Faron Pharmaceuticals has filed a patent for stable formulations of an anti-CLEVER-1 antibody or antigen binding fragments. The formulations consist of a buffer, a stabilizing agent (trehalose, proline, mannitol, or sodium chloride), and a non-ionic surfactant. These formulations can be used for the treatment of various diseases and disorders. GlobalData’s report on Faron Pharmaceuticals 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 Faron Pharmaceuticals, Personalized cancer vaccines was a key innovation area identified from patents. Faron Pharmaceuticals's grant share as of September 2023 was 43%. Grant share is based on the ratio of number of grants to total number of patents.

Stable formulation of anti-clever-1 antibody for disease treatment

Source: United States Patent and Trademark Office (USPTO). Credit: Faron Pharmaceuticals Oy

A recently filed patent (Publication Number: US20230235046A1) describes a stable pharmaceutical formulation that includes an anti-CLEVER-1 antibody or antigen binding fragment(s) thereof. The formulation consists of 1-100 mg/ml of the antibody or fragment, 5-50 mM of a histidine buffer combined with 150 mM-400 mM of a stabilizing agent such as trehalose, proline, or mannitol. The pH of the formulation is in the range of 5.5-6.5. Alternatively, the formulation can contain 5-50 mM of a Tris buffer combined with 100-200 mM of sodium chloride as a stabilizing agent, with a pH range of 7.0-7.6. Additionally, the formulation includes 0.01-0.1% (w/v) of polysorbate as a non-ionic surfactant.

The anti-CLEVER-1 antibody or antigen binding fragment(s) in the formulation have specific amino acid sequences. The heavy chain has the amino acid sequence SEQ ID NO: 7, and the light chain has the amino acid sequence SEQ ID NO: 8. The patent also mentions specific antibodies that can be used, such as bexmarilimab, which is described in WHO Drug information; Vol. 34, No. 3 (2020), as well as bexmarilimab variants and biosimilars. Another antibody mentioned is FP-1305 (DSM ACC3361).

The formulation can contain L-histidine as part of the histidine buffer, with a concentration of 5-20 mM or 5-15 mM. The stabilizing agent, which can be trehalose, proline, or mannitol, is present in a concentration of 200-360 mM, preferably 240-320 mM or 270-290 mM. Polysorbate 20 is used as the non-ionic surfactant, with a concentration of 0.01-0.05% (w/v). The composition may also include an antioxidant, specifically L-methionine, with a concentration of 5-40 mM, preferably 15-25 mM.

The formulation described in the patent can be in liquid form or in a lyophilized form. It is suitable for use as a medicament and has potential applications in the treatment of cancer, chronic infections, acute inflammatory infections, hypercholesterolemia, dyslipidemia, or atherosclerotic cardiovascular disease. The formulation is particularly suitable for intravenous administration and can be administered in a dose range of 0.1 mg/kg-50 mg/kg, preferably 0.1 mg/kg-30 mg/kg or 0.1-10 mg/kg, calculated as antibody or antigen binding fragment thereof.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

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