TEV-'278 / Teva - LARVOL DELTA

Multiomic evaluation of TEV-56278, a PD-1-targeted attenuated IL-2 molecule, in a human ex vivo tumor model and association with immune activation with enhanced effector CD8 T cell selectivity. (ASCO 2025) - " PDTF from 15 renal cell carcinoma patients were treated ex vivo with TEV-56278 [100 µg/ml], aldesleukin [100 ng/ml, as positive control], or a control PD-1 non-targeted-AttIL-2 [100 µg/ml]. We performed in-depth characterization of TEV-56278 in a human tumor ex vivo system that incorporates features of the tumor microenvironment and models the dynamic response of TEV-56278. This study confirms that TEV-56278 targets IL-2 activity to PD-1 expressing T cells within the tumor microenvironment and induces strong immune response, thereby promoting anti-tumor activity. Understanding the mechanisms that drive variable responses in PDTF may improve precision immuno-oncology efforts and help optimize our clinical development strategy."

IO biomarker • Preclinical • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CCL20 • CD8 • CXCL10 • IL12A • IL2

A first-in-human study evaluating safety, tolerability and efficacy of TEV-56278, as monotherapy and in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors (AACR 2025) - P1 | "After determination of the monotherapy RP2D, 2 cohorts of patients with locally advanced or metastatic primary and secondary resistant melanoma (A&B) and 2 cohorts of primary and secondary resistant non-small cell lung cancer (NSCLC; [C&D]) will be accrued to evaluate the primary objective of anti-tumor activity. The Simon two-stage admissible design will be used for Cohort B (RP2D and a dose <rp2d); a="" bayesian="" approach="" will="" be="" used="" for="" a,="" c,="" and="" d="" with="" rp2d.="" the="" objective="" response="" rate="" (orr)="" duration="" of="" (dor)="" assessed="" based="" on="" evaluation="" criteria="" in="" solid="" tumors=""..."

Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • P1 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A first-in-human study evaluating safety, tolerability and efficacy of TEV-56278, as monotherapy and in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors (SITC 2024) - P1 | "All enrolled subjects must provide signed informed consent prior to any study related procedures being completed.Download figure Open in new tab Download powerpoint Abstract 671 Figure 1 Overall trial schematic diagram. DL=dose level; MSI-H=high microsatellite instability; NSCLC=non-small cell lung carcinoma; RCC=renal cell carcinoma; RP2D=recommended Phase 2 dose; SCCHN=squamous cell carcinoma of head and neck; TNBC=triple-negative breast cancer"

Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • P1 data • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • MSI

Preclinical in vivo characterization of the anti-tumor activity of a non-blocking PD-1 antibody fused to attenuated IL-2 (SITC 2024) - "Additionally, the ability of a human anti-PD1-IL2Att, TEV-56278, to induce anti-tumor immune responses was evaluated in humanized immune-system mouse models engrafted with human melanoma tumor cells...Our preclinical models highlight the potential of anti-PD1-IL2Att as an effective anti-tumor immunotherapy. Ethics Approval The in vivo animal studies described in the abstract were approved by the following ethics review boards: IACUC #: NPC-TE-IL-2307-447 (Israel Ministry of Health); IACUC ASP #: 980701 (Charles River) and IACUC ASP #: 980702 (Charles River)."

IO biomarker • Preclinical • Colorectal Adenocarcinoma • Colorectal Cancer • Melanoma • Oncology • Solid Tumor • CD69 • CD8 • HAVCR2 • IL2

An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=240 | Not yet recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Combination therapy • Metastases • Monotherapy • New P1 trial • Oncology • Solid Tumor

An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=240 | Recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor