US 12295968

Here's a concise summary of US patent 12295968, based on the provided patent text and current information:

US Patent 12295968: Compositions and methods for targeted immunomodulatory antibodies and fusion proteins

• Title: Compositions and methods for targeted immunomodulatory antibodies and fusion proteins
• Assignee: Johns Hopkins University [cite: US12295968B2]
• Inventors: Atul Bedi, Rajani Ravi [cite: US12295968B2]
• Filing Date: 2024-09-12 [cite: US12295968B2]
• Issue Date: 2025-05-13 (This is the publication date for the granted patent, US12295968B2) [cite: US12295968B2]

Abstract:
The invention generally relates to targeted immunomodulatory antibodies and fusion proteins for cancer therapy. Specifically, it provides compositions and methods for targeted immunostimulatory or immunosuppressive antibodies and fusion proteins designed to counteract or induce immune tolerance in cancer cells. The core discovery is that these targeted molecules can reverse or promote immune tolerance, which cancer cells utilize to evade elimination by chemotherapy or tumor-targeted antibodies through immunosuppressive mechanisms in the tumor microenvironment. The invention offers effective compositions and methods for cancer treatment, potentially in combination with other existing therapies. [cite: US12295968B2]

Litigation Status:
As of the current date, the patent family for US12295968B2 has litigation. A PTAB (Patent Trial and Appeal Board) case, PGR2026-00025, was filed and is currently pending. [cite: US12295968B2] This indicates a challenge to the patent's validity at the PTAB. No direct CAFC (U.S. Court of Appeals for the Federal Circuit) dockets for this specific patent number were found for 2026 through the general search, which is consistent with a pending PTAB action as CAFC appeals typically follow final decisions from the PTAB.

Plain-Language Overview of Independent Claims:

The patent includes 22 independent claims. Here's an overview of the key independent claims:

• Claim 1: This claim describes a molecule comprising a targeting part and an immunomodulatory part. The targeting part specifically binds to a target on a tumor cell or its surroundings (like tumor tissue, blood vessels, or immune cells within the tumor). The immunomodulatory part specifically binds to an immunosuppressive molecule (such as TGF-β, PD-L1/PD-L2, RANKL, or VEGF) that is expressed by the targeted tumor cell or immune suppressor cells within the tumor. [cite: US12295968B2]
• Claim 2: This claim is similar to Claim 1 but specifies that the targeting part specifically binds to a target on regulatory T cells (Tregs), myeloid suppressor cells (MDSC), or dendritic cells (DC). The immunomodulatory part then binds an immunosuppressive molecule that helps these suppressor cells develop, survive, or function. [cite: US12295968B2]
• Claim 3: This claim details the molecule where the immunomodulatory part binds to Transforming growth factor-beta (TGF-β), Programmed death-1 ligand (PD-L1 or PD-L2), Receptor activator of nuclear factor-κB ligand (RANKL), or vascular endothelial growth factor (VEGF). [cite: US12295968B2]
• Claim 18: This claim is for a composition that includes the molecule described in any of the preceding claims, along with a cell (which could be a tumor cell, an immune cell, or a dendritic cell). [cite: US12295968B2]
• Claim 19: This claim describes a method to counteract or overcome immune tolerance by administering one or more of the invented molecules to a patient who needs it. [cite: US12295968B2]
• Claim 20: This claim covers a method for preventing or treating a neoplastic disease (cancer) by administering one or more of the invented molecules to a patient. [cite: US12295968B2]
• Claim 38: This claim is for a method of preventing or treating a neoplastic disease (specifically a non-T cell malignancy not expressing CD4 on the tumor cell) by administering an antibody that targets and depletes CD4+ regulatory T cells (Tregs) in combination with another cytotoxic anticancer therapy. [cite: US12295968B2]
• Claim 42: This claim describes a method for preventing or treating a neoplastic disease by administering one or more of the invented molecules in combination with another anticancer therapy. [cite: US12295968B2]
• Claim 45: This claim is for a method of preventing or treating a neoplastic disease by administering one or more of the invented molecules in combination with an antibody or molecule that inhibits the production or function of regulatory T cells (Tregs) or depletes their number. [cite: US12295968B2]
• Claim 50: This claim covers a method for treating immune cells by contacting them ex vivo (outside the body) or in vitro (in a lab setting) with a molecule of the invention. [cite: US12295968B2]
• Claim 51: This claim describes a method for treating a neoplastic disease by administering a composition of immune cells (that have been contacted with the invented molecule) to a patient. [cite: US12295968B2]
• Claim 52: This claim is for a method of inducing or promoting immune tolerance by administering one or more of the invented molecules to a patient. [cite: US12295968B2]
• Claim 53: This claim describes a method for preventing or treating an autoimmune or inflammatory disease by administering one or more of the invented molecules to a patient. [cite: US12295968B2]
• Claim 54: This claim is similar to Claim 53, but specifies administering the molecule in combination with another anti-inflammatory or immunosuppressive therapy. [cite: US12295968B2]
• Claim 55: This claim covers a method of treating immune cells by contacting them ex vivo or in vitro with a molecule of the invention, specifically for inducing immune tolerance or treating autoimmune/inflammatory diseases. [cite: US12295968B2]
• Claim 56: This claim describes a method of treating an autoimmune or inflammatory disease or preventing rejection of grafted cells/tissue by administering a composition of immune cells (contacted with the invented molecule) to a patient. [cite: US12295968B2]