given the recent progress of India-based company Zydus, which reported 67% efficacy using its DNA vaccine on 30,000 patients, Inovio's executives are confident that they can "top" that performance using the CELLECTRA in vivo electroporation system for inoculating patients with INO-4800. This, according to them is a better delivery mechanisms for DNA plasmids than the jet injector used by Zydus.
Moreover, the Zydus vaccine, in some way validates the DNA rationale, but being realistic, even with a better vaccine, the time factor is playing against Inovio and a "Made in India" vaccine may be cheaper than INO-4800. Still, the fact that the biotech is focusing efforts in other geographies is a positive.
Second, there is VGX-3100, an investigational DNA-based immunotherapy being developed as an alternative to surgery and ablation for cervical High-Grade Squamous Intraepithelial Lesion (HSIL), with the aim of preserving reproductive health while treating precancerous disease. In this case, dataset for the REVEAL 1 study should be provided by the end of the year.
Third, there is INO-4800 used in a combined therapy with Sinovac's vaccine.
Finally, with a rich pipeline in different areas of unmet medical needs, Inovio simply cannot be ignored,
NIH further adds that heterologous prime-boost (in this case using INO-4800 and CoronaVac together) represents a new way of immunization.
Pursuing further, there is also INO-4802, Inovio's second generation, pan-COVID vaccine candidate, which is designed to protect against current and future variants of concern. A lot of praises were voiced about the cure during the earnings call.
Inovio dosed the first subject in its Phase 2 clinical trial for INO-4700, its DNA vaccine candidate for the Middle East Respiratory Syndrome (MERS), a viral respiratory illness for which there is currently no approved vaccine. It is caused by a coronavirus that is about 100 times deadlier than COVID-19 and fatal to approximately 34% of those infected. The Phase 2 trial is being conducted at sites in Jordan and Lebanon, where MERS cases have been reported.
Inovio's pursuit of a MERS vaccine is funded by a previously announced $56 million grant from Coalition for Epidemic Preparedness Innovations (CEPI), also including INO-4500 for Lassa fever. An additional funding of $10.3 million to partners for Lassa fever has been announced.
Exploring further, the biotech remains diversified in immuno-oncology through its INO-5401 compound in a partnership with Regeneron (NASDAQ: REGN). Survival data will be shared during an oncology conference in the fourth quarter of this year.
Separately, the University of Pennsylvania enrolled its first patient in a Phase 1b investigator-sponsored study of INO-5401 (alone or in combination with INO-9012) for adult cancer and non-cancer patients with BRCA1 or BRCA2 mutations.
As a consequence of these clinical studies, R&D expenses for the second quarter were $70.8 million compared to $22.4 million for the same period in 2020. Going deeper, the increase was primarily attributable to scale-up activities for INO-4800, including acquisition of manufacturing equipment, drug production, and clinical study expenses. These increases were offset by an increase in funding through grant agreements, amounting to $8.1 million.
