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DRUG:

IOV-4001

i
Other names: IOV-4001, PD-1 knocked-out modified TIL, IOV4001, IOV 4001
Associations
Company:
Iovance Biotherap
Drug class:
Immunostimulant
Related drugs:
Associations
2years
Trial in progress: A phase 1/2 open-label study (IOV-GM1-201) of TALEN-mediated PD-1-inactivated autologous tumor-infiltrating lymphocytes (TIL; IOV-4001) in patients with advanced melanoma and NSCLC (SITC 2022)
Secondary endpoints include complete response rate, duration of response, disease control rate, progression-free survival, overall survival, feasibility, and additional safety. Trial Registration NCT05361174
Clinical • P1/2 data • Tumor-Infiltrating Lymphocyte • PD(L)-1 Biomarker • IO biomarker
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PD-1 (Programmed cell death 1)
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BRAF mutation • BRAF V600
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IOV-4001
over2years
A phase I/II open-label study (IOV-GM1-201) of TALEN-mediated PD-1 inactivated autologous tumor-infiltrating lymphocytes (TIL; IOV-4001) in patients with advanced melanoma and NSCLC (ESMO 2022)
The primary endpoints of phases 1 and 2 are safety (DLTs and AEs) and objective response rate per RECIST v1.1, respectively. Secondary endpoints include complete response rate, duration of response, disease control rate, progression-free survival, overall survival, feasibility, and additional safety.
Clinical • P1/2 data • Tumor-Infiltrating Lymphocyte • PD(L)-1 Biomarker • IO biomarker
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PD-1 (Programmed cell death 1)
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BRAF mutation • BRAF V600
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IOV-4001
over2years
Enrollment open
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BRAF (B-raf proto-oncogene)
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BRAF mutation
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cyclophosphamide • IOV-4001
over2years
New P1/2 trial
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BRAF (B-raf proto-oncogene)
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BRAF mutation
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cyclophosphamide • IOV-4001
over2years
Preclinical activity and manufacturing feasibility of genetically modified PDCD-1 knockout (KO) tumor-infiltrating lymphocyte (TIL) cell therapy (AACR 2022)
Background: Adoptive cell therapy with autologous TIL has demonstrated an objective response rate (ORR) of 36% in the post-immune checkpoint inhibitor (ICI) setting in patients (pts) with advanced/unresectable melanoma (Sarnaik JCO 2021), while in ICI-naïve pts who received early-line combination of TIL and pembrolizumab, the ORR was 60%, with a 30% CR rate (O’Malley SITC 2021). Although effective, anti-PD-1 therapy is limited by poor penetration into the tumor, internalization, and endocytic clearance, in contrast with TIL, which overcome this inherent limitation... Anti-tumor activity of PD-1 KO TIL was superior to mock TIL suggesting that endogenous PD-1 inhibition may confer a functional advantage to the TIL over an antibody combination. PD-1 KO TIL clinical manufacturing was feasible and the TIL product quality attributes and phenotype were acceptable; importantly, lack of complete PD-1 KO may spare other PD-1-dependent in vivo cellular functions. Together, these data support clinical investigation of IOV-4001, an autologous PD-1 KO TIL cell therapy.
Preclinical • Tumor-Infiltrating Lymphocyte • PD(L)-1 Biomarker • IO biomarker
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PD-1 (Programmed cell death 1) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
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Keytruda (pembrolizumab) • IOV-4001 • Undisclosed anti PD-1 mAb