Our Pipeline

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

 

Our Pipeline

A clinical-stage company advancing a broad pipeline of novel therapies to address barriers to effective 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 malignancies. Our diverse pipeline targets triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), ovarian cancer, endometrial cancer, melanoma and colorectal cancer (CRC) — 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 Candidate/
Modality
Target
Genetic
Reprogramming
c-Jun
NR4A3
Epigenetic
Reprogramming
Epi-R™
Stim-R™
Target Indications
PrePreclinical
Phase 1
Phase 2/
Pivotal

Target

ROR1 is a highly expressed cell surface antigen present on many aggressive solid tumors, including approximately 50% of patients with triple-negative breast (TNBC), ovarian and endometrial cancers and 35% 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. Ovarian cancer is one of the leading causes of cancer deaths among women. Endometrial cancer is the most prevalent gynecological cancer and the sixth most common malignancy worldwide.

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+ relapsed/refractory TNBC, NSCLC, platinum-resistant ovarian cancer or endometrial cancer. More information can be found on ClinicalTrials.gov.

Next Milestone

Updated data from the ongoing Phase 1 trial expected in late 2024 - early 2025

Commercial Rights
CAR T Cell image

Target

ROR1 is a highly expressed cell surface antigen present on many aggressive solid tumors, including approximately 50% of patients with ovarian and endometrial cancers.

Target Indications

Ovarian cancer is one of the leading causes of cancer deaths among women. Endometrial cancer is the most prevalent gynecological cancer and the sixth most common malignancy worldwide.

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 LYL119 in patients with ROR1+ tumors. The initial cancer types to be evaluated will include ovarian and endometrial cancers, with subsequent expansion into tumor types including NSCLC and TNBC.

Next Milestone

Initial clinical data expected in 2H 2025

Commercial Rights
CAR T Cell image

Target: Multiple antigens

Tumor infiltrating lymphocytes (TIL) products are created by expanding T cells taken from the patient’s own tumor. Previous clinical experiences suggest that the efficacy of adoptive transfer of ex vivo expanded TILs is largely driven by specific recognition of mutated tumor neoantigens specific to each patient. To date, broad efficacy of TIL therapies has been limited by variable and often poor product quality, lack of stemness or potential durability of expanded TILs, failure to maintain polyclonality of TILs during production, and failure to enrich the TIL product with tumor-reactive T cells. TIL products manufactured using Lyell’s Epi-R reprogramming technology aim to overcome these challenges.

Target Indications

Initially targeting melanoma which accounts for only ~1% of all skin cancers but is responsible for ~80% of skin cancer-related deaths. Additional cohorts in the expansion phase of the trial are expected to include patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

Development Stage

Phase 1. The Phase 1 clinical trial is an open-label, dose-escalation trial designed to evaluate the safety and anti-tumor activity of LYL845 in patients with relapsed and/or refractory metastatic or locally advanced melanoma, with expansion cohorts for patients with melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). More information can be found on ClinicalTrials.gov.

Next Milestone

Initial data expected in 2024

Commercial Rights
TIL image

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.

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