City Briefs: Avacta and 4D Pharma
Wetherby-based Avacta Group has entered into a commercial partnership with Mologic to accelerate to market its AffiDX™ SARS-CoV-2 lateral flow rapid antigen test.
The partnership which will enable Avacta’s rapid antigen test to be CE market for professional use under Mologic’s existing ISO13485 quality system. This CE mark can then be transferred to Avacta when it receives the same ISO accreditation which is expected at the end of March.
In addition the partnership provides additional manufacturing capacity through Mologic and its partners including Global Access Diagnostics, in addition to the scaled-up manufacturing capacity being built with BBI and Abingdon Health. This will enabled the delivery of several millions of tests per month and can be further increased through investment.
The agreement also sees Avacta provide access to its spike antigen test through Mologic in order to support antigen testing in low and middle income countries.
Dr Alastair Smith, chief executive officer of Avacta Group, said: “I am very pleased to announce this partnership with Mologic, which follows a close collaboration over recent months. The partnership provides Avacta with a low risk route to CE marking our rapid antigen test during Q1 ahead of achieving our own ISO13485 accreditation.
“I am also delighted that this collaboration provides an opportunity for Avacta to support antigen testing in low and middle income countries through Mologic’s international manufacturing links.
“The longer-term collaboration with Mologic, on a range of diagnostic tests, offers a significant potential opportunity for the Group. The combination our technologies to generate a world-leading second generation antigen test for SARS-CoV-2 is an exciting possibility.”
Smith however noted that there had been a delay in clinical testing its rapid spike antigen test in Europe as a result of “customs issues following the UK’s departure from the EU”, which had impacted the CE marking. He hopes however that with clinical evaluation underway in Europe if the results are positive, the business can “move quickly into full clinical validation in Europe and the UK, and subsequent CE marking through Mologic.”
Adding that “this approach it is possible to bring the test to market around the end of the first quarter of this year.”
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Leeds-based pharmaceutical company, 4D Pharma has announced a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. for the first and only immunotherapy approved as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma.
The product, BAVENCIO is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc,
Under the collaboration, 4D pharma intends to commence a clinical trial in 2021 to evaluate BAVENCIO in combination with 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.
Duncan Peyton, chief executive officer at 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.”
