Precision, pivoting to in vivo editing, punts early-phase CAR-T to Imugene for $21M upfront

Precision BioSciences has moved quickly to partner its CAR-T cell therapy candidate. Less than three weeks after confirming it planned to partner the program, the biotech has agreed to offload the asset to Imugene for $21 million upfront and much more on the back end.

North Carolina-based Precision shared early-phase clinical trial data on the allogeneic CAR-T candidate, the CD19-directed azercabtagene zapreleucel (azer-cel), in May. The clinical trial linked azer-cel to a 41% complete response in relapsed or refractory non-Hodgkin lymphoma patients. Precision saw the highest complete response rate, 61%, in a subset of 18 CD19-positive, CAR-T relapsed patients.

Subsequent talks with the FDA provided clarity on a “potential pathway toward registration,” but, with multiple programs on the go, Precision opted against walking the path itself, choosing instead to look for a partner. Enter Imugene.

The Australian biotech has agreed to pay $21 million upfront in cash and equity for global rights to the CAR-T candidate. Imugene will hand over another $8 million, again in cash and equity, once the therapy completes phase 1b dosing in the CAR-T relapsed large B-cell lymphoma patient population. As the asset advances, Precision could receive up to $198 million in milestones plus double-digit royalties on net sales. 

Imugene has also secured an option to develop up to three other cancer programs. Each of the programs is tied to $145 million in milestones. Precision’s phase 1 PBCAR19B stealth cell and multiple myeloma CAR-T assets, plus rights to azer-cel in non-oncology indications, remain available for partnering. 

Precision wants to partner the cell therapy programs and pivot to the in vivo gene editing applications of its technology. The Imugene deal supports the plan by adding to Precision’s bank balance and wiping $20 million off its annual spending, changes that could extend the biotech’s cash runway to the third quarter of 2025, up from the first quarter of 2025 under the previous plan.

Over the length of its cash runway, Precision plans to advance a chronic hepatitis B gene editing program, which it plans to file to test in humans next year, and support other in vivo gene editing programs it is working on with Eli Lilly and Novartis.

It appears investors may still need some convincing. While Precision’s share price did rise 30% in early premarket trading Wednesday in the wake of news of the Imugene deal, the stock still only sits at 69 cents.