Articles from jCyte, Inc.

A new preclinical study titled “Intravitreal Transplantation of Retinal Progenitor Cells Improves Outcome Measures in a Rat Model of Diabetic Retinopathy” reports that retinal progenitor cells (RPCs) may provide both functional and anatomical benefits in diabetic retinopathy (DR), one of the leading causes of vision loss worldwide and the most common eye disease afflicting over 600 million people worldwide with diabetes.

jCyte, a clinical-stage biotechnology company developing transformative cell therapies for retinal diseases, today announced the publication “Retinal Progenitor Cells (jCell) for Retinitis Pigmentosa” containing results from its Phase I/IIa clinical trial evaluating the safety and tolerability of intravitreal injection of retinal progenitor cells (RPCs) in adults with non-syndromic retinitis pigmentosa (RP).

jCyte, Inc. is pleased to announce the first patients have been enrolled and treated in the JC02-88 study evaluating the safety and efficacy of jCell (famzeretcel) for the treatment of retinitis pigmentosa (RP). The jCell dose being studied in this trial is approximately 50% higher than the highest dose administered in previous jCyte clinical trials.

Researchers from the Gavin Herbert Eye Institute and Sue & Bill Gross Stem Cell Research Center at the University of California, Irvine, in collaboration with the Neuroscience Research Institute at the University of California, Santa Barbara, have published a pioneering preclinical study demonstrating the effectiveness of intravitreal injection of retinal progenitor cells (RPCs) (jCell) in treating photoreceptor degeneration. This research has been published on July 24 in the International Journal of Molecular Sciences.

jCyte, Inc., a pioneering biotechnology company dedicated to preserving and restoring vision in patients with retinitis pigmentosa (RP) and other degenerative retinal disorders, is pleased to announce the successful outcome of its pre-phase 3 Type B meeting with the US Food and Drug Administration (FDA) held on January 16, 2024. Additionally, the company is gearing up to commence its pivotal US trial for jCell in the second half of 2024.

jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the expansion of the company’s leadership team with the appointment of Dr. Stewart Craig as Chief Technology Officer. In his new role, Dr. Craig will be the strategic and technical lead for all drug product development activities, including manufacturing process development, GMP facility design, build-out and scale-up, technology transfer, analytical test method development, quality control, drug product formulation development, and CMC regulatory interactions and filings.

jCyte, Inc., today announced key findings presented at AAO 2021 which demonstrated that retinitis pigmentosa (RP) patients with a baseline central visual field diameter greater than 20 degrees had a profound response to jCell treatment in its Phase 2b study, the largest randomized clinical trial ever conducted in RP for a locally administered investigational treatment.

jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the continued expansion of the company’s leadership team with the appointment of Peter Kuper as Senior Vice President of Finance and Information Technology. Mr. Kuper joins jCyte with over 25 years of investment banking, security analysis, and venture capital experience having played significant leadership roles in making and moving public and private markets, cultivating startups, and leading numerous large IPOs that raised over $4 billion in investment capital.

jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the continued expansion of the company’s executive management team with the appointment of John Pollack, MD, FASRS, as the company’s first Chief Medical Officer (CMO).

jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, today announced the expansion of the role of Dr. Samir Mody. In addition to his Chief Commercial Officer responsibilities focused on preparing for the North American launch of jCell, Dr. Mody will now also assume leadership for the Global Pricing, Health Economics, and Reimbursement functions for jCyte.

jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the expansion of the company’s leadership team with the appointment of R. Heath Coats as Vice President of CMC, Regulatory Compliance and Quality Control. In his new role, Mr. Coats will be the strategic and technical lead for manufacturing design, technology transfer, analytical test development, quality control, drug product formulation development, facility buildout, and CMC regulatory interactions and filings for jCyte’s first-in-class regenerative cell therapy, jCell, for retinitis pigmentosa (RP) and future indications.

jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced today the continued expansion of the Company’s leadership team with the appointment of Dr. Rebecca Kammer as Vice President of Clinical Operations. In her new role, Dr. Kammer will be responsible for the leadership, oversight, and execution of clinical trials and studies to support the development of jCell for current and future indications. Dr. Kammer will also be responsible for the creation, refinement, and supervision of clinical trial endpoints and other assessments conducted at the centralized jCyte Low Vision Testing Center.

jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the continued expansion of the Company’s leadership team with the appointment of Victor Chao as Vice President of Chemistry, Manufacturing and Controls (CMC) Operations.

jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the continued expansion of the company’s executive management team with the appointment of Adrian Morris as Chief Development Officer. Mr. Morris brings to jCyte over three decades of pharmaceutical industry experience in global leadership roles in R&D, commercial strategy, marketing, and business development, including a remarkable track record of successfully guiding the development and leading the launch of numerous innovative breakthrough therapies that went on to become blockbuster assets for GlaxoSmithKline.

jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the further expansion of the company’s executive management team with the appointment of Adam Walsh, M.D. as Chief Financial Officer. Dr. Walsh brings to jCyte over two decades of Wall Street experience as both an award-winning biotechnology equity research analyst and investment banker, and a strong foundation in corporate finance and strategy with outstanding corporate and institutional relationships across the sector.

jCyte, Inc., a biotech company dedicated to improving the lives of patients with retinal degenerative diseases, today announced the further expansion of the company’s executive management team with the appointment of John Sholar as General Counsel. Mr. Sholar brings to jCyte more than 20 years of industry experience, serving as the head of North American legal for a large publicly traded pharmaceutical company, in private practice as a law firm partner focused on intellectual property development and pharmaceutical patent licensing and litigation, and in the military as a Naval Officer leading teams in new mission areas around the globe.

jCyte, Inc. today announced presentations at the prestigious Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting. Following the Phase 2b headline results of jCell therapy in retinitis pigmentosa (RP) first presented at the American Society of Retinal Specialists (ASRS) Annual Meeting, further detailed analyses from this study, the largest randomized clinical trial ever conducted in RP for a locally administered investigational treatment, were presented at ARVO by Dr. David Liao from Retina Vitreous Associates in Los Angeles, and Dr. Sunil Srivastava from the Cleveland Clinic Cole Eye Institute.