Tislelizumab

Feb. 05, 2025 -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical-stage biotechnology company pioneering innovative cancer and viral infection treatments, today announced the Company has received Clinical Trial Authorization from Health Canada to initiate its clinical trial for its lead asset, Decoy20. This approval will allow the Company to expand its ongoing U.S. clinical trial, INDP-D101, to Canadian sites, broadening patient recruitment and enhancing its clinical research program. The trial will enroll patients in Canada under the current protocol, which involves weekly dosing of Decoy20. Indaptus also plans to submit an amendment to Health Canada to incorporate its upcoming combination trial, which pairs Decoy20 with Beigene’s PD-1 checkpoint inhibitor, tislelizumab. Jeffrey Meckler, CEO of Indaptus, commented, “We are pleased to bring Canadian investigators and patients into our clinical efforts, creating a more diverse and robust data set. Health Canada’s approval followed a comprehensive review of our safety data and trial design. Expanding to Canada represents a significant step in our mission to evaluate Decoy20, a broad immune system activator, in patients with solid tumors.” Roger Waltzman, Chief Medical Officer, added, “The addition of Canadian trial sites should allow us to accelerate the collection of valuable clinical data more efficiently, and from a broader, more diverse population. This expansion is critical as we continue to evaluate Decoy20’s unique ability to activate both the innate and adaptive immune systems, potentially addressing the challenges associated with solid tumors. By enhancing our trial infrastructure, we aim to accelerate our understanding of Decoy20’s full therapeutic potential, refine its dosing regimen, and improve treatment outcomes for patients facing difficult-to-treat cancers. We are confident this progress will pave the way for key insights that could bring us closer to meaningful advances in cancer treatment." 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 product candidates 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 product candidates 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, pancreatic 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 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. The content above comes from the network. if any infringement, please contact us to modify.

HONG KONG, Feb. 5, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce the completion of patient enrollment in the global Phase III clinical trial (HARMONi-6/AK112-306) evaluating ivonescimab, its independently developed PD-1/VEGF bispecific antibody. This clinical study, conducted in China, compares ivonescimab in combination with platinum-based chemotherapy to tislelizumab (a PD-1 inhibitor) combined with platinum-based chemotherapy as a first-line treatment for squamous non-small cell lung cancer (sq-NSCLC). In addition, several international Phase III clinical trials of ivonescimab are underway. These clinical studies include the HARMONi-3 clinical trial, which compares ivonescimab plus chemotherapy to pembrolizumab plus chemotherapy for the first-line treatment of both sq-NSCLC and non-squamous NSCLC (nsq-NSCLC). This trial is being efficiently led by Summit Therapeutics, Akeso's global partner for ivonescimab. The HARMONi-6/AK112-306 trial is one of six registrational/Phase III studies worldwide for ivonescimab for lung cancer. It is also one of six studies where PD-1/L1 inhibitors are used as comparators. This initiative is a critical step in advancing cancer immunotherapy, establishing superior global treatment standards, and exploring the full clinical and commercial potential of ivonescimab within Akeso's portfolio. Ivonescimab, in combination with chemotherapy, has already been approved in China for the treatment of EGFR-TKI-resistant, non-squamous NSCLC. The New Drug Application (sNDA) for ivonescimab monotherapy as a first-line treatment for PD-L1-positive NSCLC (in comparison to pembrolizumab) is currently under review and has been granted priority status in China. As a next-generation, highly efficacious cancer immunotherapy, ivonescimab is also in multiple Phase III studies beyond lung cancer. These studies include ongoing Phase III trials for PD-L1-positive head and neck squamous carcinoma (vs. pembrolizumab), first-line treatment of biliary tract cancer (with chemotherapy vs. durvalumab + chemotherapy), and the first-line treatment of pancreatic cancer. Clinical trials of ivonescimab for the first-line treatment of triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, ovarian cancer and gastric cancer, are also in progress. As these studies progress, ivonescimab has the potential to redefine the standard of care in immuno-oncology around the world, with its clinical and commercial potential realized on a global scale. Data indicates that the annual incidence of advanced, driver gene-negative sq-NSCLC exceeds 520,000 cases, with many patients ineligible for anti-angiogenesis treatments like bevacizumab. While PD-1/L1 inhibitors combined with chemotherapy have become the global standard of care, including in the U.S. and China, the prognosis for these patients remains poor, highlighting a critical unmet need. Phase III studies show that ivonescimab, targeting both PD-1 and VEGF, offers a synergistic anti-tumor effect with a favorable safety profile. This makes ivonescimab a promising alternative for sq-NSCLC patients who cannot receive bevacizumab due to bleeding risks. Ivonescimab is poised to transform first-line treatment for locally advanced or metastatic sq-NSCLC, providing a safer and more effective immunotherapy option that exceeds current treatment standards. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED