CARLSBAD, Calif .– (COMMERCIAL THREAD) – Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), today announced that Lineage and its subsidiary, Cell Cure Neurosciences Ltd., have entered into an exclusive global collaboration and licensing agreement with Roche and Genentech , member of the Roche group (SIX: RO, ROG; OTCQX: RHHBY), for the development and commercialization of a retinal pigment epithelium (RPE) cell therapy for the treatment of eye disorders, including macular degeneration advanced dryness related to age (dry AMD) with geographic atrophy (GA).
Genentech will assume responsibility for the continued clinical development and commercialization of Lineage’s OpRegen program, which is currently being evaluated in an open-label, phase 1 / 2a, dose-escalating clinical safety and efficacy study. in patients with advanced dry AMD with GA. Under the terms of the collaboration agreement, Lineage will complete activities related to the ongoing clinical study, for which recruitment has been completed, and perform certain manufacturing activities. Genentech to make $ 50 million upfront payment to Lineage and Lineage is eligible to receive up to $ 620 million in additional milestone payments for development, approval and sales, in addition to double-digit tiered royalties .
âGenentech is an undisputed global leader in ophthalmology and has demonstrated a long-standing commitment to patients, innovative research and successful product development,â said Brian M. Culley, CEO of Lineage. âTheir desire to combine our cell therapy technology with their expertise and capabilities in ophthalmology will help advance the OpRegen program more quickly and we are successfully considering patients with serious eye disorders, such as dry macular degeneration associated with age. Lineage’s goal is to launch a new branch of regenerative medicine, based on the transplantation of whole cells into the body to restore activity lost due to aging, injury or disease. We believe that the results we have demonstrated to date with OpRegen represent a paradigm shift that many did not believe possible with cell therapy, by restoring retinal tissue and potentially arresting or reversing the expansion of geographic atrophy. . I am incredibly proud of what the Lineage team has accomplished with the OpRegen program and look forward to joining forces with the Genentech team as they strive to take this program to the next level and potentially to patients in need of treatment.
Mr. Culley continued, âGoing forward, Lineage will remain focused on advancing our spinal cord injury and oncology programs as well as announcing new disease settings where we plan to deploy our technology. either by ourselves or through strategic alliances. At Lineage, we are all extremely proud to have the opportunity and responsibility to advance an exciting new branch of medicine, and our goal is to have a profound impact on the patients who inspire us.
âGenentech has a long-standing commitment to the discovery and development of new drugs for the treatment of serious eye disorders such as advanced dry AMD with GA, which is one of our areas of focus in ophthalmology,â said said James Sabry, MD, Ph.D., Global Head of Pharmaceutical Partnerships, Roche. âWe are delighted to partner with Lineage Cell Therapeutics to advance potential new therapies in an area of ââhigh unmet medical needs. ”
Conference Call Information
Lineage will host a live conference call and webcast today starting at 8 a.m. ET to discuss the collaboration with the Roche Group and Genentech. Interested parties can access the conference call by dialing (866) 888-8633 from the United States and Canada and (636) 812-6629 from elsewhere outside the United States and Canada and should request the “Cell line therapeutic appeal”. A live webcast of the conference call will be available online in the Investors section of the Lineage website. A replay of the webcast will be available on the Lineage website for 30 days and a phone replay will be available until December 27, 2021, by dialing (855) 859-2056 from the US and Canada and ( 404) 537-3406 from the outside. in the US and Canada and entering conference ID 5174206.
OpRegen was developed in part through contributions and financial grants from Hadasit Medical Research Services and Development Ltd. (âHadasitâ) and the Israel Innovation Authority (âIIAâ). Lineage is obligated to pay a portion of the upfront, milestone, and royalty payments it receives to Hadasit and The IIA. OpRegen is currently being evaluated in a phase 1 / 2a open-label, dose-escalating safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from a pluripotent cell line. established and transplanted subretina in patients with advanced dry AMD with GA. The study included 24 patients in 4 cohorts. The first 3 cohorts recruited only legally blind patients with better corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort recruited 12 patients with better vision (BCVA of 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new ‘thaw-and-inject’ formulation of OpRegen, which can be shipped directly to sites and used immediately after thawing, eliminating the complications and logistics of having to use a facility. of dose preparation. The primary objective of the study was to assess the safety and tolerability of OpRegen based on the incidence and frequency of adverse events occurring during treatment. The secondary objectives are to assess the preliminary efficacy of OpRegen treatment by evaluating changes in ophthalmologic parameters measured by various methods of primary clinical relevance. OpRegen has been well tolerated to date and there have been no new unexpected ocular or systemic adverse events or serious adverse events related to OpRegen or the study procedures that were not previously reported.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its strong proprietary cell therapy platform and associated in-house development and manufacturing capabilities. With this platform, Lineage develops and manufactures specialized and terminally differentiated human cells from its starting materials of pluripotent and progenitor cells. These differentiated cells are developed to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means to help the body build an effective immune response against cancer. Lineage’s clinical programs are found in markets with billion dollar opportunity and include three allogeneic (âoff-the-shelfâ) product candidates: (i) OpRegenÂ®, a developing retinal pigment epithelium graft therapy 1 / 2a for the treatment of age-related dry macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in phase 1 / 2a of development for the treatment of acute spinal cord injury; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious diseases, currently in phase 1 clinical development for the treatment of non-chronic lung cancer. small cells. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.
Lineage cautions you that all statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements, in some cases, may be identified by words such as “believe”, “aim”, “may”, “will”, “estimate”, “continue”, “anticipate”, “conceive”, “have”. intention to, “” expect “,” might “,” may “,” plan “,” potential “,” predict “,” seek “,” should “,” should “,” contemplate “,” project “,” target “,” tend to “or the negative version of such words and phrases. Such statements include, without limitation, statements relating to the collaboration and license agreement with Roche and Genentech and the planned activities under the collaboration and licensing agreement, the initial consideration, milestone and royalty payable to Lineage, the potential benefits of treatment with OpRegen, and Lineage’s plans to advance its injury programs. spinal cord and oncology and announce new disease contexts where it plans to deploy its technology. Our forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to differ materially from future results, performance or achievements expressed or implied by forward-looking statements. of this press release, including the risk that competing alternative therapies could negatively impact the business potential of OpRegen, which could materially negatively impact milestone and royalty payments payable to Lineage under of the Collaboration and License Agreement, the risk that Roche and Genentech may not be successful in completing further clinical trials for OpRegen and / or obtaining regulatory approval for OpRegen in a particular jurisdiction, and the risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with Securities and Ex change Commission (SEC). Lineage’s forward-looking statements are based on its current expectations and involve assumptions which may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under “Risk Factors” in Lineage’s periodic reports to the SEC, including Lineage’s most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the SEC and its other reports, which are available on the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage assumes no obligation to update these statements to reflect events which occur or circumstances which exist after the date on which they were made, except as required by law.