TIL
Product Candidate
Indication(s)
IND-Enabling
Phase 1
Phase 2
Pivotal
Lifileucel/LN-144
Melanoma (post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
C-144-01 Study, Cohorts 2 & 4 FDA RMAT designation
Lifileucel
Cervical cancer (post-chemo; post-chemo & post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
C-145-04 Study, Cohorts 1 & 2 FDA BTD
LN-145
NSCLC (2L post-chemo & post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-LUN-202 Study, Cohorts 1 & 2
LN-145
NSCLC (2-4L incl. post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-COM-202 Study, Cohort 3B
LN-145
HNSCC (post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
C-145-03 Study, Cohort 2
TIL Combinations
Product Candidate
Indication(s)
IND-Enabling
Phase 1
Phase 2
Pivotal
Lifileucel + pembro
Melanoma (anti-PD-1 naïve)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-COM-202 Study, Cohort 1A
Lifileucel + pembro
Cervical cancer (1L, chemo & anti-PD-1 naïve)
IND-Enabling
Phase 1
Phase 2
Pivotal
C-145-04 Study, Cohort 3
LN-145 + pembro
NSCLC (anti-PD-1 naïve)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-COM-202 Study, Cohort 3A
LN-145 + ipi/nivo
NSCLC (post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-COM-202 Study, Cohort 3C
LN-145 + pembro
HNSCC (anti-PD-1 naïve)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-COM-202 Study, Cohort 2A
PD-1 Selected TIL
Product Candidate
Indication(s)
IND-Enabling
Phase 1
Phase 2
Pivotal
LN-145-S1
Melanoma (post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-COM-202 Study, Cohort 1B
LN-145-S1
HNSCC (post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
C-145-03 Study, Cohort 4
Third Generation (Gen 3) TIL: 16-day manufacturing
Product Candidate
Indication(s)
IND-Enabling
Phase 1
Phase 2
Pivotal
LN-145 Gen 3 + core biopsy
NSCLC (2L post-chemo & post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-LUN-202 Study, Cohort 3
LN-145 Gen 3
Melanoma (post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-COM-202 Study, Cohort 1C
LN-145 Gen 3
HNSCC (post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
C-145-03 Study, Cohort 3
PBL Therapy
Product Candidate
Indication(s)
IND-Enabling
Phase 1
Phase 2
Pivotal
PD-1 Inactivated TIL
Product Candidate
Indication(s)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-4001
Melanoma (post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-GM1-201, Cohort 1
IOV-4001
NSCLC (2-4L incl. post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-GM1-201, Cohort 2
IL-2 Analog
Product Candidate
Indication(s)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-3001
Multiple
IND-Enabling
Phase 1
Phase 2
Pivotal
1L=first line; 2L=second line; 4L=fourth line; BTD=breakthrough therapy designation; BTKi=Bruton’s tyrosine kinase inhibitor; CLL/SLL=chronic lymphocytic leukemia/small lymphocytic lymphoma; HNSCC=head and neck squamous cell carcinoma; IL-2=interleukin-2; ipi/nivo=ipilimumab/nivolumab; NSCLC=non-small cell lung cancer; PBL=peripheral blood lymphocytes; PD-1=programmed cell death protein-1; pembro=pembrolizumab; RMAT=Regenerative Medicines Advanced Therapy; TIL=tumor infiltrating lymphocytes
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.