Racura Oncology has treated the first patient in its phase 1 HARNESS 1 clinical trial of RC220 for EGFR mutant non-small cell lung cancer (NSCLC).

The patient received RC220 at 50mg/m² with no adverse events observed during or after infusion, marking the start of dosing in the study.

The patient was treated by Principal Investigator Associate Professor Surein Arulananda and his team at Monash Health in Victoria.

HARNESS 1 is assessing whether RC220 (E,E bisantrene) can be safely combined with the standard of care tyrosine kinase inhibitor osimertinib (Tagrisso; AstraZeneca) in patients with EGFR-mutant NSCLC, where resistance to targeted therapy remains a major clinical challenge.

The study uses single patient cohorts for the first three dose escalations – 50mg/m², 100mg/m² and 150mg/m² – before progressing to larger groups to identify the maximum tolerated dose of RC220 in combination with osimertinib.

The staged approach is designed to support careful dose escalation while generating early safety and pharmacokinetic data.

Daniel Tillett, Chief Executive Officer and Managing Director of Racura Oncology, said: “Treating the first patient in HARNESS 1 is an important step in the clinical development of RC220 and reflects the progress being made across Racura’s oncology pipeline.

“This trial is focused on a patient group where resistance to current targeted therapies remains a significant challenge. We are grateful to A/Prof Surein Arulananda and his team at Monash Health for their work in recruiting and treating the study’s first participant.”

Anocca has dosed the first patients in its phase 1 VIDAR 1 clinical programme, marking the initial clinical use of ANOC 001, a precision TCR-T cell therapy targeting KRAS G12V mutations in pancreatic cancer.

The company confirmed that multiple sites across Europe have now administered the treatment.

ANOC 001 is the first therapy to emerge from Anocca’s programme in pancreatic ductal adenocarcinoma, a highly aggressive cancer type with a five-year survival rate below 10%.

The therapy is designed for patients whose tumours carry specific KRAS mutations, which occur in the vast majority of pancreatic cancer cases.

The product was discovered, developed and manufactured at Anocca’s facilities in Sweden and is the first non-viral gene-edited T-cell therapy to be evaluated in Europe.

Reagan Jarvis, co-founder and Chief Executive Officer of Anocca, said: “The dosing of patients marks an important milestone for Anocca, and demonstrates our ability to develop, manufacture and clinically deploy precision TCR-T cell therapy products.

“The novel ANOC 001 clinical candidate was developed with Anocca’s proprietary analytical platform that maps targets and identifies, characterises and engineers T-cell receptors. We are grateful to our team, investors and partners whose efforts and participation made this milestone possible.”