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

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Indaptus Therapeutics (Nasdaq: INDP) has secured new patent approvals in China, Japan, and Israel for its Decoy platform, covering treatments for Hepatitis B virus (HBV) and HIV infections. The patents extend to combination therapies with approved and investigational treatments.

The company's Decoy platform uses attenuated and killed bacteria to stimulate the immune system. Preclinical studies have shown significant single-agent activity in HBV and HIV infection models. The Decoy20 candidate is currently in Phase 1 clinical trials for advanced cancers in the U.S.

The patent expansion is particularly significant in Asia, where China accounts for approximately 87 million people living with chronic HBV, representing one-third of global cases. Japan has approximately 1.1-1.2 million HBV-affected individuals. Globally, HBV caused an estimated 1.1 million deaths in 2022, primarily from cirrhosis and liver cancer.

Indaptus Therapeutics (Nasdaq: INDP) ha ottenuto nuove approvazioni di brevetto in Cina, Giappone e Israele per la sua piattaforma Decoy, che copre trattamenti per il virus dell'epatite B (HBV) e le infezioni da HIV. I brevetti si estendono a terapie combinate con trattamenti approvati e in fase di sperimentazione.

La piattaforma Decoy dell'azienda utilizza batteri attenuati e uccisi per stimolare il sistema immunitario. Gli studi preclinici hanno mostrato un'attività significativa come agente singolo nei modelli di infezione da HBV e HIV. Il candidato Decoy20 è attualmente in fase 1 di sperimentazione clinica per tumori avanzati negli Stati Uniti.

L'espansione dei brevetti è particolarmente significativa in Asia, dove la Cina conta circa 87 milioni di persone affette da HBV cronico, rappresentando un terzo dei casi globali. Il Giappone ha circa 1,1-1,2 milioni di individui colpiti da HBV. A livello globale, l'HBV ha causato circa 1,1 milioni di morti nel 2022, principalmente a causa di cirrosi e cancro al fegato.

Indaptus Therapeutics (Nasdaq: INDP) ha conseguido nuevas aprobaciones de patentes en China, Japón e Israel para su plataforma Decoy, que abarca tratamientos para el virus de la hepatitis B (VHB) y las infecciones por VIH. Las patentes se extienden a terapias combinadas con tratamientos aprobados e investigacionales.

La plataforma Decoy de la empresa utiliza bacterias atenuadas y muertas para estimular el sistema inmunológico. Los estudios preclínicos han mostrado una actividad significativa como agente único en modelos de infección por VHB y VIH. El candidato Decoy20 se encuentra actualmente en ensayos clínicos de fase 1 para cánceres avanzados en EE.UU.

La expansión de patentes es particularmente significativa en Asia, donde China representa aproximadamente 87 millones de personas que viven con VHB crónico, lo que representa un tercio de los casos globales. Japón tiene aproximadamente 1,1-1,2 millones de individuos afectados por VHB. A nivel global, el VHB causó aproximadamente 1,1 millones de muertes en 2022, principalmente por cirrosis y cáncer de hígado.

Indaptus Therapeutics (Nasdaq: INDP)중국, 일본, 이스라엘에서 간염 B 바이러스(HBV) 및 HIV 감염 치료를 위한 Decoy 플랫폼에 대한 새로운 특허 승인을 확보했습니다. 이 특허는 승인된 치료법과 연구 중인 치료법과의 병용 요법을 포함합니다.

회사의 Decoy 플랫폼은 약화된 세균과 사멸된 세균을 사용하여 면역 체계를 자극합니다. 전임상 연구에서는 HBV 및 HIV 감염 모델에서 단일 약제로서 상당한 활성을 보여주었습니다. Decoy20 후보는 현재 미국에서 진행 중인 1상 임상 시험에 있습니다.

특허 확장은 아시아에서 특히 중요하며, 중국은 약 8,700만 명의 만성 HBV 환자가 살고 있어 전 세계 사례의 3분의 1을 차지합니다. 일본에는 약 110만-120만 명의 HBV 감염자가 있습니다. 전 세계적으로 HBV는 2022년에 약 110만 명의 사망을 초래했으며, 주로 간경변과 간암으로 인한 것입니다.

Indaptus Therapeutics (Nasdaq: INDP) a obtenu de nouvelles approbations de brevets en Chine, au Japon et en Israël pour sa plateforme Decoy, couvrant des traitements contre le virus de l'hépatite B (VHB) et les infections par le VIH. Les brevets s'étendent aux thérapies combinées avec des traitements approuvés et en cours d'investigation.

La plateforme Decoy de l'entreprise utilise des bactéries atténuées et tuées pour stimuler le système immunitaire. Des études précliniques ont montré une activité significative en tant qu'agent unique dans des modèles d'infection par le VHB et le VIH. Le candidat Decoy20 est actuellement en essais cliniques de phase 1 pour des cancers avancés aux États-Unis.

L'expansion des brevets est particulièrement significative en Asie, où la Chine compte environ 87 millions de personnes vivant avec une infection chronique par le VHB, représentant un tiers des cas mondiaux. Le Japon compte environ 1,1-1,2 million d'individus touchés par le VHB. À l'échelle mondiale, le VHB a causé environ 1,1 million de décès en 2022, principalement dus à la cirrhose et au cancer du foie.

Indaptus Therapeutics (Nasdaq: INDP) hat neue Patentanmeldungen in China, Japan und Israel für seine Decoy-Plattform erhalten, die Behandlungen für das Hepatitis-B-Virus (HBV) und HIV-Infektionen abdeckt. Die Patente erstrecken sich auf Kombinationstherapien mit genehmigten und in der Erprobung befindlichen Behandlungen.

Die Decoy-Plattform des Unternehmens nutzt abgeschwächte und abgetötete Bakterien, um das Immunsystem zu stimulieren. Präklinische Studien haben eine signifikante Einzelwirkungsaktivität in Modellen von HBV- und HIV-Infektionen gezeigt. Der Kandidat Decoy20 befindet sich derzeit in Phase-1-Studien für fortgeschrittene Krebserkrankungen in den USA.

Die Patentexpansion ist besonders bedeutend in Asien, wo China etwa 87 Millionen Menschen mit chronischem HBV zählt, was ein Drittel der globalen Fälle ausmacht. Japan hat etwa 1,1-1,2 Millionen HBV-betroffene Personen. Weltweit verursachte HBV im Jahr 2022 schätzungsweise 1,1 Millionen Todesfälle, hauptsächlich durch Leberzirrhose und Leberkrebs.

Positive
  • Secured new patents in three major markets (China, Japan, Israel)
  • Phase 1 clinical trial ongoing for Decoy20 in advanced cancers
  • Preclinical studies showed significant efficacy in HBV and HIV models
  • Patents cover both single-agent and combination therapies
Negative
  • Still in early clinical stage with main candidate only in Phase 1
  • Faces competition in large markets with existing treatments

Insights

Indaptus Therapeutics' expanded patent portfolio in China, Japan, and Israel represents a strategic intellectual property milestone for this $10M market cap clinical-stage biotech. The patents specifically cover their Decoy bacteria platform for HBV and HIV treatments, including combination approaches with existing therapies.

The HBV market opportunity is particularly significant in these regions, with China accounting for 30% of global cases (87 million patients). Japan adds another 1.1-1.2 million potential patients. With HBV causing approximately 1.1 million deaths annually, primarily from complications like cirrhosis and liver cancer, the addressable market remains substantial.

What makes this development noteworthy is the dual-application potential. While these patents focus on infectious diseases, Indaptus is simultaneously advancing Decoy20 in Phase 1 clinical trials for advanced cancers. This two-pronged approach potentially diversifies their commercial opportunities across multiple therapeutic areas.

For clinical-stage biotechs, robust patent protection is foundational for long-term value creation. These patents provide important market exclusivity should their therapies prove successful through clinical development. However, investors should recognize that patent milestones, while important for competitive positioning and potential partnership discussions, represent early steps in a lengthy development journey requiring significant additional capital to reach commercialization.

The mechanism behind Indaptus' Decoy platform - using attenuated and killed bacteria to stimulate immune responses - represents an innovative approach to both infectious disease and cancer treatment. Their preclinical data showing single-agent activity against both HBV and HIV suggests broad immunomodulatory potential.

From a clinical perspective, HBV remains one of the most challenging chronic infections worldwide. Current treatments rarely achieve complete viral clearance, with most patients requiring lifelong therapy. The global statistics cited - 87 million cases in China and over 1.1 million deaths annually - underscore the persistent treatment gap.

What's particularly intriguing is the platform's dual utility. The same immunostimulatory approach showing promise in infectious disease models has demonstrated tumor eradication in preclinical cancer models, with Decoy20 now in Phase 1 clinical evaluation. This suggests an underlying versatility in modulating immune responses against different disease targets.

However, the clinical development path remains long and uncertain. Moving from preclinical promise to approved therapy requires demonstrating safety, efficacy, and manufacturing consistency across multiple trial phases. The intellectual property protection now secured in these key markets provides necessary runway for this development process, though successful commercial products remain years away pending clinical validation.

NEW YORK, March 04, 2025 (GLOBE NEWSWIRE) -- 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

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things, our research and development plans. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to the following: our limited operating history; conditions and events that raise substantial doubt regarding our ability to continue as going concern; the need for, and our ability to raise, additional capital given our lack of current cash flow; our clinical and preclinical development, which involves a lengthy and expensive process with an uncertain outcome; our incurrence of significant research and development expenses and other operating expenses, which may make it difficult for us to attain profitability; our pursuit of a limited number of research programs, product candidates and specific indications and failure to capitalize on product candidates or indications that may be more profitable or have a greater likelihood of success; our ability to obtain and maintain regulatory approval of any product candidate; the market acceptance of our product candidates; our reliance on third parties to conduct our preclinical studies and clinical trials and perform other tasks; our reliance on third parties for the manufacture of our product candidates during clinical development; our ability to successfully commercialize Decoy20 or any future product candidates; our ability to obtain or maintain coverage and adequate reimbursement for our products; the impact of legislation and healthcare reform measures on our ability to obtain marketing approval for and commercialize Decoy20 and any future product candidates; product candidates of our competitors that may be approved faster, marketed more effectively, and better tolerated than our product candidates; our ability to adequately protect our proprietary or licensed technology in the marketplace; the impact of, and costs of complying with healthcare laws and regulations, and our failure to comply with such laws and regulations; information technology system failures, cyberattacks or deficiencies in our cybersecurity; and unfavorable global economic conditions. These and other important factors discussed under the caption “Risk Factors” included in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed with the SEC on November 12, 2024, our most recent Annual Report on Form 10-K filed with the SEC on March 13, 2024, and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. All forward-looking statements speak only as of the date of this press release and are expressly qualified in their entirety by the cautionary statements included in this press release. We undertake no obligation to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events, except as required by applicable law.

Contact: investors@indaptusrx.com

Investor Relations Contact:
CORE IR
Louie Toma
louie@coreir.com


FAQ

What new patents did Indaptus Therapeutics (INDP) receive in 2025?

In March 2025, INDP received patents in China, Japan, and Israel for its Decoy platform, covering HBV and HIV treatments and combination therapies.

How does Indaptus Therapeutics' Decoy platform technology work?

The Decoy platform uses attenuated and killed bacteria designed to stimulate the immune system to fight infections and cancer.

What is the current development stage of Indaptus' Decoy20 candidate?

Decoy20 is currently in Phase 1 clinical trials in the United States for patients with advanced cancers.

How many people are affected by chronic HBV in China according to INDP's announcement?

According to the announcement, approximately 87 million people in China live with chronic HBV, representing nearly one-third of global cases.

What diseases does Indaptus Therapeutics' new patent portfolio target?

The patents cover treatments for Hepatitis B virus (HBV) and human immunodeficiency virus (HIV), along with cancer therapies.

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