Lineage establishes exclusive worldwide collaboration with Genentech

$670 million for the development and commercialisation of cell therapy for the treatment of ocular disorders.

Lineage Cell Therapeutics, Inc, today announced that Lineage and its subsidiary, Cell Cure Neurosciences Ltd, have entered into an exclusive worldwide collaboration and licence agreement with Roche and Genentech, a member of the Roche Group, for the development and commercialisation of a retinal pigment epithelium (RPE) cell therapy for the treatment of ocular disorders, including advanced dry age-related macular degeneration (dry AMD) with geographic atrophy (GA).

Longevity.Technology: Cell therapy is at the cutting edge of regenerative medicine; cell therapy has the potential to slow and reverse disease, to repair damaged organs and, eventually, cure many life-threatening and age-related conditions. The eye seems to be ideal for work in this area (Dr David Sinclair has shown that neurons in the eye can be reset to a youthful state with a gene therapy that induced expression of three of the Yamanaka factor proteins) and Lineage is skilled in the development and manufacture of specialised, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. This collaboration will drive cell therapy progress forward and we look forward to the results.

Genentech will assume responsibility for further clinical development and commercialisation of Lineage’s OpRegen program, which currently is being evaluated in a Phase 1/2a open-label, dose escalation 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 enrolment is complete, and perform certain manufacturing activities. Genentech will pay Lineage a $50 million upfront payment and Lineage is eligible to receive up to $620 million in additional development, approval and sales milestone payments, in addition to tiered double-digit royalties.

“Genentech is a clear global leader in ophthalmology and has demonstrated a longstanding commitment to patients, innovative research and successful product development,” said Brian M Culley, Lineage’s CEO. “Their desire to combine our cell therapy technology with their ophthalmology expertise and capabilities will help advance the OpRegen program more rapidly and we believe successfully to patients with serious ocular disorders, such as dry age-related macular degeneration.

“Lineage’s objective is to pioneer a new branch of regenerative medicine, based on transplanting whole cells into the body to restore activity lost to aging, injury or disease. We believe the results we have demonstrated to date with OpRegen represent a paradigm change many did not believe possible with cell therapy, by restoring retinal tissue and potentially halting 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 work to take this program to the next level and potentially to patients in need of treatment.”

Mr Culley continued, “Looking ahead, 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 on our own or through strategic alliances. All of us at Lineage are immensely proud to have the opportunity and responsibility to advance a new and exciting branch of medicine, and our aim is to make a profound impact on the patients who serve as our inspiration.”

“Genentech has a longstanding commitment to discovering and developing novel drugs for the treatment of serious eye disorders such as with advanced dry AMD with GA, which is one of our focus areas within ophthalmology,” said James Sabry, MD, PhD, global head of Pharma Partnering, Roche. “We are excited to partner with Lineage Cell Therapeutics to advance potential new therapies in an area of high unmet medical need.”