IAVI and CureVac Partner to Accelerate Development and Testing of AIDS Vaccine Candidates

NEW YORK and TUBINGEN, Germany, Sept. 10, 2015 /PRNewswire-USNewswire/ -- The non-profit International AIDS Vaccine Initiative (IAVI) and biopharmaceutical company CureVac are partnering to accelerate the development of AIDS vaccines, utilizing novel immunogens developed by IAVI and partners, delivered via CureVac's novel messenger RNA (mRNA) technology.

HIV's envelope protein or "trimer" is the primary target for antibodies that can neutralize a wide range of the virus' strains, and which hold enormous promise in the quest for efficacious and broadly applicable AIDS vaccines. In a major breakthrough, researchers have recently designed immunogens that successfully mimic this trimer.

In this collaboration, IAVI has selected one of its leading HIV trimer constructs to launch the mRNA evaluation in small-scale clinical trials: mRNA that encodes for the chosen trimer mimic will be constructed using CureVac's RNActive® technology and injected with the aim of stimulating the body to produce HIV trimer proteins and then related neutralizing antibodies. To date, most AIDS vaccine candidates have been based on DNA, viral vectors or protein. Using mRNA could accelerate the development and testing of AIDS vaccine candidates.

"This collaboration could be a real game-changer," said IAVI Chief Scientific Officer Wayne Koff. "The development of vaccines that can generate neutralizing antibodies against HIV is a top priority for IAVI and many other researchers. Researchers at IAVI's Neutralizing Antibody Center at The Scripps Research Institute and elsewhere have designed several novel immunogens that have the potential to elicit such antibodies. We are very hopeful that using mRNA will enable us to develop and test these immunogens comparatively quickly, saving both time and money."

"IAVI is an ideal partner to bring highly innovative HIV vaccine designs into human testing," said CureVac co-founder and CEO Ingmar Hoerr. "We are excited to benefit from IAVI's expertise in AIDS vaccine development, and its network and experience across the United States, Europe, Africa and India and to accelerate such development on the basis of our RNActive® technology."

CureVac is pioneering the use of natural and chemically unmodified mRNA as a data carrier to instruct the human body to produce proteins capable of fighting a wide range of diseases. CureVac's mRNA- based vaccine candidates are also thermostable, which eliminates the need for cold-chain storage and infrastructure that pose a major challenge in vaccine supply in developing countries.

Under the terms of the agreement, IAVI will provide several stabilized HIV envelope trimer sequences, which CureVac will transfer into its RNActive® technology for preclinical and clinical development. The partners will work with U.S., German and African health authorities with an eye to initiating clinical trials in 2016.

About IAVI

The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996, IAVI works with partners in 25 countries to research, design and develop AIDS vaccine candidates. The organization also conducts policy analysis and serves as an advocate for the

AIDS vaccine field. It supports a comprehensive approach to addressing HIV and AIDS that balances the expansion and strengthening of existing HIV prevention and treatment programs with targeted investments in the design and development of new tools to prevent HIV. IAVI is dedicated to ensuring that a future AIDS vaccine will be available and accessible to all who need it. IAVI's work is made possible by generous support from many donors including: the Bill & Melinda Gates Foundation; the Ministry of Foreign Affairs of Denmark; Irish Aid; the Ministry of Finance of Japan in partnership with The World Bank; the Ministry of Foreign Affairs of the Netherlands; the Norwegian Agency for Development Cooperation (NORAD); the United Kingdom Department for International Development (DFID), and the United States Agency for International Development (USAID). The full list of IAVI donors is available at www.iavi.org.

About CureVac

CureVac is the leading company in messenger RNA (mRNA) based drugs with more than 15 years of expertise and the most advanced and broadest clinical pipeline in the industry. Until today CureVac received from dievini (Dietmar Hopp) and Bill & Melinda Gates Foundation approx. $220 million in equity investments.

Started in 2008 CureVac's mRNA products are subject of seven active clinical studies in more than 350 patients and healthy volunteers as of today, including a Phase IIb trial in prostate cancer. CureVac's mRNA technology is also the foundation for several high-profile partnerships involving multinational corporations and organizations, including agreements with Boehringer Ingelheim, Sanofi Pasteur, and Johnson & Johnson, as well as the Bill & Melinda Gates Foundation.

CureVac's proprietary technology platform utilizes natural, chemically unmodified mRNA, which studies have shown elicits greater therapeutic responses than chemically modified mRNA. CureVac's mRNA programs include novel mRNA-based cancer immunotherapies and prophylactic vaccines against infectious diseases (RNActive®), molecular therapies designed to trigger the body's own production of therapeutic proteins (RNArt®), and RNA encoded antibodies (RNAntibody®). In 2006, CureVac successfully established the first GMP facility worldwide for the manufacturing of mRNA. In 2016 CureVac will start the construction of an industrial scale production facility with a capacity of 30 million doses per year.

For more information, please visit www.curevac.com

Media Contacts

For IAVI: in Europe, Hester Kuipers, [email protected], +31 20 521 0343; elsewhere, Barbara Rosen [email protected], +1 212 847 1056

For CureVac: in New York, Andrew Mielach, [email protected], +1 (212) 375-2694; in Germany, Verena Lauterbach, [email protected], +49 (7071) 920 53 756


Editors Notes

This collaboration is aimed at accelerating the development of a vaccine to help stop the spread of HIV and end AIDS. In 2014, almost 37 million people were living with HIV; 2 million people (almost 5,500 a day) contracted the virus, and 1.2 million people died from AIDS-related illnesses.
We now know that the immune systems of some people living with HIV naturally produce powerful broadly neutralizing antibodies (bNAbs) against many HIV variants. There's been tremendous progress recently in finding very potent bNAbs, identifying where on the virus they bind (HIV's envelope protein or trimer), characterizing the binding sites, and designing immunogens (the active component of vaccines) to mimic them. We've also seen that administering bNAbs can protect monkeys from HIV-like infections.
IAVI and partners are working to accelerate all stages of developing bNAb-inducing vaccines – from immunogen design and screening through manufacturing of the most promising candidates and testing in clinical trials. This includes work at IAVI's laboratories in New York and London; IAVI's Neutralizing Antibody Center at The Scripps Research Institute in California; a partnered laboratory with the Government of India in Delhi; and Clinical Research Center partners in East and South Africa.
CureVac works in the field of drugs and vaccines based on Messenger-RNA (mRNA). One of the company's focuses is to develop safe, efficacious and cost-effective mRNA vaccines against infectious diseases such as HIV. The basic principle is to use natural and chemically unmodified mRNA as a data carrier to instruct the human body to produce proteins capable of fighting disease.
In the collaboration announced today, IAVI and CureVac aim to develop a new and faster way to use HIV envelope trimer mimics as immunogens to stimulate a protective immune response. The selected immunogens were developed by IAVI specifically to produce bNAbs against HIV.
To date, most AIDS vaccine candidates have been based on DNA, viral vectors or proteins. In the first, DNA encoding for the immunogen (a protein) is injected to induce the body to transcribe its genetic information into mRNA, which is then translated into a protein. Vector-based approaches rely on benign viruses to deliver the DNA instead of injecting it directly. In the third approach, the protein immunogen is injected directly. This collaboration will explore if using mRNA could circumvent the transcription step involved in using DNA as well as several of the challenges involved in using proteins (including complex isolation or laboratory synthesis and cold chain.)
Development time of AIDS vaccine candidates that deliver an immunogen via mRNA is measured in months, as compared to years with other approaches, representing potential savings of both time and money. IAVI and CureVac believe that mRNA technology has the potential to accelerate screening of promising immunogens, with the goal of identifying one or more that are capable of inducing bNAbs in humans.
CureVac's RNActive® vaccine platform may be particularly suited to address the challenging HIV, as it has successfully triggered an antibody response as well as a cellular immune response to other pathogens. Both these responses are thought to be needed for an efficacious HIV vaccine.
The partners hope to complete preclinical work in the first half of 2016, with an eye to launching a clinical trial in the second half of the year. Evaluation of a second envelope construct is under discussion.