YH32364 / Yuhan Corp, ABL Bio - LARVOL DELTA

Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Yuhan Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors (clinicaltrials.gov) - P1/2 | N=80 | Not yet recruiting | Sponsor: Yuhan Corporation

New P1/2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Yuhan Corporation announces preclinical study results of targeted anticancer drug YH42946 and immunotherapy drug YH32364 at AACR [Google translation] (BioTimes) - "At this conference, Professor Cho Byung-chul’s research team at Yonsei Cancer Hospital presented key preclinical results based on various cell experiments, including patient-derived cells (PDCs), on the anticancer effect of YH42946 on EGFR exon 20 insertion mutations in non-small cell lung cancer. As a result, YH42946 was confirmed to have a broad inhibitory effect on EGFR exon 20 insertion mutations as well as activity against the existing HER2 exon 20 insertion mutation....In vitro cell-based tests showed that YH32364 exhibited potent antitumor effects, including T cell activation, compared to competitive drugs in lung and colon cancer cells expressing EGFR and harboring KRAS mutations, and confirmed combined efficacy with anti-PD1 antibodies in head and neck cancer cells."

Preclinical • Colon Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer

YH32364 (ABL104), a bispecific antibody against EGFR and 4-1BB, demonstrates potent anti-tumor efficacy through tumor-directed 4-1BB agonism (AACR 2025) - "etc.Collectively, non-clinical studies demonstrate that YH32364 exhibits EGFR-dependent antitumor activity and induces long-term immunologic memory without hepatotoxicity. These findings suggest that YH32364 offers distinct advantages over conventional EGFR-targeted therapies by leveraging 4-1BB-mediated immunotherapy."

Clinical • Oncology • EGFR • IFNG • TNFRSF9

Yuhan Corporation, Immune Oncology Drug 'YH32364' Phase 1/2 Trial Plan (IND) Approved by Ministry of Food and Drug Safety [Google translation] (BioTimes) - "Yuhan Corporation...announced that it received approval for the phase 1/2 clinical trial plan (IND) for YH32364, a new immune anticancer drug under development, from the Ministry of Food and Drug Safety on April 7....The approved study this time is a first-in-human phase 1/2 clinical trial that will evaluate the safety, tolerability, pharmacodynamics, and antitumor activity of YH32364 in patients with locally advanced or metastatic solid tumors with confirmed EGFR overexpression."

New P1/2 trial • Oncology • Solid Tumor

ABL Bio, Yuhan Corporation and YH32364 (ABL104) Poster Presentation at AACR [Google translation] (BioTimes) - "ABL Bio...announced on the 10th that it will be presenting the non-clinical data of YH32364 (ABL104) as a poster at the annual conference of the American Association for Cancer Research (AACR). The YH32364 (ABL104) poster will be jointly presented by ABL Bio and its partner company Yuhan-Yanghaeng....The title of the ABL104 poster is 'YH32364 (ABL104), a bispecific antibody against EGFR and 4-1BB, demonstrates potent anti-tumor efficacy through tumor-directed 4-1BB agonism' and is scheduled to be released on April 29."

Preclinical • Oncology

Yuhan Corporation joins the race to develop 4-1BB target immune anticancer drug (Chosun Biz) - "Yuhan Corporation is conducting preclinical trials of 'YH32364' with solid cancer as an indication, and plans to submit an investigational new drug (IND) application to the regulatory authorities by the end of this year."

IND • Preclinical • Solid Tumor

YH32364 (ABL104), a novel EGFR/4-1BB bispecific antibody exhibits potent antitumor efficacy with an excellent safety profile (SITC 2022) - "YH32364 exhibited superior efficacy on tumor regression and anti-tumor immunity in MC38/hEGFR-bearing h4-1BB KI mouse models, compared to the equimolar dosing of cetuximab. Conclusions YH32364 exhibited potent in vitro and in vivo efficacy and it was well tolerated and safe potentially due to tumor-localized T cell activation. These results suggest that YH32364 could be a promising therapeutic for EGFR-overexpressing cancer patients, especially with EGFR drug resistance."

Clinical • Oncology • IFNG • TNFRSF9