Our Pipeline
A late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies.
Our Pipeline
A late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies.
Our pipeline of next-generation CAR T-cell product candidates target hematologic malignancies and solid tumors indications with large unmet need.
Our product candidates are enhanced with proprietary technology and manufacturing protocols designed to generate potent, tumor-reactive, long-lasting and functional T cells to drive durable tumor cytotoxicity.
Product Candidate/
Modality
Modality
Target
Technology
Target Indications
PrePreclinical
Phase 1
Pivotal
Target
Ronde-cel (LYL314) is a dual-targeting CD19/CD20 CAR T-cell product candidate designed to target both CD19 and CD20, two antigens present on B-cell lymphoma.
Target IndicationsB-cell lymphoma is a type of non-Hodgkin lymphoma that originates in the B-cells. It is the most common type of lymphoma, comprising approximately 85% of all lymphomas in the United States. While the first generation of CD19 CAR T cell therapies delivered a major advance in treatment for patients with B-cell lymphoma, there remains a need for therapies that deliver more complete and durable responses. More than 40% of patients treated with a CD19 CAR T-cell therapy are not disease-free after treatment and 50% of patients who do respond, progress or relapse within six months.
Development Stage
Pivotal: PiNACLE is a single-arm pivotal trial of ronde-cel in patients with large B-cell lymphoma receiving treatment in the 3L+ setting. The trial is expected to enroll approximately 120 patients. Patients may be treated with ronde-cel in either the inpatient or outpatient setting. The primary endpoint of the trial is the overall response rate. More information about the PiNACLE trial can be found on clinicaltrials.gov (NCT05826535) here.
Next Milestone
- PiNACLE trial progress update expected late-2025
- BLA submission expected in 2027
Commercial Rights
Target
Ronde-cel (LYL314) is a dual-targeting CD19/CD20 CAR T-cell product candidate designed to target both CD19 and CD20, two antigens present on B-cell lymphoma.
Target IndicationsB-cell lymphoma is a type of non-Hodgkin lymphoma that originates in the B-cells. It is the most common type of lymphoma, comprising approximately 85% of all lymphomas in the United States. While the first generation of CD19 CAR T cell therapies delivered a major advance in treatment for patients with B-cell lymphoma, there remains a need for therapies that deliver more complete and durable responses. More than 40% of patients treated with a CD19 CAR T-cell therapy are not disease-free after treatment and 50% of patients who do respond, progress or relapse within six months.
Development Stage
Phase 1-2. The Phase 1-2 trial is a multi-center, open-label clinical trial designed to evaluate the tolerability and clinical benefit of Ronde-cel in patients with relapsed/refractory aggressive B-cell lymphoma and determine a recommended Phase 2 dose.
Next Milestone
- Presentation of more mature data expected in late 2025
- Initiation of a pivotal trial expected by early 2026
Commercial Rights
Solid Tumors Programs
Undisclosed
Anti-exhaustion
Stemness
TME functional enhancement
Undisclosed
Target
Solid Tumors Programs
Technology
- Undisclosed
Target Indications
- Anti-exhaustion
- Stemness
- TME functional enhancement
Learn More About Our Technologies
Our proprietary reprogramming technologies are designed to address barriers to consistent, reliable and durable responses to cell therapy in solid tumors.
Learn More