Carlsbad-based Lineage Cell Therapeutics, Inc. is expanding its operations at home and abroad.
The company announced on Oct. 3 an expansion of its Good Manufacturing Practice (GMP) manufacturing facility in Jerusalem, Israel as well as a new R&D facility located near its headquarters in Carlsbad. The new Carlsbad R&D facility will broaden Lineage’s research capabilities in the U.S. and support the development of current and future allogeneic cell transplant programs.
“What’s notable about this is we haven’t had any kind of research and development in Carlsbad or San Diego County before this,” said Lineage CEO Brian Culley, adding that prior to this new facility most of the company’s research was conducted in Israel. “So being able to establish some of this in the U.S. I think will be beneficial for us.”
The new Lineage R&D facility is located at 1915 Aston Ave., walking distance to the company’s headquarters in Carlsbad.
Lineage will be leasing a portion of the 11,000-square-foot building exclusively and a portion will be shared space.
“What I’m most excited about is the opportunity our new lab affords us to collaborate with partners in the San Diego biotech community,” said Lineage Executive R&D Director Tia Hexom. “We have an incredibly talented pool of scientists in our community, and we’re excited to tap more fully into the resources which Carlsbad and San Diego have to offer.”
Culley said he envisions the new lab facility as a “center of excellence” for Lineage’s longer-term programs, rather than existing programs.
“I think of it as the very early stage exploratory, high-risk center for us rather than the operation in Israel which is a lot more GMP clinical production and scale up,” he said.
The expansion of Lineage’s Israel-based facility will increase the company’s infrastructure, including development and optimization of larger-scale clinical manufacturing processes.
Culley said the expansion was necessary because the existing space was getting too “squished” as Lineage was ramping up its operations developing OpRegen therapy, a retinal pigment epithelium cell replacement therapy which has completed enrollment in a Phase 1/2a clinical trial for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration.
The program has expanded since Lineage signed a deal with Roche and Genentech potentially worth $670 million in December last year. Per the agreement, Lineage is responsible for making the clinical trial material for the next studies and must also teach Roche how to manufacture the material so they can produce it in their own facilities, Culley said.
Another reason Lineage expanded its footprint and operations was to reduce the company’s reliance on vendors and reduce costs and risks of timeline uncertainty or supply chain disruption.
“It’s incredibly frustrating to call a supplier and want to get a hold of some reagent and you find on that phone call it’s on backorder or not available,” Culley said. “Cutting out middle people helps us avoid disruption because time is just so expensive in this industry already. We need to make sure that we have access to the things we need because the cells won’t wait – if they’re hungry you have to feed them.”
As part of the deal with Roche, Lineage received a $50 million upfront payment which Culley said offers the company flexibility and runway to make “modest investments” in this uncertain economy in preparation for a turnaround in the market.
Lineage Cell Therapeutics, Inc.
CEO: Brian Culley
Business: Cell therapies
Stock: LCTX (NYSE American)
Revenue: $3.89 million (2021)
Notable: Lineage is the only company that has shown retinal restoration using stem cells.