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▎The content team editor of WuXi AppTec recently, Precigen ActoBio announced the positive interim data of the phase 1b/2a clinical trial of the microbial therapy AG019 under investigation for the treatment of type 1 diabetes (T1D)
.
Based on the company's proprietary technology platform, AG019 uses genetic engineering to modify bacteria to deliver proteins and peptides to mucosal sites to achieve non-viral delivery of therapeutic drugs
.
The test results proved that AG019 monotherapy, or combined with CD3-targeted antibody therapy teplizumab, showed encouraging metabolic-immunological response and good safety, reducing the patient's glycosylated hemoglobin (HbA1c) and long-term blood glucose Control related important indicators
.
As a chronic autoimmune disease, the immune system of patients with type 1 diabetes will mistakenly attack their own pancreatic islet β cells, leading to gradual damage and death of β cell function.
In the end, patients need to rely on exogenous insulin for treatment
.
For people who are genetically susceptible to type 1 diabetes, the disease has begun to develop before the obvious symptoms of hyperglycemia appear, mainly manifested by the appearance of autoantibodies (anti-insulin and anti-pancreatic antibodies, etc.
) and abnormal glucose tolerance
.
During this period, the β cells in the pancreas are basically still intact, which provides a crucial window for intervention and preservation of β cells
.
Currently, there is a lack of methods to prevent the onset of type 1 diabetes in high-risk groups
.
AG019 is made from genetically engineered Lactococcus lactis, a probiotic bacteria commonly found in dairy products
.
The modified Lactococcus lactis can deliver the self-antigen human proinsulin and the cytokine human interleukin-10 (IL-10) to the mucosal lining of the gastrointestinal tissues to stimulate immune tolerance
.
AG019 can reduce or eliminate damage to insulin-producing cells by inducing specific regulatory T cells (Tregs), potentially stabilizing or improving endogenous insulin production
.
▲This therapy introduces a therapeutically effective transgene into the genome of Lactococcus lactis (picture source: Precigen ActoBio's official website) AG019 monotherapy data shows that 100% of adult patients (9/9) 12 months after the start of administration And 92% of patients 17 years and older (11/12) had HbA1c below the target value of 7%
.
HbA1c levels below 7% are an important indicator of long-term blood glucose control defined by the American Diabetes Association (ADA)
.
And, within 12 months after the start of administration, 78% of adult patients (7/9) and 75% of patients 17 years and older (9/12) insulin-corrected HbA1c (IDAA1C) stabilized below 9
.
Previous studies have shown that the stable reduction of these two indicators can reduce the long-term risk of microvascular complications, including diabetic retinopathy, nephropathy and other vascular complications
.
In addition, in an analysis up to 6 months after the start of dosing, AG019 monotherapy reduced the number of traditional T cells with inflammatory phenotypes in 100% of adult patients (4/4), while inhibitory receptors The average expression of PD-1 remained stable overall
.
Dr.
Pieter Rottiers, CEO of Precigen ActoBio, said: "The exciting data of AG019 monotherapy reinforces our belief that AG019 has the potential to become an independent therapy
.
We look forward to further exploring the role of AG019 in type 1 diabetes.
Potential
.
"Reference: [1] Precigen ActoBio Announces Additional Positive Interim Data from Phase 1b/2a Study of AG019 ActoBiotics™, A Novel Therapy Designed to Address the Underlying Cause of Type 1 Diabetes, Retrieved October 1, 2021, from https:// the-underlying-cause-of-type-1-diabetes-301389445.
htmlDisclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for information exchange only, and the views in the article do not represent WuXi AppTec's position , Does not mean that WuXi AppTec supports or opposes the views
in the
article .
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital
.
.
Based on the company's proprietary technology platform, AG019 uses genetic engineering to modify bacteria to deliver proteins and peptides to mucosal sites to achieve non-viral delivery of therapeutic drugs
.
The test results proved that AG019 monotherapy, or combined with CD3-targeted antibody therapy teplizumab, showed encouraging metabolic-immunological response and good safety, reducing the patient's glycosylated hemoglobin (HbA1c) and long-term blood glucose Control related important indicators
.
As a chronic autoimmune disease, the immune system of patients with type 1 diabetes will mistakenly attack their own pancreatic islet β cells, leading to gradual damage and death of β cell function.
In the end, patients need to rely on exogenous insulin for treatment
.
For people who are genetically susceptible to type 1 diabetes, the disease has begun to develop before the obvious symptoms of hyperglycemia appear, mainly manifested by the appearance of autoantibodies (anti-insulin and anti-pancreatic antibodies, etc.
) and abnormal glucose tolerance
.
During this period, the β cells in the pancreas are basically still intact, which provides a crucial window for intervention and preservation of β cells
.
Currently, there is a lack of methods to prevent the onset of type 1 diabetes in high-risk groups
.
AG019 is made from genetically engineered Lactococcus lactis, a probiotic bacteria commonly found in dairy products
.
The modified Lactococcus lactis can deliver the self-antigen human proinsulin and the cytokine human interleukin-10 (IL-10) to the mucosal lining of the gastrointestinal tissues to stimulate immune tolerance
.
AG019 can reduce or eliminate damage to insulin-producing cells by inducing specific regulatory T cells (Tregs), potentially stabilizing or improving endogenous insulin production
.
▲This therapy introduces a therapeutically effective transgene into the genome of Lactococcus lactis (picture source: Precigen ActoBio's official website) AG019 monotherapy data shows that 100% of adult patients (9/9) 12 months after the start of administration And 92% of patients 17 years and older (11/12) had HbA1c below the target value of 7%
.
HbA1c levels below 7% are an important indicator of long-term blood glucose control defined by the American Diabetes Association (ADA)
.
And, within 12 months after the start of administration, 78% of adult patients (7/9) and 75% of patients 17 years and older (9/12) insulin-corrected HbA1c (IDAA1C) stabilized below 9
.
Previous studies have shown that the stable reduction of these two indicators can reduce the long-term risk of microvascular complications, including diabetic retinopathy, nephropathy and other vascular complications
.
In addition, in an analysis up to 6 months after the start of dosing, AG019 monotherapy reduced the number of traditional T cells with inflammatory phenotypes in 100% of adult patients (4/4), while inhibitory receptors The average expression of PD-1 remained stable overall
.
Dr.
Pieter Rottiers, CEO of Precigen ActoBio, said: "The exciting data of AG019 monotherapy reinforces our belief that AG019 has the potential to become an independent therapy
.
We look forward to further exploring the role of AG019 in type 1 diabetes.
Potential
.
"Reference: [1] Precigen ActoBio Announces Additional Positive Interim Data from Phase 1b/2a Study of AG019 ActoBiotics™, A Novel Therapy Designed to Address the Underlying Cause of Type 1 Diabetes, Retrieved October 1, 2021, from https:// the-underlying-cause-of-type-1-diabetes-301389445.
htmlDisclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for information exchange only, and the views in the article do not represent WuXi AppTec's position , Does not mean that WuXi AppTec supports or opposes the views
in the
article .
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital
.
