Interferon tau mutants and methods for making them

Details Interferon tau mutants and methods for making them Interferon tau mutants and methods for making them

2000-06-22

2004-12-21

Kemmerer, Elizabeth (Department: 1646)

Chemistry: molecular biology and microbiology

Micro-organism, tissue cell culture or enzyme using process...

Recombinant dna technique included in method of making a...

C435S069510, C530S351000, C424S085400, C424S085700

Reexamination Certificate

active

06833256

ABSTRACT:

FIELD OF THE INVENTION
The present invention is directed to the field of animal and human health, and more particularly to pharmacological uses of analogs or mutants of interferon-tau (IFN-&tgr;) that differ from native IFN-&tgr; because of substitutions of amino acids near the amino terminus of the IFN-&tgr; molecule that impart improved biological activity. The IFN-&tgr; mutants described in this disclosure have low toxicity, retain the same or slightly reduced antiviral activity compared with highly effective IFN-alpha, and have enhanced antiproliferative activity compared to native IFN-tau, making them useful in treating viral infections, cancer, and immune system diseases including autoimmune diseases. The present invention is also directed to a method for making novel recombinant proteins, especially interferons, interleukins, and cytokines, polypeptide hormones and other biopharmaceuticals that have improved biological activity over known proteins and/or lower toxicity and/or increased stability.
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INTRODUCTION
The term “interferon” generically refers to a group of vertebrate glycoproteins and proteins that are known to have various biological activities, including antiviral, antiproliferative, and immunomodulatory properties at least in the species of animal from which such substances are derived and sometimes the interferons have cross species activity. The following definition of interferon has been accepted by an international committee assembled to devise a system for the orderly nomenclature of interferons: “To qualify as an interferon a factor must be a protein which exerts virus nonspecific, antiviral activity at least in homologous cells through cellular metabolic processes involving synthesis of both RNA and protein.” Journal of Interferon Research, 1, pp. vi (1980). “Interferon” as used to describe the present invention shall be deemed to have that definition. The type I interferons (IFN-&agr;, -&bgr;, -&ohgr;, and -&tgr;) are a group of proteins produced by the body to defend cells by inhibiting viral replication and decreasing cell proliferation.
IFN-alphas have been shown to inhibit various types of cellular proliferation. IFN.alpha.'s are especially useful against hematologic malignancies such as hairy-cell leukemia (Quesada, et al., 1984). Further, these proteins have also shown activity against multiple myeloma, chronic lymphocytic leukemia, low-grade lymphoma, Kaposi's sarcoma, chronic myelogenous leukemia, renal-cell carcinoma, urinary bladder tumors and ovarian cancers (Bonnem, et al.,
J. Bio. Response Modifiers
3:580(1984); Oldham,
Hospital Practice
20:71(1985). The role of interferons and interferon receptors in the pathogenesis of certain autoimmune and inflammatory diseases has also been investigated (Benoit, et al.,
J. Immunol
150(3):707(1993).
IFN-alphas are also useful against various types of viral infections (Finter, et al.,
Drugs
42(5):749(1991). Alpha interferons have shown activity against human papillomavirus infection, Hepatitis B, and Hepatitis C infections (Finter, et al., 1991; Kashima, et al., (
Laryngoscope
98:334(1988); Dusheiko, et al.
J. Hematology
3 (suppl.2):S199(1986); Davis, et al.,
N. England J. Med
. 321:1501(1989). The journal articles listed in this application are all incorporated in their entirety.
Interferons of the alpha type (IFN-&agr;s) are FDA-approved for the treatment of several diseases, including chronic hepatitis B and C, genital warts, hairy cell leukemia, and Kaposi's sarcoma. They are in clinical trials for AIDS and cancers, including non-Hodgkin's lymphoma and malignant melanoma (Mariano, T. M.,
Interferons: Principles and Medical Applications
, 1992, 129-138(1992), chronic myelogenous leukemia, cutaneous squamous cell carcinoma, and laryngeal papillomatosis (Baron, S.,
JAMA
10, 1375-83(1991).
IFNs are also able to aid the body by acting in an immunomodulatory role. For example, type I IFNs have been shown to increase macrophage phagocytic activity and nitrous oxide mediated killing as well as regulate IFN-&ggr; production (Reder, A.,
Interferon Therapy of Multiple Sclerosis
, 61-64, 485-492(1997). Like other type I

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