TEV-'278 / Teva, Fosun Pharma - LARVOL DELTA

Teva and Fosun Pharma Enter into a Strategic Partnership to Develop Novel Anti-PD1-IL2 Therapy (TEV-56278) in Immuno-Oncology (GlobeNewswire) - "Teva Pharmaceutical Industries...and Shanghai Fosun Pharmaceutical (Group)...announced that the companies, through their respective subsidiaries, have entered a strategic partnership for the development of investigational TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy....Under the terms of the agreement, which aims to accelerate clinical data generation, Fosun Pharma is granted an exclusive license to develop, manufacture and commercialize TEV-56278 in Chinese mainland, Hong Kong Special Administrative Region (SAR), Macau SAR and Taiwan region and select Southeast Asian countries. Teva retains all development, manufacturing and commercialization rights to the licensed molecule in the rest of the world. The strategic partnership presents a significant step forward in the global development of TEV-56278, giving Teva the opportunity to leverage Fosun Pharma-generated data in other geographies."

Licensing / partnership • Melanoma

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