Ardelyx has filed a patent for compositions and methods to generate two-dimensional (2D) intestinal epithelial cell cultures using primary human or murine intestinal cells. These cultures accurately represent gene expression and function of the intestines. The patent also includes a high-throughput system for compound evaluation using these cultures. The method involves isolating cells from small intestine or colon tissue samples, growing them in a monolayer with specific growth factors, and differentiating them to develop mature phenotypes. GlobalData’s report on Ardelyx gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on Ardelyx, Peptide pharmacophores was a key innovation area identified from patents. Ardelyx's grant share as of September 2023 was 37%. Grant share is based on the ratio of number of grants to total number of patents.

Method for generating 2d intestinal cell cultures without cancer cells

Source: United States Patent and Trademark Office (USPTO). Credit: Ardelyx Inc

A recently filed patent (Publication Number: US20230313146A1) describes a method for generating a two-dimensional (2D) monolayer cell culture of primary intestinal cells. The method involves isolating cells from a small intestine or colon tissue sample and plating them in a monolayer in the presence of a seeding medium. The seeding medium includes various growth factors and inhibitors such as epidermal growth factor (EGF), a bone morphogenic protein (BMP) inhibitor, a leucine-rich repeat-containing G-protein coupled receptor (LGR)-5 activator, a Wnt signaling agonist, and a Rho-associated protein kinase (ROCK) inhibitor. The cells are then grown to a confluent monolayer using a growth medium and differentiated using a differentiation medium. This process results in the generation of a 2D monolayer cell culture of primary intestinal cells.

The patent also describes the composition of the seeding medium, growth medium, and differentiation medium. These mediums may include additional growth promoting and antioxidant factors, such as N2 or B27 supplements and N-acetylcysteine. The concentrations of various components in the seeding medium are specified, including EGF, BMP inhibitor (Noggin), LGR5 activator (R-spondin 1), Wnt signaling agonist (Wnt3a), and ROCK inhibitor (Y-27632 or thiazovivin). The patent further provides a specific composition for the seeding medium, which includes B27, N2, N-acetylcysteine, EGF, Noggin, R-Spondin-1, Wnt3a, and Y-27632. The growth medium and differentiation medium also contain EGF, BMP inhibitor, LGR5 activator, and Wnt signaling agonist.

Additionally, the patent describes a method for generating a 2D monolayer cell culture of stable, primary intestinal cells using human intestinal organoids. The organoids are obtained from human small intestine or colon tissue samples and the cells are dissociated and plated in a monolayer using a seeding culture medium similar to the one described earlier. The cells are then grown and differentiated to develop mature phenotypes.

Furthermore, the patent includes a method for performing a high throughput screen using the primary cell culture generated by the described methods. This involves screening a plurality of agents to identify those that modify a property of the primary cell culture originating from the intestine or colon.

Lastly, the patent describes methods for inhibiting the transport of sodium and phosphate across the 2D monolayer cell culture prepared using the described methods. This involves contacting the apical side of the monolayer with specific compounds.

In summary, the patent presents methods for generating 2D monolayer cell cultures of primary intestinal cells using different approaches, including isolating cells from tissue samples or using human intestinal organoids. The patent also provides detailed compositions for the seeding medium, growth medium, and differentiation medium, as well as methods for performing high throughput screens and inhibiting transport across the cell culture.

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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies