Great point Ken, I just don't think that GBM data comes out before 9/10/2025, but the mTNBC Pre-Clinicals could.
From December 2024 Letter to Shareholders
From March Shareholder letter
From Lalezari's Interview
From December 2024 Letter to Shareholders
Quote:"The Company has committed to repeating the study based on unpublished observations by Dr. Pestell’s lab and will now employ a treatment sequence involving temozolomide and leronlimab. This follow-up study will start immediately and should help clarify the potential therapeutic benefit of leronlimab in the treatment of GBM. CytoDyn is also currently in discussions with a key opinion leader in neuro-oncology about the possibility of initiating a pilot study in patients with GBM based on Dr. Pestell’s unpublished work and the outcome of the follow-up preclinical study."
From March Shareholder letter
Quote:"The Company also continues to explore the possible use of leronlimab in the treatment of glioblastoma multiforme (“GBM”). A preclinical study at the Albert Einstein College of Medicine sequencing temozolomide and leronlimab is now underway. CytoDyn is also in discussions with several KOLs in neuro-oncology about the possibility of initiating a pilot study in patients with GBM, also based on currently available data."
From Lalezari's Interview
Quote:"[00:31:15]: So we have the parent CRC study, a rollover with checkpoints for the CRC study, a phase 2 program for triple negative breast cancer, a compassionate use program for triple negatives, as well. And sort of the third leg of our oncology program is we've been dealing with a couple of key opinion leaders neuro-oncologists who have proposed an investigator-initiated study on glioblastoma.
[00:31:39] Okay. Again glioblastoma is one of those cancers that uses CCR5 and when you [culture glioblastoma cells with Leronlimab] put glioblastoma co-culture it with Leronlimab, those cells express PD-L1. So what they're proposing is, we know Leronlimab gets into the central nervous system, [it crosses the blood brain barrier BBB]. It gets fed across [the BBB] presumably bound to T-cells and we know this from studies in Macaques and the idea from these investigators is we do not know the site of action for the PD1 inhibitors. We don't know if it has to be in the tumor micro environment or within the brain or whether it could potentially be in the periphery.
[00:32:25]: So the idea is with patients with recurrent glioblastoma who have absolutely no treatment options, we want to give them Leronlimab in advance of their surgery, measure their PD-L1 induction and then offer them a checkpoint inhibitor with the hopes that the checkpoint activity is in the periphery, [because the ICI doesn't cross the BBB, but can reach the periphery], and then activated cells can then enter the brain and attack the [GBM] cancer that has had a disrupted micro-environment. It's a bit of a bank-shot. But one tries what one can."
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