Catalent, a contract development and manufacturing organization (CDMO) working with biopharma, cell, gene and consumer health partners, and MigVax, an Israeli biopharmaceutical company developing an oral subunit vaccine against COVID-19, 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, UK.

“We are excited to collaborate with Catalent to simplify the transportation, storage and administration of our MigVax oral Covid-19 vaccine,” said 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’.”

Jonathan Arnold, president of oral and specialty delivery at Catalent, said, “Zydis Bio technology offers numerous potential benefits to this program, and has previously been used to successfully deliver antigens to the oral mucosae. 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-square-foot site in Swindon, UK, houses the company’s Zydis development and manufacturing operation, which produces over one billion ODTs annually.