HX111 / HanX Biopharma - LARVOL DELTA

HX111 Completes First Patient Dosing (HKEXnews) - "...Hanx Biopharmaceuticals...has initiated the Phase I clinical trial of HX111, the Company’s independently developed candidate drug (an OX40-targeting antibody-drug conjugate ('ADC') candidate drug), for the treatment of relapsed/refractory lymphoma and solid tumors, and has successfully completed the first patient enrollment and dosing in the recent period."

Trial status • Lymphoma • Solid Tumor

A Clinical Study of HX111 in Patients With Advanced Solid Tumor and Lymphoma (clinicaltrials.gov) - P1/2 | N=70 | Not yet recruiting | Sponsor: Hanx Biopharmaceuticals (Wuhan) Co., Ltd.

New P1/2 trial • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Hanx Biopharmaceuticals…is pleased to announce that HX111 for Injection (the 'HX111'), an innovative drug developed by the Company, has obtained approval from the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in the People’s Republic of China (HKEXnews)

New trial • Oncology

HX111, A FIC OX40-mAb-VC-MMAE ADC for the treatment of lymphoma (SITC 2025) - "It was also tested several lymphoma-CDX and -PDXs for their anti-lymphoma pharmacology.Results VC-MMAE was chosen as the linker-payload of HX111 for its proven efficient killing of lymphoma cells, as shown by Adcetris. In addition, we also observed enhanced anti-lymphoma effects when HX111 combined with an immune checkpoint inhibitor, HX009,1 2 a BsAb of PD-1 x SIRPα in the LY6698 B-lymphoma PDX.Conclusions The lymphoma-associated OX40-expression can be explored for the treatment of OX40+ T-cell or B-cell lymphomas, both being unmet medical needs, and HX111 could potentially be such a candidate treatment, warranting further clinical investigation.Ethics Approval All animal studies were conducted at SPF facility in strict accordance with the Guide for the Care and Use of Laboratory Animals of the National Institutes of Health. The protocol was approved by the IACUC Committee."

IO biomarker • Adult T-Cell Leukemia-Lymphoma • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma • SIRPA • TNFRSF4 • TNFSF4

OX40-ADC, a potential new class of cancer immunotherapy by depleting Treg within TME (SITC 2025) - "One attempt by CD25-ADC (ADCT-301) failed for severe toxicities. A new CD25-ADC (PF-08046032) with attenuated affinity to CD25 and a less toxic VC-MMAE demonstrated preferential killings of TIL-Treg over peripheral Treg or CD8+ T cells, expecting widened therapeutic window...We plan to present the preliminary data of these studies during the meeting.Conclusions OX40-ADC can potentially deplete TIL-Treg to enhance tumor immunity/anti-tumor activities in animal models. HX111 could be such a candidate drug for tumor treatment, with enhanced efficacy when combined with PD-1 blockades."

Oncology • CCR8 • CD4 • CD8 • IL2RA

Exploration of sarcoma-associated OX40-expression using HX111, a novel FIC OX40-MaB-VC-MMAE-ADC, to treat OX40+ sarcoma (SITC 2025) - "All animal studies were conducted at SPF facility in strict accordance with the Guide for the Care and Use of Laboratory Animals of the National Institutes of Health. The protocol was approved by the IACUC Committee."

IO biomarker • Breast Cancer • Cervical Cancer • Ewing Sarcoma • Hematological Malignancies • Liposarcoma • Lymphoma • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • Spindle Cell Sarcoma • Squamous Cell Carcinoma • TNFRSF4 • TNFSF4