4D pharma, Merck get confirmation for its Keytruda MRx0518 combo study

4D pharma Wednesday said that its clinical study with Merck to test MRx0518 combined with Keytruda further support its continued investment into its oncology franchise.

The preliminary results of the combo is for patients with advanced malignancies who have previously responded and whose disease has then progressed on PD-1/PD-L1 inhibitors. These are the first observations from an oncology study in man involving a Live Biotherapeutic Product.

Chief Scientific Officer of 4D, Dr. Alex Stevenson, said: “We plan to take MRx0518 into additional clinical studies involving different tumour types and settings, either in combination or as a monotherapy. The next study with MRx0518, in combination with radiotherapy in pancreatic cancer, is planned to commence at MD Anderson before the end of the year. In addition, we continue to develop new Live Biotherapeutic candidates, with distinct modes of action, for oncology applications. The first of these, MRx1299, is currently in GMP manufacturing development.”

Key observations include tiitial data from the first six patients shows MRx0518 and Keytruda combination is well tolerated. Then, the induction of clinically relevant response in two out of six patients with prior progressive disease.

Observation will also include three patients withdrawn for disease related reasons (two following diagnosis of progressive disease and one due to a disease related adverse event).

The Phase I/II study is an open label study to evaluate the safety and preliminary efficacy of MRx0518 and KEYTRUDA® in patients with renal cell carcinoma (RCC), melanoma, non-small cell lung cancer (NSCLC) and bladder cancer who have developed resistance to PD-1/PD-L1 inhibitors. In preclinical studies, MRx0518 has previously shown significant efficacy as a monotherapy and as a combination treatment with checkpoint therapy. MRx0518 has also been shown to be a potent immunostimulant and capable of increasing the number of tumour infiltrating lymphocytes (TILs) associated with an anti-cancer effect in preclinical cancer models. Higher numbers of such TILs are generally considered to be a positive prognostic indicator for the clinical outcome of checkpoint therapies, such as KEYTRUDA®.