Our Pipeline

A clinical-stage company advancing a broad pipeline of novel therapies to address barriers to successful adoptive cell therapy in solid tumors.

We are building a multi-modal pipeline across several indications with high unmet needs for patients with solid tumor cancers.

Lyell has immense potential to target aggressive solid tumor cancers. Our diverse pipeline targets triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), melanoma, and synovial sarcoma (SS) — but these initial indications are only the beginning. Each of our programs provides opportunities to expand into additional indications beyond the patient populations initially targeted.

Product/Modality
Technology
Target
Indication
Preclinical
Phase 1
Phase 2
Phase 3

Target

ROR1 is a highly expressed cell surface antigen present on many aggressive solid tumors, including approximately 60% of patients with triple-negative breast cancer (TNBC) and 40% of patients with non-small cell lung cancer (NSCLC).

Target Indications

Breast cancer is the second most common cancer in American women and approximately 10-15% of patients with breast cancer have TNBC. Lung cancer is the second most common cancer and is the leading cause of cancer mortality worldwide. NSCLC accounts for 84% of all lung cancers.

Development Stage

Phase 1. The Phase 1 open label, dose escalation and expansion clinical trial is designed to evaluate the safety and antitumor activity of LYL797 in patients with ROR1+ TNBC or NSCLC. More information can be found on ClinicalTrials.gov.

Next Milestone

Initial data expected in 2023

Commercial Rights
CAR image

Target: Polyclonal

Tumor infiltrating lymphocytes (TIL) therapy targets a variety of antigens specific to a patient's tumor. Further, broad TIL efficacy has been limited by poor enrichment of tumor-reactive T cells, poor quality and growth potential of expanded T cells, and failure to maintain polyclonality of TILs during production. TIL products manufactured using Epi-R aim to overcome these challenges.

Target Indications

Initially targeting melanoma as melanoma accounts for only ~1% of all skin cancers but is responsible for ~80% of skin cancer-related deaths. Additional potential solid tumor indications include non-small cell lung cancer (NSCLC), colon, head and neck, cervical, breast and pancreatic.

Development Stage

Preclinical

Next Milestone

Submit IND in 2H 2022

Commercial Rights
TIL image

Target

The cell surface antigen New York esophageal squamos cell carcinoma 1 (NY-ESO-1) is a clinically validated target present in many aggressive solid tumors including synovial sarcoma (SS) and myxoid/round cell liposarcoma (MRCLS) as well as non-small cell lung cancer (NSCLC), bladder cancer, melanoma and liver cancer. NY-ESO-1 is typically associated with poor prognosis, with expression often in advanced metastatic tumors.

Target Indications

SS is a rare yet highly malignant tumor occurring in soft tissue and accounts for approximately 5-10% of all soft tissue sarcomas, with approximately 650 to 1,300 cases per year. MRCLS is one of the most common types of liposarcoma and makes up approximately 30% of all cases, with 2,000 diagnosed occurrences in the United States each year.

Development Stage

Phase 1. The Phase 1 trial will assess LYL132 in patients with NY-ESO-1+ advanced SS or MRCLS. More information can be found on ClinicalTrials.gov.

Next Milestone

Generation of clinical data (GSK run trial)

Commercial Rights
TCR image

*Our collaborator, GlaxoSmithKline (GSK), is developing an NY-ESO-1 TCR T-cell product candidate, currently in pivotal development. While we are currently evaluating Gen-R and Epi-R in separate preclinical programs for this product candidate, together these programs could represent a single future product opportunity for GSK utilizing one or both of our technology platforms.

Target

The cell surface antigen New York esophageal squamos cell carcinoma 1 (NY-ESO-1) is a clinically validated target present in many aggressive solid tumors including synovial sarcoma (SS) and myxoid/round cell liposarcoma (MRCLS) as well as non-small cell lung cancer (NSCLC), bladder cancer, melanoma and liver cancer. NY-ESO-1 is typically associated with poor prognosis, with expression often in advanced metastatic tumors.

Target Indications

SS is a rare yet highly malignant tumor occurring in soft tissue and accounts for approximately 5-10% of all soft tissue sarcomas, with approximately 650 to 1,300 cases per year. MRCLS is one of the most common types of liposarcoma and makes up approximately 30% of all cases, with 2,000 diagnosed occurrences in the United States each year.

Development Stage

Preclinical

Next Milestone

Submit IND in late 2022 – early 2023

Commercial Rights
TCR image

*Our collaborator, GlaxoSmithKline (GSK), is developing an NY-ESO-1 TCR T-cell product candidate, currently in pivotal development. While we are currently evaluating Gen-R and Epi-R in separate preclinical programs for this product candidate, together these programs could represent a single future product opportunity for GSK utilizing one or both of our technology platforms.

Learn More About Our Technologies

Our proprietary reprogramming technologies are designed to address barriers to consistent, reliable and durable responses to adoptive cell therapy (ACT) in solid tumors.

Learn More