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Sirnaomics Enters Partnership with Walvax Biotechnology to Co-Develop Its Antiviral RNAi Therapeutic Product Candidate STP702

April 29, 2021.

Sirnaomics Biopharmaceuticals (Suzhou) Co. Ltd., a subsidiary of Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer, fibrotic diseases and viral infections, announced that the company has entered into a partnership agreement with Walvax Biotechnology (Walvax) for the co-development of its anti-influenza siRNA therapeutic product candidate STP702. Sirnaomics will out-license to Walvax the exclusive development and commercialization rights for territories including mainland China, Taiwan, Hong Kong and Macao. Based on the agreement, the company will receive an initial payment of ~US$6.4 million for this asset, with additional milestone payments and royalty sharing based on product sales.  

While the medical and scientific communities are continuing the fight against the Covid-19 pandemic, there needs to be continued attention towards other viruses, such as Influenza, which cause severe epidemics worldwide. Along with its resistant strains, new pathogenic viruses continue to be discovered, creating an ongoing need for new anti-influenza treatments. RNA interference (RNAi) is a cellular gene-silencing phenomenon, in which sequence-specific degradation of target mRNA is achieved by means of complementary short interfering RNA (siRNA) molecules. This advanced therapeutic approach, using siRNA technology as a targeted inhibitor, affords a tractable strategy to combat influenza pathogenesis. SiRNAs are easy to design, and can be directed against multiple strains of the influenza virus by targeting their conserved gene regions. The newly established partnership between Sirnaomics and Walvax will specifically focus on development of the siRNA-based anti-influenza therapeutic candidate STP702.

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“Establishing this partnership with Walvax exemplifies our continued execution for development strategy,” said Patrick Lu, PhD, President and CEO of Sirnaomics, and Chairman of Sirnaomics Suzhou. “The out-licensing of our antiviral siRNA candidate, especially to an internationally well-recognized biopharma company like Walvax Bio that specializes in development of vaccine and therapeutics against various viral infections, marks a major milestone in Sirnaomics’ growth. I look forward to seeing the Sirnaomics and Walvax teams working together to develop a novel siRNA therapeutic to combat potential influenza epidemics of the future.”

“We believe our siRNA technology has extremely broad therapeutic potential and we are excited to combine Walvax’s deep vaccine expertise with our siRNA platform technology to unlock additional value outside of our core oncology and fibrosis therapeutic focus,” said Allan Shaw, Chief Financial Officer at Sirnaomics. “This alliance provides the latest validation of Sirnaomics technology platform and furthers our strategy to evaluate its potential in a wide range of new disease areas.”

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About STP702
Sirnaomics team has been working diligently on finding a better alternative for prophylaxis and therapeutic treatment of Influenza A. In silico design and in vitro screening (H1N1 in a P2- and H7N9 in a P3-environment) led to the identification of potent siRNA sequences targeting the most conserved regions of Influenza viral genes, and these siRNAs exhibited a broad anti-influenza activity. Through rational pairing of these potent siRNA oligos, a specific combination of two siRNA sequences can further improve efficacy by demonstrating synergistic antiviral activity while also broadening the potential coverage of Influenza strains. The most critical technical advancements are the nanoparticle-enhanced siRNA delivery (STP702) in the viral-challenged mouse models, resulting in more potent anti-influenza activity than the marketed chemo drugs: Ribavirin and Tamiflu.

These results are the first demonstration of a synergistic therapeutic effect from combining siRNAs in a single delivery system. They also demonstrate the utility of nanoparticle mediated delivery of siRNAs through IP administration and suggest that these siRNAs may act as a broad anti-Influenza therapeutic – offering a rapid response to newly emerging viral outbreaks where existing therapeutics and vaccines are ineffective. Finally, mutations in select gene segments within the virus can confer resistance to existing therapeutics, while the use of STP702 containing siRNAs against two distinct gene segments within the influenza viruses should greatly reduce the ability of the virus to escape therapeutic pressure and reduce this additional threat.

About Walvax
Founded in 2001, Walvax Biotechnology Co., Ltd. (Walvax) is specialized in research and development, manufacturing and distribution of vaccines. Headquartered in Kunming, China, Walvax had an IPO in 2010 (300142.SZ) with a current market value of USD$14.8 billion (April 26, 2021). The company has successfully developed 7 vaccines with NMPA (China FDA) approval, including 13-valent pneumococcal conjugate vaccine (PCV-13) approved a year ago. Other products include haemophilus influenza type b conjugate, group A and C meningococcal polysaccharide, group A and C meningococcal conjugate, group ACYW135 meningococcal polysaccharide (MenACYW135 polysaccharide), 23-valent pneumococcal polysaccharide and DTaP vaccines. In addition, Walvax’s bi-valent human papillomavirus vaccine (HPV-2) is at BLA filing stage, nona-valent HPV vaccine (HPV-9) and three other innovative vaccines are also at clinical stage. Walvax products cover markets in more than 2000 counties of 30 provinces of China. The company also works closely with business partners to export its vaccine products to more than 15 countries and areas around the globe. In addition, the company’s venture fund has invested in several innovative biopharma companies. Learn more at www.walvax.com

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About Sirnaomics, Inc.

Sirnaomics, Inc., a leading privately held biopharmaceutical company for discovery and development of RNAi therapeutics, is a Delaware corporation headquartered in Gaithersburg, Maryland, USA, with subsidiaries in Suzhou and Guangzhou, China. The Company’s mission is to develop novel therapeutics to alleviate human suffering and advance patient care in areas of high unmet medical need. The guiding principles of the company are: Innovation, Global Vision with a Patient Centered focus. Members of the senior management team have a great deal of combined experience in the biopharmaceutical industry, financial, clinical and business management in both the USA and China. The company is supported by funding from institutional investors and corporate partnerships. Sirnaomics has developed a strong portfolio of intellectual property with an enriched product pipeline. The therapeutic areas of focus include oncology and anti-fibrotic therapeutics. Learn more at www.sirnaomics.com.