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PulseSight Therapeutics launches to advance non-viral gene therapies for severe retinal diseases

News
Article

According to the company, its proprietary non-viral gene therapy platform with minimally invasive delivery technology is providing long lasting gene expression and favorable distribution in the retina.

(Image Credit: AdobeStock/natali_mis)

(Image Credit: AdobeStock/natali_mis)

PulseSight Therapeutics SAS, launching with seed finance from Pureos Bioventures and ND Capital, is positioned to clinically validate its highly innovative delivery platform by advancing two first-in-class late-stage preclinical drugs for wet and dry age-related macular diseases (AMD), including geographic atrophy (GA).

According to a news release, 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 I/II 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 eight months (in patients with chronic noninfectious uveitis).1

The company noted that current treatments for wet AMD all belong to the same class of drugs that target vascular endothelial growth factor (VEGF) and act primarily on the neovessels to reduce vascular leakage, with a limited efficacy over time leading to the need for frequent reinjections. Wet AMD is a complex disease involving many pathological pathways which lead to progressive vision loss and there remains a significant unmet need.

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 a potent 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. In addition to superior efficacy, PST-809 holds the potential to improve compliance by reducing the need for repeated anti-VEGF injections to one injection every six months, alleviating the burden of treatment for this chronic disease.1

The second program, PST-611, for geographic atrophy (GA) in late-stage dry AMD, 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 whilst also benefiting from the need for re-treatment only every six months. 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 leading venture capital investors that both bring significant 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. During his 30+ years at Novartis, he held various positions of increasing responsibilities within preclinical and clinical research as well as project management. Between 2011 and 2021, he led the company’s Ophthalmology Development Department and, during that time, was responsible for a development portfolio across back and front of the eye indications, including Lucentis. As a successful entrepreneur, Dominik Escher led the development of multiple clinically successful products during his time as CEO of ESBATech prior to its sale to Alcon (Novartis), including for Brolucizumab as a treatment for AMD. Kostas Kaloulis was co-founder and CEO of Arctos Medical, a pioneering gene therapy company addressing blindness, later acquired by Novartis.

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 pharma-biotech experienced 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 seasoned and highly skilled professionals specialized in ophthalmology, gene therapy, device and drug development, including Thierry Bordet, PhD as CSO.

According to Dominik Escher, board director of PulseSight and partner at Pureos Bioventures, pointed out that the company willpartner with ND Capital to launch PulseSight

“[It is] a company with technology and programs that has the potential to be truly life-changing for patients with diseases leading to sight loss,” he said. “We have assembled a highly experienced and motivated team, and I welcome Judith who joins as CEO and Dirk as Chairman of the Board. We have all the ingredients to ensure that PulseSight becomes a highly valuable company in the field of non-viral gene therapy in ophthalmology.”

Moreover, Judith Greciet, CEO of PulseSight Therapeutics, lauded the opportunity.

“I am excited to join the company with a validated and highly differentiating delivery platform and two non-viral gene therapy programs at late preclinical stage,” she explained in the news release. “Our proprietary non-viral gene therapy approach provides unique features in terms of efficacy, safety and durability of effect and I am thrilled to have the opportunity to work with PulseSight Therapeutics’ highly experienced team and board to build the company’s future.”

PulseSight Therapeutics Chairman Dirk Sauer also noted the company can meet unmet needs in treating retinal diseases.

“Whilst pharma has embraced the potential of gene therapy in ophthalmology, there remains an unaddressed need for non-viral approaches that would unlock the full potential of gene therapies,” he said in a news release. “I am encouraged by the data behind PulseSight’s approach and its therapies, and I look forward to working with the board and the team to validate its disruptive potential through clinical studies.”

Alongside Pureos Bioventures and ND Capital, Korea Investment Partners (KIP) has joined the seed financing round, with its VP 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.

Reference:
1. News EIN. PulseSight Therapeutics Launches to Advance Non-viral Gene Therapies with Disruptive Minimally-Invasive Delivery Technology for Severe Retinal Diseases. EIN News. Published February 28, 2024. Accessed February 28, 2024. https://tech.einnews.com/pr_news/691896529/pulsesight-therapeutics-launches-to-advance-non-viral-gene-therapies-with-disruptive-minimally-invasive-delivery-technology-for-severe-retinal
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