Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 9

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 9
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(LPS). Bacteria and purified or mono-specific TLR agonists, including LPS derivatives, have been validated and approved for prevention
and treatment of early stage cancer. However, a safe and effective TLR agonist-based approach for advanced cancer has been elusive, possibly
due to limitations in the ability of intratumorally administered, mono-specific TLR agonists to induce potent, systemic anti-tumor immune
responses. In addition, the intratumoral approach is not feasible with all tumor types or patients. Our hypothesis is that an effective
TLR agonist-based immunotherapy for advanced cancer will require invention of a packaged, multi-TLR agonist or multi-danger signal product
that is modified or attenuated to allow safe i.v. administration.

10

Our
Approach

Our
patented approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and associated anti-tumor
immune responses can be achieved by using intact bacteria, containing multiple PAMPs, which have been attenuated so that they can be
administered safely intravenously. Because LPS appears to be the most important contributor to both toxicity and efficacy, our patented
product candidates are single strains of killed, non-pathogenic Gram-negative bacteria that have been treated in an effort to kill the
bacteria and significantly reduce, but not completely eliminate, the cell surface LPS-endotoxin activity. Our product candidates are
designed to have enhanced sufficient residual LPS to synergize with other PAMPs in the bacteria to efficiently prime innate and adaptive
immune pathways. This approach has led to broad anti-tumor and anti-viral activity in preclinical models, including durable anti-tumor
response synergy observed with each of four different classes of existing agents, including NSAIDs, checkpoint therapy, targeted antibody
therapy and low-dose chemotherapy. Tumor eradication by our technology is designed to produce both innate and adaptive immunological
memory and, importantly, not require provision of an exogenous tumor antigen, potentially due to the ability of LPS and other PAMPS to
activate dendritic cells that have already captured a tumor antigen.

All
immune cells can participate in killing of tumors and viruses. As illustrated below, current therapies activate only one or a small subset
of both pathways and cure only a small percentage of patients.

Our
technology, however, is designed to synergize with existing therapies to activate both innate and adaptive immune cells, inducing efficient
anti- tumor immune responses with a wide