Method of vaccinating using allogeneic cells

Inventors

Har-Noy, Michael

Assignees

Mirror Biologics Inc

Abstract

The invention disclosed herein relates generally to immunotherapy and, more specifically, to the use of immunotherapy for treating tumors and pathogen infected tissues by first priming patients with allogeneic cells designed to be rejected by a Th1 mediated mechanism, then inducing necrosis or apoptosis in a tumor or pathogen infected lesion by methods such as cryotherapy, irreversible electroporation, chemotherapy, radiation therapy, ultrasound therapy, ethanol chemoablation, microwave thermal ablation, radiofrequency energy or a combination thereof applied against at least a portion of the tumor or pathogen infected tissue, and then delivering one or more doses of allogeneic cells (e.g., Th1 cells) within or proximate to the tumor or pathogen-infected tissue in the primed patient. The present invention provides an immunotherapeutic strategy to develop de-novo systemic (adaptive) immunity to a tumor or pathogen.

Core Innovation

The invention relates to a method of vaccinating a patient having cancerous cells or an infected tissue by administering a priming composition comprising activated Th1 memory allogeneic cells. The activated allogeneic Th1 memory cells are configured to be rejected by the patient's immune system in a manner that induces anti-allogeneic Th1 immunity, including anti-allogeneic Th1 immune memory.

The priming step further includes administering nanobeads coated with anti-CD3 and anti-CD28 monoclonal antibodies, wherein the activated allogeneic Th1 memory cells are activated by expansion with antibody coated paramagnetic beads and are then debeaded, harvested from cell culture, incubated with the nanobeads, and washed to remove unassociated nanobeads prior to administering to the patient. The method permits the patient's immune system to develop an anti-allogeneic Th1 immune memory prior to injecting an antigenic composition.

The method then injects an antigenic composition comprising an autologous lysate and the Th1 memory allogeneic cells, wherein the autologous lysate comprises antigens from the cancerous cells or the infected tissue, and wherein the Th1 memory allogeneic cells are the same as the Th1 memory allogeneic cells in the priming composition. This approach creates a rejection response, stimulates a delayed-type hypersensitivity response to the antigens, and stimulates systemic anti-tumor or anti-pathogen immunity.

In the disclosed variants, the antigenic composition can omit priming and instead use an autologous lysate formulated with allogeneic cells as an antigenic composition or vaccine, where the autologous lysate can comprise heat shock proteins and chaperone proteins. The disclosed strategy is applied to cancerous cells or pathogen-infected tissue and is associated with dendritic-cell maturation, delayed-type hypersensitivity, and systemic adaptive immunity.

Claims Coverage

The provided material identifies one independent claim describing a two-part vaccination approach that includes a priming composition with activated Th1 memory allogeneic cells plus anti-CD3/anti-CD28 nanobeads, followed by injection of an antigenic composition containing an autologous lysate and the same Th1 memory allogeneic cells to induce a rejection response, delayed-type hypersensitivity, and systemic anti-tumor or anti-pathogen immunity. The independent claim includes multiple inventive feature elements spanning priming, antigenic composition, and immunological outcomes.

Across the independent claim, the inventive concept is grounded in inducing anti-allogeneic Th1 immune memory using activated Th1 memory allogeneic cells with anti-CD3/anti-CD28 nanobeads, then delivering an antigenic composition containing an autologous lysate (cancer or infected tissue antigens) together with the same Th1 memory allogeneic cells to drive rejection, delayed-type hypersensitivity, and systemic anti-tumor or anti-pathogen immunity.

Stated Advantages

Documented Applications