Ammax Bio, Inc.

Lifemax Laboratories, Inc.

Chung-Chiang Hsu

Kirk William Johnson

Laman Alani

Michael Huang

Aihua Zhu

Wei-Hsiang Wang

Tzu-Ying Wu

Chia-Yu Kuo

The present disclosure provides compositions and methods for extended release of certain types of antibodies in vivo. It was discovered that such antibodies are able to initiate reversible gelation of hyaluronic acid (HA) by creating a depot that dissociates over time to release the antibody without any impact on its physical and chemical properties as well as its biological activity. As certain tissues and organs, such as eyes, joints and skins, contain HA, local injection of the antibodies to these tissues or organs will result in embedding of the antibody in gel formed from the HA, which becomes a repository of slow-released antibodies. In addition, slow-released formulations can be prepared with antibodies mixed with HA, optionally with other polymers.

Extended local release of anti-CSFR1 antibodies

Provided are high concentration stable formulations of anti-CSF1R/CSF1 antibodies. An example formulation includes 105 to 250 mg/mL of the antibody, 100 mM to 200 mM of arginine glutamate or arginine HCl, 10 mM to 50 mM histidine, and 0.015 to 0.035 w/v % of polysorbate 80, at a pH of 5.4 to 5.6. Also provided are methods of using the formulations for treating diseases.

High concentration formulations of anti-CSF1 and anti-CSF1R antibodies

The present disclosure provides compositions and methods for intra-articular delivery of anti-CSF1R antibodies to a tissue that is impacted by a disease that is treatable with CSF1/CSF1R inhibition and/or that expresses CSF1R. It was conventional knowledge that the intra-articular dwell time of proteins in joints is typically a few hours or less. The present disclosure shows, however, that intra-articular delivery of an anti-CSF1R antibody can lead to sustained exposure and pharmacologic activity of the antibody in the joints far beyond a few hours, providing an effective means for targeted and extended delivery of the therapeutic agent.

Targeted delivery of anti-CSF1R antibodies to joints with tenosynovial giant cell tumors

The present disclosure relates generally to depot formulations of lurasidone and methods of making depot formulations of lurasidone. The depot formulations include a suspending agent and are highly syringeable.

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Los Altos Hills, CA, United States of America

Chung-Chiang Hsu