Company Description
Indaptus Therapeutics, Inc. (Nasdaq: INDP) is a clinical-stage biotechnology company focused on developing treatments for cancer and viral infections. According to the company’s public disclosures, Indaptus is advancing a patented Decoy bacterial platform designed to activate both innate and adaptive immune responses through systemic, intravenous administration. The company is classified under pharmaceutical preparation manufacturing within the manufacturing sector.
Indaptus describes its approach as evolving from more than a century of immunotherapy advances. Its core hypothesis is that effective anti-tumor and anti-viral immune responses may require a multi-targeted package of immune-activating signals that can be delivered safely via intravenous (i.v.) infusion. To pursue this, the company has developed product candidates based on single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria engineered to function as a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (NOD)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist platform.
The company’s lead clinical candidate is Decoy20. Indaptus reports that Decoy20 and related Decoy product candidates are designed to have reduced i.v. toxicity while largely preserving their ability to prime or activate many of the cells and pathways of innate and adaptive immunity. The Decoy platform is described as antigen-agnostic, meaning it is not limited to a single tumor or viral antigen target. In standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts, Decoy candidates have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single-agent eradication of established antigen-expressing breast carcinoma, and combination-mediated eradication of established hepatocellular carcinomas, pancreatic carcinomas and non-Hodgkin’s lymphomas.
In pre-clinical studies cited by the company, Decoy product candidates have been evaluated both alone and in combination with other agents. Combination regimens have included anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, and approved targeted antibodies. These pre-clinical combination studies have been associated with tumor eradication, induction of innate and adaptive immunological memory, activation of innate and adaptive immune cells, and a transition from a “cold” to “hot” tumor inflammation signature after a single i.v. dose of a Decoy product candidate.
Beyond oncology, Indaptus reports that its Decoy candidates have shown single-agent activity in pre-clinical in vivo models of chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections. The platform has also been shown in vitro to induce activation, polarization or maturation of human macrophages, dendritic cells, natural killer (NK) cells, natural killer T (NKT) cells, CD4 T cells and CD8 T cells. Nonclinical, IND-enabling toxicology studies described by the company demonstrated i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, which Indaptus attributes in part to passive targeting to liver, spleen and tumor followed by rapid elimination of the product candidate.
Clinically, Indaptus characterizes itself as a clinical-stage company. It has reported an ongoing Phase 1/1b/2 program known as INDP-D101 evaluating Decoy20. The company has completed a monotherapy portion of this trial and has initiated a combination arm in which Decoy20 is administered with tislelizumab, a PD-1 checkpoint inhibitor supplied by BeOne (formerly known as BeiGene). Indaptus has disclosed that over 25 patients have received weekly doses of Decoy20 at a specified cell dose and that treatment has been generally well tolerated with mostly mild or moderate, transient side effects in the context described.
In updates on the INDP-D101 trial, the company reported that in the monotherapy cohort a patient with urothelial cancer and liver metastases experienced a clear reduction in the size of liver metastases consistent with a partial response, followed by disease progression at a later imaging assessment. In the initial safety cohort of the combination arm with tislelizumab, Indaptus noted that among the first evaluable participants some achieved stable disease at the first assessment while others experienced disease progression. A Safety Review Committee reviewed available safety data from a safety lead-in cohort and determined that the Decoy20 and tislelizumab combination appeared tolerable at the evaluated dose and schedule, although the company indicated that enrollment was paused pending further efficacy assessment and development planning.
Indaptus also highlights potential applications of its Decoy platform in the allogeneic cell therapy field. In a scientific presentation description, the company stated that Decoy bacteria can activate or induce production of immune cell types such as NK cells, gamma-delta T cells and M1 macrophages in vitro. These cell types are described as central to allogeneic immunotherapies, and Indaptus has suggested that Decoy bacteria may serve as a tool to enhance the potency and reproducibility of donor-derived immune cell products by improving immune cell activation during cell manufacturing.
From a corporate and capital markets perspective, Indaptus is incorporated in Delaware and lists its principal executive offices in New York, New York in SEC registration statements. The company’s common stock trades on the Nasdaq Capital Market under the symbol INDP. It has characterized itself in SEC filings as a smaller reporting company and non-accelerated filer. The company has undertaken various equity and convertible note financings, including private placements of convertible promissory notes and warrants, registered direct offerings, and standby equity purchase arrangements, as described in its Form 8-K and Form S-1 filings. Indaptus has also implemented a reverse stock split of its common stock at a ratio of one-for-twenty-eight, effective June 26, 2025, in order to increase its per-share trading price and address Nasdaq listing requirements.
In December 2025, Indaptus entered into a Securities Purchase Agreement with an investor for the sale of Series AA and Series AAA convertible preferred stock, with associated rights to convert into common stock subject to stockholder approval and Nasdaq rules. The company disclosed that it intends to use proceeds from that offering for ongoing operations, severance, general corporate and working capital purposes, and expenses related to the transaction and stockholder approvals. The same filing describes changes to the board of directors and executive leadership associated with this financing, including the appointment of a new co-chief executive officer and board chair and the entry into modification agreements with certain executive officers.
Indaptus’ public communications emphasize disciplined execution of its clinical strategy, with a focus on advancing Decoy20 in oncology, exploring combinations with PD-1 checkpoint inhibition, and managing operating expenses and financing activities to support its development plans. As with many clinical-stage biotechnology companies, Indaptus’ disclosures also highlight risks related to funding needs, regulatory approvals, clinical trial outcomes and market acceptance, which are detailed in its SEC filings and forward-looking statements.