ONO-7428 / Ono Pharmaceutical, NEX-I - LARVOL DELTA

A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors (clinicaltrials.gov) - P1 | N=35 | Active, not recruiting | Sponsor: Ono Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | N=60 ➔ 35

Enrollment change • Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Evaluation of NXI-101 in non-small cell lung cancer (NSCLC) using patient-derived organotypic tumor spheroids (PDOTS): Targeting a novel tumorigenic pathway (AACR 2024) - "Significant cytotoxicity was observed in 2 out of 10 patient tumors (20%) as a monotherapy and 4 out of 10 (40%) when used in combination with atezolizumab. These data support the prospects of NXI-101 as a first-in-class therapeutic for the treatment of NSCLC when used alone or in combination with an immune checkpoint inhibitor. Moreover, the findings highlight the PDOTS platform's substantial value in capturing patient-specific tumor response variability and providing robust support for the mechanistic evaluation of cancer therapeutics."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TGFB1

Nexi to Present at BioEurope 2025, Introducing 'NXI-201' and More [Google translation] (HIT News) - "In this presentation, Nex-I introduced its proprietary immuno-oncology drug development platform technology that transforms refractory (cold tumors) into responsive (hot tumors) tumors, as well as the progress of non-clinical trials for its main pipeline, 'NXI-201.' NXI-201 is a follow-up pipeline to 'NXI-101,' the technology of which was transferred to Ono Pharmaceutical Co., Ltd. of Japan in 2024, and is preparing to submit an IND for clinical trials within the year....At this event, the company also plans to partner on the development of ADCs using 'NXI-201' and cell surface immuno-oncology refractory target antibodies."

IND • Solid Tumor

A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Ono Pharmaceutical Co. Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Ono Pharmaceutical Co. Ltd

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

NEXI “Confirmed the anti-cancer effect of NXI-101 in a patient-derived tumor tissue model” [Google translation] (HIT News) - "NexI...announced on the 11th that it announced research results on the next-generation immuno-anticancer drug NXI-101 (development code name) at the American Association for Cancer Research (AACR 2024) on the 9th (local time)....In this announcement, NexI announced not only the anticancer treatment effect of NXI-101 in a patient-derived tumor tissue model that can reproduce an actual clinical tumor in an ex vivo environment, but also the anticancer efficacy through the expression level of ONCOKINE-1. It has been proven that it can be predicted. The company explains that it has confirmed the possibility of success of NXI-101 in future clinical trials and the possibility of its use as a biomarker."

Preclinical • Oncology • Solid Tumor

Ono Enters into a License Agreement with NEX-I to Develop and Commercialize NXI-101 (Ono Pharmaceuticals Press Release) - "Ono Pharmaceutical...announced that it has entered into a license agreement with NEX-I... for NXI-101....NXI-101 is a first-in-class antibody drug candidate targeting ONCOKINE-1, which is a cancer immunotherapy-resistant factor discovered by NEX-I through its proprietary target screening platform 'ONCOKINE platform'....Under the terms of this agreement, Ono will have an exclusive right to develop and commercialize NXI-101 and its backup antibodies worldwide. Ono will pay to NEX-I an up-front and milestone payments on the progress of development and commercialization, as well as tiered royalties based on net sales."

Licensing / partnership • Oncology