P1/2, N=140, Recruiting, Krystal Biotech, Inc. | Phase classification: P1 --> P1/2 | N=80 --> 140

P1/2, N=140, Recruiting, Krystal Biotech, Inc. | Phase classification: P1 --> P1/2 | N=80 --> 140

TILT-123 demonstrated safety and significant intratumoral immunomodulation following a single i.v. administration, warranting further investigation.

BEMPEG plus NIVO did not meet the efficacy threshold for ORR in patients with previously untreated locally advanced or metastatic urothelial carcinoma and low PD-L1 expression.

P1/2, N=25, Completed, Inge Marie Svane | Unknown status --> Completed

P2, N=106, Terminated, Sanofi | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.

P1, N=16, Completed, Merck Sharp & Dohme LLC

The safety profile of FAP-IL2v in combination with cetuximab was acceptable and pharmacodynamic markers support the proposed mode-of-action of this combination, but the overall low antitumor activity does not warrant further clinical exploration in HNSCC. [Part C of Study BP29842 (NCT02627274).].

P1, N=34, Active, not recruiting, M.D. Anderson Cancer Center | N=15 --> 34 | Trial completion date: Jun 2025 --> Oct 2027 | Trial primary completion date: Jun 2024 --> Oct 2027

P1, N=56, Not yet recruiting, Philogen S.p.A.

FAP-IL2v plus atezolizumab is clinically active and has manageable safety in patients with recurrent and/or metastatic cervical SCC.

Denileukin diftitox (ONTAK) can be safely administered intraperitoneally to recurrent refractory ovarian cancer patients. Regulatory T cells were reduced in ascites and peripheral blood, but there were no significant changes in cytokine levels.

P1, N=12, Not yet recruiting, City of Hope Medical Center

P2, N=138, Terminated, Sanofi | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.

P2, N=224, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Oct 2024 | Trial primary completion date: Feb 2025 --> Oct 2024

P2, N=296, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China

P2, N=25, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting | N=92 --> 25 | Trial completion date: Jan 2028 --> Oct 2024 | Trial primary completion date: Jan 2028 --> Oct 2024

We have created a precisely pegylated IL-2 [SAR-444245 (SAR'245) or pegenzileukin, previously THOR- 707] designed for proliferation of target CD8+ T and NK cells for anti-cancer activity, with minimal expansion of anti-target regulatory CD4+ T cells (Tregs) that counter their action, or eosinophils that trigger vascular leak syndrome (VLS)...Ex vivo, SAR'245 enhanced T-cell receptor responses alone and in combination with PD-1 inhibitors without inducing cytokines associated with cytokine release syndrome or VLS. Results support the clinical development of SAR'245 as a drug candidate for the treatment of solid tumors, alone or in combination with PD-1 inhibitory agents.

P2, N=165, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting

P1/2, N=61, Suspended, University of Wisconsin, Madison | Trial completion date: Aug 2025 --> Aug 2026 | Trial primary completion date: Aug 2024 --> Aug 2025

P2, N=14, Terminated, Sanofi | Trial completion date: Jan 2025 --> Sep 2024 | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.

P1, N=42, Recruiting, Synthekine | Not yet recruiting --> Recruiting

P1/2, N=250, Active, not recruiting, Synthorx, Inc, a Sanofi company | Recruiting --> Active, not recruiting

P1, N=200, Active, not recruiting, SOTIO Biotech AG | Trial primary completion date: Aug 2024 --> Dec 2024

P1, N=182, Recruiting, Gilead Sciences | N=132 --> 182

P1/2, N=47, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2024 --> Jul 2025

In addition, the combination with immune checkpoint inhibitors further boosted the therapeutic efficacy of our molecule. Tripokin represents a promising clinical candidate for the simultaneous delivery of interleukin-2 and tumor necrosis factor to neoplastic sites.

P2, N=59, Active, not recruiting, Sanofi | Trial completion date: Feb 2025 --> Nov 2024

P1, N=42, Not yet recruiting, Synthekine

P2, N=166, Active, not recruiting, SOTIO Biotech AG | Trial completion date: Dec 2025 --> Nov 2024 | Trial primary completion date: Sep 2025 --> Aug 2024

P2, N=16, Terminated, SOTIO Biotech AG | N=52 --> 16 | Trial completion date: Nov 2024 --> Jun 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2024 --> Mar 2024; Due to lack of efficacy shown at the time of the interim analysis.

P2, N=92, Recruiting, Amgen | N=140 --> 92

P1/2, N=12, Terminated, Altor BioScience | N=52 --> 12 | Unknown status --> Terminated; The study was terminated early due to low enrollment.

Changes in tumor biomarkers were comparable between arms. These biomarker results help provide a better understanding of the mechanism of action of BEMPEG + NIVO and may help contextualize the clinical observations from PIVOT IO 001.

P1, N=240, Recruiting, Teva Branded Pharmaceutical Products R&D, Inc. | Not yet recruiting --> Recruiting

P1, N=52, Active, not recruiting, Cue Biopharma | Recruiting --> Active, not recruiting

P1, N=240, Not yet recruiting, Teva Branded Pharmaceutical Products R&D, Inc.

P2, N=168, Terminated, Amgen | Phase classification: P2b --> P2

P1/2, N=62, Terminated, BioNTech SE | Active, not recruiting --> Terminated; Sponsor decision

P1, N=556, Recruiting, Innovent Biologics (Suzhou) Co. Ltd.

P3, N=783, Completed, Bristol-Myers Squibb | Trial completion date: Sep 2023 --> Mar 2024

P2, N=320, Recruiting, Amgen | Trial completion date: May 2026 --> Dec 2025 | Trial primary completion date: Jul 2025 --> Feb 2025