PulseSight Therapeutics Launches to Advance Non-Viral Gene Therapies for Severe Retinal Diseases
PulseSight Therapeutics launched today with a portfolio that includes two first-in-class late-stage preclinical drugs for wet and dry age-related macular diseases (AMD), including geographic atrophy (GA).
PulseSight’s proprietary non-viral gene therapy ocular platform uses an electro-transfection system to deliver DNA plasmids encoding therapeutic proteins into the ciliary muscle to treat major eye diseases. The technology has already been validated in a first phase 1/2 clinical study, demonstrating a good safety profile of both the plasmid and the delivery system, as well as a long-lasting clinical benefit up to 8 months (in patients with chronic noninfectious uveitis), according to PulseSight.
The company’s lead program, PST-809, is a potential first-in-class therapy for wet AMD that comprises a dual-gene plasmid encoding for anti-VEGF, aflibercept, together with decorin, an anti-angiogenic and anti-fibrotic native protein that reduces choroidal neovascularization (CNV), vascular leakage, and subretinal fibrosis preventing the epithelial mesenchymal transition of the retinal pigment epithelial (RPE) cells, or even favoring RPE healing. In preclinical studies, PST-809 has shown superior efficacy to intravitreal aflibercept to reduce vascular leakage and to promote RPE wounds healing, indicating its potential to promote disease regression and durably prevent vision loss in patients, according to PulseSight. PST-809 also holds the potential to improve compliance by reducing the need for repeated anti-VEGF injections to one injection every 6 months, alleviating the burden of treatment for this chronic disease.
The second program, PST-611 for geographic atrophy (GA) uses the same disruptive delivery technology with a plasmid that encodes the human transferrin protein, a natural iron transporter involved in the control of iron levels in the eye. PST-611 holds the potential to effectively address many of complex pathophysiological pathways involved in GA/dry AMD while also benefiting from the need for re-treatment only every 6 months, according to PulseSIght. Preclinical experiments of PST-611 conducted across various disease models show the beneficial effects of transferrin to remove iron, reduce oxidative stress, preserve the integrity of the retinal pigment epithelium, and prevent retinal degeneration and vision loss. In addition to GA, PST-611 has upside for the potential treatment of other neurodegenerative retinal disorders such as glaucoma or retinitis pigmentosa for which PST-611 has been awarded orphan drug designation by the FDA and EMA.
The company has been financed with seed investment from venture capital investors that both bring experience in ophthalmology, with Dominik Escher, PhD, founding partner of Pureos Bioventures, and Kostas Kaloulis, PhD, Venture Partner at ND Capital joining the board. Dirk Sauer, previously Head of Ophthalmology at Novartis, has joined the board as independent chair. Francine Behar-Cohen, MD, PhD, an ophthalmic surgeon, researcher and entrepreneur, founder and inventor of the technology, provides ongoing valuable expertise into the programs and is an observer on the board.
The company has a highly experienced leadership team led by newly appointed CEO Judith Greciet, PharmD. She brings over three decades of experience in the pharma and biotech industries, notably as CEO of Onxeo and as President of Eisai France. She joins professionals specialized in ophthalmology, gene therapy, device and drug development, including Thierry Bordet, PhD as CSO.
Alongside Pureos Bioventures and ND Capital, Korea Investment Partners (KIP) has joined the seed financing round, with Joon Hyun as an observer on the board. PulseSight is currently raising a Series A financing round to advance its programs into clinical proof-of-concept.