Next-Generation Targeted Delivery Systems with Enhanced Shiga Toxin Effector Polypeptides

Publication ID: 24-11857628_0005_PTD
Published: October 28, 2025
Category:Future Evolutions & Paradigm Shifts

Legal Citation

pr1or.art Inc., “Next-Generation Targeted Delivery Systems with Enhanced Shiga Toxin Effector Polypeptides,” Published Technical Disclosure No. 24-11857628_0005_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857628_0005_PTD
This technical disclosure describes improvements that would be readily apparent to a Person Having Ordinary Skill In The Art (PHOSITA) when considered in combination with the foundational architecture disclosed in U.S. Patent No. 11,857,628.

Summary of the Inventive Concept

The inventive concept envisions a next-generation targeted delivery system leveraging enhanced Shiga toxin effector polypeptides with improved binding affinity, cytotoxicity, and selectivity, thereby revolutionizing the treatment of diseases and disorders.

Background and Problem Solved

The original patent disclosed cell-targeting molecules comprising Shiga toxin effector polypeptides for site-specific conjugation. However, these molecules may have limitations in terms of binding affinity, cytotoxicity, and selectivity. The new inventive concept addresses these limitations by introducing engineered Shiga toxin effector polypeptides with enhanced properties, enabling more effective and targeted therapies.

Detailed Description of the Inventive Concept

The inventive concept comprises a system for targeted delivery of Shiga toxin effector polypeptides, featuring a cell-targeting molecule with an engineered Shiga toxin effector polypeptide having at least one amino acid substitution conferring enhanced binding affinity to a target biomolecule. The cell-targeting molecule is encapsulated in a nano-carrier designed to release the molecule in response to a specific physiological signal. Additionally, the inventive concept encompasses methods for treating diseases or disorders using these cell-targeting molecules, as well as compositions and kits for preparing such molecules.

Novelty and Inventive Step

The new inventive concept introduces the use of engineered Shiga toxin effector polypeptides with enhanced binding affinity, cytotoxicity, and selectivity, which is not anticipated by the original patent. The combination of these polypeptides with nano-carriers and payload molecules represents a non-obvious advancement in the field of targeted delivery systems.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept may include the use of different nano-carrier materials, payload molecules, or targeting moieties. Variations may also include the application of the inventive concept to different disease or disorder areas, such as cancer, autoimmune diseases, or infectious diseases.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in the development of targeted therapies for various diseases and disorders. The market for such therapies is expected to grow substantially, driven by the increasing need for more effective and selective treatments. The inventive concept is poised to capture a significant share of this market, offering a competitive advantage to companies and researchers developing targeted delivery systems.

CPC Classifications

SectionClassGroup
A A61 A61K45/06
A A61 A61K38/00
A A61 A61K38/164
A A61 A61K47/6829
C C07 C07K14/195
C C07 C07K14/25
A A61 A61K2039/6037
C C07 C07K2319/05
C C07 C07K2319/55

Field of Art

Biotechnology and molecular medicine, specifically targeting therapeutic delivery systems using modified protein scaffolds, with expertise in protein engineering, cell-targeting molecules, and targeted therapeutic design

Person of Ordinary Skill (PHOSITA) Profile

A molecular biologist or protein engineer with advanced degrees, familiar with protein modification techniques, site-directed mutagenesis, and targeted delivery strategies, possessing skills in computational protein design and understanding structure-function relationships

Obviousness Rationale

A person of ordinary skill would recognize that the PTD's variations represent predictable extensions of the source patent's core teachings about Shiga toxin effector polypeptides. The disclosed amino acid substitutions and nano-carrier delivery mechanisms are logical incremental improvements that follow established protein engineering principles. The PTD's approach of systematically modifying binding regions and introducing targeted delivery mechanisms represents a standard approach to enhancing therapeutic protein performance.

Obvious Combinations & Variations

Source Patent Element
Shiga toxin effector polypeptide with specific amino acid substitutions (e.g., R248A, R251A)
PTD Variation
Additional amino acid substitutions targeting enhanced binding affinity and cytotoxicity
Obviousness Reasoning
Routine protein engineering technique of systematic mutation to optimize protein function, with predictable results in modifying protein characteristics
Source Patent Element
Cell-targeting molecule with binding region for extracellular biomolecules
PTD Variation
Nano-carrier encapsulation system for controlled release of cell-targeting molecule
Obviousness Reasoning
Known drug delivery strategy of using responsive nano-carriers to modulate therapeutic protein release, representing a standard approach in targeted medicine
Source Patent Element
Shiga toxin A subunit with site-specific modifications
PTD Variation
Engineered binding regions for selective targeting of specific cell types or biomarkers
Obviousness Reasoning
Predictable application of protein scaffold engineering to create more precise targeting mechanisms, utilizing well-established molecular biology techniques
Source Patent Element
Polypeptide with amino acid substitutions at specific positions
PTD Variation
Combination with checkpoint inhibitors for enhanced cancer treatment
Obviousness Reasoning
Obvious combination of known therapeutic modalities using a standard protein engineering approach to create multi-functional therapeutic molecules
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857628 and the published technical disclosure, a person of ordinary skill in the art would find the claimed variations obvious and anticipated, as the disclosed modifications represent predictable extensions of known protein engineering techniques applied to Shiga toxin effector polypeptides, with no evidence of unexpected results or non-obvious innovation beyond the scope of routine molecular design strategies.

Original Patent Information

Patent NumberUS 11,857,628
TitleShiga toxin A subunit effector polypeptides, Shiga toxin effector scaffolds, and cell-targeting molecules for site-specific conjugation
Assignee(s)Molecular Templates, Inc.