Lyvgen Biopharma has partnered with Bristol Myers Squibb (BMS) to carry out a Phase II clinical trial of the former’s antibody, LVGN7409, plus docetaxel or nivolumab in advanced/metastatic non-small cell lung cancer (NSCLC) patients.
The open-label, randomised, multicentre trial of the combination therapy is anticipated to commence in the first half of next year.
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According to the agreement, the trial will be sponsored by Lyvgen while BMS will provide nivolumab for the combination study.
Lyvgen holds LVGN7409’s international commercial and development rights.
A recombinant monoclonal antibody, LVGN7409 acts on CD40 for activation in the tumour microenvironment.
Lyvgen chief medical officer Hubert Chan said: “Lyvgen believes that the combination therapy targeting co-stimulatory checkpoint CD40 and co-inhibitory checkpoint PD-1 may offer the greatest chance to increase immunotherapy effectiveness in patients with resistant or refractory diseases, further validating the synergy observed in our pre-clinical studies for the combination of LVGN7409 and an immune check-point inhibitor.
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By GlobalData“Through this Phase II study, we are enthusiastic to demonstrate that the stimulation of CD40 has the potential to reverse an immune-suppressed tumour microenvironment, characterised by drug resistance, and to improve anti-tumour efficacy when added to the current ‘standard of care’ therapy.”
A human monoclonal antibody of BMS, nivolumab attaches to the PD-1 and hinders its interaction with PD-L1 and PD-L2.
Docetaxel is an anti-tubulin chemotherapy agent intended for treating several cancer types.
In January last year, the company dosed the first subject in a Phase I clinical trial of LVGN7409 to treat patients with advanced or metastatic malignancy in the US.
The first-in-human, open-label, two-stage, non-randomised trial is designed to detect the recommended Phase II dose of LVGN7409 as a monotherapy, and with an anti-PD-1 antibody and/or CD137 agonist.
