Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (Nod)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The products are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy products represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical studies tumor eradication was observed with Decoy products in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated safe i.v. 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. Indaptus’ Decoy products have also produced significant single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.
vista's key points
- Indaptus in headquartered in New York City & their stock trades on the Nasdaq under the symbol “INDP.”
- Building upon the long-standing observation of tumor regression in the setting of bacterial infection, Indaptus has developed a unique and patented approach designed to exploit bacteria’s natural ability to fully engage the human immune system and cure disease.
- Indaptus' novel insights have enabled the Company to create proprietary, attenuated and killed non-pathogenic gram-negative bacteria that have demonstrated broad anti-tumor and anti-viral activity in pre-clinical models to date.
- With the ability to harness both the body’s innate and adaptive immune responses, Indaptus believes they are uniquely positioned to revolutionize the treatment of cancer and certain infectious diseases.
- Indaptus is leveraging their novel insights into the levels and ratios of activating signals needed to safely elicit a broad immune response, they are creating and advancing a pipeline of proprietary, attenuated and killed non-pathogenic gram-negative bacterial candidates designed to be widely accessible, with broad anti-tumor and anti-viral activity.
- Indaptus therapeutic candidates, include their lead candidate Decoy20 that has have demonstrated, in pre-clinical studies, the ability to elicit single-agent activity and durable anti-tumor responses in the combination setting against colorectal, hepatocellular, pancreatic carcinoma, and non-Hodgkin’s lymphoma in standard pre-clinical models.
- Indaptus believes that Decoy candidates are unique in their ability to synergize with each of a wide variety of existing therapies, including checkpoint therapy and targeted antibodies, to produce durable anti-tumor responses against established tumors, with induction of both innate and adaptive immunological memory.
- Based on Indaptus' positive pre-clinical results to date, they have initiated their first Phase 1 clinical trial in December 2022 and dosed their first patient in March 2023.
- The Company announced the completion of the first cohort of its INDP-D101 trial and receipt of authorization from its Safety Review Committee to proceed into the second cohort of the Phase 1 trial.
- A compound from the Company’s Decoy platform was presented in a poster titled, “A systemically administered killed bacteria-based multiple immune receptor agonist for pulsed anti-tumor immunotherapy ,” at the American Association for Cancer Research Conference 2023. The poster highlighted that Decoy10 demonstrated 90% reduction of LPS-endotoxin activity and use of 100% killed, non-pathogenic bacteria.
- The Company’s Chief Scientific Officer, Michael Newman, Ph.D., was named Chair for two of the three days of the 4 th STING & TLR-Targeting Therapies Summit held in Boston from May 9 to 11, where he was also a featured speaker.
- The Company received patent allowances for its Decoy immunotherapy platform in Brazil and India. The Indian patent allowance brought the number of countries in which the Company holds patent protection to 32.
- Roger Waltzman, M.D. was appointed the Chief Medical Officer of Indaptus, effective August 7, 2023.
- As of June 30, 2023, the Company had cash, cash equivalents and marketable securities of approximately $19.7 million. The Company expects that its current cash, cash equivalents and marketable securities will support its ongoing operating activities into the second quarter of 2024. This cash runway guidance is based on the Company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken. Indaptus continues to assess all financing options that would support its corporate strategy.
19 September 2023 | 12:00 pm
6 September 2023 | 12:05 pm
29 August 2023 | 12:44 pm
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