KH815 / Chengdu Kanghong Pharma - LARVOL DELTA

From Unmet Medical Need to Drug Candidate: A Translational Therapeutic Development Roadmap Illustrated by Dual-Payload Antibody-Drug Conjugates. (PubMed, Biomolecules) - "Single-payload ADCs such as trastuzumab deruxtecan and sacituzumab govitecan have transformed treatment across multiple solid tumors, yet most patients ultimately relapse through antigen loss, defective intracellular trafficking, drug efflux, payload-target alterations, and tumor heterogeneity, creating an emerging post-ADC treatment gap...We further summarize resistance-guided payload pairing strategies, including topoisomerase I plus tubulin inhibitors, topoisomerase I plus DNA-damage-response inhibitors, cytotoxic plus immunomodulatory payloads, and cell-permeable plus non-permeable combinations; the conjugation chemistries that enable defined dual-payload products; the preclinical validation, pharmacological optimization, and developability hurdles that separate promising biology from viable therapeutics; and the rapidly expanding clinical landscape, including the first-in-human program KH815 and emerging bispecific dual-payload constructs...Collectively, this review..."

First-in-human • Journal • Review • Gene Therapies • Oncology • Solid Tumor • TOP1

KH815, a novel dual-payload TROP2-directed antibody-drug conjugate, shows potent antitumor efficacy in pre-clinical tumor model (AACR 2025) - "Several antibody-drug conjugates (ADCs) targeting TROP2, such as sacituzumab govitecan and datopotamab deruxtecan, have shown promising anti-tumor activity in multiple solid tumors, particularly in breast cancer. The non-GLP toxicity study in cynomolgus monkeys provided evidence of the favorable safety profile of KH815, the highest non-severely toxic dose (HNSTD) is 40 mg/kg/dose.In summary, KH815, an ADC with dual toxins and unique mechanisms of action, displayed superior anti-tumor effects, the ability to overcome drug resistance, and an acceptable safety profile in preclinical studies. These findings support the potential of KH815 as a promising advanced therapeutic candidate for tumors."

ADC • Preclinical • Breast Cancer • Oncology • Solid Tumor

KH815, a novel dual-payload TROP2-directed antibody-drug conjugate, shows potent antitumor efficacy in pre-clinical tumor model [WITHDRAWN] (AACR 2025) - "Several antibody-drug conjugates (ADCs) targeting TROP2, such as sacituzumab govitecan and datopotamab deruxtecan, have shown promising anti-tumor activity in multiple solid tumors, particularly in breast cancer. The non-GLP toxicity study in cynomolgus monkeys provided evidence of the favorable safety profile of KH815, the highest non-severely toxic dose (HNSTD) is 40 mg/kg/dose.In summary, KH815, an ADC with dual toxins and unique mechanisms of action, displayed superior anti-tumor effects, the ability to overcome drug resistance, and an acceptable safety profile in preclinical studies. These findings support the potential of KH815 as a promising advanced therapeutic candidate for tumors."

ADC • Preclinical • Breast Cancer • Oncology • Solid Tumor

Translational study and first-in-human (FIH) study design of KH815, a novel dual-payload TROP-2 targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors (ESMO 2025) - P1 | "Especially, in a Trodelvy-resistant Triple-Negative Breast Cancer (TNBC) PDX model, KH815 demonstrated significantly superior anti-tumor activity compared to Sacituzumab Govitecan and Datopotamab Deruxtecan. 30 to 60 participants are planned for each dose levels in phase Ib. One patient enrolled as of May 5th, 2025."

Clinical • First-in-human • Metastases • P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

First-In-Human Study in Participants with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Chengdu Kanghong Biotech Co., Ltd.

New P1 trial • Oncology • Solid Tumor