VALNEVA and HOOKIPA Sign a Collaboration and Manufacturing Agreement

Valneva and HOOKIPA Sign a Collaboration and Manufacturing Agreement

Saint-Herblain, France, and Vienna, Austria, December 06, 2018 - Valneva Sweden AB, the Swedish subsidiary of Valneva SE ("Valneva"), and HOOKIPA Pharma Inc. ("HOOKIPA") today announced that they have entered into a three-year collaboration and manufacturing agreement.

Under the terms of the agreement, Valneva Sweden will provide analytical services, develop process scale-up and produce GMP clinical trial material to support the development of new immunotherapies based on HOOKIPA's Vaxwave^®* and TheraT^®* arenavirus vector- technologies. In return, Valneva will receive fixed and success-based service fees. The agreement may be extended beyond three years.

Janet Hoogstraate, Chairman of Valneva Sweden, commented, "We are excited to collaborate and support HOOKIPA in its innovative development of novel immunotherapeutics to help overcome infectious diseases and cancers. This collaboration is a great recognition of Valneva's strong technical and industrialization capabilities. Our dedicated Swedish unit has an excellent track record in development and clinical manufacturing."

Joern Aldag, Chief Executive Officer of HOOKIPA, added, "The collaboration with Valneva will give us access to a dedicated GMP facility and qualified workforce for the manufacture of clinical trial material according to our specific needs. It emphasizes our strategy to secure sufficient manufacturing capacity, reduce cycle times and increase the robustness and consistency of the process. We look forward to working with Valneva's great team."

About Valneva SE

Valneva is a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs. Valneva's portfolio includes two commercial vaccines for travelers: IXIARO^®/JESPECT^® indicated for the prevention of Japanese encephalitis and DUKORAL^® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has proprietary vaccines in development including a unique vaccine against Lyme disease. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 450 employees. More information is available at .

About HOOKIPA

HOOKIPA Pharma Inc. is a clinical stage biopharmaceutical company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform that is designed to reprogram the body's immune system.

Our proprietary arenavirus-based technologies, Vaxwave^®*, a replication-deficient viral vector, and TheraT^®*, a replication-attenuated viral vector, are designed to induce robust antigen specific CD8+ T cells and pathogen-neutralizing antibodies. Both, Vaxwave^® and TheraT^®, are designed to allow for repeat administration while maintaining an immune response. TheraT^®* has the potential to induce CD8+ T cell response levels previously not achieved by other published immuno-therapy approaches. Our "off-the-shelf" viral vectors target dendritic cells in vivo to activate the immune system.

We have successfully completed a Phase 1 trial of a Vaxwave^®-based prophylactic vaccine to protect against cytomegalovirus infection. We have initiated enrollment for a Phase 2 trial in cytomegalovirus-negative patients awaiting kidney transplantation from cytomegalovirus-positive donors. To expand our infectious disease portfolio, we have entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to jointly research and develop functional cures for HIV and Hepatitis B infections. We are building a proprietary immuno-oncology pipeline by targeting virally mediated cancer antigens, self-antigens and next-generation antigens. 

Find out more about HOOKIPA online at .

*Registered in Europe; Pending in the US.

Investor and Media Contacts

HOOKIPA

Nina Waibel                                                               Marine Popoff

Head of Communications                                          Communications & IR Manager

                       

Media enquiries (for HOOKIPA)

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Valneva Forward-Looking Statements

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the  ability to manufacture, market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing the information in these materials as of the date of this press release, and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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