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Eyevensys Presents Initial Data from Phase I/II, Non-Viral Gene Therapy for Ocular Diseases

Eyevensys Presents Initial Data from Phase I/II, Non-Viral Gene Therapy for Ocular Diseases 1920 1281 Eyevensys

Eyevensys this week presented results from part 1 of its phase I/II study for non-infectious uveitis (NIU) at the Ophthalmology Innovation Summit’s (OIS) 11th Annual OIS@AAO conference on October 10, 2019 in San Francisco. Dr. Ronald R. Buggage, MD, Chief Medical Officer of Eyevensys, discussed the novel technology during the Gene & Cell Therapy Spotlight session. 

The company’s technology is a non-viral gene therapy ocular drug delivery platform that uses a two-part Electrotransfection System, including a proprietary Ocular Device and Electrical Pulse Generator, that delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle. This turns the eye into a biofactory, allowing the ciliary muscle to produce the therapeutic protein. The secreted protein reaches the back of the eye, including the retina and choroid. 

Eyevensys has successfully completed Part 1 of a clinical safety study of its lead product EYS606, a non-viral vector encoding an anti-TNFα protein. Tumor necrosis factor alpha (TNFα) is a cytokine that has been shown to play a pivotal role in mediating intraocular inflammation. The trial enrolled nine patients (three patients per cohort) with late-stage, NIU in France and the U.K. The study revealed no serious adverse events related to the Eyevensys technology and the overall early safety profile was similar to that of other intraocularly administered ophthalmic treatments. 

Despite their advanced disease stage at enrollment three of the 9 patients treated with EYS606 showed clinical improvements lasting for six months after one administration of the treatment. The first patient treated in the lowest dose cohort experienced a >10 ETDRS letter improvement in best corrected visual acuity while two patients treated in the highest dose cohort showed a significant reduction of macular edema via optical coherence tomography (OCT) associated with at least +12 ETDRS letters increase in BCVA from baseline. 

An investigational new drug (IND) application was filed in July 2019 and subsequently cleared with the U.S. Food and Drug Administration in August 2019. This IND allows Eyevensys to further validate the technology in a phase II clinical study targeting patients with active chronic NIU. In parallel, Eyevensys is also advancing preclinical programs using different proteins for other ophthalmic diseases, including retinitis pigmentosa, dry AMD, glaucoma, macular edema associated with wet-AMD, DME, and CRVO. 

Dr. Buggage said, “We are extremely proud to reach this stage of development with our lead clinical candidate based on the Eyevensys technology. The potential to express a diversity of therapeutic proteins at effective intraocular concentrations sustained for over 6 months with our minimally invasive, non-viral gene therapy drug delivery platform will revolutionize the way we treat ocular diseases while reducing the burden of treatment for both patients and ophthalmologists.” 

Dr. Patricia Zilliox, Chief Executive Officer, said, “We’re pleased to have an opportunity to share these initial findings from our lead study with our peers and offer a glimpse into ongoing development at 

Eyevensys to date. With these results, we can continue to move forward with our strategy to introduce our proprietary technology, the Electrotransfection System, into the treatment paradigm to improve long-term therapeutic outcomes.” 

About Eyevensys 

Eyevensys is a private clinical stage biotechnology company developing its innovative technology to enable the sustained intraocular production of therapeutic proteins to treat a broad range of ophthalmic diseases. 

The Eyevensys technology, developed by Dr. Francine Behar-Cohen in Paris, uses electroporation to deliver improved proprietary DNA plasmids encoding therapeutic proteins into the ciliary muscle of the eye. This approach facilitates the sustained intra-ocular production of therapeutic proteins. 

Eyevensys’ lead product EYS606 is a potential new treatment for patients with chronic non-infectious Uveitis (NIU). EYS606 combines Eyevensys’ proprietary Electrotransfection System with plasmids encoding for the production of a potent fusion protein which neutralizes the activity of TNFα, a cytokine that has been shown to play a pivotal role in mediating intraocular inflammation in NIU. EYS606 is currently in a phase I/II clinical trial in the EU and has been granted an Orphan drug designation by the European Medicines Agency (EMA) for the treatment of NIU. The therapeutic potential of EYS606 in patients with active, chronic NIU will be further investigated in Part 2 of the ongoing EYS606-CT1 study in the EU and in the Phase 2 EYS606-CT2 (Electro) Study that will be launched in the US in early 2020. 

Eyevensys was founded in 2008. It is headquartered in Paris, France, incorporated in the U.S., and is funded by Boehringer Ingelheim Venture Fund, BPIFrance, CapDecisif, Inserm Transfert, Pontifax and GHS. 

For more information about Eyevensys please visit www.eyevensys.com. 

Media Relations Contact: 

Marion Janic, RooneyPartners 

mjanic@rooneyco.com

+1-212-223-4017

Ophthalmology Innovation Summit Oct 10, 2019 San Francisco, California

Ophthalmology Innovation Summit Oct 10, 2019 San Francisco, California 2560 1440 Eyevensys

European Society of Cataract & Refractive Surgeons (ESCRS) Sep 14 to Sep 18, 2019 Paris, France

European Society of Cataract & Refractive Surgeons (ESCRS) Sep 14 to Sep 18, 2019 Paris, France 1874 1065 Eyevensys

Eyevensys Appoints New Board Member, Gerald Cagle

Eyevensys Appoints New Board Member, Gerald Cagle 1920 1280 Eyevensys

Eyevensys today announced that Gerald (Jerry) Cagle, Ph.D., former Senior Vice President and Chief Scientific Officer at Alcon Laboratories has joined its Board  of Directors.

Dr. Cagle is a highly respected pharmaceutical executive with managerial, technical and business experience spanning almost 40 years. Dr. Cagle served in key leadership roles for Alcon Laboratories Inc., including positions in clinical research, regulatory affairs, and product development. During the last 13 years at Alcon, he held the position of Senior Vice President and Chief Scientific Officer, introducing a range of new products. Dr. Cagle holds 28 issued patents in both drug and device areas and has published numerous scientific articles. More recently, he has served on the Boards of several life sciences companies.

Dr. Patricia Zilliox, CEO of Eyevensys, stated: “I am excited to welcome Dr. Cagle to our Board of Directors. His extensive wealth of product development and industry experience will be key to leverage our unique EyeCET platform. We expect Jerry’s expertise to be valuable as we further progress our lead product EYS606, currently in a Phase I/II clinical trial for the potential treatment of non-infectious uveitis (NIU).”

Dr. Gerald Cagle said: “I am delighted to join Eyevensys’ Board and look forward to working with a strong team and unlock the potential of its pioneering ocular drug delivery technology. The EyeCET technology is a very promising approach to address the deficiencies of current therapies for the treatment of a range of eye diseases. I look forward to contributing to the preclinical and clinical development efforts. ”

Eyevensys Appoints Dr. Patricia Zilliox as Chief Executive Officer

Eyevensys Appoints Dr. Patricia Zilliox as Chief Executive Officer 1667 2500 Eyevensys

Paris (France), December 12th, 2017 – Eyevensys, a clinical stage biotech company developing non-viral gene therapies for ophthalmic diseases, today announced the appointment of Dr. Patricia Zilliox as CEO.

Dr. Zilliox, who joined the Eyevensys board in May 2016, has more than 25 years of global clinical development expertise. She previously served as Chief Drug Development Officer of the Clinical Research Institute, a division of the Foundation Fighting Blindness, in Columbia, MD, USA. From late 2008 until May 2011, Dr. Zilliox was head of clinical development at Alcon Laboratories, managing clinical development programs in areas of eye diseases such as glaucoma, allergy, dry eye, infectious diseases of the eye, and retinal diseases such as dry- and wet-AMD. Dr. Zilliox previously worked for Alcon in Paris, France, where she was responsible for the execution of Alcon’s European ophthalmology clinical trials.

Garth Cumberlidge, Chairman of Eyevensys’ Board, said, “I am delighted that Patricia has agreed to become the Company’s new CEO. Patricia’s strong clinical development experience in the field of ophthalmology together with her expertise at the Foundation Fighting Blindness will be important assets in building significant value for Eyevensys and its unique proprietary EyeCET technology. I am confident in Patricia’s ability to enhance and execute the company’s strategic plan to bring new medicines to market and create value for the Company’s shareholders.”

Garth added, “On behalf of Eyevensys board, I would also like to take this opportunity to thank Raffy Kazandjian for nurturing Eyevensys from its formative days to a clinical stage company.”

Dr. Patricia Zilliox stated: “It is a pleasure to become the CEO of a company I already know well and one that combines world-class scientific innovation, unique technology with significant commercial potential and a team of experts in the field of ophthalmology who are committed to bringing innovative products to ophthalmic patients. I am looking forward to leading our efforts to further the clinical development of our lead product EYS606 and to develop a strong portfolio of proprietary products to treat major ophthalmic diseases leveraging our unique EyeCET platform.”

Eyevensys Appoints Thierry Bordet Ph.D. as Pre-Clinical Director

Eyevensys Appoints Thierry Bordet Ph.D. as Pre-Clinical Director 1668 2500 Eyevensys

Paris (France), 13th September 2017 – Eyevensys, a clinical stage biotech company developing its proprietary EyeCET platform, the first non-viral gene expression technology that enables the safe, local, sustained production of therapeutic proteins in the eye to address a wide range of ophthalmic diseases, announces today the appointment of Thierry Bordet, Ph.D. as Pre-Clinical Director.

Thierry will be directing Eyevensys’ pre-clinical development efforts, including the generation of potential clinical candidates for the range of eye diseases that the Company is targeting such as retinal vein occlusion and retinitis pigmentosa. He will also oversee Eyevensys’ relationships with potential academic and industrial partners.

Thierry brings more than 15 years’ experience in the biotechnological sector having managed drug development programs for small molecules, gene therapies, cell-based therapies and tissue engineered products. He was most recently Pre-Clinical Development Director at the Biotherapies Institute for Rare Diseases, in Evry, France where he designed development strategies for advanced therapy medicinal products for various indications, including inherited retinitis pigmentosa. Prior to that he spent 12 years at Trophos managing the company’s drug screening and early development programs for neurodegenerative indications. Thierry has a Ph.D. in microbiology and virology from Pierre & Marie Curie University PARIS VI.

Raffy Kazandjian, CEO of Eyevensys, said, “I am pleased to welcome Thierry to the team. Eyevensys has a unique approach to treating ophthalmic diseases based around our proprietary EyeCET platform. Our objective is to leverage our unique technology to rapidly build a comprehensive portfolio of products that will target a range of major eye diseases; and Thierry’s extensive pre-clinical research experience, as well as years of direct involvement in the development of gene therapies will be a great asset to move several of our products forward.”

Eyevensys Appoints Dr Ronald R. Buggage as Chief Medical Officer

Eyevensys Appoints Dr Ronald R. Buggage as Chief Medical Officer 2500 1667 Eyevensys

Paris (France), 4th September 2017 – Eyevensys, a clinical stage biotech company developing its proprietary EyeCET platform, the first non-viral gene expression technology that enables the safe, local, sustained production of therapeutic proteins in the eye to address a wide range of ophthalmic diseases, announces today the expansion of its executive team with the addition of Dr Ronald R. Buggage as its Chief Medical Officer. Dr Buggage brings more than 14 years’ experience from both large pharma and biotech companies having worked in senior development positions in the US and Europe. Dr Buggage will drive the Company’s drug development strategy, overseeing clinical development programs for a broad range of ophthalmic indications based Eyevensys’ unique non-viral gene therapy EyeCET platform.

Dr Buggage was most recently Division Medical Officer at Sanofi’s Ophthalmology Unit, responsible for the leadership and coordination of medical and scientific activities for its ophthalmology portfolio including development programs for ocular gene therapy. He also served as Chief Scientific Officer of Novagali Pharma, where he was responsible for the global clinical and regulatory strategy; Novagali Pharma was successfully acquired by Santen. Prior to moving to France, Dr Buggage held various positions of increasing clinical development responsibility at Novartis and Pfizer. Dr Buggage obtained his MD at UCLA School of Medicine, specializing in ophthalmology at Emory, and completed his training in ocular immunology and uveitis at the National Eye Institute of the National Institutes of Health (NIH).

Raffy Kazandjian, CEO of Eyevensys, said, “We are delighted to add such an experienced and high-calibre individual to our executive team. Ronald’s unique combination of regulatory, medical, and drug development expertise in the ophthalmic space, including uveitis, will be a major asset as Eyevensys advances its high potential pipeline. This includes our lead product EYS606 for which the first in human phase I/II clinical trial was recently initiated in France.”

He added, “Eyevensys has a unique approach to treating ophthalmic diseases based around our proprietary EyeCET platform that we believe is the only non-viral technology that enables the safe local sustained production of therapeutic proteins in the eye for up to six months. I am confident that our approach will have a clear appeal to physicians and patients, offering them a clearly differentiated alternative to existing treatments for major ophthalmic indications.”

Dr Ronald R. Buggage, CMO of Eyevensys, commented, “I am particularly thrilled to join Eyevensys at such a pivotal time. Its proprietary EyeCET platform offers an innovative approach to sustained intraocular drug delivery which combined with the non-viral delivery of the plasmids provides a convenient alternative to current biologics used to treat ophthalmic diseases. I believe that with EyeCET, Eyevensys has the potential to build an exciting, high value pipeline of new ocular therapies.”

Eyevensys Announces the First-in-Human Treatment with its GroundBreaking EyeCET ElectroTransfection Technology for Eye Diseases

Eyevensys Announces the First-in-Human Treatment with its GroundBreaking EyeCET ElectroTransfection Technology for Eye Diseases 2500 1667 Eyevensys

Eyevensys announces today that it has successfully treated the first patient in a first-in-human phase I/II trial of its lead candidate EYS606 for Non-Infectious Uveitis (NIU). The patient was treated in Paris, France at the Cochin Institute by Professor Antoine Brézin, the principal investigator of the trial, using the company’s novel EyeCET technology.

EYS606 is the first non-viral gene therapy that has the potential to treat NIU patients as replacement of systemic therapy or repeated intra-vitreal injections. EYS606 is based on Eyevensys’ EyeCET technology, which uses a proprietary electro-transfection injection system (ETIS) to deliver a plasmid encoding for the production of an anti-TNFα therapeutic protein into the ciliary muscle of the eye. TNFα is a cytokine that has been shown to play a pivotal role in mediating intraocular inflammation in NIU patients.

The phase I/II trial aims to demonstrate the safety and tolerability of the EYS606 treatment when the plasmid component of EYS606 is administered using EyeCET technology by electro-transfer into the ciliary muscle of patients with non-infectious posterior, intermediate or pan uveitis. The treatment procedure, which takes less than 5 minutes, is designed to provide the patient with a local, safe and sustained treatment, obviating the need for monthly injections. This open-label, multicentre dose escalation study will enrol up to 24 patients in France and the UK and the initial trial results are expected in the first half of 2018.

EYS606 has been granted an Orphan drug designation by the European Medicines Agency (EMA) for the treatment of NIU.

Professor Francine Behar-Cohen, Founder and Chief Scientific Officer of Eyevensys, stated: “Successfully treating our first patient is an important step towards improving outcomes for patients with NIU. This is the first time plasmid DNA has been successfully delivered to the eye via electro-transfection. This represents a major milestone for Eyevensys and a key step in validating the potential of our EyeCET platform to provide safe and long-lasting treatments for patients while avoiding the current standard of multiple injections and their associated safety risks.”

Professor Brézin, Cochin Institute, and principal investigator of the study in France, stated: “I am delighted to be part of this landmark clinical study using Eyevensys’ unique EyeCET platform. This first treatment was very well tolerated by the patient, which represents an important step towards potentially improving outcomes for patients with NIU. NIU is a rare and severe eye condition afflicting approx. 25,000 in France and there is a critical need for novel treatments.”

Eyevensys Receives Approval from the UK Medicines and Healthcare products Regulatory Agency to advance its EyeCET platform into clinical development

Eyevensys Receives Approval from the UK Medicines and Healthcare products Regulatory Agency to advance its EyeCET platform into clinical development 2500 1668 Eyevensys

Eyevensys, a private biotechnology company developing its proprietary EyeCET platform, the first non-viral gene expression technology that enables the safe, local, sustained production of therapeutic proteins in the eye to address a wide range of ophthalmic diseases, announces it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to advance its technology into clinical development.

The EyeCET platform uses Eyevensys’ proprietary electro-transfection injection system (ETIS) to deliver plasmids that encode for the production of disease-specific therapeutic proteins in the ciliary muscle of the eye. Eyevensys’ lead product, EYS606 uses a plasmid encoding for the production of anti-TNFα for the treatment of Non-infectious Uveitis (NIU). EYS606 has been granted an Orphan drug designation by the EMA for the treatment of NIU.

Raffy Kazandjian, CEO of Eyevensys, said: “We are pleased the MHRA has approved our unique technology to enter into clinical development in the UK. This validation is another commitment of EYS606 alongside the ANSM approval. We are now all set up to demonstrate that our technology can provide much better outcomes for patients with ophthalmology diseases that need improved treatment options.”