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News & Publications

Publications

Technology

Maeder T. Sweet Medicines. 2002. Sci Am 287(1): 40-7.

Venkataraman G, Shriver Z, Raman R, and Sasisekharan R.. Sequencing Complex Polysaccharides. 1999. Science 286 (5439): 537-542.

He XA, Washburn N, Arevalo E, et al. Analytical characterization of IgG Fc subclass variants through high-resolution separation combined with multiple LC-MS identification. Analytical and Bioanalytical Chemistry 2015;407(23):7055-7066.

Sobolev O, Binda E, O'Farrell S, et al. Adjuvanted influenza-H1N1 vaccination reveals lymphoid signatures of age-dependent early responses and of clinical adverse events. Nature Immunology 2016;17:204–213.

Madsen JA, Yin Y, Qiao J, et al. Covalent labeling denaturation mass spectrometry for sensitive localized higher order structure comparisons. Analytical and Bioanalytical Chemistry 2016;88(4):2478–2488.

 

Complex Generics


Glatopa™ (M356) - Posters

  • Development of the First FDA-Approved MS Generic Disease-modifying Therapy: Glatopa® (glatiramer acetate injection), NASP Annual Meeting, Sep 27, 2016  View Poster 
  • Use of Multiple, High Resolution, Orthogonal Assays for Demonstration of Biological and Immunological Equivalence of Glatopa® and Copaxone® 20 mg/mL, ACTRIMS 2016, Feb 19, 2016  View Poster 
  • Demonstration of Equivalence between Glatopa™ and Copaxone® 20 mg, ECTRIMS 31st Congress, Oct. 9, 2015  View Poster 
  • Comparative Gene Expression Profiling between Glatopa™ and Copaxone® 20 mg, ECTRIMS 31st Congress, Oct. 8, 2015 View Poster 
  • Use of Multiple, High Resolution, Orthogonal Assays for Demonstration of Biological and Immunological Equivalence of Glatopa™ and Copaxone® 20 mg, ECTRIMS 31st Congress, Oct. 8, 2015  View Poster 
  • Demonstration of Equivalence between a Generic (Glatopa™) and Brand Copaxone® (glatiramer acetate injection), American Academy of Neurology's (AAN) 2015 Annual Meeting  View Poster 
  • Comparative Gene Expression Profiling between a Generic (Glatopa™) and Brand Copaxone® (glatiramer acetate injection), American Academy of Neurology's (AAN) 2015 Annual Meeting  View Poster 
  • Comparative Efficacy between a Generic (M356) and Brand Copaxone®(glatiramer acetate injection) in an Animal Model of Multiple Sclerosis, ACRIMS-ECTRIMS 2014  View Poster 

Glatopa™ (M356) - Manuscripts

Anderson J, Bell C, Bishop J, et al. Demonstration of equivalence of a generic glatiramer acetate (Glatopa™). Journal of the Neurological Sciences 2015;359:24-34.

D’Alessandro JS, Duffner J, Pradines J, et al. Equivalent Gene Expression Profiles between Glatopa™ and Copaxone®. PLoS One. 2015 Oct 16;10(10):e0140299.

 

Biosimilars and Potentially Interchangeable Biologics

Assessment of Comparative Immunogenicity in Biosimilar Development: Immunogenicity and Pharmacokinetics Following a Single Dose of M923, a Proposed Biosimilar for Reference Adalimumab (HUMIRA®), Compared with US- and EU-Sourced Reference Adalimumab in Healthy Subjects, ACR 2016  View Poster 

A Randomised, Double-blind, Three-arm, Parallel-group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of M923 (a candidate biosimilar of adalimumab), versus US-sourced Humira and EU-sourced Humira in Healthy Subjects, EULAR 2016  View Poster 

Bosques CJ, Collins BE, Meador JW, Sarvaiya H, Murphy JL, Dellorusso G, Bulik DA, Hsu IH, Washburn N, Sipsey SF, Myette JR, Raman R, Shriver Z, Sasisekharan R and Venkataraman G. Chinese hamster ovary cells can produce galactose-α-1, 3-galactose antigens on proteins. 2011. Nat Biotechnol 29(5): 459. Epub 2011 May 6.

 

Novel Drugs


Adomiparin 

Rao SV, Melloni C, Myles-Dimauro S, Broderick S, Kosinski AS, Kleiman NS, Dzavík V, Tanguay JF, Chandna H, Gammon R, Rivera E, Alexander JH, Fier I,Roach J and Becker RC; EMINENCE Investigators. Evaluation of a new heparin agent in percutaneous coronary intervention: results of the phase 2evaluation of M118 IN pErcutaNeous Coronary intErvention (EMINENCE) Trial. 2010.Circulation 121(15): 1713-21. Epub 2010 Apr 5.

Sundaram M, Qi Y, Shriver Z, Liu D, Zhao G, Venkataraman G, Langer R and Sasisekharan R. Rational design of low-molecular weight heparins with improved invivo activity. 2003. Proc Natl Acad Sci USA 100(2): 651-6. Epub 2003 Jan 13.

 

M230, Selective Immunomodulator of Fc Receptors (SIF3)

 

M281, Anti-FcRn Antibody 

  • A Therapeutic FcRn Blocking Antibody for Rapid Clearance of IgG and IgG Autoantibodies in Immune Cytopenias and other Autoimmune Diseases  View Poster
  • Targeting the Neonatal Fc Receptor (FcRn) to Mediate Autoantibody Clearance in IgG-driven Autoimmune Disease  View Poster

 

Hyper-sialylated IVIg (hsIVIg) 

Washburn N, Schwab I, Ortiz D, Bhatnagar N, Lansing J, Medeiros A, Tyler S, Mekala D, Cochran E, Sarvaiya H, Garofalo K, Meccariello R, Meador J, Rutitzky L, Schultes B, Ling L, Avery W, Nimmerjahn F, Manning A, Kaundinya G and Bosques C. Controlled tetra-Fc sialylation of IVIg results in a drug candidate with consistent enhanced anti-inflammatory activity. PNAS 2015 112 (11) E1297-E1306; published ahead of print March 2, 2015, doi:10.1073/pnas.1422481112

 

Necuparanib – Study Discontinued

Manuscripts

Zhou H, Roy S, Cochran E, Zouaoui R, Chu CL, Duffner J, Zhao G, Smith S, Galcheva-Gargova Z, Karlgren J, Dussault N, Kwan RYQ, Moy E, Barnes M, Long A, Honan C, Qi YW, Shriver Z, Ganguly T, Schultes B, Venkataraman G and Kishimoto TK. M402, a Novel Heparan Sulfate Mimetic, Targets Multiple Pathways Implicated in Tumor Progression and Metastasis. 2011. PLoS One6(6): e21106. Epub 2011 Jun 16.

Posters

  • Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of Necuparanib Combined with nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer: Updated Phase 1 Results, ASCO 2016  View Poster 
  • Necuparanib Inhibits Pancreatic Cancer Progression and Invasion in a 3D Tumor and Stromal Cell Co-Culture System, AACR 2016  View Poster 
  • Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of Necuparanib Combined withnab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer: Phase 1 Results, ASCO 2015  View Poster 
  • Necuparanib Affects Tumor Progression and Invasion in a 3D Co-Culture System of Pancreatic Cancer Cells and Stellate Cells, AACR 2015  View Poster
  • M402 Increases Gemcitabine Uptake into Pancreatic Tumors as a Result of Stromal Matrix Remodeling, GI Cancer Symposium 2014  View Poster
  • M402, a Novel Drug Candidate for Pancreatic Cancer: Efficacy in Animal Models and Initial Clinical Study Design, Cancer Advance 2013 View Poster

  • Inhibition of Heparan sulfate proteoglycans enhanced signaling in Pancreatic Ductal Adenocarcinoma reduces EMT, AACR 2013 View Poster
  • M402, a Heparan Sulfate Mimetic and Novel Candidate for the Treatment of Pancreatic Cancer View Poster
  • M402, a Heparan Sulfate Mimetic, Inhibits Tumor Revascularization and Invasiveness after High-Dose Taxane Treatment in a Mouse Breast Cancer Model  View Poster
  • M402, a Novel Heparan Sulfate Mimetic, Inhibits Pancreatic Tumor Growth and Desmoplasia Potentially via Shh Signaling in an Orthotopic Mouse Model  View Poster
  • M402 –A novel heparan sulfate proteoglycan mimetic targeting tumor-host interactions  View Poster
  • M402, a Novel Heparan Sulfate Mimetic, Synergizes with Gemcitabine to Improve Survival and Reduce Metastasis and Epithelial-to-Mesenchymal Transition (EMT) in a Genetically Engineered Mouse Model for Pancreatic Cancer  View Poster
  • M-ONC 402-a non anticoagulant low molecular weight heparin inhibits tumor metastasis  View Poster
  • M-ONC 402, A novel non-anticoagulant heparin, inhibits P-Selectin function and metastatic seeding of tumor cells in mice  View Poster

 

Heparin

Sucharita Roy, Ahmed El Hadri, Sebastien Richard, Fanny Denis, Kimberly Holte, Jay Duffner, Fei Yu, Zoya Galcheva-Gargova, Ishan Capila, Birgit Schultes, Maurice Petitou, and Ganesh V. Kaundinya Synthesis and Biological Evaluation of a Unique Heparin Mimetic Hexasaccharide for Structure−Activity Relationship StudiesJournal of Medicinal Chemisty. 2014 Jun 12;57(11):4511-20

Kishimoto TK, Viswanathan K, Ganguly T, Elankumaran S, Smith S, Pelzer K, Lansing JC, Sriranganathan N, Zhao G, Galcheva-Gargova Z, Al-Hakim A, Bailey GS, Fraser B, Roy S, Rogers-Cotrone T, Buhse L, Whary M, Fox J, Nasr M, Dal Pan GJ, Shriver Z, Langer RS, Venkataraman G, Austen KF, Woodcock J and Sasisekharan R. Contaminated heparin associated with adverse clinical events and activation of the contact system. 2008. N Engl J Med 358(23): 2457-67. Epub 2008 Apr 23.

Guerrini M, Beccati D, Shriver Z, Naggi A, Viswanathan K, Bisio A, Capila I, Lansing JC, Guglieri S, Fraser B, Al-Hakim A, Gunay NS, Zhang Z, Robinson L, Buhse L, Nasr M, Woodcock J, Langer R, Venkataraman G, Linhardt RJ, Casu B, Torri G and Sasisekharan R. Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events. 2008. Nat Biotechnol 26(6): 669-75. Epub 2008 Apr 23.

Last Updated 11/17/2016