Mucosis Announces Re-issue of Major Patent by US Patent Office USPTO

Patented technology applied in SynGEM, a needle-free nasal spray vaccine against respiratory syncytial virus

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Re-Issuance of U.S. Patent No. RE 47,471 further bolsters Mucosis’ intellectual property portfolio

Groningen / Odijk, The Netherlands, July 2, 2019 – The trustee of biotech company Mucosis B.V., Mr. Holtz LLM and Virtuvax B.V. today announce that the US Patent Office (USPTO) has issued patent RE. 47,471 dated July 2, 2019. The patent is a reissue of Mucosis’ US Patent No. 9,060,975 (“reset patent”). The granted patent contains twenty-five claims including thirteen original as well as modified claims of the reset patent plus twelve additional new claims. Mucosis filed its application seeking reissuance in 2016, within two years after granting of the reset patent. The granted claims cover the pre-fusion RSV-F technology, which Mucosis applies in the SynGEM vaccine to protect against respiratory syncytial virus (RSV). The granted patent is set to expire in 2033.

The unique pre-fusion F subunit of RSV was used in the SynGEM vaccine and shown to raise potent immune responses against RSV. Delivered via the mucous membranes in the nose, the vaccine candidate is able to recruit antibodies to the mucosal pathways of the body, with the potential to effectively stop the virus at the mucosal linings, where over 90% of pathogens enter the body. Apart from the pre-fusion RSV-F technology, SynGEM applies Mucosis’ patented Mimopath technology, which uses bacterium-like particles (BLP) to deliver the antigen in a more natural conformation, boosting the body’s immune response to the virus. Recently published data from a Phase I clinical trial with the SynGEM vaccine, showed that it is safe and immunogenic and capable of inducing persistent antibody responses in healthy adults(1).

Mr. Holtz stated: “We are pleased that the USPTO has reissued this patent. Reissue of the patent further expands the Mucosis patent portfolio against RSV.” Ernst Soethout, managing director of Virtuvax added: “In the absence of a marketed vaccine against RSV, the prefusion F technology is one of the most promising and advanced technologies available. This patent, protecting the pre-fusion RSV-F antigen used in the SynGEM vaccine, now provides commercial protection to SynGEM and any other vaccine that exploits such in the US until 2033.”

RSV is a common contagious infection of the lungs and respiratory pathways, eliciting cold-like symptoms in adults. Whilst RSV infection is normally mild in healthy adults, the infection can lead to serious and sometimes fatal diseases such as pneumonia and bronchiolitis, most often in susceptible populations such as the young and elderly. Every year in the US, RSV infections lead to 57,527 hospitalizations of children under 5 year’s old (2) and are responsible for up to 200,000 deaths annually worldwide (3). The annual global burden of RSV illness is significant, with 33.8 million estimated new episodes of RSV-associated acute lower respiratory infection (ALRI) worldwide in children under 5, and over 3.4 million hospital admissions associated with severe RSV disease. Global mortality was estimated at 253,500 deaths in 2010.

About Mucosis

Mucosis B.V. (Mucosis) was a clinical-stage biotechnology company using a proprietary technology platform to develop next-generation needle-free human vaccines for infectious diseases. The investigational patient-friendly vaccines Mucosis developed, can be delivered via the nose or mouth to elicit a more natural immune response with a broader base of protection. Mucosis’ lead product SynGEM, a stabilized recombinant vaccine delivered intranasally to prevent respiratory syncytial virus (RSV) infection, entered human proof-of-concept studies in 2016. The Phase I study showed that the vaccine was safe and immunogenic in healthy adults.

Following an immediate shortage of capital, the District Court in Groningen, the Netherlands, declared bankruptcy of Mucosis on June 27, 2017 and appointed Mr. R.G. Holtz LLM as trustee. On behalf of the trustee, sale of the Mucosis assets is executed by the private company with limited liability Virtuvax B.V., Odijk, The Netherlands. Virtuvax B.V. provides strategic advice, technology and expertise for the development of vaccines. The company is headed by Ernst Soethout PhD and provides its services for vaccine development globally.

References

1. Ascough S, Vlachantoni I, Kalyan M, Haijema BJ, Wallin-Weber S, et al. Local and Systemic Immunity Against RSV Induced by a Novel Intranasal Vaccine: A Randomised, Double- Blind, Placebo-Controlled Trial. Am J Respir Crit Care Med. 2019 Feb 12. doi: 10.1164/rccm.201810-1921OC.

2. Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, et al. The burden of respiratory syncytial virus infection in young children. New Engl J Med. 2009;360(6):588-98.

3. Nair H., Nokes D., Gessner B., Dherani M., Madhi S., Singleton R., et al. (2010) Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet 375: 1173–1181

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Media Enquiries: Virtuvax BV

Ernst Soethout PhD, managing director

Virtuvax BV

Odijk, the Netherlands

e-mail: e.soethout@virtuvax.nl

Tel : +31 6 2989 4729

Mr. Job Holtz LLM, trustee

Bout Advocaten – Bout Lawyers

Groningen, the Netherlands

e-mail: holtz@boutadvocaten.nl

Tel: +31 5 0314 0840