Neoleukin Therapeutics has dosed the first subject with its NL-201 plus Keytruda (pembrolizumab), in a combination arm of Phase I clinical trial on relapsed or refractory solid tumour patients.
A de novo agonist of the IL-2 and IL-15 receptors, NL-201 can extend cancer-fighting CD8 T cells and natural killer (NK) cells without having a bias toward cells expressing the alpha receptor subunit (CD25). Keytruda is an anti-programmed death-1 (PD-1) therapy of Merck (known as MSD in North America).
The trial’s combination arm will enrol up to 132 subjects.
It will analyse the safety and efficacy of NL-201 and Keytruda combination in subjects with relapsed or refractory solid tumours.
Being carried out under a clinical partnership and supply agreement between Neoleukin and Merck, the trial is evaluating the safety, pharmacodynamics, pharmacokinetics, immunogenicity and antitumor activity.
According to the preclinical data, NL-201 showed the ability to elicit and expand CD8+ and NK cells at low doses with reduced impact on immunosuppressive regulatory T cells.
In addition, the therapy was found to have monotherapy and combination activity across various preclinical syngeneic tumour models.
Neoleukin chief medical officer Priti Patel said: “We are pleased to begin the combination arm of our NL-201 trial and evaluate the potential to combine these two agents, which demonstrated encouraging preclinical anti-tumour activity in multiple tumour models.
“Based on the preclinical information, we believe that adding NL-201 to pembrolizumab has the potential to provide increased benefits to patients, and we are excited to learn more through this part of the study.”
Leveraging de novo protein design technology, Neoleukin develops immunotherapies for cancer, inflammation and autoimmunity.
The company utilises complicated computational methods for designing proteins that show specific pharmaceutical properties for offering potentially superior treatment benefit versus native proteins.