Approach
Our approach represents, what we believe to be, a disruptive breakthrough in the ability to selectively modulate the immune system in a targeted manner directly in the patient’s body, creating potentially life-changing therapeutics for new standards of care.
Our solutions aim to enhance the desired therapeutic affects while also avoiding the negative side effects of systemic, indiscriminate approaches, thereby providing more effective therapeutic indices.
Broad Disease Coverage
Access to a growing set of targets in autoimmune disease and oncology to address unmet needs in multiple indications.
Improved Tolerability & Enhanced Efficacy
Potential to improve overall treatment experience and clinical potential through reduced side effects and improved efficacy.
Convenient Administration
Standard intravenous (IV) injection delivery with an intermittent dosing schedule that can be administered by specialists and community-based physicians.
Potential
Engineering Therapeutics Designed for Selectivity
Using nature’s signals to transform and expand select immune cells for effective treatment of autoimmune disease and cancer.
Broad Clinical Application Serving Unmet Needs
Our modular approach enables flexible design and rapid and efficient expansion of pipeline addressing unmet needs in multiple indications.
Clinically Derisked
Derisked with clinical activity and tolerability shown across a wide range of cancers, (CUE-100 series) with key modular components having potential for direct application in autoimmune disease.
Scalable Manufacturing
Established platform production processes for the CUE-100 series based on FDA-endorsed requirements, producing stable, high-quality molecules at scale.
Pipeline Programs
Our pipeline features a series of next generation targeted therapeutic candidates based on a modular platform design, that has been clinically derisked. By combining validated components with defined functions, our modular approach enables rapid and efficient expansion of our pipeline, derisked with clinical activity across a wide range of cancers, with application in autoimmune disease and the potential to address further unmet needs in multiple indications.
Autoimmune and Oncology Pipeline Assets
CUE-401, our lead CUE-400 series candidate is designed to induce stable FOXP3+ regulatory immune T cells. FOXP3+Tregs (both nTregs and iTregs) are critical in maintaining immune tolerance and homeostasis of the immune system. CUE-401 has been demonstrated in multiple preclinical models to proliferate both FOXP3+ nTregs, as well as induce and proliferate FOXP3+ iTregs.
CUE-501, our lead CUE-500 series candidate, is a bispecific designed to direct selective memory T cells to target and deplete B cells to address autoimmune and inflammatory diseases.
The CUE-100 series of biologics have been specifically engineered and designed with the potential to enhance efficacy and reduce the severe toxicities associated with non-specific IL-2 cancer immunotherapies. They have been designed to selectively engage and modulate tumor-specific immune T cells by exploiting the specificity provided by nature through selectivity of the T cell receptor (TCR), thereby avoiding the toxicities and side effects associated with indiscriminate immune activators.
Our lead clinical candidate, CUE-101, has demonstrated clinical activity, including tumor reductions and survival benefit along with a favorable tolerability profile in monotherapy second line (2L)+ patients, as well as in combination with standard of care KEYTRUDA® in first line (1L) patients, from our Phase 1 trials. These trials evaluated patients with human papilloma virus (HPV+) recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). These results show the clinical applicability of our technology platforms and therapeutic potential of our advanced pipeline of biologics for the treatment of cancer.
