Our Cell Therapies

We are committed to developing transformative cell therapies to improve outcomes for patients with cancer.

 

Our Cell Therapies

We are committed to developing transformative cell therapies to improve outcomes for patients with cancer.

Cell Therapy

Our body’s immune system can recognize cancer cells as abnormal and kill them. However, this process can fail to get rid of cancer cells entirely. Immunotherapy is a treatment for some types of cancer that helps the body’s immune system find and kill cancer cells.

Autologous T-cell therapy is a highly personalized immunotherapy that involves taking cells from the patient, improving their functionality and transferring them back to the patient. By reprogramming the T cells, they can be designed with the potential to address a wide range of diseases, including cancer. Unlike other cancer therapies that might require ongoing treatments, cell therapies often offer a one-time treatment option.

Steps Involved in Treatment with a Cell Therapy

cell or tissue collection
Cell or tissue collection
Manufacturing
Manufacturing
(cell reprograming and expansion)
cell or tissue collection
Lymphodepletion
(preparing the body for treatment)
cell or tissue collection
Single dose of cell therapy
cell or tissue collection
Post-treatment monitoring

Why was Lyell founded with a focus on solid tumors?

90% of cancers are solid tumors. Yet, cell therapies have shown limited success in treating solid tumors. Our goal is to change this. Our T-cell reprogramming technologies are designed to address efficacy barriers to cell therapy in solid tumors.

Learn More

Learn more about Lyell's approach and capabilities to tackling solid tumors with cell therapy.

At Lyell, we are applying our technology to reprogram chimeric antigen receptor (CAR) T cells to resist exhaustion and remain potent. CAR T cells are cells that are modified to recognize and kill cancer cells that have specific biomarkers or antigens (types of proteins) on their cell surface.
We use two different and complementary types of reprogramming technologies that are designed to make our cell therapy product candidates more potent and longer lasting to fight solid tumors.

Genetic Reprogramming, which includes our c-Jun overexpression and NR4A3 knockout technologies, aims to delay exhaustion and create more potent T cells with enhanced and long-lasting cancer-fighting ability

Epigenetic Reprogramming, which includes our Epi-R™ manufacturing protocol and Stim-R™ technology, aims to enhance qualities of stemness, persistence and function of T cells to drive potent and long-lasting cancer cell killing

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A patient living with cancer in bed

Our Product Candidates

Clinical Trials

The participation of patients and their families in clinical trials enables us to evaluate our investigational product candidates for safety and efficacy. We are driven to defeat cancers and are grateful for those who choose to join us on this journey.

We are advancing a pipeline of next-generationn CAR T-cell product candidates including our lead program, LYL314 (formerly IMPT-314), that is in Phase 1-2 clinical development for aggressive B-cell lymphoma.

Disease facts:
  • Non-Hodgkin lymphoma (NHL) is a common cancer. It is estimated that approximately 81,000 people in the United States will be diagnosed with NHL in 2024
  • B-cell lymphoma is the most common type of NHL, comprising approximately 85% of all lymphomas in the United States.
LYL314
  • Next-generation dual-targeting CD19/CD20 investigational CAR T-cell therapy designed for improved durability
  • Targets CD19 and CD20, two proteins present on B-cell lymphoma
Learn More

Expanded Access Policy

Lyell is committed to developing safe and effective CAR T-cell therapies for patients with cancer. Our goal is to provide our therapies to patients at the appropriate time and in a clinically appropriate manner.

Additionally, cell therapies are made through highly complex manufacturing processes which Lyell performs in-house. When considering whether or not to offer expanded access of our investigational therapies (i.e., those that have not yet been approved by regulatory authorities such as the Food and Drug Administration in the United States), Lyell considers our ability and resources to ensure adequate manufacturing capacity for our ongoing clinical trials and development programs.

At this time, based on these factors and our current phase of clinical development, we currently only provide access to our investigational cell therapies through participation in our clinical trials.

Under certain circumstances, individuals participating in our clinical trials may become eligible for expanded access. Should an individual wish to apply for expanded access, the individual’s clinical trial investigator should submit a request to expandedaccess@lyell.com. Upon receiving a request, Lyell will acknowledge receipt within 5 business days and will assess:

  • The availability of satisfactory alternative therapies;
  • The sufficiency of the evidence that the potential benefit to the patient would likely outweigh the potential risks based on available safety and efficacy information;
  • Lyell’s resourcing and manufacturing capability to support our current clinical trials; and,
  • Whether granting expanded access would potentially compromise the scientific validity of broader development programs or interfere with or delay current clinical trials or regulatory filings designed to make the investigational cell therapy available to a broad patient population.

Lyell will review and respond to each request on a case-by-case basis.

The posting of this policy is not a guarantee of access to any specific investigational cell therapy by any individual patient.

If you are a patient who is interested in accessing our investigational cell therapies, please speak with your physician. You may also learn more about Lyell’s ongoing clinical trials by going to www.clinicaltrials.gov and searching for NCT05826535.

If you are a physician who is interested in learning more about our investigational cell therapies, or participating in our clinical trials, please submit a request to clinicaltrials@lyell.com and our team will respond as soon as possible.