AGEN1571 / Agenus - LARVOL DELTA

Study of AGEN1571 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=22 | Completed | Sponsor: Agenus Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jan 2027 ➔ Dec 2024 | Trial primary completion date: Jan 2027 ➔ Dec 2024

Trial completion • Trial completion date • Trial primary completion date • Solid Tumor

Study of AGEN1571 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: Agenus Inc. | Recruiting ➔ Active, not recruiting | N=98 ➔ 22

Combination therapy • Enrollment change • Enrollment closed • Metastases • Oncology • Solid Tumor

Agenus Reports Fourth Quarter and Full Year 2022 Financial Results and Outlines 2023 Objectives (GlobeNewswire) - "Additional 2023 Catalysts and Operational Objectives: Complete enrollment of the Phase 1b study of AGEN2373 (anti-CD137) and botensilimab in melanoma. Initiate combination cohorts of AGEN1571 (anti-ILT2) with botensilimab and balstilimab....Advance 7 existing clinical collaborations evaluating combinations of external agents with our PD-1 and CTLA-4 antibodies sponsored and executed by partners."

Licensing / partnership • Trial status • Oncology • Solid Tumor

Study of AGEN1571 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: Agenus Inc. | Trial completion date: Jun 2028 ➔ Jan 2027 | Trial primary completion date: Jun 2028 ➔ Jan 2027

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Botensilimab modulates innate and adaptive gene expression programs resulting in superior immune stimulation relative to a first-generation anti-CTLA-4 antibody (SITC 2022) - "In patients with advanced solid tumors, botensilimab alone and in combination with balstilimab (anti-programmed cell death protein 1 [PD-1] antibody) demonstrated durable clinical responses in nine different immunotherapy-resistant or poorly immunogenic tumor types. Increased expression of LILRB1 and TNFRSF9 in botensilimab-treated immune subsets supports the combination strategies with AGEN1571 (anti-ILT2) and AGEN2373 (anti-CD137) currently under clinical investigation. Ethics Approval This study was approved by WCG IRB Ethics Board; approval number 120160614."

IO biomarker • Oncology • Solid Tumor • CD4 • CD8 • GZMB • LILRB1 • TNFA

Agenus Provides Corporate Update and Second Quarter 2022 Financial Report (GlobeNewswire) - "Clinical-stage pipeline continues to advance: Company to present additional Phase 1b botensilimab expansion cohort data with longer follow-up at a major medical conference later this year; Dosing underway in Phase 1 study to evaluate AGEN1571 as a monotherapy and in combination with botensilimab and/or balstilimab in participants with advanced solid tumors; Enrollment continues in Agenus directed trials, such as a combination study involving AGEN2373 (CD137 agonist) and botensilimab."

P1 data • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Agenus Announces First Patient Dosed in Phase 1 Study of AGEN1571 (anti-ILT2) in Advanced Solid Tumors (GlobeNewswire) - P1 | N=NA | NCT05377528 | Sponsor: Agenus | "'ILT2 is a major suppressor of anti-tumor immune responses and contributes to resistance to PD-1-directed therapies,' said Steven O'Day....'We believe AGEN1571 has best-in-class potential to overcome this resistance and combining AGEN1571 with botensilimab and/or balstilimab may further enhance innate and adaptive anti-tumor immunity.'"

Media quote • P1 data

Agenus Announces First Patient Dosed in Phase 1 Study of AGEN1571 (anti-ILT2) in Advanced Solid Tumors (GlobeNewswire) - "Agenus...announced that the first patient has been dosed in the Phase 1 study of AGEN1571 in advanced solid tumors. The dose-escalation and expansion study will evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of AGEN1571, a novel anti-ILT2 antibody designed to modulate tumor-associated macrophages, T, NK, and NKT cells. Participants will receive treatment with AGEN1571 as a single agent or in combination with botensilimab (Fc-enhanced anti-CTLA-4) and/or balstilimab (anti-PD-1)."

Trial status • Oncology • Solid Tumor

Study of AGEN1571 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: Agenus Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Oncology • Solid Tumor

Study of AGEN1571 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=98 | Not yet recruiting | Sponsor: Agenus Inc.

Combination therapy • New P1 trial • Oncology • Solid Tumor

AGEN1571 is a novel high-affinity ILT2 antagonist antibody that promotes adaptive and innate immune responses (AACR 2022) - "AGEN1571 is a novel high-affinity ILT2 antagonist antibody that effectively antagonizes ILT2 to enhance T cell, NK cell, NKT cell, and myeloid activity. These data support clinical development of AGEN1571 as a therapeutic agent for patients with solid tumors."

IO biomarker • Oncology • Solid Tumor • CD4 • CD8 • HLA-B • HLA-C • PD-1

Agenus Presents Data on AGEN1571 (anti-ILT2) at AACR and Announces IND Clearance (Agenus Inc.) - "'The ILT receptor family represents a key suppressor of anti-tumor immunity that contributes to resistance to CTLA-4 and PD-1 directed therapies' said Steven O'Day, MD...'Blocking this receptor family offers the potential to overcome this resistance. This approach is validated by the durable clinical responses achieved in PD-1 resistant cancers with an ILT4 antagonist discovered by Agenus and licensed to Merck. AGEN1571 represents our first fully-owned clinical stage myeloid targeting agent.'"

Media quote

Agenus Presents Data on AGEN1571 (anti-ILT2) at AACR and Announces IND Clearance (GlobeNewswire) - "AGEN1571 demonstrates superior functional activity compared to the clinical-stage competitor with:~10-fold higher binding affinity to all isoforms of ILT2, enabling superior binding to cells expressing low levels of ILT2; Complete blockade of ILT2-ligand interactions for more effective immune activation and anti-tumor therapeutic potential; Enhanced activation of T, NK, and NKT cells for improved tumor-killing; Superior ability to switch myeloid cells to a pro-inflammatory state, which further boosts T and NK cell immunity; Higher potency in boosting endogenous anti-tumor immunity to synergize with the patient’s anti-tumor antibodies or targeted therapies; Combinations with botensilimab (Fc-enhanced CTLA-4) and other immuno-oncology agents lead to stronger immune cell activation. IND application cleared by the FDA; clinical trial to commence."

IND • Preclinical • Oncology

Agenus Corporate Update and Fourth Quarter & Full Year 2021 Financial Report (GlobeNewswire) - “AGEN1571, a novel program targeting tumor-associated macrophages, is entering clinical development in 2022”

Clinical • Oncology • Solid Tumor