PulseSight Therapeutics to Present Data on PST-611 at EVER Congress 2024

PARIS, Oct. 07, 2024  – PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology, is pleased to confirm that it will be presenting data on its lead program PST-611, expressing human transferrin, in dry age-related macular degeneration (AMD)/geographic atrophy (GA) at the European Association for Vision and Eye Research 27th EVER Congress, being held in Valencia, Spain, November 3rd – 5th 2024.

Presentations have been accepted for an oral and a poster presentation:

  • Oral Presentation by Dr Thierry Bordet (CSO): Transferrin is a drug candidate for the treatment of geographic atrophy (GA)/dry age-related macular degeneration (AMD)
    Presentation on November 5th, 2024, 09:20-10:35 CET (ID# T.129)
  • Poster Presentation by Dr Karine Bigot (Head Pharmacology & Toxicology): Non-clinical safety of PST-611, non-viral vectorized human transferrin, for the treatment of geographic atrophy (GA)
    Presentation on November 5th, 2024, 11:05-12:05 CET (ID# T.063)

Thierry Bordet, CSO of PulseSight Therapeutics, said, “EVER attracts top European researchers and the most innovative industry players, and I am delighted that we have been accepted to present our recent promising data on PST-611, our pioneering, first-in-class non-viral vectorized gene therapy for the treatment of dry AMD/GA.

PST-611 is a DNA plasmid encoding human transferrin, a highly potent iron chelator. Excess iron is known to be highly toxic to retinal cells, leading to oxidative stress, inflammation, and ferroptosis. By restoring normal iron homeostasis, transferrin mitigates these toxic effects and protects retinal cells, offering the potential to slow GA lesions growth and improve patient’s visual function.

Additionally, PST-611 benefits from a very good safety profile, as will be presented by my colleague Karine, further supported by the safety data from an earlier clinical trial with our previous candidate (PST-606 in uveitis).”

The company is planning to submit a phase I clinical trial authorization (CTA) by end October, to be closely followed by a phase II proof-of-concept to demonstrate the efficacy and the safety of its drug candidate by end 2027.

Media contact

Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

About age-related macular degeneration (AMD)

AMD is a disease with progressive, painless loss of central vision with a strong burden on patients’ everyday life, impacting their ability to read, recognize faces, and see objects and, ultimately, leading to irreversible vision loss in the elderly. After reaching an intermediate stage, AMD can progress to either ‘Wet AMD’ or ‘Dry AMD’, which can then evolve into GA (geographic atrophy), leading to irreversible blindness. In all its forms, AMD represents a compelling unmet need for more effective and durable treatment options, with a large and growing market, estimated to reach $27.5 Billion by 2031.

About PulseSight Therapeutics

PulseSight is clinical-stage biotech company committed to developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology to protect and improve the vision of patients with retinal disease with a focus on age-related macular degeneration (AMD) including wet AMD and geographic atrophy (GA) secondary to dry AMD.

Already clinically validated for its safety and sustained activity, PulseSight’s technology platform delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle using an electro-transfection system. The ciliary muscle cells act as biofactories, expressing therapeutic proteins that reach the retina with high distribution, providing a safe and long-lasting treatment for major eye diseases.

About PST-611 for GA

PST-611 encodes the human transferrin protein, a crucial regulator of iron homeostasis and holds the potential to effectively address key pathological mechanisms in GA, whilst requiring re-treatment only every six months. This program is ready to enter the clinic by the end of 2024.

About PST-809 for Wet AMD

PST-809 is a dual-gene plasmid encoding for anti-VEGF aflibercept and decorin, an anti-angiogenic and anti-fibrotic native protein, showing superior efficacy against anti-VEGF gold standard while limiting the need for frequent reinjection. PST-809 is at the very late stage of preclinical IND-enabling studies.

Based in Paris, France, the company’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

For more information visit www.PulseSightTherapeutics.com

Follow us on LinkedIn – https://www.linkedin.com/company/pulsesight-therapeutics/

PulseSight Therapeutics reinforces its scientific leadership in ophthalmology with the establishment of an International Scientific and Clinical Advisory Board

Paris, France,4 September 2024 – PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology, is pleased to announce that it has established a scientific and clinical advisory board (SAB) of internationally recognized ophthalmology experts.

The SAB members, from Europe, the USA and Australia, bring decades of clinical and scientific experience in both fundamental and clinical research in retinal and macular diseases.

  • Prof Frank G. Holz, Professor and Chair of the Department of Ophthalmology, University of Bonn, Germany. Prof Holz will chair the SAB.
  • Prof Francine Behar-Cohen, MD, PhD, Professor of Ophthalmology at Cochin Hospital, Paris, Director of research at INSERM, and Professor at the University of Paris Cité, France. Prof Behar-Cohen discovered and developed the technology; she is also a member of the Board, as an observer.
  • Dr Joshua Dunaief MD PhD, Adele Niessen Professor of Ophthalmology at The Perelman School of Medicine at the University of Pennsylvania, PA.
  • Prof Robyn Guymer AM, Deputy Director, Head of Macular Research at CERA (Centre for Eye Research Australia), Melbourne, Australia, Professor of Ophthalmology at Melbourne University and senior retinal specialist at the Royal Victorian Eye and Ear Hospital.
  • Prof Eleonora Lad, MD PhD Vice Chair, Associate Professor of Ophthalmology and Vice Chair, Clinical Research at the Duke Eye Center, NC, USA

PulseSight’s lead program PST-611 in GA is ready to enter the clinic by the end of 2024, whilst its second program, PST-809 in wet AMD is at the very late stage of preclinical IND-enabling studies.

Judith Greciet, CEO of PulseSight Therapeutics said, “I am delighted to welcome these world-class seasoned experts as founding members of our SAB. Their depth and breadth of clinical and scientific expertise will bring invaluable contribution to our development plans, as we navigate early clinical development. Their enthusiastic agreement to join the SAB underlines the interest in our innovative programs and reinforces our confidence that PST-611, followed by PST-809, have the potential to significantly change the prognostic of these highly disabling, difficult to treat diseases.”

Chairman of PulseSight Therapeutics, Dirk Sauer added, “Having been in the ophthalmology field for more than two decades, I appreciate the challenges ahead of us as well as the potential of our novel non-viral approach. I would like to deeply thank the members of the SAB for their time and commitment to supporting us to unlock the full potential of our disruptive and innovative therapy platform.”

Full details on the SAB members can be found on the PulseSight web site – here

-ENDS-

About age-related macular degeneration (AMD)
AMD is a disease with progressive loss of vision with a strong burden on patients’ everyday life, impacting their ability to read, recognize faces, and see objects and, ultimately, leading to irreversible vision loss in the elderly. After reaching an intermediate stage, AMD can progress to either ‘Wet AMD’ or ‘Dry AMD’, which can then evolve into GA (geographic atrophy), leading to irreversible blindness. In all its forms, AMD represents a compelling unmet need for more effective and durable treatment options, with a large and growing market, estimated to reach $27.5 Billion by 2031.

About PulseSight Therapeutics

PulseSight is clinical-stage biotech company committed to developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology to address severe eye diseases.  Company’s current candidates focus on age-related macular degeneration (AMD) including wet AMD and geographic atrophy (GA) secondary to dry AMD.

Already clinically validated for its safety and sustained activity, PulseSight’s technology platform delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle using a user-friendly, injection like procedure based on electro-transfection. The ciliary muscle cells act as biofactories, expressing therapeutic proteins that reach the retina with high distribution, providing a safe and long-lasting treatment for major eye diseases.

About PST-611 for GA
PST-611 encodes the human transferrin protein, a crucial regulator of iron homeostasis and holds the potential to effectively address key pathological mechanisms in GA, whilst requiring re-treatment only every four to six months. This program is ready to enter the clinic by the end of 2024.

About PST-809 for Wet
PST-809 is a dual-gene plasmid encoding for anti-VEGF aflibercept and decorin, an anti-angiogenic and anti-fibrotic native protein, showing superior efficacy against anti-VEGF gold standard while limiting the need for frequent reinjection. PST-809 is at the very late stage of preclinical IND-enabling studies.

Based in Paris, France the company’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

For more information visit www.PulseSightTherapeutics.com

Follow us on LinkedIn – https://www.linkedin.com/company/pulsesight-therapeutics/

Media contact
Sue Charles, Charles Consultants
T: +44 (0)7968 726585,
E: sue@charles-consultants.com

 

PulseSight Therapeutics Confirms H2 2024 Conference Schedule

Paris, France, 28 August 2024 – PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology, is pleased to confirm its schedule of scientific and business conference attendance for H2 2024.

  • July 17-20, American Society of Retina Specialists, ASRS Annual Meeting, Stockholm
    – CEO Judith Greciet, Chairman Dirk Sauer and founder Francine Behar-Cohen attended
  • September 18, Retina Forum, Barcelona
    – CEO Judith Greciet presenting and Chairman Dirk Sauer attending
  • September 25-26, Sachs Biotech in Europe Forum, Basel
    – CEO Judith Greciet presenting
  • November 3-5, EVER Congress, Valencia
    – CSO Thierry Bordet presenting

PulseSight Therapeutics, a clinical stage biotech launched in February 2024, is advancing two first-in-class drugs ready for clinical trials targeting dry age-related macular diseases (AMD), including geographic atrophy (GA), and wet AMD both major causes of blindness in the elderly.

PulseSight’s proprietary non-viral vectorized therapy platform uses an electro-transfection system to deliver DNA plasmids encoding therapeutic proteins into the ciliary muscle to treat eye diseases.

At the conferences, PulseSight will be presenting progress with its lead program PST-611 in GA as well as the company’s clinical development plan, for both PST-611 and PST-809 (in wet AMD).

Judith Greciet, CEO of PulseSight Therapeutics said, “PulseSight has all the ingredients to become a leading biotech in the field of non-viral gene therapy in ophthalmology. Our proprietary innovative platform provides unique features in terms of efficacy, safety and durability of effect, as already validated in clinic. Our two programs, PST-611 in GA and PST-809 in wet AMD are targeting severe diseases with wide unmet needs. They both have the potential to become future blockbusters. We have exciting times ahead and I look forward to progressing our therapies into the clinic to evaluate their potential to be truly life-changing for patients with diseases leading to sight loss.”

PulseSight is currently raising a Series A financing round to advance its programs into clinical proof-of-concept studies.

-ENDS-

Media contact

Sue Charles, Charles Consultants

T: +44 (0)7968 726585, E: sue@charles-consultants.com

About age-related macular degeneration (AMD)
AMD is a disease with progressive, painless loss of central vision with a strong burden on patients’ everyday life, impacting their ability to read, recognize faces, and see objects and, ultimately, leading to irreversible vision loss in the elderly. After reaching an intermediate stage, AMD can progress to either ‘Wet AMD’ or ‘Dry AMD’, which can then evolve into GA (geographic atrophy), leading to irreversible blindness. In all its forms, AMD represents a compelling unmet need for more effective and durable treatment options, with a large and growing market, estimated to reach $27.5 Billion by 2031.

About PulseSight Therapeutics
PulseSight is clinical-stage biotech company committed to developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology to protect and improve the vision of patients with retinal disease with a focus on age-related macular degeneration (AMD) including wet AMD and geographic atrophy (GA) secondary to dry AMD.

Already clinically validated for its safety and sustained activity, PulseSight’s technology platform delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle using an electro-transfection system. The ciliary muscle cells act as biofactories, expressing therapeutic proteins that reach the retina with high distribution, providing a safe and long-lasting treatment for major eye diseases.


About PST-809 for Wet
PST-809 is a dual-gene plasmid encoding for anti-VEGF aflibercept and decorin, an anti-angiogenic and anti-fibrotic native protein, showing superior efficacy against anti-VEGF gold standard while limiting the need for frequent reinjection. PST-809 is at the very late stage of preclinical IND-enabling studies.

Based in Paris, France the company’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

For more information visit www.PulseSightTherapeutics.com

Follow us on LinkedIn – https://www.linkedin.com/company/pulsesight-therapeutics/

 

PulseSight Therapeutics Launches to Advance Non-viral Gene Therapies with Disruptive Minimally-Invasive Delivery Technology for Severe Retinal Diseases

  • Unique proprietary non-viral gene therapy platform with minimally invasive delivery technology providing long lasting gene expression and favorable distribution in the retina.
  • Focus on age-related macular degeneration (AMD) including wet AMD and late-stage dry AMD/geographic atrophy (GA), a rapidly growing market expected to reach $27.5bn by 2031.
  • A substantially de-risked platform and two first-in-class gene therapies heading to the clinic, having the potential to become future blockbusters.
  • Highly experienced management team and Board of Directors – Judith Greciet, CEO and Dirk Sauer, ex-Novartis Global Development Unit Head, Ophthalmology, as Independent Chair of the Board.
  • Compelling investment case with a Series A capital raising underway, backed by two ophthalmology experienced venture investors, Pureos Bioventures and ND Capital.

Paris, France, 28 February 2024 – PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral gene therapies with minimally-invasive delivery technology, launches today with seed finance from Pureos Bioventures and ND Capital. It is poised 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), major diseases of the elderly leading to blindness.

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).

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.

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.

Dominik Escher, board director of PulseSight and Partner at Pureos Bioventures said, “Pureos is delighted to partner with ND Capital to launch PulseSight, a company with technology and programs that has the potential to be truly life-changing for patients with diseases leading to sight loss.  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.”

Judith Greciet, CEO of PulseSight Therapeutics said, “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. 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.”

Chairman of PulseSight Therapeutics, Dirk Sauer said, “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. 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 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.

-ENDS-

Media contact

Sue Charles, Charles Consultants

T: +44 (0)7968 726585, E: sue@charles-consultants.com

About age-related macular degeneration (AMD)

AMD is a disease with progressive, painless loss of central vision with a strong burden on patients’ everyday life, impacting their ability to read, recognize faces, and see objects and, ultimately, leading to irreversible vision loss in the elderly. AMD is a complex disease due to multiple physio-pathological pathways. After reaching an intermediate stage, AMD can progress to either ‘Wet AMD’ or ‘Dry AMD’, which can then evolve into GA (geographic atrophy), leading to irreversible blindness. In all its forms, AMD represents a compelling unmet need for more effective and durable treatment options, with a large and growing market, estimated to reach $27.5 Billion by 2031. Currently, Roche and Novartis’ Lucentis, Regeneron’s Eylea, and Novartis’ Beovu are all available for managing wet AMD. But they are not curative and require multiple dosing and monthly monitoring of patients.

About PulseSight Therapeutics

PulseSight is an ophthalmology drug development company developing disruptive non-viral gene therapies with minimally-invasive delivery technology designed to address the unmet need for treatments against severe retinal diseases leading to blindness, with a focus on age-related macular degeneration (AMD) including wet AMD and geographic atrophy (GA) in late-stage dry AMD.

Lead program, PST-809, in wet AMD and a second program, PST-611, in dry AMD/GA are at the very late stage of preclinical IND enabling studies and build on over a decade of development of non-viral gene therapies. PulseSight has a unique approach to the administration of disease-modifying genes through its proprietary electro-transfection technology. Already validated in the clinic for safety and delivery, this non-viral delivery platform delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle to safely and sustainably treat major eye diseases. The company’s technology and therapeutic applications are covered by an IP portfolio of 11 patent families, with 90 granted patents.

Based in Paris, France the company’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

For more information visit www.PulseSightTherapeutics.com

Follow us on LinkedIn – https://www.linkedin.com/company/pulsesight-therapeutics/