Massachusetts Institute of Technology

Tokitae LLC

Ana Jaklenec

Robert Samuel Langer

Lowell L Wood, Jr

Boris Nikolic

William Henry Gates, Iii

Philip A Welkhoff

Stephany Yi Tzeng

Thanh Duc Nguyen

James J Norman

Philip Andrew Eckhoff

Robert S Langer, Jr

Kevin McHugh

Xian Xu

Robert S Langer

Aaron C Anselmo

Xueguang Lu

William Gates

Kevin Mchugh

Microparticulate compositions and methods for delivery and pulsatile release of one or more sting agonists and/or receptors have been developed. The compositions include polymeric microdevices formed from biodegradable and biocompatible polymers or co-polymers thereof including a shell and compartment(s) or discrete regions in the compartment(s) formed by an additive process such as micromolding, three dimensional printing and lithography. The compositions include microdevices that release individual doses of incorporated STING agonist and/or receptors at defined times, for example, in pulses up to several months after administration with essentially no leakage between releases.

Compositions of polymeric microdevices and methods of use thereof in cancer immunotherapy

Emulsion-based and micromolded ('MM') or three dimensional printed (“3DP”) polymeric formulations for single injection of antigen, preferably releasing at two or more time periods, have been developed. Formulations are preferably formed of biocompatible, biodegradable polymers. Discrete regions encapsulating antigen, alone or in combination with other antigens, adjuvants, stabilizers, and release modifiers, are present in the formulations. Antigen is preferably present in excipient at the time of administration, or on the surface of the formulation, for immediate release, and incorporated within the formulation for release at ten to 45 days after initial release of antigen, optionally at ten to 90 day intervals for release of antigen in one or more additional time periods. Antigen may be stabilized through the use of stabilizing agents such as trehalose glass. In a preferred embodiment for immunization against polio, antigen is released at the time of administration, and two, four and six months thereafter.

Micromolded or 3-D printed pulsatile release vaccine formulations

Salt formulations, which are resistant to moisture and cooking conditions, are described herein. The formulations provide particles of micronutrients and vitamins encapsulated within heat resistant pH-sensitive water-insoluble polymers, which are packaged within a salt shell. The pH-sensitive, water-insoluble, thermally stable materials stabilize the micronutrients, particularly at high temperatures, such as during food preparation and cooking, and release the micronutrients at the desired locations such as the stomach, small intestine, etc. Preferred pH-sensitive polymers release at a low pH, less than the pH present in the stomach. The particles can be used to deliver daily-recommended doses of micronutrients simultaneously with salt, eliminating the need for vitamin pills. This is particularly important in populations suffering from severe malnutrition.

Fortified micronutrient salt formulations

Emulsion-based and micromolded ('MM') or three dimensional printed ('3DP') polymeric formulations for single injection of antigen, preferably releasing at two or more time periods, have been developed. Formulations are preferably formed of biocompatible, biodegradable polymers. Discrete regions encapsulating antigen, alone or in combination with other antigens, adjuvants, stabilizers, and release modifiers, are present in the formulations. Antigen is preferably present in excipient at the time of administration, or on the surface of the formulation, for immediate release, and incorporated within the formulation for release at ten to 45 days after initial release of antigen, optionally at ten to 90 day intervals for release of antigen in one or more additional time periods. Antigen may be stabilized through the use of stabilizing agents such as trehalose glass. In a preferred embodiment for immunization against polio, antigen is released at the time of administration, and two, four and six months thereafter.

Methods of encapsulating microorganisms, or components thereof, for targeted enteric delivery to an animal host have been developed. In particular, the encapsulation provides a prolonged survival, extended retention and a pH-sensitive release of the encapsulated microorganisms or antigenic components thereof at targeted sites within the gastrointestinal tract. The formulations are useful for diagnostic, therapeutic and prophylactic purposes and can alter a host's microbial composition associated with a condition or a disease state.

pH-responsive mucoadhesive polymeric encapsulated microorganisms

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Lexington, MA, United States of America

Ana Jaklenec