Mymetics Corp (MYMX)

[Work Harder]

National Institute of Allergies and Infectious Diseases

IPCAVD Program Highlights

• Duke University has been funded with two IPCAVD grants to develop mRNAs in lipid nanoparticles (LNPs) for mRNA administration for induction of either protective non-neutralizing antibodies (nNAbs) or broadly neutralizing Abs (bNAbs). Under this funding mechanism, the Bart Haynes group at Duke is developing process and GMP manufacture optimal mRNA immunogens and mRNA-LNP formulations for use in human Phase I trials.

• Dr. Ruth Ruprecht and Mymetics Corporation have been funded to develop and GMP manufacture a novel virosomal HIV vaccine. The product concept involves influenza virosomes enveloping virus-like
particles that display on their surface elongated HIV gp41 peptides (virosome-P1) or recombinant truncated HIV gp41 (virosome-rgp41). Powdered particulate dosage forms of new virosome vaccine candidates will be GMP manufactured and administered as nasal spray.

Preclinical HIV Vaccine Development22

Process development for the first synthetic glycopeptide HIV immunogen nanoparticle vaccine has started.
Chemistry and Manufacturing Controls (CMC)-compliant process and GMP manufacturing will be developed
to conduct Phase 1 clinical trials. Progress on building an armamentarium of particulated adjuvants for
preclinical and clinical studies includes the following:

• GMP GLA-LSQ liposomal adjuvant for antigen-adjuvant comparison clinical study. In Q1 2019, NIAID’s
Vaccine Translational Research Branch (VTRB) acquired this liposomal adjuvant for a Julie
McElrath/HVTN clinical trial comparing a variety of adjuvants.

• Delta inulin (Advax™), a polysaccharide particle adjuvant. GMP manufacturing process development is
ongoing to produce the adjuvant of appropriate quality to support clinical trials.

https://www.nano.gov/sites/default/files/NIH-2020-NNI-progress-plans-final.pdf

McElrath Lab

& Julie liked the finish line from Texas Biomed w/ a complete revamp of her LIKED ON page.

University of Pennsylvania now

https://research.fredhutch.org/mcelrath/en.html

National HIV/AIDS Strategy (2022-2025)

https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025

Better get cracking Astro Admin

LOL