VEC.L Regulatory News (VEC)

Vectura Group plc

Global development agreement with Dynavax for lung cancer programme using Vectura's smart nebuliser technology (VR347)

Chippenham, UK - 16 August 2017: Vectura Group plc (LSE: VEC) ("Vectura", "the Group"), an industry-leading device and formulation business for inhaled airways products, today announces that following successful completion of the feasibility work it has signed an exclusive global agreement with Dynavax Technologies Corporation (NASDAQ: DVAX; "Dynavax"), a clinical-stage immunotherapy company, for the clinical application of Vectura's proprietary smart nebuliser technology to deliver Dynavax's investigational immunotherapeutic agent to lung cancer patients (VR347).

VR347

Vectura's AKITA® smart nebuliser will be used by Dynavax to deliver DV281, a novel Toll-Like Receptor 9 (TLR9) agonist designed specifically for local delivery to primary lung tumours and lung metastases in order to generate an anti-tumour immune response. Vectura's FAVORITE™ nebulisation technology combines optimising patient's inhalation technique with the effective control of the flow rate and volume of the drug being delivered. This approach maximises the efficiency of the nebulisation and enables consistent targeted drug deposition.

The AKITA® device will initially be used in the development programme with a plan to move to the FOX® handheld device as a next step.

The agreement covers the Phase I and Phase II development programmes and Vectura will provide devices and device related support to Dynavax which is responsible for the rest of the programme. Whilst addressing a substantial market opportunity, in these early phases the Group is eligible to receive modest milestones and development services revenues and does not expect a material impact on R&D expenditure which remains within the previous annual guidance range of £65-75m for 2017 and 2018.

James Ward-Lilley, Chief Executive Officer, commented:

"We are pleased to announce this additional new programme leveraging Vectura's smart nebulisation device technology. The collaboration with Dynavax is an exciting innovative programme combining the development of a new treatment option for patients with lung cancer along with targeted inhaled delivery. This agreement underlines the increasing recognition of the utility of Vectura's unique smart nebuliser technology and devices by existing and potential development partners."

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About Vectura

Vectura, a FTSE250 company listed on the London Stock Exchange (LSE: VEC), is an industry-leading device and formulation business for inhaled airways products offering a uniquely integrated inhaled drug delivery platform. With our extensive range of device and formulation technologies, integrated capabilities and collaborations, we are a leader in the development of inhalation products, increasing our ability to help patients suffering from respiratory diseases. 

Vectura has eight inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams, and a portfolio of drugs in clinical development, a number of which have licence agreements with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Bayer, Chiesi, Almirall, Janssen, and Tianjin KingYork. For further information, please visit Vectura's website at www.vectura.com.

About DV281

DV281 is Dynavax's proprietary investigational TLR9 agonist designed specifically for focused delivery to primary lung tumors and lung metastases. DV281 is similar in biological activity and mechanism of action to Dynavax's Phase II immunotherapy candidate, SD-101, but has been optimised for administration as an aerosol. Both SD-101 and DV281 activate plasmacytoid dendritic cells which then stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as DV281 and SD-101 have been shown to stimulate potent Type 1 interferon induction along with maturation of dendritic cells to effective antigen-presenting cells, both activities are important for the induction of effective anti-tumor immunity.

About Dynavax

Dynavax is a clinical-stage immunology company focused on leveraging the power of the body's innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax is developing product candidates for use in multiple cancer indications and as a vaccine for the prevention of hepatitis B. Dynavax's lead product candidates are SD-101, an investigational cancer immunotherapeutic currently in Phase II studies, HEPLISAV-B, a Phase III investigational adult hepatitis B vaccine, and DV281, planned to enter the clinic in 2017. For more information, please visit www.dynavax.com.

Forward-looking statements

This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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