Biotech
Wednesday, August 16th, 2023 6:59 am EDT
Struggling biotechnology company Precision Biosciences has agreed to sell several experimental “off the shelf” cell therapies to cancer immunotherapy developer Imugene in a bid to raise cash and focus exclusively on gene editing.
In the deal announced Wednesday, Precision will sell rights to a treatment known as azer-cel, which is currently in early-stage testing for patients with relapsed or refractory large B-cell lymphoma. The company has been evaluating azer-cel in patients whose disease progressed following treatment with other cell therapies. It will now hand those responsibilities to Imugene, along with an option to develop up to three other Precision cancer drugs in the future.
Imugene is also receiving the biotech’s CAR-T infrastructure and cell therapy staff, enabling Precision to cut about $20 million in annual expenses, the company said.
Precision is getting $21 million in cash and equity up front, and could receive another $8 million once dosing is completed in an ongoing trial. It’s also eligible for $198 million in future payments, as well as royalties, if azer-cel progresses. Precision could additionally get up to $145 million for each other program Imugene licenses.
The company said it now has enough cash to operate through the third quarter of 2025.
The deal amounts to a retreat from cell therapy research for Precision, which was formed around a gene editing technology and has been using it to develop cancer immunotherapies as well as treatments for a variety of other conditions. The company is looking for partners for its remaining cell therapy assets, which include a preclinical lymphoma program, multiple myeloma research and rights to develop azer-cel outside of oncology.
In cell therapy, Precision has specifically been focused on “allogeneic” medicines. These treatments are made from donor cells, not the immune cells of individual patients, and have long been thought of as potentially convenient alternatives to the personalized CAR-T therapies that have come to market in recent years.
Yet, like others developing allogeneic treatments, Precision has struggled with the endeavor. Azer cel didn’t prove as durable as CAR-T therapies in early testing. The company then narrowed its focus to patients who had relapsed after CAR-T treatment, where the benefits appeared greater. It also advanced a newer program designed to overcome azer-cel’s weaknesses.
Precision reported results in June 2022 that showed promise, but also safety concerns, and met with the Food and Drug Administration earlier this year to figure out the program’s next steps. Afterward, the company shifted its strategy, revealing plans to pivot away from cell therapy in a move some analysts viewed as the result of a regulatory setback.
“Our speculation is that the FDA feedback may have implied a more arduous clinical development path than previously expected,” Stifel analyst Benjamin Burnett wrote in late July.
Precision, for its part, has said the decision is meant to support a focus on inside-the-body gene editing medicines. The company has partnerships in place with Eli Lilly, Novartis and startup iECURE. All of its work is in preclinical testing. Precision intends to update investors on its efforts at an R&D day next month.
Shares, however, have hovered at around $1 for more than a year, and have lost most of their value since the company’s initial public offering in 2019.
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