CLIO-8221 / Hummingbird Biosci, Callio Therapeutics - LARVOL DELTA

Development of CLIO-8221: A HER2-targeted multi-payload ADC to address ADC resistance (AACR 2026) - "CLIO-8221 shows in vitro cell killing activity across cell lines with a range of HER2 expression levels and Trastuzumab-DXd (T-Dxd) sensitivities, and drives tumor regressions after a single dose in T-DXd-resistant and refractory xenograft models, with strong durable activity seen at 3 mg/kg. CLIO-8221 is a first-in-class anti-HER2 dual payload ADC that allows targeted delivery of TOP1i and ATRi payloads to HER2 expressing tumors to maximize anti-tumor efficacy, overcome TOP1i resistance, and reduce systemic toxicity. Our findings strongly support the development of CLIO-8221 as a potential therapeutic option for HER2-positive cancers and a phase 1/2 study of CLIO-8221 in patients with advanced solid tumors has been initiated."

ADC • Oncology • Solid Tumor • HER-2

Callio Therapeutics Doses First Patient in Phase I Clinical Trial of Dual-Payload ADC CLIO-8221 in Advanced HER2-Expressing Solid Tumors (GlobeNewswire) - "The Phase I clinical trial (NCT07300943) is ongoing in Australia and the U.S., with Callio Therapeutics having received IND clearance from the U.S. Food and Drug Administration (FDA) this month. The IND is also under review by the China National Medical Products Administration (NMPA), and the trial is expected to expand to multiple sites in China."

IND • Trial status • Solid Tumor

Study in Advanced Solid Tumor Patients (clinicaltrials.gov) - P1/2 | N=306 | Recruiting | Sponsor: Callio Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Hummingbird Bioscience Announces Poster Presentation on HMBD-802, Novel Dual-Payload Antibody-Drug Conjugate, at EORTC-NCI-AACR 2024 (GlobeNewswire) - "Hummingbird Bioscience...announced a poster presentation on HMBD-802, a novel first-in-class dual-payload anti-HER2 antibody-drug conjugate, at the 36th EORTC-NCI-AACR symposium (23-25 October 2024)."

Preclinical • Oncology