On April 27, 2022 Ashvattha Therapeutics ("Ashvattha"), a clinical stage company developing novel hydroxyl dendrimer therapeutics, reported it has secured $69 million in a Series B financing and in a separate agreement entered an exclusive licensing deal with Huadong Medicine (Press release, Ashvattha Therapeutics, APR 27, 2022, View Source [SID1234613043]). Proceeds will support the advancement of Ashvattha’s pipeline of hydroxyl dendrimer therapeutics (HDTs), including multiple clinical stage programs. Ashvattha launched a Phase 2 study in severe COVID-19 earlier this year and in 2022 plans to launch a Phase 2 study in wet AMD/DME and Phase 1/2 study in ALS.
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The Series B financing was led by Huadong Medicine Investment Holding Co., Ltd, with participation from existing investors, including Natural Capital, Plum Alley, Tribe Capital and several prominent technology and biotech angel investors bringing Ashvattha’s total funding to $69 million.
The exclusive licensing agreement with Huadong which includes up to $45 million advanced payments for product development, grants Huadong development and commercialization rights to its pipeline assets in China and parts of southeast Asia. Under the terms of the exclusive licensing agreement:
Huadong will advance up to $30 million to cover research and development costs for Ashvattha’s hydroxyl dendrimer clinical candidates, OP-101, D-4517.2 and OP-801, and $15 million for additional preclinical candidates
Huadong will gain exclusive licensing rights to develop, manufacture and commercialize these candidates in China, and southeast Asian countries such as Singapore and Malaysia.
Huadong will pay Ashvattha a royalty of 10% of net sales of licensed products
HDTs have been shown to selectively target reactive inflammatory cells in diseased tissue, with the ability to cross the blood-brain barrier and blood-retinal barrier to treat neurology, ophthalmology, and inflammatory diseases. Interim data from ongoing Phase 2 PRANA clinical study in severe COVID-19 patients demonstrated the ability of OP-101, an HDT, to cross the blood-brain barrier and reduce neuronal injury and systemic hyperinflammation, reinforcing the potential of the HD platform.
"We believe that hydroxyl dendrimer therapeutics are the future of precision medicine and look forward to demonstrating this with multiple clinical data catalysts in our ophthalmology, neurology and inflammatory programs this year," said Jeffrey Cleland, Ph.D., Chairman & CEO of Ashvattha Therapeutics. "This investment and partnership confirm confidence in our approach to precision medicine with disease-cell selective HDTs, as well as the broad potential of our platform, and the potential to dramatically increase the therapeutic index of drugs."
Mr. Lv Liang, Chairman of Huadong Medicine, added, "We believe Ashvattha’s hydroxyl dendrimer platform has the potential to produce highly selective drugs. This collaboration will enable us to build an R&D ecosystem, further enriching our pipeline in the fields of tumor, immunity and endocrinology. This allows us to accelerate scientific research innovation and internationalization. We look forward to working with Ashvattha to advance a new class of therapeutics that may hold the potential to enhance the treatment landscape for a broad range of patient populations."
About OP-101
OP-101 is an HDT with N-acetyl cysteine (NAC) that selectively targets reactive macrophages and microglia, which are responsible for hyperinflammation, lung injury and multi-organ failure caused by viral or bacterial infections, including COVID-19.
About D-4517.2
D-4517.2 is an HDT with potent anti-angiogenic activity inhibiting VEGFR/PDGFR that selectively targets reactive inflammatory cells and crosses the blood-retinal barrier.
About OP-801
OP-801 is an HD imaging agent that provides information on uptake of HDs across tissue barriers including the blood brain barrier. 18F-OP-801 selectively targets reactive microglia in regions of neuroinflammation in neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease.