NorthStrive Biosciences Inc. ("NorthStrive Biosciences"), a subsidiary of PMGC Holdings Inc. (NASDAQ:ELAB) ("PMGC" or the "Company"), today announced plans to initiate an independent flow cytometry, or FACS, analysis program to further characterize EL-22, the Company’s engineered Lactobacillus casei-based therapeutic candidate designed to express a latent myostatin antigen to help preserve muscle during weight loss treatments, including GLP-1 receptor agonists.
Establishing Manufacturing Comparability
The planned study is intended to provide quantitative measurement of target antigen expression on NorthStrive-manufactured L. casei cells and support comparability analysis against material previously manufactured by MOA Life Plus Co. Ltd. NorthStrive believes this work represents a key step in building a stronger analytical and manufacturing characterization package for EL-22.
Study Design
The FACS analysis is expected to evaluate a panel of Lactobacillus samples, including NorthStrive-manufactured material and appropriate controls, using antibody-based detection and live/dead cell analysis. The goal is to generate reproducible quantitative data on target antigen expression at the bacterial cell surface and across individual cells, key measures for product identity, manufacturing consistency, and comparability.
The Company expects to work with an independent contract research organization specializing in flow cytometry analysis. The planned work is expected to include antibody conjugation, live/dead marker analysis, sample testing, and data generation across the sample panel.
Development Objectives
NorthStrive believes this analytical program may support several important development objectives:
- Quantifying latent myostatin antigen expression on engineered L. casei cells
- Comparing NorthStrive-manufactured EL-22 material against previously manufactured material
- Strengthening the Company’s product identity and manufacturing consistency package
- Supporting future analytical method development and comparability assessments
- Building the product characterization foundation for future IND-enabling development of EL-22
EL-22 and the Engineered Probiotic Platform
EL-22 is part of NorthStrive’s engineered probiotic platform, which is designed to express therapeutic proteins directly from genetically engineered Lactobacillus casei. The Company believes this approach may offer a differentiated method of biologic delivery with potential advantages in patient convenience, accessibility, and manufacturability across multiple disease areas.
The planned FACS program builds on NorthStrive’s broader strategy to advance its live biotherapeutic platform through disciplined, milestone-driven development focused on product characterization, manufacturing quality, and regulatory readiness.
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