Look again @ Leronlimab (PRO 140) Combined With Ca
Post# of 155188
(Total Views: 695)
Posted On: 07/05/2025 3:42:40 PM
Look again @ Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC
Phase II:
The change from baseline in circulating tumor cells (CTC) level in the peripheral blood. [Time Frame: Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months.]
Phase II:
Progression Free Survival (PFS) according to RECIST v1.1 in participants with Detectable Programmed Death-Ligand 1 (PD-L1) [Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment]
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Aug. 12th. 2024 our current CRC:
The study will include a ** SAFETY LEAD-IN ** treating ** FIVE PATIENTS ** in the 350 mg leronlimab arm prior to beginning enrollment to the 700 mg leronlimab arm.
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Leronlimab does no harm @ 350mg or 700 mg.
We of course know & so safe to say our current CRC is 1st 5 responding as safe.
__
Next CRC 20 @ 700 mg
2nd DSMB look.... safe.
Remaining 45 of our 60,
DSMB says @ 700 mg's
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Cytodyn May 13th, 2025:
" CytoDyn’s results indicate that 15/17 (88%) of patients who received a weekly dose of 525 mg or higher experienced a significant increase in PD-L1 expression on their CTCs over a 30-to-90-day period after starting leronlimab."
2nd comment from the press release:
"The Company confirmed that 5/5 patients (100%) who demonstrated a significant increase in PD-L1 expression after receiving leronlimab and received treatment with any ICI remain alive today."
__
1. The protocol stopped CTC monitor after 6 months
2. PD-L1 observation out to 2 years
This shows Mgt. confidence that current CRC dosing @ 700 mg's, will easily be a lasting upregulating for later dosing an ICI.
Does May 13th, 2025 news kind of read they did 525 mg & ICI @ same time in those 30 - 90 days ?....or not ?
Or just referencing each, without saying @ what point in time they dosed an ICI?
A seperate ICI trial also makes sense because ICI effectiveness is not Cytodyn or Leronlimabs duty.
Like clearing an Hiv resevoir, we're giving ICI a job to do.
Maybe the Statistical Analysis Plan will have addtl info too about the trial overall after it's filed....
We're looking @ an LL / ICI combo potential of:
New SOC for all solid tumors.
Also creating access to massive untapped markets.
Phase II:
The change from baseline in circulating tumor cells (CTC) level in the peripheral blood. [Time Frame: Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months.]
Phase II:
Progression Free Survival (PFS) according to RECIST v1.1 in participants with Detectable Programmed Death-Ligand 1 (PD-L1) [Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment]
__
Aug. 12th. 2024 our current CRC:
The study will include a ** SAFETY LEAD-IN ** treating ** FIVE PATIENTS ** in the 350 mg leronlimab arm prior to beginning enrollment to the 700 mg leronlimab arm.
__
Leronlimab does no harm @ 350mg or 700 mg.
We of course know & so safe to say our current CRC is 1st 5 responding as safe.
__
Next CRC 20 @ 700 mg
2nd DSMB look.... safe.
Remaining 45 of our 60,
DSMB says @ 700 mg's
__
Cytodyn May 13th, 2025:
" CytoDyn’s results indicate that 15/17 (88%) of patients who received a weekly dose of 525 mg or higher experienced a significant increase in PD-L1 expression on their CTCs over a 30-to-90-day period after starting leronlimab."
2nd comment from the press release:
"The Company confirmed that 5/5 patients (100%) who demonstrated a significant increase in PD-L1 expression after receiving leronlimab and received treatment with any ICI remain alive today."
__
1. The protocol stopped CTC monitor after 6 months
2. PD-L1 observation out to 2 years
This shows Mgt. confidence that current CRC dosing @ 700 mg's, will easily be a lasting upregulating for later dosing an ICI.
Does May 13th, 2025 news kind of read they did 525 mg & ICI @ same time in those 30 - 90 days ?....or not ?
Or just referencing each, without saying @ what point in time they dosed an ICI?
A seperate ICI trial also makes sense because ICI effectiveness is not Cytodyn or Leronlimabs duty.
Like clearing an Hiv resevoir, we're giving ICI a job to do.
Maybe the Statistical Analysis Plan will have addtl info too about the trial overall after it's filed....
We're looking @ an LL / ICI combo potential of:
New SOC for all solid tumors.
Also creating access to massive untapped markets.
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