I provide this to give an idea of how quickly Leronlimab

I provide this to give an idea of how quickly Leronlimab actually works. In some cases, CTC are reduced in just one dose. The evidence of reduced tumor burden is also documented here. The two criteria that the mysterious partner is looking for is Cold to Hot and ORR%. With an open trial, and once 700mg is on board, the results should be evident fairly quickly. The partner does not need to wait to the very end of the trial to enact the S3. They might see the early signals that the trial will deliver and then act upon those.


CytoDyn
NCT03838367
Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC

P1/2
CytoDyn, Inc.
N=48
Active, not recruiting
Non-Randomized
PRNewswire 2025 - Clinical Trials Demonstrate Monitoring PD-L1 Upregulation Using LifeTracDx Blood Test Could Support New Treatment Path for Metastatic Triple Negative Breast Cancer

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"Creatv Bio...in collaboration with CytoDyn Inc...presents promising four-year survival rates from a pooled clinical trial analysis of patients with metastatic triple-negative breast cancer ('mTNBC' treated with leronlimab and PD-L1 immune checkpoint inhibitors ('ICI' ....Results indicated that leronlimab treatment correlated with increased expression of PD-L1 on circulating tumor associated cells, as measured using the LifeTracDx blood test from Creatv. The analysis also revealed promising survival observations among patients who experienced a significant increase in PD-L1 expression and subsequently pursued treatment with an ICI. Four year follow-up results were presented at the ESMO Breast Cancer meeting on May 15, 2025.... In the trials presented at ESMO, results showed that monitoring the expressions of PD-L1 before and after induction of leronlimab using the LifeTracDx blood test identified upregulation of PD-L1 expression in 76% of patients after therapy induction. "

ESMO-BC 2025 (E-Poster, On-demand) - 369P - Observed survival following treatment with Leronlimab in patients with metastatic triple-negative breast cancer (mTNBC)

SABCS 2021 (Poster) - P5-17-08 - A phase Ib/II study of leronlimab combined with carboplatin in patients with CCR5+ metastatic triple-negative breast cancer (mTNBC)
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GlobeNewswire 2021 - CytoDyn’s Final mTNBC Report Indicates as Much as 980% Increase in 12-Month Overall Survival and Up to 660% in 12-Month Modified Progression Free Survival

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P1b/2, N=48; NCT03838367; Sponsor: CytoDyn, Inc; "CytoDyn Inc…announced today an update to previously reported preliminary results from its Phase 1b/2 trials and compassionate use with leronlimab to treat a total of 30 metastatic triple-negative breast cancer (mTNBC) patients. Decrease in Circulating Tumor Cells (CTC) as reported using the LifeTracDx™ test developed by Creatv MicroTech, Inc., after induction with leronlimab was associated with a 400%-660% increase in mPFS .../12-month PFS (Progression Free Survival) and a 570%-980% increase in mOS (modified Overall Survival) /12-month OS (Overall Survival). Decreases in CTC after leronlimab induction were seen in 73% of the 30 patients in the study.

LifeTracDx™ appears to aid as a parallel diagnostic tool in identifying patients that respond to leronlimab. Data from these 30 patients are aligned with the premise that a majority of mTNBC patients respond to leronlimab if CTC reduction is is observed following one leronlimab dose. "

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GlobeNewswire 2021 - CytoDyn Announces Preliminary Results from 30 mTNBC Patients Treated with Leronlimab. Decreases in CAMLs after 4 Doses of Leronlimab were Identified in Over 70% of Patients and were Associated with a 450% Significant Increase in Overall Survival at 12-Month Analysis

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P1b/2, N=48; NCT03838367; Sponsor: CytoDyn, Inc; “CytoDyn will seek FDA guidance on proceeding with an expedited regulatory plan for approval of leronlimab with existing FDA Fast Track designation for mTNBC…Key findings from the interim 12-month analysis include the following: 72% of patients had a decrease in CAMLs (cancer-associated macrophage-like cells) ~30 days after induction of leronlimab - The decrease in CAMLs was associated with: A ~300% increase in mean progression-free survival (mPFS); A significant ~450% increase in overall survival (OS) at 12 months;

High CCR5 in tumor tissue biopsies may help to stratify patients likely to progress on leronlimab; Decreases in CAMLs and CTCs (circulating tumor cells) appear to be related to slower progression and lower mortality; CAMLs appear to identify populations that are responding to leronlimab.”

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AACR-I 2020 (Poster) - CT233 - [VIRTUAL] Phase Ib/II study of leronlimab (PRO 140) combined with carboplatin in CCR5+ mTNBC patients
GlobeNewswire 2020 - CytoDyn reports remarkable outcomes for additional cancer patients in mTNBC Trial; following an overwhelming community response , CytoDyn expects to enroll more than 20 patients in its 22 solid tumor cancer trial in the next 60 days

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P1/2, N=48; NCT03838367; Sponsor: CytoDyn, Inc; “CytoDyn Inc…announced today continued positive data for its mTNBC and MBC patients…The proposed mechanism of action (MOA) consisting of inhibition of Tregs and repolarization of macrophages has demonstrated a predictable, sustained response that has reduced the size of primary and metastatic tumors and reduced circulating tumor cells in all patients tested so far. ’”

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GlobeNewswire 2020 - CytoDyn reports continued positive clinical data on its phase 1b/2 mTNBC and expanded access studies for MBC ahead of Breakthrough Therapy Designation Decision from the FDA

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P1/2, N=48; NCT03838367; Sponsor: CytoDyn, Inc; “CytoDyn Inc…announced today continued positive data for its mTNBC and MBC patients…’The patients enrolled in the mTNBC Phase 1b/2 trial continue to demonstrate meaningful results that support the hypothesis regarding leronlimab’s mechanism of action’…’In the four patients (1 with MBC, 3 with TNBC) now with results from leronlimab therapy, patients #1-3 have zero CTCs and zero EMTs and Patient #4, who has been treated with leronlimab for 2 weeks showed a decrease of CTCs and EMTs from 8 to 2. New data from Patient #2 with Stage 4 MBC and who has been treated with 10 weekly doses of leronlimab showed zero CTCs and zero EMTs, in addition to the shrinkage or disappearance of some brain metastases as previously reported. ’”

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GlobeNewswire 2020 - CytoDyn announces stunning results from clinical trials evaluating mTNBC and MBC with leronlimab and will request an emergency type C meeting with FDA to enroll 50 awaiting patients with a serious solid tumor cancer condition

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P1/2, N=48; NCT03838367; Sponsor: CytoDyn, Inc; “New data from the first patient enrolled in the Company’s mTNBC Phase 1b/2 trial showed no detectable levels of circulating tumor cells (CTC) with leronlimab in combination with carboplatin at 16 weeks of treatment….New data from the second patient enrolled in the Company’s mTNBC Phase 1b/2 trial showed no detectable levels of CTC with leronlimab in combination with carboplatin after two weeks of treatment. This patient also showed a 70% reduction in EMT cells after just two weeks of treatment. Initial data from the third patient in the mTNBC trial indicated the CTC dropped to zero after two weeks of treatment with leronlimab ….we have heard from over 50 individuals who are waiting to be treated with leronlimab and our regulatory team is reaching out to the FDA to organize an emergency Type C meeting to discuss the data evidenced in our clinical trials.”

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GlobeNewswire 2020 - Impressive results continue from CytoDyn’s clinical trials evaluating two patients with leronlimab, one in mTNBC and one in MBC

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P1/2, N=48; NCT03838367; Sponsor: CytoDyn, Inc; “CytoDyn Inc….announced today additional promising results from its clinical trials evaluating leronlimab for the treatment of metastatic triple-negative breast cancer (mTNBC) and metastatic breast cancer (MBC). New data from the first patient enrolled in the Company’s metastatic triple-negative breast (mTNBC) Phase 1b/2 trial continues to show no detectable levels of circulating tumor cells (CTC) or putative metastatic cells in the peripheral blood following 15 weeks of treatment with leronlimab in combination with carboplatin. The second patient, enrolled through an emergency investigational new drug (IND) with stage 4 HER2+ MBC that has metastasized to the liver, lung and brain, showed a 50 percent shrinkage of the primary tumor and no new metastasis in the brain after treatment with leronlimab as a monotherapy. "

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GlobeNewswire 2020 - CytoDyn files for Breakthrough Therapy Designation with the FDA for the use of leronlimab for the treatment of metastatic triple-negative breast cancer
“CytoDyn Inc…announced today that the Company has filed for Breakthrough Therapy designation (BTD) with the U.S. Food and Drug Administration (FDA) for the use of leronlimab as an adjuvant therapy for the treatment of metastatic triple-negative breast cancer (mTNBC). The BTD filing is based on data from the first patient in the Company’s mTNBC Phase 1b/2 trial and an additional single-patient trial under an emergency investigational new drug (IND) protocol evaluating leronlimab for the treatment of HER2+ metastatic, stage 4, breast cancer (MBC).”