tw0122
2 월 전
$1.70 offering of Indaptus, for the issuance and sale of an aggregate of 1,643,837 of its shares of common stock. In a concurrent private placement, Indaptus has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 1,643,837 of its shares of common stock. The combined effective purchase price for each share of common stock and associated warrants is $1.825. The warrants will have an exercise price of $1.70 per share,
In pre-clinical studies tumor eradication was observed with Decoy product candidates 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 candidate, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated 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 candidate. Indaptus’ Decoy product candidates have also produced meaningful single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.
PonkenPlonken
6 월 전
" [...] Chief Medical Officer, Roger Waltzman, M.D., will present an update on the Company’s lead product candidate, Decoy20, at the 7th Annual Next-Gen Immuno-Oncology Conference in Boston on June 20-21, 2024.
Dr. Waltzman will present preliminary results from the Company’s ongoing Phase 1 study of Decoy20, an intravenous treatment using killed bacteria designed to broadly stimulate the immune system, in patients with advanced solid tumors.
Jeffrey Meckler, Indaptus CEO commented, “We are excited to share our latest findings from our Phase 1 clinical trial of Decoy20, and we are grateful for the opportunity to be invited to provide continued updates. We remain optimistic regarding the results seen to date and anticipate providing continued updates as they develop.”
$$$$
PonkenPlonken
6 월 전
looks like its finally happening.
I dont mind them taking their time. Insiders are smart and know how to execute. See director Roger Pomerantz as per his LinkedIn:
"Led the development of 14 approved small and large molecule drugs, HIV, HCV, TB, CMV, and C Diff and Microbiome"
"Led and Completed over 160 Value-Creating Business Development, Licensing,
Acquisition and Partnership Deals (including large pharma with large pharma partnerships) at Tibotec Pharma, Johnson and Johnson, and Merck & Co, in Over 20 Diverse Therapeutic Areas, for Large and Small Molecules. Completed Deals and Partnerships in All Emerging Markets, eg. BRIC, especially in China"
subslover
3 년 전
Indaptus Therapeutics Announces FDA Clearance of Investigational New Drug Application to Initiate Phase 1 Clinical Trial of Decoy20 in Solid Tumors
NEW YORK, May 19, 2022 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the "Company”), today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a Phase 1 clinical trial in patients with advanced solid tumors where currently approved therapies have failed. The Company plans to initiate the clinical trial in the second half of 2022.
“We are excited to begin our first in human study of Decoy20, as there is still a significant unmet medical need for patients with advanced solid tumors. This is an important milestone for Indaptus, which brings us one step closer to our goal of demonstrating the utility of a multi-targeted and antigen-agnostic, systemic immunotherapy that primes and activates both innate and adaptive anti-tumor immune responses,” said Jeffrey Meckler, Chief Executive Officer of Indaptus.
“Tumors remodel and inhibit systemic immune responses and Indaptus’ Decoy technology is unique in its ability to mobilize both innate and adaptive anti-tumor immune pathways with systemic administration in pre-clinical tumor models, while at the same time not inducing sustained hallmarks of cytokine release syndromes in pre-clinical toxicology studies,” said Dr. Michael Newman, Founder and Chief Scientific Officer of Indaptus.
“The trial is a Phase 1, open-label dose escalation and expansion study evaluating the safety, tolerability and preliminary efficacy of Decoy20 in patients with advanced solid tumors. We look forward to demonstrating the safety profile of Decoy20 and developing an effective, novel therapy for cancers unresponsive to existing approved therapies,” continued Mr. Meckler.
About the Phase 1 Study
The Phase 1 study is designed to evaluate the safety, tolerability, and preliminary efficacy of Decoy 20 and will follow a 3+3 design of dose-escalation cohorts. The study protocol allows for exploration of additional dosing regimens, including continuous weekly administration after initial safety has been established. Decoy20 has the potential to treat a wide range of solid tumors including hepatocellular, colorectal and pancreatic carcinomas.
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells 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. Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria, with reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cellular components of innate and adaptive immunity. Decoy20 represents an antigen-agnostic technology that has produc