Interim data show CSF biomarkers of neurodegeneration and synaptic dysfunction as well as neuroimaging biomarkers improved after three months of therapy with XPro1595
Data support initiation of blinded randomized Phase 2 study before year end
LA JOLLA, CA, USA I January 21, 2021 I INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, announced today that results from a Phase 1b study demonstrate that XPro1595, an investigational dominant-negative protein that neutralizes soluble TNF, decreases biomarkers of neuroinflammation across multiple measures and assays, including cerebrospinal fluid (CSF) and MRI, in patients with Alzheimer’s disease (AD). The data suggest that decreasing neuroinflammation results in significant improvements in biomarkers of neurodegeneration and synaptic function.
The goal of the ongoing Phase 1b open label dose escalation trial is to demonstrate that XPro1595, when given as a subcutaneous injection once weekly, will decrease neuroinflammation in patients with mild to moderate AD. The data shows that cytokine/chemokine CSF levels after 12 weeks of therapy were decreased, with multiple statistically significant reductions (e.g., c-reactive protein (CRP) & YKL-40, p<0.0001). Additionally, there was a significant correlation between neuroinflammation, as measured by CSF, and MRI white matter free water (R2=0.75; p<0.01), a validated biomarker of neuroinflammation. This supports the use of white matter free water as a neuroinflammatory biomarker of treatment response in future studies.
Proteomic CSF analysis revealed that targeting neuroinflammation led to a significant change in multiple AD-related pathways including immune/inflammatory response, CNS neuronal function and injury, dendritic spine morphogenesis and synaptic plasticity. Notably, the analysis found an approximate two-fold reduction in the neurodegeneration markers visinin-like protein 1 (VILIP-1) and neurofilament light (NFL), and an approximate three-fold change in contactin-2 and a half-fold change in neurogranin, both proteins associated with synaptic plasticity (p<0.0001).
“Demonstrating changes in neuroinflammatory biomarkers across multiple measures (CSF and MRI) and assays in a small dataset gives us great confidence that XPro1595 is having the desired effect in the CNS,” said CJ Barnum, Ph.D., Head of Neurosciences at INmune Bio. “To see an impact on AD relevant disease pathways by three months that are sustained in patients that opted to enroll in the extension study for an additional nine months is more that we could have hoped for at this stage of development and will be of enormous value in planning the Phase 2 study.”
RJ Tesi M.D., chief executive officer of INmune Bio, said, “With these data, we remain committed to initiating a Phase 2 clinical trial in patients with Alzheimer’s disease this year. Data from the Phase 1b trial will help determine the exact design of the Phase 2 trial which will be a blinded, randomized, placebo controlled clinical trial that will validate these biomarkers and begin to explore the clinical impact of XPro1595.”
The Company will host a Key Opinion Leader webinar today, January 21, at 8:00am ET, where it will present biomarker data from six patients in the 1mg/kg treatment group in detail. The company will also report on the use novel MRI technologies to capture qualitative changes in both gray matter and white matter that may provide a more sensitive, non-invasive biomarker as compared to traditional volumetric MRI measures and CSF, respectively. These data are an extension and expansion of the data presented at the Company’s 13 July 2020 webinar. During that webinar, XPro1595 was shown to decrease neuroinflammation as measured by MRI analyzing white matter free water and other biomarkers.
About XPro1595
XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that acts differently than currently existing TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro1595 could have substantial beneficial effects in patients with Alzheimer’s disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.
About INmune Bio, Inc.
INmune Bio, Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms. The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is currently being developed for COVID-19 complications (Quellor™), cancer (INB03™), Alzheimer’s and Treatment Resistant Depression (XPro1595), and NASH (LIVNate™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation. To learn more, please visit www.inmunebio.com.
SOURCE: INmune Bio
Post Views: 103
Interim data show CSF biomarkers of neurodegeneration and synaptic dysfunction as well as neuroimaging biomarkers improved after three months of therapy with XPro1595
Data support initiation of blinded randomized Phase 2 study before year end
LA JOLLA, CA, USA I January 21, 2021 I INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, announced today that results from a Phase 1b study demonstrate that XPro1595, an investigational dominant-negative protein that neutralizes soluble TNF, decreases biomarkers of neuroinflammation across multiple measures and assays, including cerebrospinal fluid (CSF) and MRI, in patients with Alzheimer’s disease (AD). The data suggest that decreasing neuroinflammation results in significant improvements in biomarkers of neurodegeneration and synaptic function.
The goal of the ongoing Phase 1b open label dose escalation trial is to demonstrate that XPro1595, when given as a subcutaneous injection once weekly, will decrease neuroinflammation in patients with mild to moderate AD. The data shows that cytokine/chemokine CSF levels after 12 weeks of therapy were decreased, with multiple statistically significant reductions (e.g., c-reactive protein (CRP) & YKL-40, p<0.0001). Additionally, there was a significant correlation between neuroinflammation, as measured by CSF, and MRI white matter free water (R2=0.75; p<0.01), a validated biomarker of neuroinflammation. This supports the use of white matter free water as a neuroinflammatory biomarker of treatment response in future studies.
Proteomic CSF analysis revealed that targeting neuroinflammation led to a significant change in multiple AD-related pathways including immune/inflammatory response, CNS neuronal function and injury, dendritic spine morphogenesis and synaptic plasticity. Notably, the analysis found an approximate two-fold reduction in the neurodegeneration markers visinin-like protein 1 (VILIP-1) and neurofilament light (NFL), and an approximate three-fold change in contactin-2 and a half-fold change in neurogranin, both proteins associated with synaptic plasticity (p<0.0001).
“Demonstrating changes in neuroinflammatory biomarkers across multiple measures (CSF and MRI) and assays in a small dataset gives us great confidence that XPro1595 is having the desired effect in the CNS,” said CJ Barnum, Ph.D., Head of Neurosciences at INmune Bio. “To see an impact on AD relevant disease pathways by three months that are sustained in patients that opted to enroll in the extension study for an additional nine months is more that we could have hoped for at this stage of development and will be of enormous value in planning the Phase 2 study.”
RJ Tesi M.D., chief executive officer of INmune Bio, said, “With these data, we remain committed to initiating a Phase 2 clinical trial in patients with Alzheimer’s disease this year. Data from the Phase 1b trial will help determine the exact design of the Phase 2 trial which will be a blinded, randomized, placebo controlled clinical trial that will validate these biomarkers and begin to explore the clinical impact of XPro1595.”
The Company will host a Key Opinion Leader webinar today, January 21, at 8:00am ET, where it will present biomarker data from six patients in the 1mg/kg treatment group in detail. The company will also report on the use novel MRI technologies to capture qualitative changes in both gray matter and white matter that may provide a more sensitive, non-invasive biomarker as compared to traditional volumetric MRI measures and CSF, respectively. These data are an extension and expansion of the data presented at the Company’s 13 July 2020 webinar. During that webinar, XPro1595 was shown to decrease neuroinflammation as measured by MRI analyzing white matter free water and other biomarkers.
About XPro1595
XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that acts differently than currently existing TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro1595 could have substantial beneficial effects in patients with Alzheimer’s disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.
About INmune Bio, Inc.
INmune Bio, Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms. The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is currently being developed for COVID-19 complications (Quellor™), cancer (INB03™), Alzheimer’s and Treatment Resistant Depression (XPro1595), and NASH (LIVNate™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation. To learn more, please visit www.inmunebio.com.
SOURCE: INmune Bio
Post Views: 103
