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ALT-LS2 2019-01-04T13:26:12+00:00

ALT-LS2: SC (subcutaneous) formulation of trastuzuamb with longer shelf-life with an ALT-B4 enzyme

Herceptin, a humanized monoclonal antibody developed by Roche against Her2, has been used for the treatment of breast cancer and recently of gastric cancer. Compared with the IV formulation of Herceptin which takes up to 90 minutes for administration, SC formulation takes less than 5 minutes and has occupied more than 50% of Herceptin market in Europe.

Alteogen, Inc. is developing SC formulation of trastuzumab with an ALT-B4 enzyme—recombinant human hyaluronidase PH20 variant—which showed improved enzymatic activity and thermal stability compared with the wild-type PH20. Alteogen’s trastuzumab SC formualtion is a ready-to-use liquid formulation with longer shelf-life. Alteogen aims at reducing the amount of trastuzumab in SC formulation (600 mg in a vial) using an ALT-B4 enzyme, similar to the amount of trastuzumab in IV formulation (440 mg in a vial).”

Research Process Pre-clinical Phase 1 Phase 2 Phase 3
ALT-LS2 Herceptin SC Biosimilar
Process Development in Progress
ALT-LS2 Herceptin SC Biosimilar
Process Development in Progress
Research
Process
Pre-clinical
Phase 1
Phase 2
Phase 3