potential rollover allows patients with disease progression to continue LL after study further validating ICI combo
“ So let's take a look at our colorectal cancer study. It's a phase two study evaluating two doses [levels] of Leronlimab
00:07:19:17 - 00:07:48:15
in combination with other agents including bevacizumab. Participants, our CCR5 positive, micro satellite stable, relapsed refractory metastatic colorectal cancer. It's an open label study. It's randomized, with two arms, open label as I mentioned. So the open label part is important because it will allow us to view, PD-L1 data as we go along
00:07:48:18 - 00:08:19:11
and hopefully we'll see our mechanism of action, that positive PD-L1 positive, throughout the study. We currently have, four clinics that are up and running. The number of patients we have, we expect to enroll our fifth patient in the study this month. That's important and it's kind of a milestone because that allows the DSMB, the monitoring board, to meet and go over the safety
00:08:19:11 - 00:08:45:04
and we would imagine, open up the enrollment to the 700mg dose. I did mention the number of clinics. We did just, sign up a really high prescribing clinic. So I expect enrollment to really accelerate here as we as we move forward, they really have a backlog of patients, in sadly with colorectal cancer. So we're really excited to have them up and running.
00:08:45:07 - 00:08:54:12
And we expect to have the full 8 to 10, clinics up and running by the by the end of the year.
00:08:54:15 - 00:09:17:27
So the other important part is the rollover protocol, which we plan on putting in place. That will allow, ensure that CRC patients can continue Leronlimab treatment beyond the 48 weeks, and allow patients with disease progression the opportunity to receive Leronlimab in combination with an ICI. So that's really important.
00:09:17:28 - 00:09:34:23
That kind of tests our theory as well, that making these patients PD-L1 positive will be effective for ICI treatment.
00:09:34:25 - 00:10:01:06
So in this study, we believe the colorectal cancer trial will further establish Leronlimab, and put us in great shape to test patients in a registrational study next….
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