You ask, "So what exactly does this mean?"
It means a couple things. Let's break it down.
"a study of subcutaneous leronlimab given in combination with a regimen of chemotherapy administered through the hepatic artery in treatment-naïve patients with mCRC who have metastatic disease confined to the liver."
This is exciting because it's a new way to use Leronlimab in crc patients. Treatment naive means they haven't had any drugs yet. The basic idea is that by getting LL in early we can show a benefit mitigating liver toxicity along with the other proposed benefits of our drug. To me, this screams of breakthrough designation.
"This study seeks to leverage CytoDyn’s previously announced data demonstrating leronlimab’s ability to mitigate liver toxicity in prior preclinical studies, as well as certain preliminary results from the phase II CRC study."
How great is that? We're already seeing results in the biomarkers of 16 patients enrolled that they feel it bolsters the hypothesis and previous data collected in the patients who have tried LL years prior.
"This study is intended to provide CytoDyn with important tumor tissue from patients treated with leronlimab. This tissue will enable us to correlate tumor levels of PD-L1 with levels concurrently measured in blood on circulating tumor cells. This tissue will also provide CytoDyn the opportunity to further clarify and understand the leronlimab-induced changes in the tumor microenvironment (TME) that lie at the heart of the “Prime and Pair” paradigm."[/i]
This is going to prove our cold-to-hot MOA in a secondary way and that's extremely beneficial. Double the proof, baby.
It remains to be seen exactly how the trial will be designed, but if part of the purpose is to get tissue samples and be able to correlate tumor levels of PDL1 with those measured in the blood on circulating tumor cells, I'd imagine patients will know what they're getting and that everyone will be getting the drug.
This part of the letter seems a bit slept on but I think it has some huge potential payoff for us.
It means a couple things. Let's break it down.
"a study of subcutaneous leronlimab given in combination with a regimen of chemotherapy administered through the hepatic artery in treatment-naïve patients with mCRC who have metastatic disease confined to the liver."
This is exciting because it's a new way to use Leronlimab in crc patients. Treatment naive means they haven't had any drugs yet. The basic idea is that by getting LL in early we can show a benefit mitigating liver toxicity along with the other proposed benefits of our drug. To me, this screams of breakthrough designation.
"This study seeks to leverage CytoDyn’s previously announced data demonstrating leronlimab’s ability to mitigate liver toxicity in prior preclinical studies, as well as certain preliminary results from the phase II CRC study."
How great is that? We're already seeing results in the biomarkers of 16 patients enrolled that they feel it bolsters the hypothesis and previous data collected in the patients who have tried LL years prior.
"This study is intended to provide CytoDyn with important tumor tissue from patients treated with leronlimab. This tissue will enable us to correlate tumor levels of PD-L1 with levels concurrently measured in blood on circulating tumor cells. This tissue will also provide CytoDyn the opportunity to further clarify and understand the leronlimab-induced changes in the tumor microenvironment (TME) that lie at the heart of the “Prime and Pair” paradigm."[/i]
This is going to prove our cold-to-hot MOA in a secondary way and that's extremely beneficial. Double the proof, baby.
It remains to be seen exactly how the trial will be designed, but if part of the purpose is to get tissue samples and be able to correlate tumor levels of PDL1 with those measured in the blood on circulating tumor cells, I'd imagine patients will know what they're getting and that everyone will be getting the drug.
This part of the letter seems a bit slept on but I think it has some huge potential payoff for us.
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