Indaptus Therapeutics Expands Patent Portfolio in China, Japan, and Israel, Strengthening its Intellectual Property for Infectious Disease and Cancer Treatments

Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, announced today that it has secured new patent approvals in China, Japan and Israel for its Decoy platform. These patents cover the use of Decoy bacteria compositions for preventing or treating Hepatitis B virus (HBV) and human immunodeficiency virus (HIV) – two diseases that continue to pose major global health challenges. The patents also extend to combination therapies with a variety of both approved and investigational treatments.

Dr. Michael Newman, Founder and Chief Scientific Officer of Indaptus, commented, “The allowance of these patents in key international markets highlights the potential of our Decoy platform in the fight against chronic infectious diseases. With millions of people affected by HBV and HIV worldwide, expanding our intellectual property reinforces the novelty and therapeutic promise of our approach.”

A Growing Global Health Need

Chronic HBV infections remain a major health concern, especially in Asia.

China has approximately 87 million people living with chronic HBV, nearly one-third of all cases worldwide.

Japan has approximately 1.1 – 1.2 million people affected by chronic HBV.

In 2022, HBV caused an estimated 1.1 million deaths worldwide, primarily due to cirrhosis and liver cancer.

Despite available treatments, new therapies are urgently needed to improve long-term outcomes.

A Unique Approach to Infectious Disease and Cancer Treatment

Preclinical studies demonstrated that Indaptus’ Decoy bacteria—which are attenuated and killed bacteria designed to stimulate the immune system—produced significant single-agent activity in standard models of chronic HBV and HIV infections.

Patented candidates from Indaptus’ Decoy platform have also produced single agent activity and durable, combination-mediated tumor eradication in multiple pre-clinical cancer models and one candidate (Decoy20) is currently being evaluated in a Phase 1 clinical trial in the U.S. for patients with advanced cancers.

With these new patents, Indaptus continues to strengthen its position as a leader in immunotherapy innovation, advancing treatments for both infectious diseases and cancer.

About Indaptus Therapeutics

Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (NOD)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The product candidates are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy product candidates represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas, pancreatic and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical studies tumor eradication was observed with Decoy product candidates in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product candidate, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed by rapid elimination of the product candidate. Indaptus’ Decoy product candidates have also produced meaningful single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.

For more information, visit www.indaptusrx.com

Forward-Looking Statements

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