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D-4517.2 (hydroxyl dendrimer VEGFR tyrosine kinase inhibitor) is a potent, subcutaneously administered anti-angiogenic nanomedicine. It is in phase 2 cliniclal studies for treatment of neovascular age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
Lead Product(s): D-4517.2
Therapeutic Area: Ophthalmology Product Name: D-4517.2
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2023
Details:
Ashvattha will present preclinical data at ARVO on its oral formulation of D-4517.2, a potent anti-angiogenic nanomedicine, in a laser-induced choroidal neovascularization (CNV) mouse model, and compare its efficacy with intravitreal aflibercept.
Lead Product(s): D-4517.2
Therapeutic Area: Ophthalmology Product Name: D-4517.2
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 03, 2023
Details:
First stage of study will evaluate safety and relative pharmacodynamic effect of different doses of subcutaneously administered D-4517.2 (hydroxyl dendrimer) compared to intravitreal (IVT) injection of aflibercept,in both wet AMD and DME patients up to 12 week.
Lead Product(s): Hydroxyl Dendrimer
Therapeutic Area: Ophthalmology Product Name: D-4517.2
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2022
Details:
Data showed OP-101 (N-acetyl Cysteine) delivered intravenously may have the potential to treat systemic inflammation and neuronal injury, reducing morbidity and mortality in hospitalized patients with severe COVID-19.
Lead Product(s): Acetylcysteine
Therapeutic Area: Infections and Infectious Diseases Product Name: OP-101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2022
Details:
Preclinical data demonstrate its hydroxyl dendrimer-based therapeutics reduce toxicity in targeted delivery to plexiform neurofibroma, a slow growing tumor associated with neurofibromatosis type 1 (NF1).
Lead Product(s): Hydroxyl Dendrimer Based Therapeutics
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2022
Details:
In animal toxicology studies, D-4517.2 demonstrated no evidence of genotoxicity and showed local reversible changes at the injection site when administered at dosages several times higher than the effective dose range determined for humans.
Lead Product(s): D-4517.2
Therapeutic Area: Ophthalmology Product Name: D-4517.2
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2022
Details:
Proceeds will support Ashvattha’s pipeline of hydroxyl dendrimer therapeutics, including OP-101 and multiple clinical stage programs. Ashvattha launched a Phase 2 study in severe COVID-19 and in 2022 plans to launch a Phase 2 study in wet AMD/DME and Phase 1/2 study in ALS.
Lead Product(s): Dendrimer N-acetyl-cysteine
Therapeutic Area: Infections and Infectious Diseases Product Name: OP-101
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Huadong Medicine Investment Holding
Deal Size: $69.0 million Upfront Cash: Undisclosed
Deal Type: Series B Financing April 27, 2022
Details:
Under the terms of the exclusive licensing agreement, Huadong will advance research and development costs for Ashvattha’s hydroxyl dendrimer clinical candidates, OP-101, D-4517.2 and OP-801, and for additional preclinical candidates.
Lead Product(s): Dendrimer N-acetyl-cysteine
Therapeutic Area: Infections and Infectious Diseases Product Name: OP-101
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Huadong Medicine
Deal Size: $45.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement April 27, 2022
Details:
A single subcutaneous or oral dose of D-4517, a sunitinib analog, resulted in comparable or better inhibition of CNV to a single intravitreal (IVT) dose of aflibercept.
Lead Product(s): Sunitinib analog
Therapeutic Area: Ophthalmology Product Name: D-4517
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2021
Details:
Ashvattha has developed a novel hepatocyte targeted hydroxyl dendrimer therapeutic which enables selective targeting of farnesoid X receptor agonists on hepatocytes through the asialoglycoprotein receptor mediated uptake after systemic administration.
Lead Product(s): Hydroxyl dendrimer
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
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