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Cue Biopharma
Cue Biopharma is a clinical-stage biotech led by Daniel Passeri, engineering T cells inside the body to avoid CAR-T toxicities.
Cue Biopharma
Cue Biopharma launched in 2015 when Daniel Passeri, who had led cancer vaccine developer Curis through a pivotal refocus, moved to Boston to build an immunotherapy company around a biologic scaffold licensed from the Albert Einstein College of Medicine. Passeri assembled a management team that included co-founder and CSO Ronald Seidel, a structural biologist whose work on T-cell receptor mimicry underpins the platform. The firm listed on Nasdaq in 2018 via a reverse merger, raising capital in a window when checkpoint inhibitors were reshaping oncology expectations. The company's core thesis is that controlling T-cell activity with soluble protein biologics — rather than engineering cells ex vivo as Gilead's Yescarta or Novartis's Kymriah do — can deliver potency without cytokine-release storms. Its lead asset in oncology, CUE-101, fuses an interleukin-2 variant to an HPV E7 peptide-presenting molecule, and completed a Phase 1b trial in combination with Keytruda in recurrent head and neck cancer. A parallel autoimmune pipeline targets disease-specific antigen-presenting cells, with preclinical work in Type 1 diabetes and lupus. The company's public disclosures name collaborations with Merck & Co. and with LG Chem in South Korea, extending its geographic reach into Asia. As of first-quarter 2025 regulatory filings, Cue Biopharma held approximately $32 million in cash and equivalents, projecting a runway into June 2026. The firm trimmed its workforce by roughly 25% in 2024 to concentrate resources behind clinical milestones, an operational pivot that Passeri articulated on the Q4 2024 earnings call as a bridge to potential partnering deals. No separate venture arm or philanthropic foundation sits alongside the public company. Cue Biopharma's structural differentiator is its "dynamic selectivity" — a design goal of biologics that activate T cells only when they encounter a multi-marker disease signature. If validated clinically, the approach would invert the CAR-T manufacturing paradigm by turning the patient's own circulatory system into the activation chamber, eliminating the need for centralized cell-processing facilities that have become a capacity bottleneck for approved therapies.
General information
Firm type
Asset Manager
Year founded
2015
AUM
Undisclosed
Location
Region
North America
Country
United States
City
Boston
Corporate office
Boston, MA, United States
Principals
Daniel Passeri
Chief Executive Officer
Ronald Seidel
Chief Scientific Officer
Sector focus
Frequently asked questions
How does Cue Biopharma's Immuno-STAT platform differ from traditional CAR-T cell therapy?
CAR-T therapies require extracting a patient's T cells, genetically engineering them in a lab, and reinfusing them — a multi-week process with risks of severe inflammatory responses. Cue Biopharma's Immuno-STAT platform delivers off-the-shelf biologic drugs that activate disease-specific T cells internally, by presenting peptide-MHC complexes alongside an engineered IL-2 signal. The goal is to avoid the manufacturing complexity and systemic toxicities that limit CAR-T use, while still achieving targeted immune activation.
What is Cue Biopharma's lead clinical asset and what indication does it target?
CUE-101 is the company's lead oncology candidate, under investigation for recurrent or metastatic HPV-positive head and neck squamous cell carcinoma. It combines an engineered interleukin-2 molecule with an HLA-bound HPV E7 peptide to selectively stimulate tumor-specific T cells. A Phase 1b trial evaluating CUE-101 in combination with Merck's Keytruda reported its final data in 2024, and the company is considering registration-enabling study designs.
Does Cue Biopharma operate as a family office or a biopharmaceutical operating company?
Cue Biopharma operates as a publicly traded biopharmaceutical company (Nasdaq: CUE), not a family office or investment vehicle. It was founded in 2015 by a management team led by Daniel Passeri and listed on Nasdaq in 2018 via a reverse merger. The firm raises capital through public equity offerings and partnership deals to fund its internal drug pipeline.
Who are Cue Biopharma's key scientific and strategic collaborators?
The company has disclosed a clinical collaboration with Merck & Co. to supply Keytruda for combination trials, and a strategic collaboration with LG Chem Life Sciences for the development of Cue Biopharma's platform in select Asian territories. In addition, early platform intellectual property was licensed from the Albert Einstein College of Medicine, where foundational structural biology work was conducted.
What is Cue Biopharma's financial runway and funding posture?
In its first-quarter 2025 10-Q filing, Cue Biopharma reported approximately $32 million in cash and equivalents, stating that its projected runway extends into June 2026. The company reduced its workforce by roughly 25% in late 2024 to contain costs while it pursues partnership discussions and milestone-driven grant funding to support pipeline advancement.
What autoimmune indications is Cue Biopharma targeting beyond oncology?
Cue Biopharma has expanded its platform into autoimmune disease, with preclinical programs in Type 1 diabetes and lupus. The autoimmune strategy relies on the same Immuno-STAT biologics to selectively suppress or eliminate autoreactive immune cells, rather than broadly immunosuppressing. The company has indicated that generating proof-of-concept data in autoimmune models is a near-term operational priority.
Who runs investment decisions or capital allocation at Cue Biopharma?
As an operating biotechnology company, Cue Biopharma does not have an investment committee allocating to external managers. Capital allocation decisions — covering clinical trial funding, business development, and strategic partnerships — are the responsibility of CEO Daniel Passeri and the board of directors. The firm does not manage third-party capital or make venture investments.
Profile maintained by Altss using OSINT (open-source intelligence), regulatory filings, licensed data partners, and verified direct submissions. Read the methodology. Last updated: . Continuous refresh with full update cycles at least every 30 days.
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