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
Lifileucel
NSCLC (2L post-chemo & post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-LUN-202 Study, Cohorts 1 & 2
Lifileucel
NSCLC (2-4L incl. post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-COM-202 Study, Cohort 3B
Lifileucel
Endometrial cancer (post anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-END-201
Lifileucel
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 (frontline)
IND-Enabling
Phase 1
Phase 2
Pivotal
TILVANCE-301 Phase 3
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
Lifileucel + pembro
NSCLC (anti-PD-1 naïve)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-COM-202 Study, Cohort 3A
Lifileucel + ipi/nivo
NSCLC (post-anti-PD-1)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-COM-202 Study, Cohort 3C
Lifileucel + 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
 
IOV-2001
CLL/SLL (post-BTK)
IND-Enabling
Phase 1
Phase 2
Pivotal
IOV-CLL-01 Study
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

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