Doing some DD on LATCH with Chat because I’ve be
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Posted On: 02/22/2025 9:42:05 AM
Doing some DD on LATCH with Chat because I’ve been thinking it could be announced before summer.
“You’re absolutely right to hone in on the LATCH study—it’s a pivotal piece of CytoDyn’s HIV cure puzzle, and it is intended for humans! I’ll clarify its status, assess the likelihood of an imminent announcement, and explore what it could mean for CytoDyn’s future ). Let’s dig in with the latest info and some critical reasoning.
LATCH Study: Human Trial Confirmation
The LATCH study—Leronlimab in Allogenic Transplant to Cure HIV—is indeed a human clinical trial, not just a preclinical effort. CytoDyn’s December 2024 shareholder letter explicitly states they’re partnering with amfAR (American Foundation for AIDS Research) to sponsor this study, which “will use leronlimab to protect CCR5+ donor immune cells from HIV infection while aiming for a cure in the setting of bone marrow transplantation provided to an HIV+ recipient.” This builds on:
• Preclinical Roots: OHSU’s work (e.g., NIH Grant 5R01AI129703) showed Leronlimab mimics a CCR5Δ32/Δ32 donor in primates, a concept proven in human cures like the Berlin and London patients.
• Human Intent: The letter emphasizes a clinical focus, and amfAR’s involvement—known for human cure research—confirms it’s not just monkeys this time. Plus, a German team’s interest in replicating LATCH in Berlin after their heterozygous CCR5 cure success further signals a human trial framework.
So, yes, LATCH is CytoDyn’s first explicit step into testing Leronlimab as a cure in humans, likely a Phase I or I/II trial given its exploratory nature.
Could They Announce It Soon?
As of February 22, 2025, here’s why an announcement (e.g., FDA clearance or trial initiation) might be plausible soon—and why it might not:
Reasons It Could Happen Soon
1 Momentum from 2024:
◦ The December 2024 letter says LATCH was “previously announced,” suggesting planning was advanced by late last year. With Max Lataillade onboard since June 2024, his regulatory expertise (from ViiV and BMS) could’ve fast-tracked FDA submission.
◦ The OHSU Gates grant (February 2025) for reservoir analysis could provide supporting data, nudging LATCH toward clearance.
2 Lataillade’s Dual Role:
◦ As Gates’ Head of HIV Drug Development, he’s got influence to align resources. If he’s pushing LATCH as a Gates priority, an announcement could tie into the Foundation’s 2025 agenda, possibly Q2 or Q3.
3 External Interest:
◦ German researchers requesting to run a parallel LATCH study (per the letter) adds urgency. CytoDyn’s “taking steps to make this a reality” suggests active progress, potentially prompting a public update.
4 Typical Timelines:
◦ If CytoDyn submitted an Investigational New Drug (IND) application in late 2024, FDA review takes ~30 days. A January 2025 submission could mean clearance by March/April 2025—ripe for a spring announcement.
“You’re absolutely right to hone in on the LATCH study—it’s a pivotal piece of CytoDyn’s HIV cure puzzle, and it is intended for humans! I’ll clarify its status, assess the likelihood of an imminent announcement, and explore what it could mean for CytoDyn’s future ). Let’s dig in with the latest info and some critical reasoning.
LATCH Study: Human Trial Confirmation
The LATCH study—Leronlimab in Allogenic Transplant to Cure HIV—is indeed a human clinical trial, not just a preclinical effort. CytoDyn’s December 2024 shareholder letter explicitly states they’re partnering with amfAR (American Foundation for AIDS Research) to sponsor this study, which “will use leronlimab to protect CCR5+ donor immune cells from HIV infection while aiming for a cure in the setting of bone marrow transplantation provided to an HIV+ recipient.” This builds on:
• Preclinical Roots: OHSU’s work (e.g., NIH Grant 5R01AI129703) showed Leronlimab mimics a CCR5Δ32/Δ32 donor in primates, a concept proven in human cures like the Berlin and London patients.
• Human Intent: The letter emphasizes a clinical focus, and amfAR’s involvement—known for human cure research—confirms it’s not just monkeys this time. Plus, a German team’s interest in replicating LATCH in Berlin after their heterozygous CCR5 cure success further signals a human trial framework.
So, yes, LATCH is CytoDyn’s first explicit step into testing Leronlimab as a cure in humans, likely a Phase I or I/II trial given its exploratory nature.
Could They Announce It Soon?
As of February 22, 2025, here’s why an announcement (e.g., FDA clearance or trial initiation) might be plausible soon—and why it might not:
Reasons It Could Happen Soon
1 Momentum from 2024:
◦ The December 2024 letter says LATCH was “previously announced,” suggesting planning was advanced by late last year. With Max Lataillade onboard since June 2024, his regulatory expertise (from ViiV and BMS) could’ve fast-tracked FDA submission.
◦ The OHSU Gates grant (February 2025) for reservoir analysis could provide supporting data, nudging LATCH toward clearance.
2 Lataillade’s Dual Role:
◦ As Gates’ Head of HIV Drug Development, he’s got influence to align resources. If he’s pushing LATCH as a Gates priority, an announcement could tie into the Foundation’s 2025 agenda, possibly Q2 or Q3.
3 External Interest:
◦ German researchers requesting to run a parallel LATCH study (per the letter) adds urgency. CytoDyn’s “taking steps to make this a reality” suggests active progress, potentially prompting a public update.
4 Typical Timelines:
◦ If CytoDyn submitted an Investigational New Drug (IND) application in late 2024, FDA review takes ~30 days. A January 2025 submission could mean clearance by March/April 2025—ripe for a spring announcement.
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Daniel Rizzo
Federal Whistleblower / Special Operations Tactical Unit
USAF: Phoenix Raven #2143
HHS & SEC Whistleblower: HL-1412396
DOJ Investigation Report/ Whistleblower ID: 20250705-0001
NIH Case Reference: CS1137565
Founder & CEO of FireGate Bioscience
USPTO: Lead Inventor of the HIV Cure & AI Federal Oversight Program
⸻
Public Links
FireGate Bioscience: https://www.firegatebioscience.com
NotYourDrug.com: https://www.notyourdrug.com
Federal Whistleblower / Special Operations Tactical Unit
USAF: Phoenix Raven #2143
HHS & SEC Whistleblower: HL-1412396
DOJ Investigation Report/ Whistleblower ID: 20250705-0001
NIH Case Reference: CS1137565
Founder & CEO of FireGate Bioscience
USPTO: Lead Inventor of the HIV Cure & AI Federal Oversight Program
⸻
Public Links
FireGate Bioscience: https://www.firegatebioscience.com
NotYourDrug.com: https://www.notyourdrug.com