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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) announced its Q4 and fiscal year 2022 results alongside updates on its Phase 1 clinical trial of Decoy20 for solid tumors. The first patient was dosed in March 2023, showing manageable adverse events. Research and development expenses rose by 150% to approximately $6.3 million for the year, while general and administrative expenses increased by 65% to about $8.6 million. The loss per share for 2022 was $1.73, down from $1.89 in 2021. Indaptus reported cash, cash equivalents, and marketable securities of approximately $26.4 million as of December 31, 2022, expecting operational funding until Q2 2024.
Indaptus Therapeutics (Nasdaq: INDP) announced that the American Association for Cancer Research (AACR) accepted its abstract for presentation at the annual scientific conference from April 14-19, 2023, in Orlando. The poster, titled “A systemically administered killed bacteria-based multiple immune receptor agonist for pulsed anti-tumor immunotherapy,” will be presented by Michael J. Newman, Ph.D., on April 18, 2023. Indaptus focuses on innovative therapeutics leveraging a Decoy anti-tumor platform that activates immune responses safely via intravenous delivery. This technology shows promise in treating various cancers and chronic infections.
Indaptus Therapeutics (Nasdaq: INDP) announced the addition of Emory Winship Cancer Institute as a clinical trial site for its Phase 1 trial of INDP-D101, a treatment targeting advanced solid tumors. This open-label study aims to assess the safety, tolerability, and pharmacokinetics of Decoy20, the company’s lead compound. Emory's participation indicates validation of Decoy20’s scientific concepts and the urgent need for treatment options in this area. The trial will enroll patients who have exhausted standard therapies, with initial data anticipated as sites are activated.
Indaptus Therapeutics has initiated the first human dosing in its Phase 1 clinical trial of Decoy20, aimed at treating advanced solid tumors. The initial subject reported expected, manageable side effects linked to immune activation, which aligns with Indaptus' therapeutic hypothesis. This trial will evaluate the safety, tolerability, and pharmacokinetics of Decoy20, with further subjects expected to be enrolled soon. The primary endpoint focuses on the incidence and severity of adverse events, with important secondary endpoints including response rates and immunological effects.
Indaptus Therapeutics (Nasdaq: INDP) has appointed Dr. Robert Martell to its Board of Directors. Dr. Martell brings over 20 years of experience in the pharmaceutical industry, previously serving as Head of Research and Development at Curis, Inc. His extensive background includes roles in both publicly traded and private companies, as well as significant positions at major firms like Bayer and Bristol-Meyers Squibb. The Company aims to leverage Dr. Martell's expertise in drug development and oncology to advance its clinical programs, particularly those using its Decoy platform for cancer treatments.
Indaptus Therapeutics (Nasdaq: INDP) has announced the addition of Morristown Medical Center as a new clinical trial site for its Phase 1 trial of INDP-D101, a treatment for advanced solid tumors. Patient screening is expected to begin soon. The trial aims to assess the safety, tolerability, and pharmacokinetics of Decoy20, the company's lead compound. The expansion of trial sites is expected to expedite patient enrollment, aiding in gathering initial data. Indaptus believes Decoy20 has the potential to innovate solid tumor treatments, with ongoing studies showing promising pre-clinical results against various carcinomas.
Indaptus Therapeutics (Nasdaq: INDP) has initiated its first-in-human Phase 1 clinical trial, INDP-D101, evaluating Decoy20 for patients with advanced solid tumors. The trial commenced at USC Norris Cancer Center, aiming to assess safety, tolerability, and pharmacokinetics of Decoy20. The study will determine the maximum tolerated dose and investigate its clinical activity. Encouraged by preclinical data, Indaptus aims to advance to the trial's expansion phase following dose determination. Initial cohort results are expected in 2023.
Indaptus Therapeutics (Nasdaq: INDP) has reported its Q3 2022 financial results and is on track to initiate a Phase 1 clinical trial of Decoy20 for treating solid tumors in Q4 2022. The FDA cleared the IND application for this trial, aimed at evaluating Decoy20's safety and efficacy. In Q3 2022, R&D expenses rose to $1.6 million, while general and administrative expenses decreased to $2.0 million. The company holds approximately $28.5 million in cash and expects to fund operations into Q2 2024 without additional financing.
Indaptus Therapeutics announced that CEO Jeffrey A. Meckler will present at the LD Micro Main Event XV from October 25-27, 2022, at the Luxe Sunset Boulevard Hotel in Los Angeles. The presentation is scheduled for October 25 at 3:30 PM PT (Track 3). Interested parties can register to watch the presentation online. Indaptus focuses on immunotherapy, leveraging patented technology to activate immune responses against tumors and chronic viral infections. The company aims to develop innovative therapies and will hold one-on-one meetings during the conference.
Indaptus Therapeutics (Nasdaq: INDP) announced its CEO, Jeffrey A. Meckler, will present a corporate overview at the 24th Annual H.C. Wainwright Global Investment Conference on September 12, 2022, at 2:00 PM ET. The event will be held at the Lotte New York Palace Hotel from September 12 to 14. A live webcast will be available on the company’s website, with a replay accessible for 90 days after the event. Management will also hold one-on-one meetings post-conference. Details for registration and additional information can be found in the press release.
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