Catalent & MigVax Sign Agreement to Develop an Orally Disintegrating Freeze-Dried Tablet Vaccine Against COVID-19

Catalent and MigVax recently announced they have signed a development agreement to leverage Catalent’s proprietary Zydis Bio orally disintegrating tablet (ODT) technology for delivering the MigVax-101 vaccine.

MigVax’s lead oral vaccine program, MigVax-101, has shown positive results in preclinical tests. As an oral formulation, MigVax-101 could offer significant potential advantages in low-and middle-income countries over today’s first-generation injected vaccines, including ease of administration, transport and storage, the potential to tackle future variants, and applicability to a broader population. In addition, MigVax’s oral approach may allow for mucosal protection, a benefit that may prove important in preventing infection.

Zydis technology creates a freeze-dried tablet that disperses almost instantly in the mouth without water, and is recognized as one of the world’s best-performing ODTs, offering multiple advantages over conventional oral dosage forms, including improved patient compliance, adherence, and convenience. Utilizing the Zydis ODT technology, Catalent’s innovative Zydis Bio facilitates the oral delivery of macromolecules. Under the terms of the agreement, Catalent will undertake a feasibility study to formulate MigVax-101 into a Zydis Bio ODT dose form and evaluate its preclinical performance and stability properties. Work will be carried out at Catalent’s Zydis facility in Swindon, U.K.

“We are excited to collaborate with Catalent to simplify the transportation, storage and administration of our MigVax oral Covid-19 vaccine,” said Mr. Ran Amir, MigVax’s CEO. “Once our vaccine can be transported using the Zydis Bio technology, in unrefrigerated vehicles and stored in standard warehouses, it will be much easier and cost-effective for countries everywhere to roll out mass-vaccination programs. We believe this is a major step forward that will help society cope with the viruses in our midst as we continue returning to the new normal.”

“Zydis Bio technology offers numerous potential benefits to this program, and has previously been used to successfully deliver antigens to the oral mucosae,” added Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. He added, “In addition, the ease of administration and the potential for removal of the need for cold chain storage and transport means that the oral vaccine would have significantly fewer restrictions in terms of global distribution, compared with current cold chain injectable vaccines.”

Catalent’s 250,000-sq-ft site in Swindon, UK, houses the company’s Zydis development and manufacturing operation, which produces over one billion ODTs annually.

MigVax Ltd., an affiliate of The Migal Galilee Research Institute, is developing a novel COVID-19 vaccine based on Migal’s well-established vaccine against infectious bronchitis virus, a coronavirus strain that causes bronchial disease in poultry. Using the methods learned from the existing vaccine, MigVax’s new vaccine is an oral subunit human vaccine against COVID-19 administered as a tablet. The first investment round was led by OurCrowd, a global venture investing platform that empowers institutions and individuals to invest and engage in emerging companies. MigVax partnership with CEPI’s to kick off ambitious program to develop an oral tablet vaccines that are broadly protective against both SARS-CoV-2 variants and other coronaviruses such as SARS and MERS. For more information, visit http://www.migvax.com

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of nearly 7,000 products to over 1,000 customers annually. Catalent’s expert workforce exceeds 19,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, NJ, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visit www.catalent.com.