Dendranib

Presentations highlight the therapeutic potential of Ashvattha’s novel CSF1R tyrosine kinase inhibitor (CSF1R dendranib) for multiple sclerosis (MS) based on symptom reduction in the EAE preclinical model CSF1R dendranib (H74DS3M8) clinical candidate is orally bioavailable and designed to avoid safety concerns of other CSF1R tyrosine kinase inhibitors using Ashvattha’s proprietary hydroxyl dendrimer nanomedicine technology Reduction in neuroinflammation following treatment with CSF1R dendranib in EAE model demonstrated by collaborators at Stanford University using Ashvattha’s 18F-OP-801 PET imaging agent REDWOOD CITY, Calif., May 23, 2024 (GLOBE NEWSWIRE) -- Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company advancing a new class of nanomedicine therapeutics that traverse tissue barriers to selectively target activated cells in regions of inflammation, today announced that the company will present preclinical data at the upcoming Consortium of Multiple Sclerosis Centers (CMSC) and Society of Nuclear Medicine & Molecular Imaging 2024 annual meetings. The presentations will demonstrate the therapeutic potential of Ashvattha’s novel CSF1R dendranib for MS, based on symptom reduction in a mouse experimental autoimmune encephalitis (EAE) model of MS. Additionally, the presentation by Ashvattha’s collaborators at Stanford University will demonstrate reduction in neuroinflammation following CSF1R dendranib treatment by PET imaging using Ashvattha’s proprietary 18F-OP-801 radioimaging agent. Details for the presentations are as follows: CMSC Annual Meeting 2024 May 29 – June 1, 2024 Music City Center, Nashville, TN Poster Title: A Novel ‘Dendranib’ Inhibiting CSF1R Tyrosine Kinase (H74DS3M8) is an Immunomodulatory and Anti-Inflammatory Agent that Attenuates EAE and Promotes Disease Improvement Poster Board Label: DMT41 Presenter: S. Sakura Minami, Ph.D., Ashvattha Therapeutics Date/Time: Thursday, May 30, 2024, 5:00-7:00 p.m. CT SNMMI Annual Meeting 2024 June 8-11, 2024 Metro Toronto Convention Center, Toronto, ON, Canada Presentation Title: Early detection and tracking of activated macrophages and microglia in a mouse model of multiple sclerosis using 18F-OP-801 PET imaging before and after a novel immunomodulatory drug Session Title: Brain Imaging Council Young Investigator Award Presenter: Renesmee C. Kuo in Michelle James Lab at Stanford University Date/Time: Saturday, June 8, 2024, 2:05-2.15 p.m. ET About Ashvattha Therapeutics Ashvattha Therapeutics is advancing a new class of clinical-stage nanomedicine therapeutics that traverse tissue barriers to selectively target activated cells only in regions of inflammation. Our targeted nanomedicine approach seeks to redefine precision medicine, empowering a new standard of care across ophthalmology, neurology, and inflammation. For more information, visit: Media Contact Michael Fitzhugh LifeSci Communications mfitzhugh@lifescicomms.com 628-234-3889

The study will evaluate the safety, tolerability, and ability of 18F-OP-801 to cross the blood-brain barrier and selectively target neuroinflammation in individuals with amyotrophic lateral sclerosis, Alzheimer’s disease, multiple sclerosis and Parkinson’s disease Preliminary data expected in 1H 2024 REDWOOD CITY, Calif., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company advancing a new class of nanomedicine therapeutics that traverse tissue barriers to selectively target activated cells in regions of inflammation, today announced that the first patient has been enrolled in its expanded Phase 1/2 study of 18F-OP-801, a hydroxyl dendrimer (HD) imaging agent. The study will evaluate the safety, pharmacokinetics and biodistribution of an intravenously administered dose of 18F-OP-801 in patients with amyotrophic lateral sclerosis (ALS), Alzheimer’s disease (AD), multiple sclerosis (MS) and Parkinson’s disease (PD). “This study builds on preclinical data which demonstrated 18F-OP-801's ability to cross the blood-brain barrier and be taken up by activated microglia in regions of neuroinflammation in multiple disease models. We have already demonstrated in the first part of this clinical trial that there is no appreciable uptake in the brains of healthy volunteers, as expected. Our focus now turns to enrolling subjects with neurodegenerative conditions to determine the uptake of 18F-OP-801 in regions of neuroinflammation to support the use of this agent as a companion biomarker for one of our HD therapeutics,” said Jeffrey Cleland, Ph.D., Chairman, President, and CEO of Ashvattha Therapeutics. “We look forward to evaluating imaging data in this study over the next several months and also expect to have initial results from our Phase 2 trial of D-4517.2 in patients with wet AMD and DME in the first half of 2024.” The Phase 1/2 study will initially enroll up to 20 subjects with ALS, AD, MS, and PD. In addition to evaluating the safety and tolerability of 18F-OP-801, major objectives of the study are to measure the biodistribution and clearance of 18F-OP-801 and to evaluate its ability to detect regions of neuroinflammation via PET imaging in subjects with disease compared to age-matched healthy volunteers. Additional objectives include determining the correlation between PET imaging signal, biomarkers of disease activity and clinical disease assessments. The study will also assess test/retest repeatability of 18F-OP-801 uptake in a subset of subjects. About 18F-OP-801 18F-OP-801 is a hydroxyl dendrimer (HD) imaging agent that has been shown to cross the blood-brain barrier and selectively target activated microglia and macrophages in regions of neuroinflammation in multiple animal models1. These studies establish the potential to visualize the extent and progression of neuroinflammation with high specificity and sensitivity in human neurodegenerative diseases via serial imaging with 18F-OP-801. Furthermore, because all HDs distribute the same way in the body, the amount of 18F-OP-801 in the brain provides an estimate of the amount of HD therapeutic that will get to the same cells in the brain enabling an image-treat-reimage paradigm using 18F-OP-801 as a companion biomarker for treating conditions such as amyotrophic lateral sclerosis, Alzheimer’s disease, multiple sclerosis, and Parkinson’s disease. About Ashvattha Therapeutics Ashvattha Therapeutics is advancing a new class of clinical-stage nanomedicine therapeutics that traverse tissue barriers to selectively target activated cells only in regions of inflammation. Our targeted nanomedicine approach seeks to redefine precision medicine, empowering a new standard of care across ophthalmology, neurology, and inflammation. For more information, visit: [1] Henningfield, C.M., Cleland, J.L., Sharma, R., Green, K.N. Selective targeting of plaque-associated microglia through systemic dendrimer administration in an Alzheimer’s disease model. Alzheimer’s & Dementia. 2020; Volume 16. Issue S2. Media Contact Michael Fitzhugh LifeSci Communications mfitzhugh@lifescicomms.com 628-234-3889