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- | ITIL-306 / Instil Bio
Phase classification, Metastases: ITIL-306 in Advanced Solid Tumors (clinicaltrials.gov) - Mar 5, 2024
P1, N=51, Active, not recruiting, Sponsor: Instil Bio
Phase classification: P1a/1b --> P1
- ITIL-306 / Instil Bio
Anti-folate receptor alpha (FR?) CoStimulatory Antigen Receptor (CoStAR (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_785;
Background ITIL-306 is a genetically engineered autologous TIL cell therapy that amplifies TCR-specific antigen recognition signals (Signal 1) with an FR?-specific CoStimulatory Antigen Receptor (CoStAR; Signal 2)...CoStAR engineered CD4+ T cells support CoStAR engineered CD8+ T cells in a contact independent manner. These data support the ability of CoStAR-transduced T cells to proliferate independent of cytokine support, while implying that potential clinical manipulations known to increase the levels of circulating cytokines, such as increasing intensity of lymphodepleting chemotherapy and addition of exogenous IL-2 infusions, could further augment the activity of CoStAR-TILs in vivo.
- ITIL-306 / Instil Bio
Single cell RNA sequencing reveals functionally validated signatures of cytotoxicity in anti-FR? CoStimulatory Antigen Receptor (CoStARTM) activated CD4+ T cells (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_782;
Background ITIL-306 is a genetically engineered autologous TIL cell therapy that amplifies TCR-specific antigen recognition signals (Signal 1) with an FR?-specific CoStimulatory Antigen Receptor (CoStAR; Signal 2)...Conclusions CoStAR provides functional benefit to both CD4+ and CD8+ T cells in overlapping and distinct ways. Enhancement of CD4+ cytotoxicity by CoStAR was an unexpected, yet intriguing observation which strengthens the rationale for CoStAR engineering approaches for TIL therapy, where CD4+ T cell-mediated anti-tumour responses have been identified as potential drivers of cancer regression in patients.
- || ITIL-306 / Instil Bio
Enrollment closed, Metastases: ITIL-306 in Advanced Solid Tumors (clinicaltrials.gov) - Feb 24, 2023
P1a/1b, N=51, Active, not recruiting, Sponsor: Instil Bio
Enhancement of CD4+ cytotoxicity by CoStAR was an unexpected, yet intriguing observation which strengthens the rationale for CoStAR engineering approaches for TIL therapy, where CD4+ T cell-mediated anti-tumour responses have been identified as potential drivers of cancer regression in patients. Recruiting --> Active, not recruiting
- | ITIL-306 / Instil Bio, ITIL-168 / Instil Bio
$TIL Voluntarily paused enrollment in ITIL-168 and ITIL-306 trials pending outcome of manufacturing analysis and implementation of corrective actions (Twitter) - Oct 31, 2022
- ITIL-306 / Instil Bio
ITIL-306-201: A multicenter, first-in-human phase 1a/1b study of ITIL-306, an engineered autologous tumor-infiltrating lymphocyte (TIL) cell therapy product, in adults with advanced solid tumor (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_1091;
P1a/1b
Key exploratory endpoints include association of biomarkers with response (eg, tumor FRα expression) and characterization of ITIL-306 activation, trafficking, persistence, and phenotype. The study is open ( NCT05397093 ).
- ITIL-306 / Instil Bio
Anti-folate receptor alpha (FRα) CoStimulatory Antigen Receptor (CoStAR) improves T-cell function across physiologically relevant ranges of FRα expression and T-cell receptor (TCR) affinities (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_619;
P1a/1b
Further, CoStAR improved T-cell function at low FRa expression levels, supporting the evaluation of ITIL-306 activity across multiple tumors, including those with low FRα expression. These results are being explored in a first-in-human clinical study with ITIL-306 ( NCT05397093 ).
- ||| ITIL-306 / Instil Bio
Enrollment open, Metastases: ITIL-306 in Advanced Solid Tumors (clinicaltrials.gov) - Jul 11, 2022
P1a/1b, N=51, Recruiting, Sponsor: Instil Bio
These results are being explored in a first-in-human clinical study with ITIL-306 ( NCT05397093 ). Not yet recruiting --> Recruiting
- ||| ITIL-306 / Instil Bio, KSQ-001 / KSQ Therap
Can genetic edits 🧬to TIL replace IL-2? Multiple vectors entering clinic (KSQ-001, ITIL-306) including this #ASCO22 poster: https://t.co/b63HPqeXOk (Twitter) - May 31, 2022
- ||| ITIL-306 / Instil Bio, KSQ-001 / KSQ Therap
Can genetic edits 🧬to TIL replace IL-2? Multiple vectors entering clinic (KSQ-001, ITIL-306) including this #ASCO22 poster: https://t.co/EuLtZsuLvK (Twitter) - May 31, 2022
- ||| ITIL-306 / Instil Bio
New P1 trial, Metastases: ITIL-306 in Advanced Solid Tumors (clinicaltrials.gov) - May 30, 2022
P1a/1b, N=51, Not yet recruiting, Sponsor: Instil Bio
- |||| ITIL-306 / Instil Bio
Biomarker, Tumor microenvironment: $TIL Instil Bio Announces IND Clearance of First CoStAR-TIL program, ITIL-306, Designed to Enhance Activity in the Tumor Microenvironment https://t.co/0jgykgrjRS (Twitter) - May 27, 2022
- ITIL-306 / Instil Bio
Antitumor activity of T cells expressing a novel anti-folate receptor alpha (FOLR1) costimulatory antigen receptor (CoStAR) in a human xenograft murine solid tumor model and implications for in-human studies. (Available On Demand; 190) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1595;
Effects were not observed with CoStAR alone, underscoring that signaling through CoStAR alone does not induce T-cell effector function. The sustained proliferation of anti-FOLR1 CoStAR T cells without exogenous IL-2 support in vitro and in vivo supports a clinical TIL regimen free of high-dose IL-2.
- ITIL-306 / Instil Bio
ITIL-306: A novel costimulatory antigen receptor (CoStAR) that enhances function of TILs harvested from lung, renal, and ovarian tumors (Section 35) - Mar 9, 2022 - Abstract #AACR2022AACR_4765;
Anti-FOLR1 CoStAR TIL manufacturing is feasible in tumors associated with FOLR1 expression, including ovarian, lung, and renal. A first-in-human clinical study of ITIL-306, an anti-FOLR1 CoStAR TIL product, is planned.
- ITIL-306 / Instil Bio
Costimulatory antigen receptor (CoStAR): a novel platform that enhances the activity of tumor infiltrating lymphocytes (TILs) (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_856;
Instil plans to initiate its first-in-human clinical trial with ITIL-306, an investigational anti-FOLR1 CoStAR TIL product in 1H 2022. Additional scFv targets are being evaluated for clinical application across a broad range of solid tumor histologies.
- ITIL-306 / Instil Bio
Potent T cell costimulation mediated by a novel costimulatory antigen receptor (CoStAR) with dual CD28/CD40 signaling domains to improve adoptive cell therapies (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_308;
Similar observations with an analogous anti-FOLR1 CoStAR have been observed, indicating broad applicability of the CoStAR platform across target molecules and tumor indications. Instil plans to initiate its first-in-human clinical trial with ITIL-306, an investigational anti-FOLR1 CoStAR TIL product in 1H 2022.