Investigational TIL therapy
Tumor infiltrating lymphocyte (TIL) therapy is our lead T-cell-based immunotherapy platform. We are currently investigating TIL therapy in clinical trials of multiple advanced solid tumors, including melanoma, non-small cell lung cancer (NSCLC) and cervical cancer. Our initial strategy is to deliver TIL as a single-agent therapy for patients with late-stage solid tumor cancers. For earlier intervention, we are investigating the potential of our TIL therapy in combination with a class of immunotherapy drugs called immune checkpoint inhibitors, or ICIs.
These immunotherapy drugs seek to overcome one of the main escape mechanisms of cancer against an immune system attack. TIL therapy and ICIs have the potential to work synergistically to target and attack cancer cells while breaking down barriers to enable the immune system to mount a response. We are currently investigating TIL in combination with ICIs in clinical trial cohorts of patients with melanoma, lung, cervical and head and neck cancers who have not previously received ICIs.
Key steps in the TIL therapy process
A tumor sample is removed from the patient and shipped overnight to our centralized manufacturing facility, where the TIL are isolated.
The patient-specific TIL are amplified and reinvigorated using our proprietary manufacturing process, which we refer to as Gen 2 to reflect our successful efforts to streamline TIL manufacturing from several weeks to 22 days. The TIL therapy is cryopreserved and sent back for infusion into the patient.
The patient receives a preparative regimen (lymphodepleting chemotherapy) prior to TIL infusion. The treatment regimen is completed with a short course of interleukin-2 (IL-2) to promote T-cell activity.
Immunotherapy for blood cancers
Our peripheral blood lymphocyte (PBL) therapy platform leverages circulating tumor reactive T cells in the blood to address blood cancers. PBL therapy is an individualized, one-time therapy that is manufactured from a patient’s blood sample and infused back into the patient. Once inside the body, PBL therapy deploys millions of personalized, patient-specific PBL cells to recognize, target and attack the patient’s diverse blood cancer cells. We are investigating proof of concept for the PBL platform in a clinical trial of our lead PBL therapy, IOV-2001, in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Key steps in the PBL therapy process
A blood sample is drawn from the patient and shipped overnight to our centralized manufacturing facility. The blood is collected during treatment with a Bruton’s tyrosine kinase inhibitor (BTKi), which improved PBL cell growth and function against leukemia cancer cells in preclinical studies.
The patient-specific PBLs are amplified and reinvigorated from the blood sample using our proprietary 9-day manufacturing process. The PBL therapy is cryopreserved and sent back for infusion into the patient.
The patient receives a preparative regimen (lymphodepleting chemotherapy) prior to PBL infusion. The treatment regimen is completed with a short course of interleukin-2 (IL-2) to support growth and activation of the PBL cells and augment their anticancer activity in the patient.
TIL and PBL therapies are investigational therapies that have not been approved for any indication by the Food and Drug Administration (FDA) or any other regulatory agency. The safety and efficacy of these therapies have not been determined.