Intermediate-size expanded access trial of autologous hybrid treg/TH2 cell therapy (rapa-501) of amyotrophic lateral sclerosis - ALS is a lethal neurodegenerative disease accelerated by…
Active Cooperative Agreement Awarded Last action
- Award ID
- U01NS136020
- Recipient
-
The General Hospital Corporation UEI FLJ7DQKLL226
- Awarding agency
-
National Institute of Neurological Disorders and Stroke
National Institutes of Health, Department of Health and Human Services
- Obligated
- $54,362,651
Award facts
- Assistance listing
- 93.310 Trans-NIH Research Support
- Completion date 85% complete
- Originally
- Funding agency
- Office of the Director National Institutes of Health, Department of Health and Human Services
- Place of performance
- Boston, MA 02114, USA
Award details come from USAspending.gov.
Description
Intermediate-size expanded access trial of autologous hybrid treg/TH2 cell therapy (rapa-501) of amyotrophic lateral sclerosis - ALS is a lethal neurodegenerative disease accelerated by neuroinflammation. Current FDA-approved therapies have modest benefits and do not address inflammation. To address this, rapa therapeutics, LLC (rapa) has developed an autologous t cell therapy (rapa-501) that reduces inflammation, with the goal of reducing ALS morbidity and mortality. Rapa-501 are manufactured EX vivo to attain dual treg/TH2 anti- inflammatory activity and a t-stem phenotype that permits t cell therapy without conditioning chemotherapy. In an ongoing clinical trial of rapa-501 in people with ALS (pwals) (NCT04220190), rapa-501 cells were found to be safe (no product-related adverse events), biologically active (diverse anti-inflammatory effects in pwals), and showed early trends toward stabilizing pulmonary function decline. A phase 2/3 expansion cohort was added to the trial to assess whether rapa-501 is efficacious in standard-risk pwals. We will extend rapa-501 therapy to pwals not eligible for this ongoing phase 2/3 trial or other ALS trials, which nearly universally require that participants have a slow vital capacity (SVC) value of =50% of predicted normal. The proposed EAP will enroll pwals who have SVC values
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $0 | |
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| Amendment | $3,993,521 | |
| Amendment | $3,993,521 | |
| Amendment | $6,151,947 | |
| Amendment | $6,151,947 | |
| Amendment | $11,665,635 | |
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| Amendment | $0 | |
| Amendment | $11,203,040 | |
| Original award | $11,203,040 |
Show all 15
Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| Rapa Therapeutics, LLC | $2,525,822 | |
| Rapa Therapeutics, LLC | $20,387,972 |
Quick answers
Who received award U01NS136020?
U01NS136020 was awarded to The General Hospital Corporation by National Institute of Neurological Disorders and Stroke (National Institutes of Health) on September 25, 2023.
How much is award U01NS136020 worth?
$54,362,651 has been obligated on U01NS136020.
Which agency awarded U01NS136020?
National Institute of Neurological Disorders and Stroke (National Institutes of Health) awarded U01NS136020, with funding from Office of the Director (National Institutes of Health).
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