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Accelagen accelerates time to market for European clients: Potentially best-in-class study for Treatment of BKV Infection sees exciting results

Accelagen accelerates time to market for European clients: Potentially best-in-class study for Treatment of BKV Infection sees exciting results

Local CRO, Accelagen, attracts innovative European drug and antibody developers to trial in Australian market

Engaged by world-renowned European clients and collaborators, Memo Therapeutics AG (“MTx”) based in Switzerland, and Vakzine Projekt Management GmbH (VPM) based in Germany, leading Australian Contract Research Organisation (CRO), Accelagen, has successfully completed Phase 1 Clinical Trials for the AntiBKV antibody, designed to target BK polyomavirus (BKV) infection in renal transplant patients.

A potentially best and first-in-class therapy, the trial represents both a potential breakthrough treatment for those affected by, or at risk of, BKV infection following renal transplantation worldwide, as well as the accelerated time to market for international drug developers and biotechs looking to harness Australia’s world class healthcare system and best-in-class regulatory processes.

Greg Plunkett, CEO and Founder of Accelagen comments: “At Accelagen, our process is based on a genuine partnership with clients and a deep commitment to understanding their goals and co-creating a clear pathway to market. We know both VPM and MTx to be trusted collaborators who are equally dedicated to ensuring outputs have a tangible impact on the future of human health. We are honoured to collaborate with them on this journey, delivering clinical trials in Australia that are already yielding positive results.”

Lending its unique process, accelerated timelines and industry expertise, Accelagen oversaw the management and delivery of Phase I — single-blind, partially randomised, placebo-controlled clinical trials — in 40 healthy adults who were administered single and multiple ascending intravenous doses of AntiBKV antibody (ClinicalTrials.gov: NCT05358106). 

Trials concluded in January 2023 with no relevant adverse effects seen up to the highest dose of 2000 mg, and pharmacokinetics were found to be normal and linear. This will progress to MTx’ submission of an Investigational New Drug Application (“IND”) during the first quarter of 2023, designed to initiate a multicentre study in the US. 

“The timelines our team developed created a clear and efficient pathway to the successful conclusion of the BKV antibody trial. Our team embarked on a well-established strategy that ensured ethics approval was granted promptly and study start up activities could be expedited to ensure study close out met MTx’ goal.

“Australia’s advantageous position for clinical trials, combined with our team’s unique ability to accelerate assets into the clinic, we are seeing more and more international clients, particularly from Europe, with a keen interest in conducting trials here,” Mr Plunkett adds.

Dr. Jürgen Beck, Chief Medical Officer of MTx added: “The Phase I trials for AntiBKV were very much a three-way collaboration between our team, Vakzine Projekt Management and our chosen CRO, Accelagen. We were encouraged by the initial clinical data yielded as a result, but also by the timeline we were able to achieve working with Accelagen in the Australian market. The efficient turnaround in Phase I trials means that there is potential to present a game-changer for thousands of patients globally, who are currently seriously underserved.” 

AntiBKV has the potential to be a best- and first-in-class antibody for the treatment of BKV infection in kidney transplant recipients. With 50,000 kidney transplant procedures carried out in the US and Europe alone, AntiBKV addresses a large and rapidly growing market, with an estimated size well beyond USD 1 billion.

“Accelagen has been a welcome partner on the delivery of this project and an important addition to our own expanding network of cooperation partners, enabling us to increase our offerings in clinical trials and further deliver on our commitment to support clients in expediting their pipeline development,” adds Dr. Leander Grode, Managing Director of VPM. 

Accelagen is looking forward to continuing this important work with MTx and VPM to advance AntiBKV and to further build on important asset studies and positively impact human health and wellness the world over.

 

About Accelagen

Accelagen is a leading Contract Research Organisation (CRO) that works with innovative clients both in Australia and across the globe, employing a unique approach to process and people to cocreate meaningful outcomes that have a tangible impact on the future of human health and wellness. Accelagen is underpinned by the desire and courage to do things differently. Guided by purpose, the company continues to attract like-minded experts who share this desire and who won’t settle for the status quo. By bringing attention to the human side of what can be a very clinical field, Accelagen leads the way in using data and research to solve social and environmental issues that will change the world.

About Memo Therapeutics AG

Memo Therapeutics AG (MTx) is a clinical-stage biopharma company developing best-in-class therapeutic antibodies to transform the lives of patients with virus infections and cancer. MTx’s lead program, AntiBKV, is a highly effective and safe neutralising antibody to treat BK virus infection in kidney transplant recipients. This infection can lead to loss of kidney function, as well as organ failure and rejection. MTx’ pipeline consists of additional therapeutic antibodies focusing on infectious diseases, such as cytomegalovirus (CMV), as well as undisclosed immuno-oncology targets.

The pipeline derives from MTx’s industry-leading throughput and functional screening capabilities, which can cover the entire antibody repertoire. Using its immortal cell libraries and unique nano droplet technology, MTx identifies and isolates the most potent antibodies based on functionality at an unprecedented rate, including discovering ultra-rare antibodies that competing technologies fail to identify. MTx is a private company located in Schlieren / Zurich, Switzerland.

About VPM

Vakzine Projekt Management GmbH (VPM) is a German consultancy and service provider established in 2002. Within the last two decades, VPM has successfully managed and consulted the development of promising biopharmaceutical candidates, ranging from small molecules, recombinant proteins up to gene-modified live vaccines and ATMPs. For its customers from the pharmaceutical industry, academic research and small biotechnology companies, VPM has helped develop their products from preclinical phase through clinical phases I-III and approval, managing the processes more cost-effectively and with higher success probabilities. Read more about VPM here.
 

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