IBB0979 / SunHo BioPharma - LARVOL DELTA

IBB0979, A novel B7H3/IL-10 immunocytokine of monovalent anti-B7H3 antibody fused with IL-10 homodimer (AACR 2024) - "IBB0979 is the world's first B7H3/IL-10 immunocytokine receiving IND approvals from both the FDA and the NMPA, showing excellent preclinical efficacy and safety profile. The Phase I clinical trial is currently on-going, with the first patient dosed in July 2023 and achieved SD at first efficacy evaluation after 2 cycles of administration. Since B7H3 is overexpressed in a wide range of cancers including lung, prostate, glioma, thyroid, head and neck, rectal, breast, skin, renal cell, and ovarian cancers, IBB0979 has the potential to become a next-generation therapy for resolving T cell exhaustion in cancer patients."

Brain Cancer • CNS Tumor • Glioma • Oncology • Ovarian Cancer • Solid Tumor • CD276 • CD8 • IL10

A Phase II/III Study of IBB0979 in Combination With Topotecan Versus Topotecan in Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Clinical Trial to Evaluate Effect of IBB0979 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=25 | Recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. | Trial completion date: Jun 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Nov 2025

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Clinical Trial to Evaluate Effect of IBB0979 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=25 | Recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.

Metastases • New P1/2 trial • Gastrointestinal Cancer • Oncology • Solid Tumor

SunHo Announces First Patient Dosed in Phase I/II Clinical Trial of a Potential First-in-class Immunocytokine IBB0979 (PRNewswire) - "SunHo BioPharmaceutical...announced that IBB0979 (B7H3-IL10 immunocytokine), a potential first-in-class immunocytokine developed in-house for the treatment of locally advanced or metastatic solid tumors has entered Phase I/II clinical trials. The first patient has been dosed on Jul 20th, 2023."

Trial status • Oncology • Solid Tumor