4D Pharma secures cancer clinical trial with Merck and Pfizer
(DDDD ) has announced a clinical trial and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. in which it will evaluate its cancer treatment, MRx0518, alongside BAVENCIO®, a treatment for urothelial carcinoma, a form of bladder cancer.
Urothelial carcinoma is the most common type of bladder cancer, accounting for about 90% of all bladder cancers. It also accounts for 10% to 15% of kidney cancers diagnosed in adults.
BAVENCIO® (avelumab), which is co-developed and co-commercialised by both Merck and Pfizer, is known as the first and only immunotherapy approved as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma.
In the US, the FDA has already granted accelerated approval for BAVENCIO as a treatment for adults and paediatric patients 12 years and older with metastatic Merkel cell carcinoma.
Today’s statement highlighted that this indication is approved under accelerated approval based on tumour response rate and duration of response. It said continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
4D intends to start a clinical trial in 2021 to evaluate BAVENCIO alongside MRx0518 as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.
Shares in 4D Pharma have increased by over 45% in value since the beginning of November 2020 to open 2.86% higher this morning at 135.25p following the announcement.
4D’s MRx0518 is a single strain Live Biotherapeutic product developed to treat cancer. The product is delivered as an oral capsule and stimulates the body's immune system, directing it to produce cytokines and immune cells that are known to attack tumours.
A fourth clinical trial of MRx0518 in combination with BAVENCIO® (avelumab) in the first-line maintenance setting for urothelial carcinoma, conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer, is expected to initiate during the course of 2021.
Commenting on the announcement, Duncan Peyton, CEO of 4D Pharma said, "With this second clinical trial collaboration for MRx0518 with a leading immune checkpoint inhibitor, 4D is able to evaluate MRx0518 in a new combination and earlier treatment setting.
He commented, “This collaboration allows us to continue to build a broad understanding of the safety and efficacy of MRx0518 across a range of solid tumors and stages of disease.”
Peyton said this collaboration follows “promising data” already generated in combination with checkpoint inhibitor pembrolizumab in refractory patients, and MRx0518 monotherapy data demonstrating single agent immuno-modulation presented last year at SITC.
He added that, "The combination of MRx0518 with BAVENCIO has the potential to further enhance the positive clinical outcomes achieved by BAVENCIO for the significant number of patients in this treatment setting."
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