HANNOVER, Germany, Jan. 25, 2023 (GLOBE NEWSWIRE) -- Vakzine Projekt Management GmbH (VPM), a German drug development consultancy and service provider supporting small and medium pharma and biotech companies with its exceptional expertise spanning the complete pharmaceutical value chain from drug discovery to clinical development, marketing authorization and market access, today announced the successful completion of a clinical client project for Memo Therapeutics AG (MTx), Switzerland. The project included a Phase I clinical trial with AntiBKV, an antibody targeting BK polyomavirus (BKV) infection in renal transplant patients. VPM oversaw the clinical trial and performed translational project management, whereas the Australian cooperation partner and contract research organization (CRO) Accelagen managed the trial, yielding positive results, with all endpoints met.
In this phase I, single-blind, partially randomized, placebo-controlled clinical trial, 40 healthy adult volunteers were administered single and multiple ascending intravenous doses of AntiBKV (ClinicalTrials.gov: NCT05358106). No relevant adverse events were seen up to the highest dose of 2000 mg and pharmacokinetics were found to be normal and linear. MTx plans to submit an Investigational New Drug Application (IND) during the first quarter 2023 to initiate a multicenter study in the U.S..
Dr. Karsten Fischer, Chief Executive Officer of Memo Therapeutics AG, commented: “VPM has supported our drug development from the very start, throughout Phase I, and helped us to conclude our trial efficiently, cost-effectively and successfully. The broad expertise and commitment of VPM made the trial run smoothly, within budget and on time. As a next step we plan to initiate a multicenter study in the U.S.. For similar development projects in the future, we will continue to count on VPM’s support.”
CEO and Founder of Accelagen, Greg Plunkett, added: “We know VPM as trusted cooperation partner, and together we realized the efficient execution of this clinical program. We have seen that their expertise and strong collaboration facilitates fast and seamless development in all important geographies of the world. The outcomes we have achieved together exemplifies our shared values and commitment to making a difference to the future of healthcare.”
“Our work with Memo Therapeutics, especially on AntiBKV, has driven the transformation of a ground-breaking idea into a life-saving potential medication, based on the in-depth knowledge and experience of successful pharmaceutical development strategies across a broad range of indications within VPM. Furthermore, our reliable, internationally renowned CRO partner Accelagen supports us in our endeavors, with highly efficient trial and regulatory processes and international standards,” said Dr. Leander Grode, Managing Director of VPM. “By engaging with our expanding network of cooperation partners, we aim to increase our offerings in clinical trials and our commitment to supporting clients in their pipeline development and building value in their companies.”
BKV is a wide-spread virus persisting in approximately 80-90 % of the population. While clinically not relevant in healthy individuals, the virus is often reactivated in immunosuppressed patients. Reactivation has been shown to be a frequent cause of kidney transplant deterioration and rejection. AntiBKV is intended to provide an acute treatment, reduce the viral load below the detection limit and thus, for the first time, provide a causal treatment of polyomavirus-associated nephropathy.
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 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 on: https://www.vpm-consult.com/en/
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 neutralizing 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. Memo’s pipeline consists of additional therapeutic antibodies focusing on infectious diseases, such as cytomegalovirus, 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 unprecedent rate, including discovering ultra-rare antibodies that competing technologies fail to identify. MTx is a private company located in Schlieren/Zurich, Switzerland.
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 co-create 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 for social and environmental issues that will change the world.
Dr. Leander Grode, CEO
Tel: +49 511 16 99 08 19
MC Services AG
Dr. Brigitte Keller
Tel.: +49 89 210 228 0