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Indaptus Therapeutics Expands Patent Portfolio in China, Japan, and Israel, Strengthening its Intellectual Property for Infectious Disease and Cancer Treatments
Indaptus Therapeutics Receives Approval from Health Canada to Expand Clinical Trial of Decoy20
Check Out the Investor Presentation HERE
Hello Everyone,
The markets are certainly choppy right now and there is a lot of uncertainty.
Investor sentiment is notably pessimistic because geopolitical tensions, trade policy uncertainties, and economic concerns.
With that being said, we can always find opportunities.
There is always an exception to the rule.
Last week while the market was blood red and getting absolutely decimated we were able to profile a 20%+ runner that was sitting under a buck.
We have a past winner back on deck for Tuesdays session and it is sitting at .80 which is right in the wheelhouse of some of our better profiles in the past few months.
We haven’t taken a look at this one in about a year but we think you should research this one thoroughly while it is sitting here under a dollar.
Pull up INDP right away.
This one has under 12 million shares in the float.
We looked at it a few times over a year ago in early 2024 and we saw it move up at much higher prices.
It is sitting here at just .80 or so right now. Make sure you keep reading.
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.
We haven’t seen any insider selling in INDP however the CEO did put some money where his mouth is and acquired over 125k shares at significantly higher prices.
Indaptus Therapeutics Expands Patent Portfolio in China, Japan, and Israel, Strengthening its Intellectual Property for Infectious Disease and Cancer Treatments
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.
Indaptus Therapeutics Receives Approval from Health Canada to Expand Clinical Trial of Decoy20
NEW YORK, Feb. 05, 2025 (GLOBE NEWSWIRE) — Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical-stage biotechnology company pioneering innovative cancer and viral infection treatments, today announced the Company has received Clinical Trial Authorization from Health Canada to initiate its clinical trial for its lead asset, Decoy20. This approval will allow the Company to expand its ongoing U.S. clinical trial, INDP-D101, to Canadian sites, broadening patient recruitment and enhancing its clinical research program. The trial will enroll patients in Canada under the current protocol, which involves weekly dosing of Decoy20. Indaptus also plans to submit an amendment to Health Canada to incorporate its upcoming combination trial, which pairs Decoy20 with Beigene’s PD-1 checkpoint inhibitor, tislelizumab.
Jeffrey Meckler, CEO of Indaptus, commented, “We are pleased to bring Canadian investigators and patients into our clinical efforts, creating a more diverse and robust data set. Health Canada’s approval followed a comprehensive review of our safety data and trial design. Expanding to Canada represents a significant step in our mission to evaluate Decoy20, a broad immune system activator, in patients with solid tumors.”
Roger Waltzman, Chief Medical Officer, added, “The addition of Canadian trial sites should allow us to accelerate the collection of valuable clinical data more efficiently, and from a broader, more diverse population. This expansion is critical as we continue to evaluate Decoy20’s unique ability to activate both the innate and adaptive immune systems, potentially addressing the challenges associated with solid tumors. By enhancing our trial infrastructure, we aim to accelerate our understanding of Decoy20’s full therapeutic potential, refine its dosing regimen, and improve treatment outcomes for patients facing difficult-to-treat cancers. We are confident this progress will pave the way for key insights that could bring us closer to meaningful advances in cancer treatment.”
SCIENCE & PIPELINE
Novel Insights. Novel Therapies.
Historically, we know that tumor regression has been observed in the presence of bacterial infection. We also know that bacteria contain immune system danger signals, called pathogen-associated molecular patterns (PAMPs), that collectively can activate all of the cellular components of our innate and adaptive immune pathways. PAMPs are recognized by receptors, such as Toll-like (TLR), NOD, STING and RIG-I, that are found on and involved in activation of many different innate and adaptive immune cells.
Our platform is based on the hypothesis that highly efficient anti-tumor immunotherapy will require safe activation of both innate and adaptive cellular immunity in both tumors and immune organs, and that this might be achieved with a multi-targeted package of bacterial PAMPs, in the form of attenuated and killed, intact but non-pathogenic bacteria delivered intravenously. While current therapies are increasingly becoming more and more personalized and costly, we are advancing an approach designed to be widely accessible, with broad anti-tumor and anti-viral activity not dependent on the targeting of specific tumor or viral antigens.
Current Approaches
Current immunotherapies only cure a very small percentage of advanced cancer patients because they activate only one or a few innate or adaptive immune cell types.
The Indaptus Approach
Goal: to safely and effectively activate both innate and adaptive cellular anti-tumor pathways by passively targeting both the tumor and immune organs.
A Unique Approach
Previous research has shown that lipopolysaccharide (LPS), an endotoxin that binds to Toll-like receptor 4 (TLR4), is a key bacterial PAMP that activates the immune system. Activated TLR4 has been shown to play a role in dendritic cell activation and T-cell-mediated anti-tumor immune responses. Our novel insights have enabled us to create attenuated and killed, non-pathogenic gram-negative bacteria with unique levels of LPS – levels that have now been shown in pre-clinical studies to be sufficient to synergize with other PAMPs in the bacteria to safely prime and/or activate innate and adaptive immune pathways. We currently have a broad patent portfolio with 34 issued or granted patents that are based on the technology originally developed by our Founder and Chief Scientific Officer, Dr. Michael Newman, at Indaptus’ predecessor company, Decoy Biosystems.
Based on our successes to date, we are now building a pipeline of therapeutic candidates designed to be delivered intravenously, targeting cancers and infectious diseases with high unmet medical needs.
Results to Date
We are currently advancing our lead candidate, Decoy20, through Phase 1 clinical trial. To date, Decoy20 and/or related candidates have demonstrated broad anti-tumor and anti-viral activity in pre-clinical models, including high percentage complete and durable anti-tumor responses in combination with different classes of existing therapeutics.
- In oncology, Decoy candidates have demonstrated the ability to eradicate established tumors in a murine model of hepatocellular carcinoma in combination with either a non-steroidal anti-inflammatory drug (NSAID) or an anti-PD-1 agent, and more efficiently with both. Tumor eradication has occurred with a wide therapeutic index and has led to induction of 100% immunological memory. In combination with low-dose chemotherapy, Decoy candidates have also produced highly efficient eradication of established tumors in a mouse model of non-Hodgkin’s Lymphoma (NHL), also with induction of immunological memory. Combination-mediated tumor eradication has also been observed with a human tumor xenograft NHL model with inclusion of a targeted antibody. Decoy candidates have also produced significant single agent activity in murine models of both metastatic pancreatic carcinoma and orthotopic, colorectal carcinoma.
- In infectious disease, single agent Decoy therapeutics have produced significantly broader activity than standard of care treatment in a pre-clinical model of chronic Hepatitis B infection, as well as single agent activity against chronic HIV infection in a pre-clinical humanized mouse model.
Generation and/or activation of the cells required for innate and adaptive anti-tumor and anti-viral immune responses takes place, to a significant extent, outside of the tumor or sites of infection, including in the spleen. Our intravenous therapeutic candidates are expected to passively target the liver, spleen, and leaky vasculature of tumors, producing immune activation in an immune organ, as well as a common site for primary and metastatic cancer and HBV infection, the liver. As our therapeutic candidates are expected to be cleared very quickly by the liver and spleen, we anticipate a low risk of non-specific autoimmune side effects relative to other types of immunotherapies designed for continuous exposure.
We have initiated our Phase 1 clinical trial of Decoy20 in December 2022 and dosed our first patient in March 2023.
NEWS
3 days ago
Mar 4, 2025
Feb 25, 2025
Indaptus Therapeutics Receives Approval from Health Canada to Expand Clinical Trial of Decoy20
Feb 5, 2025
Jan 13, 2025
Indaptus Therapeutics Provides Year-End Review and Outlook for 2025
Jan 8, 2025
Nov 22, 2024
Indaptus Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update
Nov 12, 2024
Nov 11, 2024
Nov 7, 2024
Indaptus Therapeutics to Present at Two Upcoming Investor Conferences
Oct 23, 2024
Oct 22, 2024
Oct 15, 2024
Oct 10, 2024
Indaptus Therapeutics to Participate in a Fireside Chat at the 2024 Maxim Healthcare Virtual Summit
Oct 8, 2024
Sep 5, 2024
Indaptus Therapeutics to Present at the H.C. Wainwright 26th Annual Global Investment Conference
Sep 3, 2024
Indaptus Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update
Aug 12, 2024
Aug 7, 2024
Jun 11, 2024
MANAGEMENT TEAM
JEFFREY A. MECKLER
Chief Executive Officer
Jeffrey Meckler currently serves as our Chief Executive Officer, bringing more than 30 years of financial and healthcare leadership experience to the company. Most recently, Jeff was the CEO of Intec Pharma, and prior to that, CEO of Cocrystal Pharma, transforming it from a research company into a clinical and development company. Earlier in his career, Jeff was managing director of the Andra Group, a life sciences consulting firm, and acted as a director and interim CEO of Cypress Bioscience after its acquisition by Royalty Pharma. Jeff started his career at Pfizer, where he held a series of positions in manufacturing systems, market research, business development, strategic planning and corporate finance, which included playing a significant role in acquisitions and divestitures. He has also served as a director of QLT, Inc., Cocrystal Pharma, ClearFarma USA, Kyalin Bioscience, and Alveolus, and currently serves as director of Travere Therapeutics, where he also previously served as Chairman. Jeff is the past President and continues to serve on the Board of Children of Bellevue, a non-profit organization focused on advocating and developing pediatric programs at Bellevue Hospital Center. He holds a B.S. in industrial management, an M.S. in industrial administration from the Tepper School of Business at Carnegie Mellon University, and a J.D. from Fordham University’s School of Law.
MICHAEL J. NEWMAN, PH.D.
Founder and Chief Scientific Officer
A founder of the company, Dr. Michael Newman currently serves as our Chief Scientific Officer. Most recently, he was Founder and CEO of Decoy Biosystems, where he developed the technology that serves as the foundation of Indaptus. With more than 35 years of experience carrying out and managing oncology drug discovery through early development in academia and at pharmaceutical and biotechnology companies, Michael has also served as a consultant to ~35 companies, assisting with target identification and prioritization, management of R&D, fundraising, and in/out-licensing. His previous positions include faculty appointments in biochemistry at Brandeis University and the Roche Institute of Molecular Biology, Senior Associate Director of Oncology at Sandoz Pharmaceuticals (world-wide head of Cancer Biology), Executive Director of Oncology at Novartis Pharmaceuticals (Head of Cancer Biology in the U.S.), and senior management positions at several Biotechnology companies, where he also managed drug discovery programs in inflammation, diabetes, and infectious disease. Michael received a Bachelor’s degree in biology from the University of California at San Diego, a Ph.D. in cell and developmental biology from Harvard Medical School (National Science Foundation Pre-doctoral Fellow) and carried out post-doctoral research at Cornell University.
WALT A. LINSCOTT
Chief Operating Officer
Walt Linscott brings more than three decades of global leadership, entrepreneurial and professional experience with broad business development, operational, regulatory, and transactional experience in the Life Sciences sector to his current role as Chief Operating Officer at Indaptus. Most recently, he held the position of Chief Business Officer at the company. Prior to Indaptus he was the Chief Business Officer at Intec Pharma. He is also a Founding executive member of Oxford Strategic Alliance, a multinational business development and referral enterprise for strategic advice, management and investment development/management for individuals and companies that are globalizing. Previously, Walt served as President, COO and General Counsel at Treiber Therapeutics, an anti-viral-focused venture he co-founded. He has also served in a variety of General Counsel and Corporate Secretary roles at Cocrystal Pharma, Carestream Health, and Solvay Pharmaceuticals, where he also led compliance, IP, security, privacy, public affairs and government affairs functions. In addition, he was previously an Associate and Partner at Thompson Hine where he founded the firm’s Atlanta office, served as Partner in Charge, and as Chair of the firm’s Life Science Practice Group. Walt holds a Master of Science in Experimental and Translational Therapeutics with honors from the University of Oxford, a Master’s degree in Global Business from the University of Oxford and Master’s degree in Entrepreneurship from Cambridge University. He earned his J.D. from the University of Dayton School of Law where he served as Managing Editor of the Law Review. After graduating with a Bachelor’s degree from Syracuse University and prior to entering law school, he earned a commission and served on active duty as an Officer in the United States Marine Corps. Walt is also a Certified Flight Instructor and was previously a professional stunt pilot.
ROGER J. WALTZMAN
Chief Medical Officer
Roger Waltzman, M.D., M.B.A. currently serves as our Chief Medical Officer. Dr. Waltzman is a board-certified medical oncologist whose career highlights include the roll of Chief Medical Officer of publicly traded company, Molecular Templates (2019-2023) and multiple senior drug development roles at Novartis Oncology (2007–2013), where he played a leading role in the development of imatinib, nilotinib, and ruxolitinib. From 2013 to 2016, Dr. Waltzman was the Full Development Head of Malaria Drug Development at Novartis. More recently, Dr. Waltzman was CMO at Rgenix (now Inspirna), where he supervised the development of immuno-oncology and metabolic inhibitor assets through Phase 1 a/b. Previously, he served as CSO at Jaguar Health and Napo Pharmaceuticals, where he led scientific aspects of development and commercialization of Mytesi® (crofelemer).
Before joining the industry, Dr. Waltzman held assistant professorships in medical oncology and palliative care at Saint Vincent’s Hospital and Mount Sinai School of Medicine in New York. He completed his fellowship in hematology/oncology at Memorial Sloan Kettering Cancer Center. Dr. Waltzman earned a Master of Business Administration at Columbia Business School and a Doctor of Medicine and Bachelor of Arts from Brown University.
NIR SASSI
Chief Financial Officer
Nir Sassi currently serves as our Chief Financial Officer, bringing a broad skillset across management, corporate finance, due diligence, accounting, and financial analysis. Prior to joining Indaptus, Nir spent 11 years at Intec Pharma, starting as Vice President of Finance and ending his tenure there as Chief Financial Officer. Previous to that, Nir served as a Senior Manager at PricewaterhouseCoopers Israel for eight years, including two years relocation to the PWC New York office. He is a certified public accountant in Israel and holds a Bachelor’s degree in economics and accounting from Ben Gurion University in Beer Sheva, Israel.
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