Cue Biopharma, Inc. (Cue), an immunotherapy company developing biologics engineered to selectively modulate disease-relevant T cell subsets to treat cancer and autoimmune disease, announced today a total of $26 million of invested private capital, led by MDB Capital Group. Guided by an experienced management team and preeminent board members and scientific advisors, Cue will use the proceeds to accelerate development of its novel platform of T cell receptor (TCR) targeted biologics to control immune responses in patients. Cue was founded in 2015 with $10 million of seed funding, followed by a $16.4 million follow-on financing.

"It has become increasingly clear that more effective and less toxic approaches to immune modulation are needed via precise communication with and control of T cells," said Daniel Passeri, M.Sc., J.D., President and Chief Executive Officer of Cue Biopharma. "With the Cue platform, we have demonstrated selectivity for and modulation of disease-relevant T cells. Our lead candidate has exhibited significant potential in preclinical cancer models and has shown impressive synergy when combined with checkpoint inhibitors. Our approach to modulating the immune system to treat disease could have great clinical benefit for patients, while reducing collateral toxicities often seen with less selective immunotherapies."

"Cue biologics are engineered to engage and modulate specific disease-relevant subpopulations of T cells within a patient’s body, without activating T cells with similar signaling receptors, that are not relevant to the disease," said Steven Almo, Ph.D., Chair of the Department of Biochemistry at Albert Einstein College of Medicine/Montefiore Medical Center, scientific founder of Cue and Chairman of the Cue Scientific and Clinical Advisory Board. "The company has made impressive progress and I look forward to working closely with Cue as it brings its drug candidates into the clinic and advances its growing pipeline."

The Cue platform was developed in Dr. Almo’s laboratory at the Albert Einstein College of Medicine as part of a five-year, Specialized Center grant from the National Institutes of Health (NIH). This funding enabled the technology to be built into an industry-scale drug design platform capable of rapid and efficient molecular prototyping and development. Cue is leveraging these design capabilities in its discovery efforts.

Immune Responses, On Cue

Cue Biopharma has developed a highly productive platform for designing biologic drugs that generate tailored immune responses from disease-relevant T cell populations by emulating the signals, or cues, delivered by the body’s antigen presenting cells. This approach has the potential to be highly effective both as a monotherapy and also in combination with checkpoint inhibitors, while simultaneously avoiding the toxicity limitations experienced when non-specific T cell activation is involved.

Cue biologics are being designed to achieve a high level of specificity through the fusion of engineered T cell costimulatory signaling molecules (ligands) with a T cell receptor targeting complex (peptide-MHC) on a traditional antibody scaffold. The peptide interacts with disease-relevant T cells and the biologic delivers one of Cue’s engineered signaling ligands, thereby enabling exclusive modulation of the T cell population of interest. Cue biologics are expected to be capable of eliciting targeted T cell stimulation and expansion in the context of oncology or T cell downregulation in the context of autoimmune disease. The peptides capable of selectively targeting T cell subsets are interchangeable on the Cue construct, allowing for rapid extension to different indications simply by changing the specific peptide.

The versatility and flexibility of the Cue platform allows for highly efficient design and development of biologics that provide a rapid path from concept to in-vivo validation and selection of clinical candidates.

Cue Names Management Team, Board of Directors, Scientific Advisory Board

In conjunction with the launch of the company, Cue is announcing the members of its management team, which will be led by Daniel Passeri, M.Sc., J.D., President and Chief Executive Officer; Ronald Seidel, Ph.D., Executive Vice President, Head of Research and Development; and Rodolfo Chaparro, Ph.D., Executive Vice President, Head of Immunology.

Daniel Passeri is a seasoned biotechnology executive with more than 20 years of experience managing drug discovery and development programs as well as business development activities on behalf of publicly traded companies, with deep experience in both oncology and strategic partnership generation. Prior to joining Cue, Mr. Passeri served as President and Chief Executive Officer as well as Vice Chairman of the Board of Curis, Inc.

Dr. Ronald Seidel is a co-founder of Cue Biopharma and co-inventor of Cue’s technologies, and previously served as Research Assistant Professor of Biochemistry and Associate Director of the Macromolecular Therapeutic Development Facility (MTDF) at the Albert Einstein College of Medicine.

Dr. Rodolfo Chaparro is also a co-founder of Cue Biopharma and co-inventor of Cue’s technologies, and previously served as a faculty member in the Department of Biochemistry at the Albert Einstein College of Medicine in New York.

Cue also named the independent members of its Board of Directors, which include Peter Kiener, D.Phil.; Barry Simon, M.D.; and Steven McKnight, Ph.D. Dr. Kiener has deep experience in both biologics and immunotherapy, including as EVP and Global Head of Biologics at MedImmune/AstraZeneca, and is currently the Chief Scientific Officer at Sucampo. Dr. Simon is President and COO of NantKwest and has held senior level roles at several companies including F. Hoffmann-La Roche, Roche Labs, Connetics Corp. and Immunomedics. Dr. McKnight leads an active research laboratory at UT Southwestern Medical Center, was co-founder of San Francisco-based, Tularik, Inc., and founder of Dallas-based Peloton Therapeutics.

Cue has formed an industry-leading Scientific and Clinical Advisory Board, comprising Steven Almo, Ph.D.; Hidde Ploegh, Ph.D.; and David Baker, Ph.D. Dr. Almo is best known for his high resolution structural and biochemical characterization of the CTLA-4 and PD-1 immune checkpoint proteins and their respective ligands. Dr. Ploegh is a member of the Program in Cellular and Molecular Medicine at Boston Children’s Hospital. He is also recognized for his contributions to molecular immunology. Dr. Baker is a Professor of Biochemistry, Director of the Institute for Protein Design, Investigator of the Howard Hughes Medical Institute, and adjunct professor of Genome Sciences, Bioengineering, Chemical Engineering, Computer Science, and Physics at the University of Washington. His research group is focused on the prediction and design of macromolecular structures, interactions and functions.

About Cue Biopharma

Cue Biopharma™ (Cue) is an immunotherapy company developing biologics engineered to selectively communicate with disease-relevant T cell subsets to treat cancer and autoimmune disease. Cue biologics have the potential to be highly effective as monotherapies as well as synergistic with existing checkpoint inhibitors, while reducing collateral toxicities often seen with less selective immunotherapies. Through this platform approach, Cue has developed a promising pipeline with its lead candidate currently approaching the clinic. Headquartered in Kendall Square, Cambridge, MA, Cue is led by a strong, experienced management team and scientific advisory board (SAB) with deep expertise in the design and clinical development of protein biologics, immunology and immuno-oncology.