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Indaptus Therapeutics, Inc. (Nasdaq: INDP) is a pioneering pre-clinical biotechnology company focused on developing revolutionary treatments for cancer and certain infectious diseases. By harnessing the body’s innate and adaptive immune responses, Indaptus aims to cure disease through its proprietary platform that leverages bacteria's natural ability to activate both immune pathways.
The company’s flagship candidate, Decoy20, demonstrates significant promise in pre-clinical trials, showcasing single-agent activity and durable anti-tumor responses. These trials span various cancer models, including colorectal, hepatocellular, pancreatic carcinoma, and non-Hodgkin's lymphoma. Indaptus' technology involves the use of attenuated and killed non-pathogenic Gram-negative bacteria to safely elicit broad immune responses.
In line with its commitment to transparency and education, Indaptus actively engages with the public through social media platforms. The company shares updates on its groundbreaking research, educational content about cancer immunotherapy, and behind-the-scenes insights into its scientific progress. This engagement aims to build a community passionate about medical advancements.
Indaptus has recently advanced its innovative immunotherapy for the treatment of solid metastatic tumors into Phase 1 human trials. The safety and efficacy of Decoy20 in these trials have been promising, allowing the company to progress to multi-dosing regimens. This phase aims to further explore the safety and potential benefits of repeated Decoy20 administrations.
With a strong foundation built on over a century of immunotherapy advancements, Indaptus Therapeutics is poised to make significant strides in cancer and viral infection treatment. The company’s technology has shown potential in pre-clinical models to eradicate tumors when combined with other therapies, such as anti-PD-1 checkpoint inhibitors and low-dose chemotherapy.
Indaptus’ forward-looking strategy includes ongoing research and development activities, aiming to demonstrate the utility of its technology for treating solid tumors and chronic viral infections. The company's innovative approach, coupled with a robust pre-clinical pipeline, positions it uniquely in the biotechnology landscape, making it a noteworthy entity for investors and researchers alike.
Indaptus Therapeutics (Nasdaq: INDP) has announced a $2.135 million registered direct offering and concurrent private placement. The company will issue 1,817,017 common shares along with unregistered warrants to purchase an equal number of shares. The combined purchase price is $1.175 per share, with warrants exercisable at $1.05 per share for five years. The proceeds will fund research and development activities, working capital, and general corporate purposes. The offering, expected to close around November 25, 2024, includes participation from a company officer and is being facilitated by Paulson Investment Company as the exclusive placement agent.
Indaptus Therapeutics (Nasdaq: INDP) reported Q3 2024 financial results and corporate updates. The company announced a clinical supply agreement with BeiGene to evaluate cancer treatment combinations and progressed its Phase 1 trial of Decoy20. Research and development expenses decreased to $1.5 million from $2.2 million year-over-year. General and administrative expenses fell to $1.7 million from $2.0 million. Loss per share improved to $0.32 from $0.47. Cash position stood at $7.4 million as of September 30, 2024, expected to support operations into Q1 2025. The company completed a $3 million registered direct offering in August 2024, netting approximately $2.5 million.
Indaptus Therapeutics (NASDAQ: INDP) announced the publication of groundbreaking research in Frontiers in Immunology, detailing their novel Decoy platform and Decoy20 immunotherapy candidate. The research demonstrates how their technology activates multiple immune pathways using attenuated, killed bacteria to fight cancer.
Preclinical studies showed Decoy20's effectiveness against various cancers, including colorectal, pancreatic, hepatocellular cancers, and lymphomas, both as a single agent and in combination with other therapies. The platform's unique 'pulse-prime' approach enables broad immune system activation while reducing toxicity compared to traditional immunotherapies. The company is currently conducting Phase 1 clinical trials for Decoy20 in advanced solid tumors and plans to combine it with BeiGene's tislelizumab.
Indaptus Therapeutics has presented interim safety data from its Phase 1 clinical trial of Decoy20 at the SITC 2024 Annual Meeting. The data comes from two cohorts totaling 13 patients receiving single administration and one cohort of 6 patients receiving weekly administration. Results showed mainly mild to moderate and transient side effects with weekly intravenous administration. The pharmacokinetic analysis confirmed rapid clearance from bloodstream, supporting the company's 'pulse' approach. One patient with squamous cell carcinoma of the head and neck showed stable disease at first imaging. The trial is now enrolling patients with 6 tumor types for weekly dosing, and the company has partnered with BeiGene to test Decoy20 in combination with tislelizumab.
Indaptus Therapeutics (Nasdaq: INDP) has announced its participation in two upcoming investor conferences in New York City. CEO Jeffrey A. Meckler will present at BioFuture 2024 on October 28 at 3:30 PM ET at Cure by Deerfield, and at the ThinkEquity Conference on October 30 at 12:30 PM ET at the Mandarin Oriental Hotel. Meckler will be available for one-on-one meetings during both conferences. Interested investors can register to attend and schedule meetings through the provided links.
Indaptus Therapeutics (Nasdaq: INDP) has announced a clinical supply agreement with BeiGene to evaluate novel cancer treatment combinations. The planned trial, expected to start in 2025, will combine BeiGene's checkpoint inhibitor tislelizumab with Indaptus' Decoy20, a broadly targeted, short-duration systemic immune stimulator.
Decoy20, when combined with a PD-1 inhibitor and an oral non-steroidal anti-inflammatory agent, demonstrated 80-100% tumor eradication rates in preclinical studies. The trial aims to improve outcomes in human patients with various cancers, including liver, colon, and pancreatic.
BeiGene will provide access to its PD-1 inhibitor and technical expertise to accelerate the clinical trial. Indaptus will seek FDA approval to initiate the combination trial. A conference call is scheduled for October 22, 2024, at 4:30 PM ET to discuss the agreement and future plans.
Indaptus Therapeutics (Nasdaq: INDP) has announced progress in its Phase 1 trial of Decoy20, its lead drug candidate for cancer and viral infection treatment. The Safety Review Committee has approved unrestricted enrollment of patients at the lower Decoy20 dose for weekly administration. The safety profile aligns with expectations, with the most notable treatment-related adverse events being Grade 2 Infusion Related Reaction and Grade 2 Hypotension, both transient.
Dr. Roger Waltzman, Chief Medical Officer, emphasized the importance of gathering more safety and efficacy data to guide combination therapy initiation next year. CEO Jeffrey Meckler expressed confidence in Decoy20's potential impact on cancer immunotherapy, with results expected in the coming months.
Indaptus Therapeutics (Nasdaq: INDP) announced that its Founder and Chief Scientific Officer, Dr. Michael Newman, will participate in a Lumanity webinar on October 23, 2024. The webinar, titled 'Adapting to Immuno-Oncology's R&D Challenges: Refocusing on Innate Immunity as a 'Next Big Thing' in Cancer Immunotherapy,' will explore strategies for modulating innate immune pathways in cancer treatment.
Dr. Newman will share insights from Indaptus' Decoy20 platform, which uses killed, non-pathogenic Gram-negative bacteria to stimulate both innate and adaptive immune responses. The company's unique 'pulse-prime' approach aims to target hard-to-treat cancers that haven't responded to other therapies.
The webinar will feature a panel of biotech leaders discussing the potential of harnessing innate immunity in combination with checkpoint inhibitors to improve cancer control. Dr. Newman emphasized the importance of advancing drugs that modulate innate immune pathways alongside adaptive pathway activation in the evolution of cancer therapy.
Indaptus Therapeutics (Nasdaq: INDP) announced its participation in the 2024 Maxim Healthcare Virtual Summit. CEO Jeffrey A. Meckler will engage in a fireside chat with Jason McCarthy, Ph.D., Senior Managing Director and Head of Biotechnology Research at Maxim Group. The event is scheduled for Wednesday, October 16, 2024, at 11:00 AM ET.
The summit, taking place virtually from October 15 to 17, 2024, offers an opportunity for investors to gain insights into Indaptus Therapeutics' developments. A webcast of the fireside chat will be available at https://m-vest.com/events/healthcare-10152024. Additionally, Mr. Meckler will be available for one-on-one meetings throughout the summit, providing further engagement opportunities for interested parties.
Indaptus Therapeutics (Nasdaq: INDP) reports encouraging safety data for its Decoy20 clinical program. The independent Safety Review Committee has approved the continuation of dosing at a lower Decoy20 dose weekly and the initiation of dosing at a higher Decoy20 dose weekly. The safety profile aligns with Decoy20's mechanism of action, with mild-to-moderate treatment-related adverse events resolving quickly.
Dr. Roger Waltzman, Chief Medical Officer, states the company aims to evaluate patients receiving two distinct weekly doses to identify potential monotherapy activity and gather safety data for future combination therapy. CEO Jeffrey Meckler notes that enrolling multiple patients at two different weekly doses should accelerate trial progress. The company plans to provide further updates later in the year.
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