Disclosed herein are methods and compositions related to combination therapy for cancer. More specifically, several treatment modalities are used in combination to induce an effective anti-tumor immune response.

Provided herein are methods of production of recombinant Erwinia asparaginase. Methods herein produce asparaginase having high expression levels in the periplasm or the cytoplasm of the host cell having activity comparable to commercially available asparaginase preparations.

A method of reducing the asparagine content of whole grain flour for the production of baked goods includes treating whole grains by tempering the whole grains in an aqueous solution of an asparagine-reducing composition to concentrate and localize asparaginase activity in the bran and germ of the whole grains. In one approach, the asparagine-reducing composition may comprise an asparaginase enzyme. In another approach, the asparagine-reducing composition may comprise a yeast strain capable of degrading asparagine. The tempering treatment with the asparagine-reducing composition reduces asparagine in the whole grains by at least about 25%, resulting in a whole grain flour having an asparagine content of no more than about 250 ppm. Also described are baked goods having a reduced asparagine and acrylamide content comprising a whole grain flour obtained by treating whole grains with an asparagine-reducing composition during tempering.

Disclosed are methods and related compositions for concomitantly, locally administering immunosuppressants and doses of therapeutic macromolecules for reducing Type I and Type IV hypersensitivity.

Disclosed herein are methods and compositions related to combination therapy for cancer. More specifically, several treatment modalities are used in combination to induce an effective anti-tumor immune response. The present invention relates generally to the treatment of human cancer and, more specifically, to use of several treatment modalities in combination to induce effective anti-tumor immune responses.

The present invention relates to a novel, economically viable, storage stable, lyophilized composition of pegaspargase. The composition comprises pegaspargase, a cryoprotectant, a bulking agent, a buffer and may optionally contain other pharmaceutically acceptable excipients including but not limited to a salt. The composition of the present invention is stable for extended periods over significant range of temperatures, without the presence of any significant amount of impurities. The present invention also relates to an economically viable and scalable lyophilization process for the production of the storage stable composition of pegaspargase.

This invention relates to methods that provide immunosuppressants and therapeutic macromolecules that are administered within a pharmacodynamically effective window of the immunosuppressants to induce immune tolerance to the therapeutic macromolecules. The methods allow shifting the immune response in favor of tolerogenic immune response development specific to the therapeutic macromolecule.

Described are a genetically modified microorganism and corresponding methods and products. The genetically modified microorganism may include a first gene that encodes an acyl transferase and a second gene that encodes a peptide or protein. One or both of the first and second gene may be heterologous. The genetically modified microorganism may include a modified acyl-CoA biosynthetic pathway configured for one or more of: inducible biosynthesis of an acyl-CoA and over-accumulation of the acyl-CoA. The genetically modified microorganism may be effective upon fermentation to cause acylation of the peptide or protein by the acyl transferase using the acyl-CoA to provide a N-acylated peptide or protein product.

The present invention provides compositions and methods for treating a disease treatable by asparagine depletion in a human subject comprising administering to a human subject a recombinant L-asparaginase.

The present application discloses a PEGylated asparaginase and use thereof. In this application, the polyethylene glycol (PEG) is coupled to the N-terminal amino of 1 or 2 subunits of L-asparaginase, and the molecular weight of the PEG is 30-40 KDa. The PEG is preferably branched and has an aldehyde serving as an activating group. The PEGylated asparaginase is useful in the preparation of anti-tumor drugs.