INCA32459 / Incyte, Merus - LARVOL DELTA

Study of INCA32459 a LAG-3 and PD-1 Bispecific Antibody in Participants With Select Advanced Malignancies (clinicaltrials.gov) - P1 | N=46 | Active, not recruiting | Sponsor: Incyte Corporation | Trial completion date: Apr 2026 ➔ Aug 2026 | Trial primary completion date: Apr 2026 ➔ Aug 2026

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck • PD-L1

Study of INCA32459 a LAG-3 and PD-1 Bispecific Antibody in Participants With Select Advanced Malignancies (clinicaltrials.gov) - P1 | N=46 | Active, not recruiting | Sponsor: Incyte Corporation | Recruiting ➔ Active, not recruiting | N=120 ➔ 46

Enrollment change • Enrollment closed • Metastases • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck • PD-L1

Incyte drops pair of PD-L1 drugs as part of 2nd pipeline clear-out this year (FierceBiotech) - "The latest list of discontinued assets includes both of Incyte’s oral, small-molecule PD-L1 inhibitors that were being assessed in phase 1 trials. One of these, INCB99280, was being evaluated in an early-stage solid tumor trial, and the biotech had already set out plans for a phase 1/1b trial in KRASG12C-mutated solid tumors in combination with Bristol Myers Squibb’s Krazati. The other scrapped PD-L1 inhibitor, dubbed INCB99318, was also in a phase 1 solid tumor trial. Also on the chopping block are a couple of LAG3 drug candidates. One of these is a LAG-3 monoclonal antibody dubbed INCAGN2385 that was being developed with Agenus. The other was a bispecific anti–PD1 and anti–LAG-3 antibody dubbed INCA32459 that was being developed with Merus and had undergone a phase 1 study in select advanced malignancies....Finally, Incyte has removed a TIM-3 monoclonal antibody dubbed INCAGN2390, which was another product of the Merus collaboration."

Discontinued • Oncology • Solid Tumor

Merus Announces Financial Results for the Fourth Quarter and Full Year 2022 and Provides Business Update (GlobeNewswire) - "Collaborations: Incyte Corporation: Since 2017, Merus has been working together with Incyte Corporation (Incyte) under a global collaboration and license agreement focused on the research, discovery and development of bispecific antibodies utilizing Merus’ proprietary Biclonics® technology platform....Further, Incyte announced, in 2023, that INCA32459, a novel Lag3xPD-1 bispecific antibody developed through the collaboration is currently being evaluated in clinical studies. In January 2023, Merus achieved a milestone payment of $2.5 million related to this program."

Financing • Licensing / partnership • Oncology

Study of INCA32459 a LAG-3 and PD-1 Bispecific Antibody in Participants With Select Advanced Malignancies (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Incyte Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-1 • PD-L1

A human bispecific antibody targeting LAG-3 and PD-1 (INCA32459) potently activates exhausted T cells (SITC 2022) - "In a human MDA-MB-231 breast tumor model in CD34 + humanized NSG mice, INCA32459 treatment decreased tumor growth compared with a combination of PD-1 (pembrolizumab) and LAG-3 (relatlimab analog) antibodies. Conclusions We have developed INCA32459, a potent dual inhibitor of PD-1 and LAG-3 in preclinical models, which induces activation of exhausted T cells to a greater extent than a combination of bivalent monospecific antibodies targeting PD-1 (nivolumab analog) and LAG-3 (relatlimab analog). These data support the clinical evaluation of INCA32459, and a phase 1 study in cancer patients is underway."

IO biomarker • Breast Cancer • Oncology • Solid Tumor • CD34 • IL2 • LAG3 • PD-L1

A phase 1, first-in-human, open-label, multicenter study of INCA32459, a bispecific anti-PD1 and anti-LAG-3 antibody, in patients with select advanced malignancies (SITC 2022) - "Trial Registration ClinicalTrials. gov registration pending"

Clinical • P1 data • Head and Neck Cancer • Hematological Malignancies • Lymphoma • Melanoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Merus Announces Financial Results for the Third Quarter and Provides Business Update (GlobeNewswire) - "Zenocutuzumab (Zeno or MCLA-128: HER3 x HER2 Biclonics®): NRG1+ cancer and other solid tumors - Enrollment continues in the eNRGy trial; enrollment in combination study in NRG1+ NSCLC as well as monotherapy in castration resistant prostate cancer (CRPC) planned to begin enrollment in 4Q2022; Petosemtamab (MCLA-158: Lgr5 x EGFR Biclonics®): Solid Tumors - Dose expansion continues in the phase 1 trial: Merus plans to provide a clinical update for petosemtamab at a medical conference in the first half of 2023...Incyte announced this quarter that it plans to start a clinical study of INCA32459, a novel Lag3xPD-1 bispecific antibody developed in collaboration with Merus using Merus’ Biclonics® antibody platform."

Enrollment status • P1 data • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Data From Incyte’s Oncology Portfolio to Be Presented at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting (Businesswire) - "Incyte...will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, held November 8-12, 2022, in Boston and virtually....'We look forward to presenting data at the SITC Annual Meeting from our immuno-oncology pipeline, including our oral PD-L1 program, as we make progress toward our goal of identifying new solutions for patients with cancer who need additional options'."

P1 data • P2 data • Cervical Cancer • Cutaneous Melanoma • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Nasopharyngeal Carcinoma • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer

Study of INCA32459 a LAG-3 and PD-1 Bispecific Antibody in Participants With Select Advanced Malignancies (clinicaltrials.gov) - P1 | N=120 | Not yet recruiting | Sponsor: Incyte Corporation

New P1 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-1 • PD-L1