OncoResponse has entered a clinical supply agreement with Regeneron for the latter’s Libtayo (cemiplimab), a PD-1 inhibitor.
The deal will aid in analysing the fully human monoclonal antibody of OncoResponse, OR2805, along with Libtayo (cemiplimab) in advanced cancer patients.
Leveraging the B-cell discovery platform of OncoResponse, the antibody was detected from an elite cancer responder.
OR2805 attaches to CD163 that is expressed on tumour-associated macrophages (TAMs).
At present, a Phase I clinical trial is underway evaluating the safety, pharmacokinetics, and initial anti-cancer activity of OR2805 alone and along with anti-PD-1 therapy in advanced solid tumour patients.
The trial has a dose escalation phase, which is followed by a number of expansion cohorts.
Potential biomarkers’ roles will be analysed in the trial and more thoroughly in another biology cohort.
OncoResponse chief medical officer Bob Lechleider said: “We believe the ability of OR2805 to potently activate myeloid cells within the tumour microenvironment will not only provide benefit as a monotherapy, but also improve responses to currently available checkpoint inhibitor immunotherapies such as Libtayo.
“We look forward to evaluating the combination of OR2805 with Libtayo, which has demonstrated efficacy in pivotal trials, serving as the basis for FDA approval in three types of advanced cancers.”
In February this year, Regeneron and Intellia Therapeutics reported positive interim data from the ongoing Phase I trial of NTLA-2001, a CRISPR/Cas9-based therapy, for transthyretin (ATTR) amyloidosis.
NTLA-2001, which is being developed as a single-dose therapy, is an in vivo genome editing candidate given systemically or intravenously for editing genes in humans.