Vakzine Projekt Management GmbH

Hannover, Germany, May 10, 2023 – Vakzine Projekt Management GmbH (VPM) is delighted to announce the successful licensing of the novel R21/Matrix-MTM Malaria Vaccine by the Ghana Food and Drugs Authority (FDA) for use in children as young as 5 months old up to 36 months old, in Ghana. This approval is an exciting milestone and was achieved by the joint global efforts of VPM, Serum Institute of India (SII), Oxford University, and DEK Vaccines Ltd (DEK). This synergistic collaboration facilitated the accelerated licensure process in Ghana and is a step forward on the path to ensuring vaccine equity in Africa. Malaria is one of the leading causes of pediatric morbidity and mortality in sub-Saharan Africa. Children under 5 account for approximately 80% of all malaria-related deaths. R21/Matrix-MTM has emerged as the most effective vaccine against malaria ever produced and shall contribute to alleviating the burden of 600,000 deaths per year. R21/Matrix-MTM was initially developed by the lab research team of Adrian Hill, also Chief investigator of the R21/Matrix-MTM program, and Director of the University of Oxford’s Jenner Institute. SII then licensed and scaled up manufacturing of R21/Matrix-MTM for commercial use. Based on available clinical data, the efficacy of the vaccine is greater than 75%, which is far above the efficacy of the only other currently approved malaria vaccine. Notably, the manufacturing capacity of 200 million doses/year by SII will increase the current supply capacities by >20-fold globally. Adar Poonawalla, CEO, Serum Institute of India, shared, “Malaria is a life-threatening disease that disproportionately affects the most vulnerable populations in our society and remains a leading cause of death in childhood. Developing a vaccine to greatly impact this huge disease burden has been extraordinarily difficult. At the Serum Institute of India, we are committed to our vision of Health for All and ensuring equitable access to vaccines for people around the world. The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana and Nigeria is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives.” VPM was key in connecting the global partners for the approval of R21/Matrix-MTM in Ghana. DEK is a Ghanaian consortium that aims to produce its own vaccines in Ghana to secure local vaccine availability in Ghana, and eventually all of Africa. SII is the world’s largest vaccine manufacturer by doses produced and is the manufacturing and commercialization license holder for R21/Matrix-MTM. By leveraging its expertise and excellent network, VPM helped DEK and SII foster a mutually beneficial partnership that led to global success. The marketing authorization of R21/Matrix-MTM was achieved at an incredibly high pace thanks to the efficient orchestration by VPM and the regulatory expertise of DEK and SII. Other African national regulators authorities are following the positive opinion of the FDA Ghana and granted marketing authorization in their countries, and more African countries are expected to follow. This achievement also coincides with another crucial milestone: the ground-breaking ceremony of the unveiling of DEK's new vaccine manufacturing facility in Accra, Ghana. This exciting endeavor represents a major step forward for independent vaccine production and equity in Africa. VPM is proud to have contributed to this major success. “This partnership is a proof of our ambition towards supporting the development of safe and effective vaccines to ensure healthy living for all,” said by Dr. Leander Grode, Managing Director of VPM. “Our expertise in vaccine development, and our collaboration with global institutions and vaccine developers and manufacturers, further validates our role as a leading consultancy in the pharmaceutical industry." VPM remains committed to advancing innovative research and development and working collaboratively with global partners to transform ground-breaking ideas into life-saving medication. About Vakzine Projekt Management Vakzine Projekt Management GmbH (VPM) is a German consultancy and service provider established in 2002. Within the last two decades, VPM has successfully managed the development of promising biopharmaceutical candidates, ranging from small molecules, recombinant proteins up to gene-modified live vaccines and ATMPs. VPM clients are small, medium, and large biopharmaceutical enterprises, as well as private funding organizations, and research groups. VPM brought their products from preclinical stage through clinical phases I-II-III up to approval. Since 2012 VPM has its consulting and service business. Based on its in-depth experience and a strong network of reliable partners, VPM offers tailor-made hands-on services. The consulting and service offers refer to the entire product development phases as VPM has successfully progressed its own products along the development value chain. Read more about VPM on: About Serum Institute of India Driven by the philanthropic philosophy of striving to make vaccines affordable around the world, Serum Institute of India Pvt (SII), Ltd. is the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 2.5 billion doses), supplying the world’s least expensive and WHO-accredited vaccines to as many as 170 countries. It was founded in 1966 with the aim of manufacturing lifesaving immunobiological drugs including vaccines worldwide. With a strong commitment towards global health, the institute’s objective has been proliferated by bringing down the prices of newer vaccines such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. SII is credited with bringing world-class technology to India, through its state-of-the-art equipped multifunctional production facility in Manjri, Pune along with spearheading the race of vaccine development against the COVID-19 pandemic. Serum Life Sciences Ltd is a subsidiary company of Serum Institute of India, with a global sales office in London to market vaccines manufactured by Serum Institute of India. About the University of Oxford Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the seventh year running, and number 2 in the QS World Rankings 2022. At the heart of its success are the twin-pillars of their ground-breaking research and innovation and their distinctive educational offer. Through its research commercialization arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 200 new companies since 1988. Over a third of these companies have been created in the past three years. The university is a catalyst for prosperity in Oxfordshire and the United Kingdom, contributing £15.7 billion to the UK economy in 2018/19, and supports more than 28,000 full time jobs. About DEK Vaccines Ltd. DEK Vaccines Ltd. (DEK) is an offshoot of Kinapharma Ltd. DEK is an upcoming multiple vaccines manufacturing factory by the way of Fill & Finish being constructed in Accra, Ghana. DEK implements the Government of Ghana’s vision to achieve health security through production of vaccines for Africa in Ghana. Contact VPM Dr. Leander Grode, CEO Tel: +49 511 16 99 08 19 info@vakzine-manager.de

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. 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 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: 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. 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 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. Contact VPM Dr. Leander Grode, CEO Tel: +49 511 16 99 08 19 info@vakzine-manager.de Media contact MC Services AG Dr. Brigitte Keller Tel.: +49 89 210 228 0 vpm@mc-services.eu

The vaccine candidate VPM1002 shows its safety in a study with HIV- and non-HIV-exposed newborns. No other infectious disease has killed more people than tuberculosis. Currently, only one vaccine is available to prevent severe courses: Bacillus Calmette Guérin (BCG). However, it is not equally effective against all types of tuberculosis. Especially infants and immunocompromised patients are therefore in urgent need for more effective tuberculosis vaccines. A clinical trial in South Africa has now shown that the new vaccine candidate VPM1002, developed by Max Planck researcher Stefan H.E. Kaufmann and his team, is equally safe for newborns with and without HIV exposure and has fewer side effects compared to BCG. At least 20 million people worldwide suffer from tuberculosis, according to World Health Organization (WHO), with 10 million new cases every year and about 1.5 million deaths annually. The disease is caused by mycobacteria, which predominantly affect the lungs, but can also infect any other organ. Tuberculosis is particularly common in low income countries. Here, the WHO recommends that newborns be immunized against it as soon as possible. First used 100 years ago, the BCG vaccine against the disease contains attenuated pathogens of cattle tuberculosis. "We know that BCG can prevent so-called tuberculous meningitis and miliary tuberculosis in infants with a 75 to 86 percent effectiveness rate. But this is not the case for the most common form of the disease, pulmonary tuberculosis, in all age groups. Here, BCG is only insufficiently effective," explains Kaufmann, Emeritus Director at the Max Planck Institute for Multidisciplinary Sciences in Göttingen and the Max Planck Institute for Infection Biology in Berlin. Since the 1990s, the infection biologist and his team have been working on an improved next-generation vaccine, called VPM1002. To achieve this, the researchers genetically modified the attenuated BCG vaccine strain so that immune cells can better recognize the pathogens. "We developed VPM1002 in no small part to combine increased safety with improved efficacy for immunocompromised children," the Max Planck researcher reports. Vaccine candidate VPM1002 is safe The group of immunocompromised children includes, for example, HIV-exposed infants born to HIV-positive mothers. In a clinical trial in South Africa, an international research consortium including Kaufmann has now compared VPM1002 with BCG in HIV-exposed and non-HIV-exposed newborns. The study examined both the safety and the immune response induced -- called immunogenicity -- associated with the formation of immune cells and immunostimulatory proteins. The conclusion of the study: VPM1002 is safe in both HIV-exposed and non-HIV-exposed newborns, has fewer side effects than BCG, and elicits a similar immune response. In the randomized phase II double-blind study in South Africa, 416 eligible newborns were randomly selected and vaccinated before day 12 of life. 312 of them received VPM1002, and 104 received the BCG vaccine. As the study showed, VPM1002 triggered fewer vaccine-related adverse reactions than BCG. This was true for reactions occurring at the injection site, such as scarring and abscess formation, as well as enlargement of lymph nodes. This finding is important because local and regional reactions after vaccination are among the limitations of the BCG vaccine, Kaufmann points out. Newborns with or without HIV exposure showed similar immunogenicity with both vaccines. However, starting at six weeks of age, the BCG-triggered immune response was greater than in even younger infants. Phase III study investigates protection "Studies such as those described here examine a vaccine's immunogenicity, but not its protection. For the latter, we have already developed a larger phase III clinical trial and have successfully enrolled mothers with their newborns to participate. Now the clock is ticking," Kaufmann said. The infectious biologist expects initial results showing whether VPM1002 can provide comparable or better protection than existing BCG vaccines in about three years. In addition, the VPM1002 vaccine is currently evaluated in adults in two other phase III clinical trials in India for protection against tuberculosis. These trials are expected to be completed in 2023 and 2024, respectively. The Max Planck Society licensed the VPM1002 vaccine to the company Vakzine Projekt Management (VPM) in 2004. Starting in 2012, the company continued to develop the vaccine in collaboration with the Serum Institute of India, one of the world's largest vaccine manufacturers. "Serum Institute of India is giving access to a unique solution for tuberculosis elimination by detect-treat-prevent strategy. VPM1002 is a unique component of this strategy, and it will help in preventing infection and disease. The ongoing phase III trial is one of the key trials in order to strengthen our scientific rationale. Pleased to see that we have completed recruitment of all infants in such an important trial," said Umesh Shaligram, Executive Director R&D of Serum Institute of India.