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Indaptus Therapeutics develops clinical-stage immunotherapies for cancer and viral infections using its Decoy bacterial platform. The company’s lead candidate, Decoy20, is based on attenuated and killed, non-pathogenic Gram-negative bacteria designed to activate innate and adaptive immune responses, with a focus on solid tumors.
Recurring news for Indaptus covers clinical updates from the INDP-D101 program, including Decoy20 evaluation as monotherapy and in combination with the PD-1 inhibitor tislelizumab. Company updates also include preclinical research on immune-cell activation, quarterly financial results, private placements, convertible notes and warrants, at-the-market financing, reverse stock split actions, Nasdaq compliance matters, and scientific or investor conference presentations.
Indaptus Therapeutics (Nasdaq: INDP), a clinical stage biotechnology company, announced a $2.25 million private placement priced at-the-market under Nasdaq rules. The placement involves the issuance and sale of 2,109,383 shares of common stock and accompanying warrants to purchase an equal number of shares. Each share and warrant combination is priced at $1.065. The closing is expected around January 15, 2025, subject to customary closing conditions. The warrants, exercisable immediately at $0.94 per share, have a five-year term. Paulson Investment Company, is the exclusive placement agent for this offering. The gross proceeds are anticipated to be around $2.25 million, before deducting placement agent fees and other expenses. Indaptus plans to use the net proceeds to fund research and development, working capital, and general corporate purposes. The securities are offered under Section 4(a)(2) of the Securities Act of 1933 and Rule 506(b) of Regulation D, not registered under the Securities Act or state securities laws, and cannot be resold in the U.S. without registration or an applicable exemption.
Indaptus Therapeutics (Nasdaq: INDP) has released its year-end review for 2024 and strategic goals for 2025, highlighting significant clinical progress and planned trials. The company's lead candidate, Decoy20, showed promising results in its Phase 1 trial. Key milestones include:
- March 2024: Second cohort results demonstrated broad immune response across multiple tumor types.
- May 2024: Initiation of weekly-dose cohort with no new significant adverse effects.
- September 2024: Higher-dose expansion following positive safety review.
Indaptus presented Decoy20’s potential at major conferences like AACR and ASCO and published research in peer-reviewed journals. A key achievement was a clinical supply agreement with BeiGene to evaluate Decoy20 in combination with tislelizumab, their PD-1 checkpoint inhibitor.
Financially, Indaptus raised $5.5 million in 2024 to support ongoing R&D. For 2025, the company plans to:
- Launch a combination cohort with Decoy20 and tislelizumab.
- Expand clinical sites beyond the current eight.
- Provide updates on higher-dose cohorts.
- Start dosing the first patients in the combination cohort.
CEO Jeffrey Meckler expressed optimism about the progress and potential of their platform to address challenging cancers.
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.