During the webcast, Dr. Lalezari explicitly stated that all of the CytoDyn-sponsored projects in colon and breast cancer (including the KLEOS network studies, the PRE-I-SPY trials, and the UCLA/City of Hope translational biopsy work) have enjoyed discounted budgeting by their partners. He noted that these structural discounts are highly appreciated because they allow the company to move as quickly and efficiently as possible while preserving capital.
The horizontal expansion strategy is organized into two distinct clinical tracks: CytoDyn-Sponsored Trials (moving the drug into earlier lines of therapy) and Externally Funded Trials (100% funded by outside academic centers).
TRACK A: CYTODYN-SPONSORED PLATFORMS (Earlier Lines & Combination Logic)
1. The Colorectal Cancer (CRC) Pipeline
• The PRE-I-SPY Pilot Trial (3L Metastatic CRC):
• The Cohort: Refractory 3rd-line metastatic colorectal cancer patients.
• The Regimen: Leronlimab combined with an immune checkpoint inhibitor (ICI) to execute the "Prime & Pair" uncloaking clearance.
• Status: Protocol design is currently being finalized; enrollment is slated to begin before the end of December 2026.
• The KLEOS Network Initiative (Early-Stage Stage I–III CRC):
• The Cohort: Patients presenting with earlier-stage colon cancer (where tumor immune systems are less depleted, expecting more dramatic clearance kinetics).
• The Regimen: Evaluated as an early-intervention anti-cancer therapeutic.
• Status: Contract negotiations are actively underway across the KLEOS network of academic GI oncology centers.
• The UCLA / City of Hope Translational Core Study:
• The Objective: A dedicated tissue-biopsy trial led by Dr. Pashtoon Kasi (City of Hope) and Dr. Otto Yang (UCLA).
• The Metrics: Obtains and analyzes pre- and post-treatment tumor tissue to explicitly map CD8+ T-cell infiltration, M2-to-M1 macrophage repolarization, and the structural reversal of microenvironmental immune exhaustion.
2. The Breast Cancer (mTNBC) Pipeline
• The PRE-I-SPY Metastatic Trial (1L / 2L Metastatic TNBC):
• The Cohort: Advanced metastatic Triple-Negative Breast Cancer in first- or second-line settings.
• The Combination Arms: Superimposes leronlimab + an ICI directly onto either a TRODELVY (sacituzumab govitecan) backbone or a gemcitabine/carboplatin chemotherapy doublet.
• Status: Protocol is fully finalized; patient dosing escalation is preparing to kick off.
• The Parent I-SPY Neoadjuvant Trial (True Front-Line Monotherapy):
• The Cohort: Newly diagnosed, early-stage HER2-negative breast cancer patients.
• The Regimen: True leronlimab monotherapy administered in the neoadjuvant (pre-surgery) setting to reset the microenvironment.
• Status: Slated for immediate activation by the master I-SPY network the moment the PRE-I-SPY metastatic safety dosing cohort wraps up.
TRACK B: EXTERNALLY FUNDED CLINICAL PIPELINES (0% CytoDyn Capital Outlay)
These studies are fully organized, driven, and funded by outside academic medical institutions:
1. Oncology & Hematology Expansions
• Pancreatic Cancer (Mayo Clinic): Protocol drafting is actively underway for a trial testing leronlimab combined with immunotherapy—with 0% ICI delay—to instantly penetrate and melt the hyper-fibrotic pancreatic stroma wall.
• Acute Myeloid Leukemia (AML - University of Rochester): A human pilot study based on data proving that bone marrow CCR5 trafficking drives pathogenic leukemia cell survival. The Rochester team has already initiated localized fundraising and protocol drafting.
• Glioblastoma Multiforme (GBM - University of Alabama): Active protocol drafting for a clinical trial evaluating leronlimab's capacity to disrupt the neuro-stromal pathways supporting recurrent brain tumors.
• Head & Neck Cancer (Emory University): Early clinical discussions for a pilot trial pairing leronlimab + an ICI to treat refractory, HPV-associated head and neck squamous cell carcinoma (HNSCC).
2. Neuroscience & Neurodegeneration
• Alzheimer's Disease (SALIENT-AD - Weill Cornell):
• Status: The trial is 50% enrolled and actively recruiting out-of-state patients to accelerate the remaining runway.
• The Readout: Features an objective radiologic endpoint (neuroimaging tracking of neuroinflammatory and structural volume stabilization), with the unblinded data set locked to read out within 4 months of the final patient enrollment date.
The horizontal expansion strategy is organized into two distinct clinical tracks: CytoDyn-Sponsored Trials (moving the drug into earlier lines of therapy) and Externally Funded Trials (100% funded by outside academic centers).
TRACK A: CYTODYN-SPONSORED PLATFORMS (Earlier Lines & Combination Logic)
1. The Colorectal Cancer (CRC) Pipeline
• The PRE-I-SPY Pilot Trial (3L Metastatic CRC):
• The Cohort: Refractory 3rd-line metastatic colorectal cancer patients.
• The Regimen: Leronlimab combined with an immune checkpoint inhibitor (ICI) to execute the "Prime & Pair" uncloaking clearance.
• Status: Protocol design is currently being finalized; enrollment is slated to begin before the end of December 2026.
• The KLEOS Network Initiative (Early-Stage Stage I–III CRC):
• The Cohort: Patients presenting with earlier-stage colon cancer (where tumor immune systems are less depleted, expecting more dramatic clearance kinetics).
• The Regimen: Evaluated as an early-intervention anti-cancer therapeutic.
• Status: Contract negotiations are actively underway across the KLEOS network of academic GI oncology centers.
• The UCLA / City of Hope Translational Core Study:
• The Objective: A dedicated tissue-biopsy trial led by Dr. Pashtoon Kasi (City of Hope) and Dr. Otto Yang (UCLA).
• The Metrics: Obtains and analyzes pre- and post-treatment tumor tissue to explicitly map CD8+ T-cell infiltration, M2-to-M1 macrophage repolarization, and the structural reversal of microenvironmental immune exhaustion.
2. The Breast Cancer (mTNBC) Pipeline
• The PRE-I-SPY Metastatic Trial (1L / 2L Metastatic TNBC):
• The Cohort: Advanced metastatic Triple-Negative Breast Cancer in first- or second-line settings.
• The Combination Arms: Superimposes leronlimab + an ICI directly onto either a TRODELVY (sacituzumab govitecan) backbone or a gemcitabine/carboplatin chemotherapy doublet.
• Status: Protocol is fully finalized; patient dosing escalation is preparing to kick off.
• The Parent I-SPY Neoadjuvant Trial (True Front-Line Monotherapy):
• The Cohort: Newly diagnosed, early-stage HER2-negative breast cancer patients.
• The Regimen: True leronlimab monotherapy administered in the neoadjuvant (pre-surgery) setting to reset the microenvironment.
• Status: Slated for immediate activation by the master I-SPY network the moment the PRE-I-SPY metastatic safety dosing cohort wraps up.
TRACK B: EXTERNALLY FUNDED CLINICAL PIPELINES (0% CytoDyn Capital Outlay)
These studies are fully organized, driven, and funded by outside academic medical institutions:
1. Oncology & Hematology Expansions
• Pancreatic Cancer (Mayo Clinic): Protocol drafting is actively underway for a trial testing leronlimab combined with immunotherapy—with 0% ICI delay—to instantly penetrate and melt the hyper-fibrotic pancreatic stroma wall.
• Acute Myeloid Leukemia (AML - University of Rochester): A human pilot study based on data proving that bone marrow CCR5 trafficking drives pathogenic leukemia cell survival. The Rochester team has already initiated localized fundraising and protocol drafting.
• Glioblastoma Multiforme (GBM - University of Alabama): Active protocol drafting for a clinical trial evaluating leronlimab's capacity to disrupt the neuro-stromal pathways supporting recurrent brain tumors.
• Head & Neck Cancer (Emory University): Early clinical discussions for a pilot trial pairing leronlimab + an ICI to treat refractory, HPV-associated head and neck squamous cell carcinoma (HNSCC).
2. Neuroscience & Neurodegeneration
• Alzheimer's Disease (SALIENT-AD - Weill Cornell):
• Status: The trial is 50% enrolled and actively recruiting out-of-state patients to accelerate the remaining runway.
• The Readout: Features an objective radiologic endpoint (neuroimaging tracking of neuroinflammatory and structural volume stabilization), with the unblinded data set locked to read out within 4 months of the final patient enrollment date.
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