Inovio Pharmaceuticals Inc (INO)

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12/3/21 DNA molecules are extremely stable, so DNA-based vaccines do not require a frozen cold chain. The INO-4800 formulation contains only DNA, water, and salt for stabilization. The final ready-to-use liquid can be stored at room temperature for over a year, and at 37°C for over one month. Manufacturing is a straightforward process involving the fermentation of E. coli.

DNA-based vaccines generate quite specific and robust T-cell responses. “We believe those T-cell responses are key to mitigating the effects of the mutational changes of the virus,” Broderick relates. “There are no increasing side effects with more frequent administration. INO-4800 ticks all of the boxes that are needed for a global booster.”

INO-4800 has been tested against the alpha, beta, gamma, and delta variants, and it is currently being tested against lambda and mu. “So far, we have been able to generate neutralizing antibodies against all of them,” Broderick asserts. “In addition, our Cellectra device uses smart technology to ensure the vaccine is delivered in a tolerable and simple procedure.

She explains that the device “essentially pushes the DNA molecules into the cells in the right place to elicit the best type of immune response.” The device, which is battery operated, works like a laboratory electroporation device; however, it works with electrical parameters that are quite different for those used in human tissue applications. Robustly engineered, it employs a single-use disposable tip.

“Proactively, we need to have libraries of vaccines for different diseases, so that when they re-emerge, we are not scrambling to catch up,” Broderick declares. “A plug-and-play portfolio and a booster agnostic to the priming vaccine are absolutely key.”

INO-4800 is just one of a dozen DNA-based products in Inovio’s pipeline. Like INO-4800, one of these products, a therapeutic vaccine for diseases associated with human papillomavirus, is in a Phase III trial.

Smart Vaccine Design Keeps Manufacturability in Mind
Upstream and downstream advances include simpler bioconjugation, increasingly stable structures, filters for large viral vaccines, and modular facilities.

https://www.genengnews.com/topics/drug-discovery/vaccine-development/smart-vaccine-design-keeps-manufacturability-in-mind/