Indaptus Therapeutics Reports Partial Response with Decoy20 in Urothelial Cancer Patient
核心洞察
Indaptus Therapeutics announced that Decoy20 monotherapy induced a partial response in a urothelial cancer (搜索) patient with liver metastases (搜索) who had previously received anti-PD-1 (搜索) therapy.
The company has initiated combination therapy testing with seven patients receiving Decoy20 plus tislelizumab, with early results showing one patient with stable disease and two with disease progression.
Indaptus raised approximately $5.7 million in gross proceeds through convertible promissory notes to strengthen its balance sheet and support ongoing clinical development.
Indaptus Therapeutics announced promising clinical results from its ongoing INDP-D101 trial, reporting that its lead candidate Decoy20 achieved a partial response in a patient with urothelial cancer (搜索) and liver metastases (搜索). The biotechnology company also provided updates on its combination therapy program and recent financing activities.
Clinical Trial Progress and Results
The company has completed the monotherapy portion of its Phase 1 trial and initiated combination therapy testing with tislelizumab, BeOne (搜索)'s anti-PD-1 (搜索) monoclonal antibody. Dr. Roger Waltzman, Chief Medical Officer, reported that a patient in the monotherapy study who had previously received anti-PD-1 therapy experienced "a clear reduction in size of liver metastases (搜索), consistent with a Partial Response."
However, the clinical benefit was temporary, as disease progression was evident at the next scheduled imaging, leading to patient discontinuation from the study. Despite this outcome, the investigator believed the therapy provided clinical benefit for the patient over a 4-month period.
Combination Therapy Initial Results
Seven patients have been dosed in the combination therapy initial safety cohort. Among the first three evaluable patients, one achieved stable disease at the first assessment, while two patients experienced disease progression. The company continues to dose additional patients and expects to report their results in the coming weeks.
"We continue to progress our Decoy platform in the clinic to better understand this potential breakthrough therapy in combination with BeOne (搜索)'s tislelizumab," commented Jeffrey Meckler, Chief Executive Officer.
Financial Strengthening
Indaptus raised approximately $5.7 million in gross proceeds through the sale of convertible promissory notes and accompanying warrants. In July 2025, these notes were converted into common stock and pre-funded warrants, strengthening the company's balance sheet. The company remains focused on disciplined execution and anticipates sharing initial combination trial data later this year.
Decoy Platform Technology
Indaptus' patented Decoy platform is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria that produce multiple Toll-like receptor (TLR (搜索)), Nucleotide oligomerization domain (NOD)-like receptor (NLR) and Stimulator of interferon genes (STING (搜索)) agonists. The technology is designed to activate both innate and adaptive immune cells and pathways while maintaining reduced intravenous toxicity.
In preclinical studies, Decoy product candidates demonstrated single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, as well as combination-mediated eradication of established hepatocellular carcinomas, pancreatic and non-Hodgkin's lymphomas in standard preclinical models. The platform has also shown meaningful single-agent activity against chronic hepatitis B virus (搜索) (HBV) and chronic human immunodeficiency virus (HIV (搜索)) infections in preclinical models.
Safety Profile
The combination of Decoy20 with tislelizumab has demonstrated safety profiles consistent with each individual agent. IND-enabling nonclinical toxicology studies showed intravenous 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 candidate.