Intellectual Property

Symphogen has built a dominant, long-term IP position within the field of antibody-based therapeutics. Issued and pending patents broadly cover Symphogen’s proprietary methods of discovering and manufacturing recombinant human antibody mixtures with its Symplex™ discovery technology and Sympress™ manufacturing platform. Symphogen also has issued and pending patents for the use of recombinant antibody mixtures for the prevention and treatment of allergy, treatment of Idiopathic Thrombocytopenic Purpura, and prophylaxis of Hemolytic Disease in Newborns. Patents are also pending relating to recombinant antibody mixtures for treatment of cancer.

Symphogen is unique in providing a viable industrial platform for producing rpAb, and its strong patent portfolio for rpAb discovery, manufacturing, characterization and application provides Symphogen with a fully-integrated platform to continually discover and develop new drugs that can fuel partnering opportunities and grow its proprietary pipeline.

 

Technology patents
 
Pharmacokinetic assessment of recombinant proteins in complex biological samples by PK-Chromatography
Symphogen has a pending international patent application, WO 2011/042024, on a method for pharmacokinetic assessment of at least two recombinant proteins, such as therapeutic mono and polyclonal antibodies in a complex biological sample such as human, monkey or mouse serum. The method involves an affinity chromatography step resulting in up-concentration/enrichment of at least two recombinant proteins followed by another chromatography step such as weak cation exchange High Performance Liquid Chromatography (CIEX-HPLC) for detection and quantification of at least two recombinant proteins in the complex biological sample of interest.
WO2011/042024
 
Multiplex quantitation of individual recombinant proteins in a mixture by signature peptides and mass spectrometry
Symphogen has a pending international patent application, WO 2011/042027, on an analytical method for quantitation of selected multiple recombinant proteins in a complex matrix such as recombinant polyclonal antibodies in serum or recombinant polyclonal antibodies expressed in a culture supernatant. The method combines affinity purification and quantitation by mass spectrometry by use of internal reference peptides.
WO2011/042027
 
Method for identifying and selecting drug candidates for combinatorial drug products
Symphogen has a pending international patent application, WO 2010/040356, on methods for identifying and selecting chemical entities that possess or contribute to a functional effect in a combinatorial drug product such as a recombinant polyclonal antibody product. The methods are useful both for identifying optimal combinations of different antibodies with a synergistic effect against a particular target and for identifying and selecting the optimal stoichiometric ratio between individual antibodies.
WO2010040356
 
Methods for cloning avian-derived antibodies
Symphogen has patent applications pending on a further development of the Symplex™ technology aimed at isolation of variable region antibody sequences from chickens or other birds. This technology (chSymplex™) may e.g. be used to produce chimeric antibodies based on variable region sequences isolated from a transgenic chicken that expresses human immunoglobulin genes. The patent family includes WO 2010/022738 and equivalents.
WO2010022738
 
Method for characterization of a recombinant polyclonal protein
Symphogen has patent applications pending on a characterization platform for use to assess the amounts of different antibodies produced by a polyclonal cell line during production as well as batch-to-batch consistency of the antibodies present in the polyclonal products. The patent family includes WO 2009/065414.

Method for recombinant manufacturing of anti-RSV antibodies
Symphogen has patent applications pending on the manufacture of recombinant anti-RSV antibodies, using production systems which are independent of site-specific integration. The patent family includes WO 2009/030237. 
 
Recombinant polyclonal antibody production – Sympress™ II 
Symphogen has patent applications pending on methods for manufacturing recombinant polyclonal antibody products based on random integration of the individual genes of interest into host cells. The Sympress™ II technology results in the same batch-to-batch consistency and diversity as the Sympress™ I technology, but with improved expression yields. The patent family includes WO 2008/145133 and equivalents, including granted European patent EP 2 152 872 B1 and US patent 7,910,332 B2.
WO2008145133 
 
Cognate linkage of non-human variable heavy and light chains by Symplex™.
Symphogen has patent applications pending on extension of the Symplex™ technology to allow isolation of murine variable antibody regions (mSymplex™). The mSymplex™ technique generates chimeric human/non-human antibodies. The patent family includes WO 2008/104184 and equivalents, including granted European patent EP 2 121 920 B1.
WO2008104184
Characterisation of recombinant polyclonal antibody.
Symphogen has patent applications pending on methods for characterisation of a recombinant polyclonal antibody (rpAb). The patent includes methods for ensuring consistency and quality from batch to batch and verifying the presence and amount of the individual antibodies in the polyclonal antibody. The patent family includes WO 2006/007853 and equivalents, among these granted EP patent 1 787 126 B1.
WO2006007853
 
Cognate linkage of variable heavy- and light chains – Symplex™
Symphogen has patent applications pending on the Symplex™ technology in PCT as well as in non-PCT member states. Symplex™ is a technique for high throughput isolation of original (i.e. cognate) pairs of antibody heavy and light chain variable region genes from human donor blood. The patent family includes WO 2005/042774 and equivalents, among these granted US patent 7,749,697 and EP patent 1 669 912 B1.
 
Recombinant polyclonal antibody production – Sympress™ I
Symphogen has issued patents and patent applications pending on the Sympress™ I technology, a manufacturing technology based on site-specific integration of individual antibody genes of interest into host cells. The technology makes it possible to produce recombinant polyclonal antibodies in a single bioreactor with a high degree of batch-to-batch consistency. The patent family includes WO 2004/061104 and equivalents, among these granted European patent EP 1 583 830 B1.

Phage display – Symphage™
Symphogen has worldwide exclusive rights from Boston University to the Symphage™ technology, a technique for generating and screening libraries for recombinant polyclonal antibodies. The family includes WO 95/20401 and equivalents, among these issued US and EP patents: US 5,789,208; US 6,335,163; EP 1 231 268 B1; and EP 744 958 B1.
WO9520401

Product patents
 
Anti-CD5 antibodies
Symphogen has patent applications pending on an antibody composition comprising at least two anti-CD5 antibodies. The patent family includes WO 2010/022737 and equivalents.
 
Treatment of Thrombocytopenia
Symphogen has patent applications pending on an anti-Rhesus D recombinant polyclonal antibody product for use in the treatment or prophylaxis of thrombocytopenia, wherein the product is administered in a specific dose range. The patent family includes WO 2010/022734 and equivalents.
 
Recombinant anti-epidermal growth factor receptor antibody composition
Symphogen has patent applications pending on an antibody composition for use in a method for treatment of cancer in a subject that has been subjected to a prior treatment regime. The antibody composition comprises antibodies that binds to Epidermal Growth Factor Receptor (EGFR). The patent family includes WO 2010/022736
 
Pan-HER ligand traps.
Symphogen owns patent applications acquired from Receptor BioLogix on pan-HER ligand traps, which are engineered proteins combining an antibody-like element along with multiple HER (Human EGF Receptor) receptors designed to block ligands that stimulate tumor growth. These applications include WO 2007/146959
and equivalents, covering the general pan-HER ligand trap concept, and WO 2009/052184, covering optimized HER1-HER3 multimers.
 
Treatment and prevention of severe respiratory disease.
Symphogen has another patent application pending on a recombinant polyclonal antibody for the treatment and prevention of RSV infections. The patent family includes WO 2008/106980 and equivalents, including granted US patent US 7,879,329.
WO2008106980
Treatment of cancer.
Symphogen has patent applications pending on a recombinant polyclonal antibody (rpAb) for use in human cancer therapy. The rpAb binds to Epidermal Growth Factor Receptor (EGFR). The patent family includes WO 2008/104183 and equivalents, among these granted US patent US 7,887,805.

Treatment and prevention of severe respiratory disease.
Symphogen has patent applications pending on a recombinant polyclonal antibody for the treatment and prevention of RSV infections. The patent family includes WO 2007/101441.
WO2007101441
 
Treatment of ITP and prophylaxis of HDN
Symphogen has patent applications pending on an anti-Rhesus D recombinant polyclonal antibody (anti-RhD rpAb) suitable for prophylaxis of Hemolytic Disease of the Newborn (HDN) in Rhesus D-positive children of Rhesus D-negative women. Anti-RhD rpAb can also be used as treatment of Idiopathic Thrombocytopenic Purpura (ITP). The patent family includes WO 2006/007850 and equivalents.
 
Treatment of adverse effects of smallpox vaccination
Symphogen has patent applications pending on a recombinant polyclonal antibody for the treatment of adverse effects caused by smallpox vaccination and for the treatment and prophylaxis of orthopox infection in humans. The patent family includes WO 2007/065433 and granted US patent US 7,850,965.
WO2007065433
Treatment or prevention of allergy
Symphogen has issued patents and pending patent applications on a recombinant polyclonal antibody for the treatment and prevention of allergy. The patent family includes WO 01/89563 and equivalents, among these issued patents US 6,849,259 and EP 1 283 720 B1.
WO0189563