Author: edgover

Paris, France, 6th November 2024 – PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology, has presented new data on its lead program PST-611, a DNA plasmid expressing human transferrin, in dry age-related macular degeneration (AMD)/geographic atrophy (GA) at the European Association for Vision and Eye Research 27^th EVER Congress 2024.

AMD is the leading cause of central vision loss in the elderly, affecting 200 million people worldwide. AMD’s pathogenesis is complicated and involves the disruption of iron homeostasis, leading to an excess of free iron, which results in inflammation, oxidative stress, and cell death.

In advanced stages, dry AMD progresses into geographic atrophy (GA), characterized by atrophy of the retinal pigment epithelium (RPE), photoreceptors, and choriocapillaris, responsible for a progressive vision loss.

PST-611 is a first in class non-viral vectorized therapy for the treatment of dry AMD/GA coding for human transferrin, a highly potent iron chelator, thus restoring normal iron homeostasis. During his oral presentation, Dr Thierry Bordet, CSO of PulseSight showed data from a retrospective study in a large cohort of dry AMD patients confirming higher level of free iron and increased transferrin saturation in AMD patients versus control patients. Additionally, he presented data showing that transferrin supplementation in iRPE (human iPSC-derived retinal pigment epithelial) cells exposed to high concentration of iron, restores iron homeostasis and rescued RPE cells from oxidative stress, mitochondrial damage, inflammation, complement activation, and ferroptosis, preserving their integrity.

Whilst PulseSight has confirmed transferrin as a drug candidate for the treatment of GA and dry AMD, the development of novel treatments for retinal diseases is often hindered by the challenge of delivering the drug to the back of the eye. To address these limitations, Dr Karine Bigot, Head Pharmacology & Toxicology at PulseSight presented a poster demonstrating the safety of PST-611, administered to the ciliary muscle using a minimally invasive electrotransfection system.

These data support the continued clinical development of PST-611 for dry AMD/GA patients.

Thierry Bordet, CSO of PulseSight Therapeutics said, “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. As a novel non-viral vectorized gene therapy delivered through electroporation, PST-611 benefits from a very good safety profile. We are convinced that PST-611 could become a major treating option for dry AMD patients who are progressively losing sight and for which the medical need is huge. We look very much forward to demonstrating the value of our candidate in the soon to start clinical plan.”

PulseSight plans to submit a phase I clinical trial authorization (CTA) by the end the year, to be closely followed by a phase II proof-of-concept to demonstrate the efficacy and the safety of its drug candidate PST-611 by the end 2027.

References

• Oral and Poster 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 09:20- 10:35 CET
  Poster 11:05-12:05 CET (ID# T.129)
  Bordet T, Youale J, Bigot K, Jaworski T, Lebon C, Françon C, Delaunay K, Bénard R, De Bastard T, Kaddour N, Behar-Cohen F, Picard E
  PulseSight Therapeutics, Paris, France,
  Université Paris Cité; Sorbonne Université; INSERM, Paris, France
  AP-HP, Paris, France

 

• 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 11:05-12:05 CET (ID# T.063)
  Karine Bigot, Romain Bénard, Pauline Gondouin, Marie Piazza, Elise Orhan1, Elodie Touchard, Francine Béhar-cohen, Thierry Bordet
  PulseSight Therapeutics, Paris, France,
  Université Paris Cité; Sorbonne Université; INSERM, Paris, France
  AP-HP, Paris, France

-ENDS-

Media contact

Sue Charles, Charles Consultants

T: +44 (0)7968 726585

E: sue@charles-consultants.com

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 27^th EVER Congress, being held in Valencia, Spain, November 3^rd – 5^th 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 5^th, 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 5^th, 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/

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

 

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/