7 Hills Pharma announced preclinical studies reveal 7HP349, an oral integrin activator that promotes cell adhesion, significantly increases IgG binding antibodies with a vaccine targeting SARS-CoV-2 (COV2), the virus that causes COVID-19.

The data also suggest 7HP349 can be used as an immunostimulant for any COVID-19 vaccine and has the potential not only to augment the vaccines’ effectiveness, but also accelerate immune system response, allow for dose sparing and reduce or eliminate the need for boosters.

“We expect our cell adhesion agents will greatly enhance the efficacy of emerging vaccines against this coronavirus,” said 7 Hills Pharma President and CEO Upendra Marathi, Ph.D., MBA. “Although this approach is potentially applicable for all ages, we are targeting older subjects who are at greater risk because of their lower immune responses to vaccines.”

7HP349 is 7 Hills Pharma’s lead product candidate in a platform of patent-protected small molecule integrin activators that significantly enhance cell adhesion, which is essential for producing an immune response.

The company is working with The University of Texas Health Science Center at Houston (UTHealth) to develop 7HP349 as an oral immunostimulant for COVID-19 and seasonal influenza vaccinations. In preclinical studies the product has shown effectiveness in augmenting influenza, tuberculosis, and Chagas vaccines, and has demonstrated a positive safety profile.

“We believe there could be a strong positive response of 7HP349 to improve COVID-19 vaccination after a single dose,” said Jeffrey Actor, PhD, Professor in the Department of Pathology at McGovern Medical School at UTHealth.

To meet the pandemic manufacturing demands, 7 Hills Pharma also has partnered with Catalent Pharma Solutions, Eurofins Advinus, and Lipoid LLC, and developed a robust formulation and scalable manufacturing processes.

“Our softgel site in St. Petersburg, Florida, has the capacity to manufacture up to 8 billion capsules annually while Catalent’s softgel network extends to nine other sites globally. Catalent is not only well-placed to meet the demands of a pandemic vaccination program, but is also proud to continue its partnership with 7 Hills Pharma on this important program,” says Rickey Shelly, PhD, Senior Director of Technology Development at Catalent in St. Petersburg.

“We are humbled by a remarkable translational team we have assembled to meet the urgent need for an effective COVID-19 vaccination, particularly in the elderly,” said Dr. Marathi. “We are now actively seeking collaborators with clinical-stage nucleic acid, inactivated, or vectored COVID-19 vaccines that may be enhanced with our adjuvant and we expect to initiate a Phase 1 trial of 7HP349 this fall.”