Presentation at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2024 Annual Meeting Highlights Ashvattha Product Candidates for Neuroinflammation Imaging and Treatment

• Preclinical data highlights the therapeutic potential of Ashvattha’s novel CSF1R tyrosine kinase inhibitor (CSF1R dendranib) for multiple sclerosis (MS) based on symptom reduction in the EAE model
• Ashvattha’s ¹⁸F-OP-801 PET imaging agent shows reduction in neuroinflammation following treatment with CSF1R dendranib
• Presentation by Stanford University collaborator nominated for Brain Imaging Council Young Investigator Award at SNMMI Annual Meeting

REDWOOD CITY, Calif., June 10, 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 the presentation of data demonstrating the therapeutic potential of Ashvattha’s novel CSF1R dendranib for MS based on symptom reduction in a mouse experimental autoimmune encephalitis (EAE) model. This therapeutic effect was further evidenced by a reduction in neuroinflammation by PET imaging using Ashvattha’s proprietary ¹⁸F-OP-801 radiotracer. The oral presentation was delivered by Ashvattha’s collaborator from Stanford University at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2024 Annual Meeting in Toronto. The presentation was nominated for a Brain Imaging Council Young Investigator Award.

Key findings from the presentation include the following:

• PET imaging with ¹⁸F-OP-801 was able to detect activated immune cells before the onset of symptoms in the EAE model of MS.
• Treatment with Ashvattha’s CSF1R dendranib effectively reduced EAE progression comparable to the FDA-approved drug fingolimod.
• Reduction in ¹⁸F-OP-801 PET signal was consistent with symptom reduction in both treatment groups compared to disease control, indicating that ¹⁸F-OP-801 could be used to monitor therapeutic response.
• Flow cytometry confirmed that CSF1R dendranib effectively reduced microglial and infiltrating myeloid and T cell populations in the spinal cords of EAE mice.

“There continues to be an important unmet medical need for imaging agents that enable monitoring of pathophysiologic and therapeutic responses in neuroinflammatory conditions including MS,” said Michelle L. James, Ph.D., Assistant Professor, Department of Radiology and Department of Neurology and Neurological Sciences, Molecular Imaging Program at Stanford (MIPS), Stanford University School of Medicine. “Our study demonstrated that ¹⁸F-OP-801 enables early detection of neuroinflammation in a well-established preclinical model of MS. Excitingly, the imaging signal and symptoms decreased with CSF1R dendranib treatment, thus warranting further investigation of both the therapy and imaging agent.”

“These results provide preclinical validation for our strategy to develop ¹⁸F-OP-801 as a companion biomarker to treatment with CSF1R dendranib in an image-treat-reimage paradigm for patients with MS as well as other neuroinflammatory conditions,” said Jeff Cleland, Ph.D., CEO of Ashvattha Therapeutics. “In parallel, our Phase 2 study evaluating the ability of ¹⁸F-OP-801 to cross the human blood-brain barrier and selectively target neuroinflammation in patients with multiple sclerosis, amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease is anticipated to have initial results this summer.”

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: www.avttx.com

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