Rocketvax and HALIX Collaborate to Advance the VIRUFLEX™ Platform and Next-Generation Nasal COVID-19 Vaccine

Basel, Switzerland, and Leiden, Netherlands, December 16, 2024 – Rocketvax AG, a Swiss biotech leader specializing in vaccine innovation, has partnered with HALIX B.V., a top-tier Contract Development and Manufacturing Organization (CDMO), to enhance global pandemic preparedness. This collaboration focuses on Rocketvax’s groundbreaking endemic readiness platform, VIRUFLEX™ , and the development of its next-generation nasal COVID-19 vaccine.

Introducing the VIRUFLEX™ Platform and HALIX’s Role

VIRUFLEX™  is Rocketvax’s state-of-the-art endemic readiness platform, designed to accelerate the development and deployment of next-generation vaccines in response to future pandemics. It integrates cutting-edge vaccine technology, scalable production processes, and global partnerships to ensure rapid responses to emerging infectious diseases.

HALIX has been selected as a strategic CDMO partner for VIRUFLEX™ , bringing world-class expertise in vaccine manufacturing to this pioneering initiative. HALIX’s contributions include:

• GMP-Grade Manufacturing: Ensuring the highest standards of quality and safety in vaccine production, adhering to rigorous Good Manufacturing Practices (GMP).
• Expertise in Viral Vectors: Leveraging specialized experience in viral vector manufacturing to enhance the efficiency and scalability of Rocketvax’s vaccine candidates.
• Scalability and Readiness: Offering flexible infrastructure to enable rapid scale-up of vaccine production, aligning with VIRUFLEX’s mission to ensure global vaccine availability during pandemics.

Advancing the Next-Generation Nasal COVID-19 Vaccine

Rocketvax’s innovative nasal COVID-19 vaccine represents a breakthrough in mucosal immunity and pandemic preparedness. This vaccine is a testament to Rocketvax’s proprietary “reverse genetic engineering” technology, which enabled the development of a live-attenuated SARS-CoV-2 virus vaccine that offers protection against COVID-19 and potentially Long-COVID.

Key Differentiation Points:

1. Nasal Immunity: The nasal administration induces a strong localized immune response capable of neutralizing the wild-type virus at its entry point into the host, providing robust protection.
2. Broad Protein Recognition: Unlike conventional vaccines that target only the spike protein, Rocketvax’s vaccine trains the immune system to recognize all SARS-CoV-2 proteins, ensuring effectiveness against all virus variants.
3. Comprehensive Immune Activation: The vaccine activates the full spectrum of immune system components, including antibodies and immune cells. Animal studies demonstrate prolonged immune protection, a significant improvement over currently available mRNA vaccines.
4. Prevention of Virus Transmission: In contrast to mRNA vaccines, Rocketvax’s nasal vaccine prevents transmission of the wild-type virus, contributing to community-wide protection.
5. Room Temperature Stability: The vaccine’s stability at room temperature simplifies storage and distribution, eliminating the need for ultra-cold storage required by mRNA vaccines, thereby improving accessibility worldwide.

Partnership with the US Government

The development of Rocketvax’s nasal COVID-19 vaccine is further strengthened by its collaboration with the U.S. National Institutes of Health (NIH). This partnership aims to advance clinical development and expedite global access to this next-generation vaccine.

Statements from Leadership

“We are thrilled to partner with HALIX to bring the VIRUFLEX™ platform to life and revolutionize global pandemic readiness. With HALIX’s expertise in vaccine manufacturing, we are poised to deliver innovative solutions, including our groundbreaking nasal COVID-19 vaccine,” said Vladimir Cmiljanovic, CEO of Rocketvax AG.

“The VIRUFLEX™  platform exemplifies the innovative spirit needed to address global health challenges. We are honored to support Rocketvax in this mission, leveraging our manufacturing expertise to ensure the success of their vaccine candidates,” said Dr. Lutz Hilbrich, Chief Executive Officer at HALIX.

About Rocketvax AG

Rocketvax AG is a Swiss biotechnology company at the forefront of vaccine development. Through its VIRUFLEX™ platform and innovative technologies, Rocketvax aims to enhance global preparedness for pandemics and deliver next-generation vaccines addressing unmet medical needs.

About HALIX B.V.

HALIX B.V., based in Leiden, Netherlands, is a leading Contract Development and Manufacturing Organization (CDMO) specializing in biopharmaceuticals, including viral vectors and vaccines. With state-of-the-art GMP facilities, HALIX supports pharmaceutical companies worldwide in bringing innovative therapies to market.

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Rocketvax AG has prepared this press release to the best of its knowledge. The information about Rocketvax AG’s activities is current as of the date of this press release. This information is provided in summary form and does not claim to be exhaustive. The information contained in this press release does not constitute a solicitation or offer to buy, sell, or otherwise trade or engage in any similar transaction involving Rocketvax AG’s shares. The information presented herein includes certain forward-looking statements and estimates. Such information is subject to significant scientific, economic, business, and financial uncertainties that cannot be predicted in advance. Therefore, actual results may materially differ from those projected. Neither Rocketvax AG nor its group companies make any warranties, representations, or guarantees regarding the data and information made available through this communication, including but not limited to their accuracy, timeliness, completeness, marketability, commercial usability, or suitability for any particular purpose and in particular with regard to forward-looking statements and does not make any warranties or gives any guarantees on the future course of development and success of any of its products, strategies or business activities.

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* – Rocketvax AG has signed a letter of intent with NIH which outlines the intended collaboration of the parties to conduct and sponsor a clinical trial for Rocketvax AG’s leading SARS-CoV-2 vaccine candidate.