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OUR NEW PROFILE IS: (Nasdaq: INDP)

INDP Has $16 Million in Cash and Equivalents as of 9/30/23, With a Market Cap of Just $15 Million

Top line data from the INDP-D101 trial of lead compound Decoy20 was presented at the Society of Immunotherapy in Cancer on November 4, 2023.  In addition to the safety data and immune response reported previously, the Company reported that all four patients had achieved and continue to maintain stable disease, three of whom presented with progressive disease.

The Company announced the initiation and first dosing of the second cohort of its INDP-D101 trial, which will be administered at a lower dose and is expected to bring the Company closer to determination of the recommended Phase 2 dose for the multi-dosing part of the trial

Check Out the Investor Presentation HERE

Hello Everyone,

We have another company on our radar for Thursday’s session that has several catalysts that you are going to want to research.

Pull up INDP right away.

This one has under 6 million shares in the float.

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 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, 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. Indaptus’ Decoy product candidates have also produced significant single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.

Over the past 12 months we haven’t seen any insider selling. We did see one substantial Insider purchase over over 100K shares at 2.34, which are at moderately higher levels than it is currently sitting.

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.

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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.

European Patent Office Approves Key Patent for Indaptus Therapeutics’ Platform Technology

PUBLISHED

JAN 4, 2024 8:00AM EST

Patent will provide additional protection covering a composition targeting any viral infection, including hepatitis B, HIV, and influenza

NEW YORK, Jan. 04, 2024 (GLOBE NEWSWIRE) — Indaptus Therapeutics, Inc.(Nasdaq: INDP), a clinical stage biopharma company that utilizes a proprietary killed, non-pathogenic bacteria-based platform to generate stabilized packages of immune agonists to activate both innate (immediate) and adaptive (learned) cellular immune pathways, announces that the European Patent Office (EPO) has informed the company that it will grant a European patent related to the company’s platform technology, covering a composition that can be used in the prevention or treatment of viral infections.

The patent, titled “Methods of Treatment of Infections Using Bacteria,” (Application 19 866 580.4) provides protections for the application of the Company’s Decoy technology platform alone or in combination with standards of care for the prevention or treatment of any viral infection. The EPO patent will be the second patent granted to Indaptus outside the United States for this application.

Jeffrey Meckler, Indaptus Therapeutics CEO, commented, “The continued protection of our intellectual property both in the U.S. and abroad will provide a competitive advantage for the Company, which should ultimately drive significant shareholder value over time. We continue to explore the applications of our technology platform beyond solid tumors, for which we are currently engaged in a Phase 1 clinical trial, and look forward to updating our shareholders on scientific progress.”

Indaptus Therapeutics’ Decoy20 Demonstrated a Broad Immune Response of More than Fifty Cytokines and Chemokines in Patients Following a Single Dose in First Cohort of Ongoing Phase 1 Study

PUBLISHED

NOV 6, 2023 8:00AM EST

Poster presented at 38th Annual Meeting of the Society for Immunotherapy of Cancer Showed Favorable Safety Profile and Achievement of Stable Disease in All Four Patients in First Cohort.

NEW YORK, Nov. 06, 2023 (GLOBE NEWSWIRE) — Indaptus Therapeutics, Inc.(Nasdaq: INDP), a clinical biopharma company that utilizes a proprietary killed, non-pathogenic bacteria-based platform to generate a stabilized package of immune agonists to activate both innate (immediate) and adaptive (learned) cellular immune pathways, announces interim data from the first cohort of four patients in the Phase 1 INDP-D101 trial of its lead compound, Decoy20. A broad expression of cytokines and chemokines associated with innate and adaptive anti-tumor immune responses was observed, while adverse events were generally tolerable and resolved within 30 minutes to three days. Decoy20 is designed to “re-set” the immune system’s response to cancer. The poster was presented on November 4, 2023, at the Society for Immunotherapy of Cancer in San Diego.

“We are impressed that we saw short-term induction of more than 50 cytokines, chemokines and biomarkers and believe this is unprecedented with a single agent. These early data support our long-standing hypothesis that the Decoy platform may induce robust immune responses across multiple types of immune cells that we believe are important for the eradication of solid tumors,” commented Indaptus CEO Jeffrey Meckler.

“The relatively brief duration of exposure to Decoy20 supports our hypothesis of utilizing a “pulse-prime” approach, providing a short period of activation to avoid unwanted toxicities that may occur from prolonged immune activation,” commented Michael Newman, Ph.D., Indaptus Founder and Chief Scientific Officer.

As reported in the poster, trial subjects experienced transient induction of over 50 different biomarkers associated with immune responses, and generally anticipated transient adverse events.After the end of infusion, Decoy20 was cleared from the blood within 30 to 120 minutes. This rapid clearance and associated transient cytokine/chemokine induction are desired to avoid prolonged toxicity, often associated with longer term cytokine exposure. In contrast, therapeutics that are designed to be continuously present over weeks, months, or even years, such as CAR-T, can induce this type of toxicity. Peak cytokine and chemokine induction occurred within ~4 to 24 hours and most returned to baseline by 24-48 hours. Lymphocyte cell populations were transiently reduced in the blood and then rebounded, suggesting that these critical immune cells were redistributing from the circulation to lymph nodes, immune organs or sites of tumor. This supports the hypothesis of an “immune resetting” proposed mechanism of action.

In addition, each of the subjects was observed to have stable disease four weeks after a single dose, with three of them having started the trial with progressive disease.

“We look forward to continuing the trial with the current cohort having a lower dose, given the broad potential immune activation we have observed,” added Roger Waltzman, M.D., Indaptus’ Chief Medical Officer. “We anticipate that in the next stage of the trial we will assess the effect of weekly dosing (as opposed to the single dose in these first two cohorts), while analyzing a host of biomarkers, immune and tumor cells in peripheral blood, and immune cell populations in the tumor microenvironment, coupled with standard radiographic measurements.”

The poster was titled, “Preliminary results of an in progress, first-in-human Phase 1 study of Decoy20, an intravenous, killed, multiple immune receptor agonist bacterial product in patients with advanced solid tumors.” First cohort patients received a single dose of 7×107 killed Decoy20 bacteria via a one-hour IV infusion.

Indaptus Therapeutics to Present Positive Pharmacodynamic (PD) Immune and Pharmacokinetic (PK) Results with Patients from First Cohort of Ongoing Phase 1 Study of Decoy20 at Cancer Immunotherapy Meeting

PUBLISHED

OCT 31, 2023 9:01AM EDT

Poster to be presented at 38th Annual Meeting of the Society for Immunotherapy of Cancer on November 4, 2023

NEW YORK, Oct. 31, 2023 (GLOBE NEWSWIRE) — Indaptus Therapeutics, Inc.(Nasdaq: INDP) announces it will be presenting interim data from the first cohort of four patients in the Phase 1 INDP-D101 trial of its lead compound, Decoy20. The interim data, released today in abstract form, demonstrated that as of August 31, 2023, each of the first cohort participants experienced transient activation of biomarkers associated with innate and/or adaptive immune responses, and generally expected transient adverse events, both associated with predicted rapid clearance of Decoy20. The data in full will be presented in a poster at the Society for Immunotherapy of Cancer (SITC) on November 4. The conference will be held from November 1-5, 2023 in San Diego.

Michael J. Newman, Ph.D., Indaptus’ Founder and Chief Scientific Officer noted, “Even in this early study, Decoy20 is exceeding our expectations from the perspective that we are seeing activation of the immune system, based on transient expression of multiple plasma cytokines and chemokines, with expected transient adverse events. These results, in conjunction with the desired and observed rapid clearance of Decoy20 from the blood, are highly supportive of our “Pulse-Prime” hypothesis for the Decoy20 mechanism of action.”

Roger Waltzman, M.D., Indaptus’ Chief Medical Officer, added, “We are encouraged by the tolerability of Decoy20 and the notable evidence for broad immune biomarker activation at this early stage. At one month following the single dose of Decoy20, all four of the first cohort patients had stable disease. We are following these patients as well as working on enrolling the second cohort, which utilizes a lower dose. This lower dose is based on the pharmacodynamic results seen with the first cohort and plans to optimize Decoy20 for both weekly dosing and combination approaches.”

The abstract/poster is titled, “Preliminary results of an in progress, first-in-human Phase 1 study of Decoy20, an intravenous, killed, multiple immune receptor agonist bacterial product in patients with advanced solid tumors.”   First cohort patients received a single dose of 7×107 killed Decoy20 bacteria via a one-hour IV infusion. As of August 31, 2023, treatment-related adverse events, potentially expected based upon prior clinical studies with purified lipopolysaccharide, have included, among other events, changes in hemodynamic parameters, transaminase elevations, and lymphopenia; all resolved with or without treatment within 30 minutes to 3 days. The Company believes the short half-life of Decoy20 observed in blood coupled with the marked, but transient, induction of multiple cytokines and chemokines over approximately 24 hours supports the PK “pulse” and PD “prime” hypothesis for the Decoy20 immune-oncology strategy.

NEWS

PUBLISHED

FEB 15, 2024

Indaptus Therapeutics to Present at the 2024 BIO CEO & Investor Conference

PUBLISHED

FEB 8, 2024

Indaptus Therapeutics Expands Digital Presence with Launch of Social Media Channels

PUBLISHED

JAN 4, 2024

European Patent Office Approves Key Patent for Indaptus Therapeutics’ Platform Technology

PUBLISHED

NOV 6, 2023

Indaptus Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

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PUBLISHED

NOV 6, 2023

Indaptus Therapeutics’ Decoy20 Demonstrated a Broad Immune Response of More than Fifty Cytokines and Chemokines in Patients Following a Single Dose in First Cohort of Ongoing Phase 1 Study

PUBLISHED

OCT 31, 2023

Indaptus Therapeutics to Present Positive Pharmacodynamic (PD) Immune and Pharmacokinetic (PK) Results with Patients from First Cohort of Ongoing Phase 1 Study of Decoy20 at Cancer Immunotherapy Meeting

PUBLISHED

SEP 27, 2023

Indaptus Therapeutics to Present at the LD Micro Main Event XVI

PUBLISHED

SEP 26, 2023

Registration Is Now Open For Tribe Public’s Webinar Event “Immunotherapy Reimagined” Featuring Indaptus Therapeutics’ CEO On Friday, September 29, 2023

PUBLISHED

SEP 19, 2023

Indaptus Therapeutics Doses First Patient in Second Cohort of Single Dose Ranging Study of Decoy20

PUBLISHED

SEP 6, 2023

Indaptus Therapeutics to Present at the H.C. Wainwright 25th Annual Global Investment Conference

PUBLISHED

AUG 14, 2023

Indaptus Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update

PUBLISHED

AUG 10, 2023

Indaptus Therapeutics Announces Opening of Next Cohort in Single Dose Ranging Study of Decoy20

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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.

SINCERELY,

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