CERo has released new findings from its ongoing phase 1 CertainT 1 study evaluating CER 1236, a first-in-human chimeric engulfment receptor T-cell therapy being tested in patients with acute myeloid leukaemia.

Investigators have completed the dose-limiting toxicity observation period in the first cohort and reported cell expansion with no cytokine release syndrome, no ICANS and no treatment-related adverse events so far, marking a positive early safety indication for an engineered T-cell approach in AML.

A notable observation was recorded in a second patient whose myelodysplastic syndrome had progressed to AML. Investigators reported a 61-day platelet transfusion free interval after treatment with CER 1236, surpassing the commonly referenced eight week benchmark used in studies assessing platelet transfusion independence.

The result was achieved in a patient with advanced disease, including an inv3 chromosomal abnormality.

In response to these early findings, CERo has amended the CertainT 1 protocol to widen enrolment beyond AML to include advanced MDS and myelofibrosis, a move that broadens the potential clinical relevance of the platform. The company continues to escalate dosing while gathering systematic safety and early efficacy data.

CER 1236 has been engineered to combine features of both adaptive and innate immunity.

ENA Respiratory has started dosing participants in its phase 2 community study of INNA 051, a dry powder nasal spray designed to strengthen the body’s natural antiviral defences and reduce the impact of symptomatic viral respiratory infections.

The company confirmed that the first participants have now received the investigational treatment.

INNA 051 is a once-weekly, virus agnostic therapy intended to prime immune responses in the nose, where viruses such as colds, flu, RSV and coronaviruses typically enter. The aim is to help the body respond more rapidly to infection and lower the risk of complications in people more vulnerable to severe illness.

The POSITS study will evaluate the safety, tolerability and efficacy of up to three months of treatment with INNA 051. It will also assess the spray’s effect on the incidence, duration and severity of symptomatic infections caused by common respiratory viruses in young adults at increased risk due to living or working in crowded environments.

Up to 1,100 generally healthy male and female participants will be enrolled. A 200 participant safety phase A is under way during the current North American respiratory virus season, with weekly dosing for four weeks. A larger 900 participant phase B will follow next season, with dosing over three months.