Cue lays off 25%, prioritizing preclinical autoimmune assets over clinical-stage cancer drugs

When conserving scarce financial resources, biotechs often favor their assets that have made the most progress through the clinic. Not Cue Biopharma, which is prioritizing its preclinical autoimmune portfolio over its clinical-stage oncology drugs—losing a quarter of its workforce in the process.

The Boston-based company expanded its autoimmune capabilities in the first months of the year, continuing to work on a regulatory T cell-focused bispecific protein licensed from Japan’s Ono Pharmaceutical in 2023 as well as making “demonstrable preclinical progress” with a depleting autoreactive B cell program called CUE-501.

“I believe each of these autoimmune programs has the potential to address multiple diseases and create near-term and intermediate value creation opportunities,” Cue CEO Daniel Passeri said in a post-market release yesterday.

Prioritizing these preclinical programs means that the company’s two interleukin-2 (IL-2)-based cancer drugs—both of which have already made it into human trials—are being placed on the back burner.

Only last month, Cue was celebrating a “very encouraging” objective response rate of 46% produced by one of these therapies, CUE-101, in combination with Keytruda in a phase 1 study of recurrent/metastatic HPV16+ head and neck squamous cell cancer.

The other drug, CUE-102, is currently in a phase 1 study for patients with late-stage colorectal, gastric/gastroesophageal junction, pancreatic and ovarian cancers that express WT1.

“While we plan to focus our resources on our novel autoimmune programs, we intend to preserve the potential value of our clinical oncology programs by retaining requisite clinical capabilities to enable maturation of clinical survival data in the current ongoing phase 1 trials of CUE-101 and CUE-102,” Passeri explained.

“As such, we are actively pursuing third party support through partnerships and collaborations to further develop these programs,” the CEO added. “We believe the strategic measures we are taking will strengthen operational efficiencies and extend our capital runway.”

These “strategic measures” include laying off around 25% of the company’s staff across its R&D and general and administrative resources teams. Combined with “the implementation of focused operational efficiencies,” these moves are expected to pave a cash runway into the middle of next year.

The company ended March with $41 million in cash and equivalents, which Cue had previously estimated would run dry in the first quarter of 2025.