Chemistry: natural resins or derivatives; peptides or proteins; – Proteins – i.e. – more than 100 amino acid residues
Reexamination Certificate
1998-06-25
2001-10-16
Achutamurthy, Ponnathapu (Department: 1652)
Chemistry: natural resins or derivatives; peptides or proteins;
Proteins, i.e., more than 100 amino acid residues
C530S402000, C530S403000, C435S189000, C435S193000, C435S221000, C435S222000
Reexamination Certificate
active
06303752
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to modified polypeptides with reduced respiratory allergenicity, industrial compositions comprising modified polypeptide with reduced respiratory allergenicity, skin care products, the use of modified polypeptides for reducing the allergenicity of industrial composition and products and finally a method for reducing the allergenicity of polypeptides.
BACKGROUND OF THE INVENTION
For both medical and industrial applications the use of polypeptides, including enzymes, are well-known in the art. As polypeptides may potentially cause an undesired immune response—dependent on the way of challenge—typically an IgG and/or IgE response, techniques for reducing it have been developed during the last three decades.
One technique is the “PEGylation” technique where a number of polymeric molecules are coupled to the polypeptide in question. When using this technique the immune system has difficulties in recognizing the epitopes on the polypeptide's surface responsible for the formation of antibodies, thereby reducing the immune response.
For polypeptides introduced directly into the circulatory system of the human body to give a particular physiological effect (i.e. pharmaceuticals) the typical potential immune response is an IgG and/or IgM response, while polypeptides which are inhaled through the respiratory system (i.e. industrial polypeptide) potentially may cause an IgE response (i.e. allergic response).
One of the theories explaining the reduced immune response is that the polymeric molecule(s) shield(s) epitope(s) on the surface of the polypeptide responsible for the immune response leading to antibody formation. Another theory or at least a partial factor is that the heavier the conjugate is, the more reduced immune response is obtained.
U.S. Pat. No. 4,179,337 concerns non-immunogenic polypeptides, such as enzymes and peptide hormones coupled to polyethylene glycol (PEG) or polypropylene glycol (PPG). At least 15% of the polypeptides' physiological activity are maintained. The use of PEG's with a molecular weight in the range from 750 Da to 6,000 Da are exemplified in the patent. The polypeptides are not used for industrial applications.
WO 96/17929 (Novo Nordisk A/S) concerns modified polypeptide conjugates coupled to polymeric molecules such as PEG. The modified enzymes may be used for a number of industrial applications. The molecular weight of the polymeric molecules coupled to the polypeptides in the Examples are 5,000, 15,000 and 35,000 Da, respectively.
SUMMARY OF THE INVENTION
The present invention relates to modified polypeptides with reduced allergenicity and compositions and products for industrial uses comprising modified polypeptide.
It is generally believed that the molecular weight and the length of the polymeric molecules should not be too short/light, as short/light polymeric molecules cannot shield the surface of the polypeptide sufficiently.
This prejudice has now been proven wrong by the inventors for polypeptides, such as enzymes, used for industrial applications, where the polypeptide is not intended to enter the circulatory system.
The present inventors have found that when the polypeptide in question is used for industrial application, where the potential risk is an allergenic response caused by inhalation of the polypeptide, the parent polypeptide may be coupled to polymeric molecules with a molecular weight in the range from 100 Da up to 5,000 Da, preferably from 100 to 2,000 Da, especially 100 to 1,000 Da without loosing the ability to significantly reduce the respiratory allergenic response.
In the first aspect the invention relates to polypeptides coupled to polymeric molecules having a molecular weight from 100 Da to below 750 Da, especially 100 to 500 Da, such as around 300 Da.
In a second aspect the invention relates to compositions for use in industrial products comprising modified polypeptides coupled to polymeric molecules having a molecular weight from 100 Da up to 5,000 Da.
Industrial Polypeptides
Polypeptides used for industrial applications often have an enzymatic and/or anti-microbial activity. Industrial polypeptides are (in contrast to pharmaceutical polypeptides) not intended to be introduced into the circulatory system of the body.
Therefore, it is not very likely that industrial polypeptides, such as enzymes used as active ingredients in industrial compositions and/or products (defined below), such as detergents, including laundry and dish washing detergents, food or feed additives, including additives for bread making, composition for treating textiles, and personal care products, including cosmetics, come into direct contact with the circulatory system of the body of humans or animals, as such polypeptides (or products comprising such polypeptides) are not injected (or the like) into the bloodstream.
Therefore, in the case of the industrial polypeptide the potential risk is respiratory allergy (i.e. IgE response) as a consequence of inhalation of polypeptides through the respiratory passage.
In the context of the present invention “industrial polypeptides” are defined as polypeptides, including peptides, proteins and/or enzymes, which are not intended to be introduced into the circulatory system of the body of humans and/or animals.
Examples of such “Industrial polypeptides” include polypeptides with enzymatic activity as defined below.
The invention also relates to skin care products having reduced allergenicity.
Furthermore, the invention also relates to the use of modified polypeptides with a molecular weight from 100 Da up to 5,000 Da, preferably 100 to 2,000 Da, especially 100 up to 1,000 Da for reducing the allergenicity of industrial products.
Finally the invention relates to a method for reducing the allergenicity of polypeptides by coupling the polypeptide to a polymeric molecule with a molecular weight from 100 Da up to 5,000 Da.
REFERENCES:
patent: 3910825 (1975-10-01), Hüper et al.
patent: 4179337 (1979-12-01), Davis et al.
patent: 4640835 (1987-02-01), Shimizu et al.
patent: 5492821 (1996-02-01), Callstrom et al.
patent: 5661020 (1997-08-01), Snow et al.
patent: 5808096 (1998-09-01), Zaplisky
patent: 5840844 (1998-11-01), Lasky et al.
patent: 5856451 (1999-01-01), Olsen et al.
patent: 5932462 (1999-08-01), Harris et al.
patent: 0 256 127 (1988-02-01), None
patent: 0 418 625 (1991-03-01), None
patent: WO 94/06907 (1994-03-01), None
patent: WO 96/17929 (1996-06-01), None
Zaplisky, S., Advanced Drug Delivery Reviews, vol. 16, “Chemistry of polyethylene glycol conjugates with biologically active molecules”, pp. 157-182, 1995.
Deussen Heinz Josef
Fatum Tine Muxoll
Olsen Arne Agerlin
Roggen Erwin Ludo
Achutamurthy Ponnathapu
Lambiris Esq Elias J.
Moore William W.
Novozymes A/S
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