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▎WuXi AppTec content team editor Atara Biotherapeutics has updated new advances in its Phase 1 clinical trial of ATA188, an allogeneic T-cell immunotherapy targeting Epstein-Barr virus (EBV), in progressive multiple sclerosis, including new magnetic resonance imaging (MRI) biomarkers and open-label extension (OLE) trial data
.
The results showed that most patients treated with ATA188 achieved long-term and durable clinical disability improvement, and all patients who achieved stable disease in the OLE trial remained stable
for 48 months.
Multiple sclerosis (MS) is a chronic autoimmune disease
that occurs when the immune system attacks the myelin sheath that protects nerves.
The progression of MS leads to a decline
in bodily functions (e.
g.
, walking) and cognitive functions (e.
g.
, memory).
EBV is the leading cause of
MS from onset to progression.
EBV infection increases the risk of multiple sclerosis 32-fold
in susceptible people.
B cells infected with EBV drive pathological changes
in MS by stimulating autoimmune T cells and differentiating into autoimmune plasma cells.
These EBV-infected B cells are found in the central nervous system (CNS) and are able to cause chronic inflammation and produce reactive antibodies
against certain brain proteins.
Specifically targeting EBV-infected immune cells represents a new targeted therapy
.
ATA188 is an investigational off-the-shelf allogeneic T cell immunotherapy developed by Atara to specifically target EBV-infected B cells and plasma cells in progressive MS and reduce the attack
on nerve myelin sheaths.
Data from the Phase 1 clinical trial presented this time show that in the initial 12-month or OLE trial, 7 of 24 patients achieved confirmed disability improvement (CDI), 13 had stable EDSS, and 4 had confirmed disability progression ( CDP)
。 In addition, nine people met the Continuous Disability Improvement (SDI) criteria, a composite scale
that combines EDSS scores with the timed 25-foot walk test.
These data indicate that ATA188 is well tolerated and has a consistent safety profile as previously reported, with no > grade 3 events, dose-limiting toxicity, cytokine release syndrome, or graft-versus-host disease
.
As of September 2022, patients who received CDI in the OLE trial have been followed for 46.
5 months
.
All 5 patients who received CDI maintained CDI for a median of 27.
5 months, and all 8 patients who received stable EDSS maintained a stable EDSS for a median of 41.
2 months
.
In addition, patients treated with ATA188 and received CDI showed a significant reduction
in brain atrophy on longitudinal analysis of MRI images at 42 months.
"New biomarker imaging data suggest that brain structural changes and potential myelin regeneration may underlie the clinical disability improvement observed after ATA188 treatment," said Dr.
AJ Joshi, Chief Medical Officer at Atara, "We are pleased to see that the majority of patients experience CDI based on improved or long-term stable EDSS, which also indicates a shift in the natural progression process relative to expectations.
"
。 "
As WuXi AppTec's CTDMO focused on cell and gene therapies, WuXi Biologics is committed to accelerating and transforming the development, testing, manufacturing and commercialization of gene and cell therapies and other high-end therapies
。 WuXi Biologics can help customers around the world bring more innovative therapies to market sooner rather than later, benefiting patients
.
If you have related business needs, please click the picture below to fill in the specific information
.
▲If you have any business needs, please long press to scan the QR code above, or
.
The results showed that most patients treated with ATA188 achieved long-term and durable clinical disability improvement, and all patients who achieved stable disease in the OLE trial remained stable
for 48 months.
Multiple sclerosis (MS) is a chronic autoimmune disease
that occurs when the immune system attacks the myelin sheath that protects nerves.
The progression of MS leads to a decline
in bodily functions (e.
g.
, walking) and cognitive functions (e.
g.
, memory).
EBV is the leading cause of
MS from onset to progression.
EBV infection increases the risk of multiple sclerosis 32-fold
in susceptible people.
B cells infected with EBV drive pathological changes
in MS by stimulating autoimmune T cells and differentiating into autoimmune plasma cells.
These EBV-infected B cells are found in the central nervous system (CNS) and are able to cause chronic inflammation and produce reactive antibodies
against certain brain proteins.
Specifically targeting EBV-infected immune cells represents a new targeted therapy
.
ATA188 is an investigational off-the-shelf allogeneic T cell immunotherapy developed by Atara to specifically target EBV-infected B cells and plasma cells in progressive MS and reduce the attack
on nerve myelin sheaths.
Data from the Phase 1 clinical trial presented this time show that in the initial 12-month or OLE trial, 7 of 24 patients achieved confirmed disability improvement (CDI), 13 had stable EDSS, and 4 had confirmed disability progression ( CDP)
。 In addition, nine people met the Continuous Disability Improvement (SDI) criteria, a composite scale
that combines EDSS scores with the timed 25-foot walk test.
These data indicate that ATA188 is well tolerated and has a consistent safety profile as previously reported, with no > grade 3 events, dose-limiting toxicity, cytokine release syndrome, or graft-versus-host disease
.
As of September 2022, patients who received CDI in the OLE trial have been followed for 46.
5 months
.
All 5 patients who received CDI maintained CDI for a median of 27.
5 months, and all 8 patients who received stable EDSS maintained a stable EDSS for a median of 41.
2 months
.
In addition, patients treated with ATA188 and received CDI showed a significant reduction
in brain atrophy on longitudinal analysis of MRI images at 42 months.
"New biomarker imaging data suggest that brain structural changes and potential myelin regeneration may underlie the clinical disability improvement observed after ATA188 treatment," said Dr.
AJ Joshi, Chief Medical Officer at Atara, "We are pleased to see that the majority of patients experience CDI based on improved or long-term stable EDSS, which also indicates a shift in the natural progression process relative to expectations.
"
。 "
As WuXi AppTec's CTDMO focused on cell and gene therapies, WuXi Biologics is committed to accelerating and transforming the development, testing, manufacturing and commercialization of gene and cell therapies and other high-end therapies
。 WuXi Biologics can help customers around the world bring more innovative therapies to market sooner rather than later, benefiting patients
.
If you have related business needs, please click the picture below to fill in the specific information
.
▲If you have any business needs, please long press to scan the QR code above, or
