We have a GOLDEN opportunity to progress from the recent (extraordinary) success of Dr. Sacha’s and colleagues at OHSU with infant rhesus macaques.
As a short remainder, this study tested a triple combination therapy in infant macaques infected with HIV: broadly neutralizing antibodies (bnAbs) targeting the HIV envelope, standard antiretroviral therapy (ART) plus our Leronlimab.
The key finding was that the above combo significantly reduced viral reservoir seeding when given 72 hours post infection, meaning it prevented HIV from establishing long term persistence in the infants’ immune cells demonstrating that bnAbs + CCR5 blockade + ART can dramatically limit early HIV reservoir formation. After treatment the macaques have stayed healthy, maintained viral suppression and did not (and have not) experience viral rebound.
Now, around 130,000 infants acquire HIV each year, and mortality in the first year remains ~10%, even with early antiretroviral therapy (ART). Only 25–35% of infants achieve viral suppression after one year. Human infants (similar to macaques) have extremely high baseline viral loads, immature immune systems and limited ART options leading to difficulty achieving durable viral suppression.
To address this problematic several countries and institutions partnered to add a new layer of protection using broadly neutralizing antibodies (bnAbs) on top of ART.
The ENABLE project (four years EU/Global Health collaboration), launched in January 2026, aims to add the extra layer of protection using two long acting broadly neutralizing antibodies (bnAbs), namely: ePGT121v1 LS and VRC07 523 LS adding them to the standard ART at diagnosis with the aim to rapidly reduce viral load, improve viral suppression at 12 months, reduce mortality and, hopefully, provide sustained protection (bnAbs last ~3 months in the bloodstream).
These are the SAME bnAbs used in the OHSU study.
Now I guess you know where I am going !!! ENABLE project = ART + broadly neutralizing antibodies (bnAbs).
[color=rgb(220, 24, 41)]So, what is missing ??[/color] Yes !! Leronlimab !!!!
If I was Dr. Sacha or CYDY I would be pounding the door of the ENABLE administrators and telling them that there is a missing component of their trial that has proven to be safe and, dammit, stops HIV !!, and, has already been proven with macaques (very) successfully.
The ENABLE project is ongoing, has been funded and involves 21 institutions across Africa, Europe and the U.S and is conducting a Phase II/III clinical trial at eight sites in Cameroon, Mozambique, and South Africa comparing two groups:
- Standard ART alone
- ART + bnAbs at diagnosis, 3, 6, and 9 months
With the primary outcome of Viral suppression at 12 months (also reduce viral load by up to 95% early in treatment, improve survival, reduce long term HIV reservoir formation and … you guessed it: potentially contribute to future functional cure strategies.
Are you kidding me ???
So, here we have it. The only thing we need is to add Leronlimab (very safe drug) to a third group and see the (almost granted) results!!!. We just cannot afford to leave "out there" 130000 babies per year having the (potential) cure that will transform their lives. Is just not right.
I am not naïve enough to think that one can just show up with some vials of LL and demand to use in one cohort. But this project has 4 years duration, is founded, just started and MAKES SENSE There is time to propose it, design the parameters of the addition of LL to trials protocol and go through the regulatory path either with the FDA or the EMA (European Medicines Agency).
Go and pound the door please (and bring it down if necessary) !!!!
PD: Dr. Sacha and/or Dr. Haigwood, if you are reading: The coordinator of the ENABLE project is SERMAS (Servicio Madrileño de Salud) in Spain represented by Hospital Universitario 12 de Octubre
Address: Av. de Córdoba, s/n 28041 Madrid, Spain
Telephone: +34 91 390 80 00 Ask for ask for research administration or infectious disease research coordination
As a short remainder, this study tested a triple combination therapy in infant macaques infected with HIV: broadly neutralizing antibodies (bnAbs) targeting the HIV envelope, standard antiretroviral therapy (ART) plus our Leronlimab.
The key finding was that the above combo significantly reduced viral reservoir seeding when given 72 hours post infection, meaning it prevented HIV from establishing long term persistence in the infants’ immune cells demonstrating that bnAbs + CCR5 blockade + ART can dramatically limit early HIV reservoir formation. After treatment the macaques have stayed healthy, maintained viral suppression and did not (and have not) experience viral rebound.
Now, around 130,000 infants acquire HIV each year, and mortality in the first year remains ~10%, even with early antiretroviral therapy (ART). Only 25–35% of infants achieve viral suppression after one year. Human infants (similar to macaques) have extremely high baseline viral loads, immature immune systems and limited ART options leading to difficulty achieving durable viral suppression.
To address this problematic several countries and institutions partnered to add a new layer of protection using broadly neutralizing antibodies (bnAbs) on top of ART.
The ENABLE project (four years EU/Global Health collaboration), launched in January 2026, aims to add the extra layer of protection using two long acting broadly neutralizing antibodies (bnAbs), namely: ePGT121v1 LS and VRC07 523 LS adding them to the standard ART at diagnosis with the aim to rapidly reduce viral load, improve viral suppression at 12 months, reduce mortality and, hopefully, provide sustained protection (bnAbs last ~3 months in the bloodstream).
These are the SAME bnAbs used in the OHSU study.
Now I guess you know where I am going !!! ENABLE project = ART + broadly neutralizing antibodies (bnAbs).
[color=rgb(220, 24, 41)]So, what is missing ??[/color] Yes !! Leronlimab !!!!
If I was Dr. Sacha or CYDY I would be pounding the door of the ENABLE administrators and telling them that there is a missing component of their trial that has proven to be safe and, dammit, stops HIV !!, and, has already been proven with macaques (very) successfully.
The ENABLE project is ongoing, has been funded and involves 21 institutions across Africa, Europe and the U.S and is conducting a Phase II/III clinical trial at eight sites in Cameroon, Mozambique, and South Africa comparing two groups:
- Standard ART alone
- ART + bnAbs at diagnosis, 3, 6, and 9 months
With the primary outcome of Viral suppression at 12 months (also reduce viral load by up to 95% early in treatment, improve survival, reduce long term HIV reservoir formation and … you guessed it: potentially contribute to future functional cure strategies.
Are you kidding me ???
So, here we have it. The only thing we need is to add Leronlimab (very safe drug) to a third group and see the (almost granted) results!!!. We just cannot afford to leave "out there" 130000 babies per year having the (potential) cure that will transform their lives. Is just not right.
I am not naïve enough to think that one can just show up with some vials of LL and demand to use in one cohort. But this project has 4 years duration, is founded, just started and MAKES SENSE There is time to propose it, design the parameters of the addition of LL to trials protocol and go through the regulatory path either with the FDA or the EMA (European Medicines Agency).
Go and pound the door please (and bring it down if necessary) !!!!
PD: Dr. Sacha and/or Dr. Haigwood, if you are reading: The coordinator of the ENABLE project is SERMAS (Servicio Madrileño de Salud) in Spain represented by Hospital Universitario 12 de Octubre
Address: Av. de Córdoba, s/n 28041 Madrid, Spain
Telephone: +34 91 390 80 00 Ask for ask for research administration or infectious disease research coordination
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