Improved Comparison of the previous PR on 7/19 and The Compassionate Use Study of LL in BC

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This will be a better comparison of previous PR on 7/19 and the most recent one with the Compassionate Use Study of Leronlimab in Breast Cancer.

The 7/19 PR gave 700mg Leronlimab and Carboplatin weekly for 4 consecutive weeks and then stopped.

The Compassionate Use Study of Leronlimab in Breast Cancer gave 350mg Leronlimab weekly in combination with physicians choice of another medication, such as ribulin, gemcitabine, capecitabine, paclitaxel, nab-paclitaxel, vinorelbine, ixabepilone, or carboplatin, until disease progression or intolerable toxicity. So, Leronlimab would be given weekly, at only the 350mg level, in combination with physician choice med, until the cancer began growing again despite compliance with Leronlimab. This study may have started around 3/2020.

The 7/19 PR indicated that 1 month following leronlimab induction, nearly 21 out of 29 TNBC patients had reduced CAML (Cancer Associated Macrophage Like cells) and CTC (circulating tumor cells) biomarkers, which indicated: Reduced Cancer Activity.

In the new PR on the Compassionate Use Study of Leronlimab in Breast Cancer, 30 patients were in the trial and the new PR says 73%, or 21 patients also lowered their CAML and CTC biomarkers indicating the same finding: Reduced Cancer Activity. Now, this was the same results as the 7/19 PR, yet it was done at half the dosage, but it continued far beyond just an initial series of only 4 weeks 700mg leronlimab injections. If that study began in 3/2020, some patients may have received a 350mg Leronlimab injection weekly for over a year and a half, or somewhere near 75, 350mg leronlimab injections.

Under current Standard of Care, these cancer biomarkers, CAML and CTC typically return back to their elevated Cancer levels around the 2 month point following treatment. When the CAML and CTC biomarkers are at these higher levels, they indicate: Active Proliferating Cancer.

The 7/19 PR revealed that with only (4), 700mg Leronlimab injections, this return back to elevated levels of CAML and CTC was delayed to 6 months by the series of (4) 700mg leronlimab injections.

In the new PR on the Compassionate Use Study of LL in BC, it says, that there was a 400-660% increase, which correlates to 8 to 13.2 months. During these 8-13.2 months, the patients with TNBC can live with their disease. Their disease is not multiplying during these 8-13.2 months. However, in this study, since an endpoint is Disease Progression, once Active Proliferating Cancer was detected by an increase in CAML and / or CTC, then the endpoint was reached and that patient participation in trial ends. Remember though, this trial was carried out using only 350mg Leronlimab, but delivered weekly.

In standard of care, the majority of TNBC patients do not make it beyond 6-7 months. In the 7/19 PR, all 21 out of the 29 patients who actually responded to the Leronlimab treatment as seen by increases in CAML and / or CTC, remained alive at the 12 month point of analysis. 21 of 29 remained alive at 12 months with a series of (4) 700mg Leronlimab injections with carboplatin, where if they were to have received Standard of Care, they would have died by the 6-7 months point. In the latest PR on Compassionate Use Study of LL in BC, the numbers, claimed are 570-980% increase in Overall Survivability, (OS); this translates into 34 to 59 months of life with scheduled, continuous weekly 350mg Leronlimab injections. That's 3 to 5 years of life with continuous weekly Leronlimab injections.

I will assume or deduce that the 8 patients who received Leronlimab, but failed to respond with lowered CAML and / or CTC biomarkers, probably died, as they probably did not receive any other pharmacotherapy.

Now those 8 who died in original 7/19 PR, according to the PR, probably did not have elevated CCR5 within their breast cancer tumors. It can also be assumed, that since only 73% responded in the new PR on the Compassionate Use Study of LL in BC, that in like manner, either 8 or 9 patients died.

From the 7/19 PR, we know that with 4 injections of leronlimab, the lives ~21 out of ~29 TNBC patients were saved, and the quality of their life was improved for at least 6 months. With the serial injections, we know that improvement extends beyond a year and their lives remain preserved for 3-5 years while continuously dosing only 350mg Leronlimab weekly.

In 7/19 PR, the relevant biomarkers indicated that the return of the cancer occurred at about the 6 month point after the initial (4) weekly doses of 700mg Leronlimab. By giving only 350mg Leronlimab continuously on a weekly basis, the return of the cancer on average may be appreciated at about 8 - 13 months and was verified as such to be there by measuring the quantity of CAMLs (cancer associated macrophage cells) and CTCs (circulating tumor cells).

Hypothesizing, in the 7/19 PR, the cancer probably started to regrow to produce the CAMLs at about the 5 month point. Switching to the continuous delivery on a weekly basis, we can delay the Active Proliferation of the Cancer until 8 - 10 months while 350mg Leronlimab is continuously injected weekly.

Based on the above, I speculate that we would need to give 700mg weekly on a continuous basis or 700mg weekly for (4) consecutive weeks, repeated every 3rd month, indefinitely, and that may be what is required to stop TNBC in its tracks, and / or to keep it in remission. To stop rekindling of the cancer and the subsequent elevation of these biomarker cells.