MigVax taps Catalent to deliver COVID-19 vaccine orally

MigVax has teamed with Catalent to develop its subunit COVID-19 vaccine MigVax-101 using the CDMO’s Zydis orally disintegrating tablet (ODT) technology.

Israeli crowdfunded biotech MigVax has developed an oral vaccine against COVID-19 that uses a chimeric protein to generate three kinds of simultaneous immunological responses: mucosal, blood-based, and cell-mediated immunity.

To overcome delivery issues, the firm has tapped contract development and manufacturing organization (CDMO) Catalent to undertake a feasibility study to formulate MigVax-101 using its Zydis Bio orally disintegrating tablet (ODT) dose form technology.

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“The MigVax-101 vaccine utilizes a chimeric protein to generate three kinds of simultaneous immunological responses: mucosal, blood-based, and cell-mediated immunity,” Catalent spokesman Chris Halling told BioProcess Insider.

“The Zydis Bio ODT offers opportunities for the oromucosal delivery of this chimeric protein in an ODT formulation to elicit a local mucosal effect. Therefore, this study will assess the feasibility of ODTs to deliver the MigVax-101 vaccine to the oral mucosae and trigger a mucosal immune response. In addition, by administering the vaccine sublingually, the acidic environment and enzymes of the digestive system can be bypassed and potentially absorbed into the bloodstream via the oral mucosa.”

While financials of the deal were not disclosed, Halling said work will be carried out at Catalent’s Zydis facility in Swindon, UK.

Zydis

The oral delivery technology has been proven commercially and is employed by ALK-Abelló for its Grazax and Grastek allergy therapy. Catalent has also demonstrated an increase in bioavailability of sublingually delivered Calcitonin – a 32 amino acid peptide hormone – using Zydis compared to that delivered orally to the gastrointestinal (GI) tract in preclinical models, Halling said.

“Zydis Bio technology has the potential to overcome some of the challenges associated with the oral delivery of proteins and peptides (e.g., pH in the GI tract, peptidase and proteolytic enzyme activity, potential interaction with other constituents of GI fluids and typically high molecular weight). however, some applications require a dose size that cannot yet be delivered in an ODT,” we were told.

“The bigger challenge lies in whether the right magnitude and form of an immune response could be induced. As we make advances in formulation approaches to optimize immunogenicity or dose, Catalent will continue to build up data to support the delivery of different vaccine antigens to generate a better mucosal immune response for pathogens that infect via the mucosa.”