Thread by @hannu

1/ I haven't talked much about what we've been building at @HelixNano, but we just reached a milestone worth sharing: Human Research Ethics Committee (HREC) approval in Australia to start a Phase 1 clinical trial. ( )A thread! 👇️einpresswire.com/article/697341…

2/ The product candidate we will test in healthy volunteers is called HN-0001. We designed it from ground up to address one of the biggest unmet needs for COVID-19: giving immunosuppressed and immunocompromised patients a better preventative option.

3/ Immunocompromised individuals accounted for ~4% of population, but 24% of COVID deaths in a large UK population sample in 2022. Even immunocompromised with multiple vaccine shots remain at increased risk for severe outcomes. ().thelancet.com/journals/lanep…

4/ Certain immunocompromised, like solid organ and stem cell transplant recipients, had >10x higher risk. Prolonged infections in immunocompromised hosts may also play a role in SARS-CoV-2 variant evolution ().thelancet.com/journals/lanmi…

5/ All this is to say -- immunocompromised and immunosuppressed *need* better protection from COVID, and lost their only option when Evusheld, an AstraZeneca drug, had its EUA revoked in late 2022 after it became ineffective against new variants. ().theatlantic.com/health/archive…

6/ HN-0001 incorporates two new HelixNano-patented technologies to boost efficacy: next-gen mRNA chemistry for better tolerability (in the same conceptual lineage as Karikó & Weissman Nobel work (), and a novel design element to turn up the immune response volume.nobelprize.org/prizes/medicin…

7/ In preclinical studies, we saw potent immune responses against SARS-CoV-2 in both healthy AND immunosuppressed animals!

8/ The HREC approval lets HelixNano Australia, our subsidiary, to get confirmation from the Australian Therapeutics Goods Administration (TGA) to activate the trial site and begin recruitment. We'll initially test HN-0001 in healthy volunteers, and also include an approved mRNA vaccine as a comparator.

9/ If everything goes well, the next step will be a follow-up trial in immunosuppressed and immunocompromised individuals. COVID-19 is not going away, and everyone deserves to be protected.

10/ HN-0001 also illustrates how fundamentally different mRNA vaccines can be from traditional vaccines. To echo our SAB chair @geochurch, mRNA lets us interface with the immune system with unprecedented precision, and augment it when it struggles -- now for COVID, next for cancer, aging and nearly all disease.

11/This milestone was possible through the outstanding work of our clinops team and manufacturing and regulatory partners. We are also grateful for the support of visionary investors, including @hellotvc @fiftyyears @sama @davidhelgason and @bryan_johnson, to name but a few. Thank you!