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Indaptus Therapeutics Initiates #Unrestricted Enrollment of Patients on Decoy20 Weekly Dosing Based on Encouraging Safety Data Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical stage #biotechnology company dedicated to pioneering #innovative #cancer and #viralinfection treatments, provides an update regarding key clinical advancements in its Phase 1 trial of lead drug candidate Decoy20.  The Safety Review Committee examined weekly administration data at the lower Decoy20 dose and cleared unrestricted enrollment of patients at this dose. The safety profile observed to date remains aligned with Decoy20’s expected mechanism of action. The most clinically relevant treatment-related adverse events include Grade 2 Infusion Related Reaction and Grade 2 Hypotension, both of transient duration. “Unrestricted enrollment of patients at the lower Decoy20 dose will enable us to gather more safety and efficacy data, which is crucial for assessing the full potential of Decoy20. The data will guide how we initiate combination therapy next year, a critical phase in advancing Decoy20,” said Dr. Roger Waltzman, Indaptus Chief Medical Officer. Jeffrey Meckler, Chief Executive Officer, added, “We continue to gather robust data on Decoy20, which remains consistent with our expectations from preclinical studies. We believe the continuation of this trial, and the eventual initiation of combination therapy studies presents an important opportunity to have a potentially significant impact on cancer immunotherapy. We look forward to sharing these results in the coming months.”

Truly interesting development in #head&neck #cancer with potential to offer important new treatment option for patients with low #PDL-1 expression. CEL-SCI Corporation just announced that following good overall survival (#OS) PhIII results (NCT01265849) in this patient population with resectable #SCCHN of oral cavity after #neoadjuvant peritumoral/perilymphatic administration of #Multikine (Leukocyte Interleukin injection with defined mixture of naturally derived cytokines) it will open confirmatory trial specifically targeting PDL-1 low patient subgroup (https://lnkd.in/enA72EGd). This development strategy is a result of discussions with #FDA and indicates high interest to sufficiently verify positive efficacy and safety outcomes in PDL-1 low patient population with prospective BM-defined design. Interesting to point is that this development follows outcome of Keytruda in a similar setting in #Keynote 689 published about month ago where neoadjuvant/adjuvant #Keytruda (#Pembrolizumab) had positive effect upon event-free survival (EFS) and major pathological response (mPR) with potential OS benefit possibly limited to PDL-1 high patient population. Considering that approximately 70% of #SCCHN patients have low PDL-1 expression advance of Multikine can truly bring great benefit as a treatment option. Especially in light of PD-L1 "low" positivity definition for Multikine confirmatory study that is quite wide and includes patients with TPS less than 10. Cel-SCI announced start of the trial in 1Q of 2025. #Clinical oncology #strategy #SCCHN #FDA #PhIII #OS #PDL-1

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Semaglutide 2.4 mg demonstrates superior improvement in both liver fibrosis and MASH resolution in the ESSENCE trial Part 1 of the ongoing ESSENCE trial, a pivotal phase 3, 240-week, double-blinded trial in 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3)1. Part 1 of the ESSENCE trial evaluated the effect of once-weekly semaglutide 2.4 mg on liver tissue (histology) compared to placebo on top of standard of care for the first 800 randomised people at 72 weeks. At week 72, 37.0% of people treated with semaglutide 2.4 mg achieved improvement in liver fibrosis with no worsening of steatohepatitis compared to 22.5% on placebo2. 62.9% of people treated with semaglutide 2.4 mg achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to 34.1% on placebo2. The primary endpoint of trial has 3 items: - Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No) [Time Frame: From randomisation (week 0) to week 72] - Part 1: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No) [Time Frame: From randomisation (week 0) to week 72] - Part 2: Cirrhosis-free survival (Yes/No) [Time Frame: From randomisation (week 0) to week 240] Study arms: Semaglutide (Subcutaneous) Vs Placebo Novo Nordisk PR: https://lnkd.in/gZVDQmZ2

We’re excited to announce a new clinical supply agreement with BeiGene that we hope will help advance our program and support our mission to transform cancer care! We plan to explore combining BeiGene's PD-1 inhibitor, tislelizumab, with our innovative immune-stimulating therapy, Decoy20.  With encouraging preclinical data showing tumor eradication rates of 80-100% when #Decoy20 was used in combination with a PD-1 inhibitor, we’re optimistic about the potential to deliver better outcomes for cancer patients.  We hope to kick off the first clinical trial of this promising combination in 2025. Please join our call at 4:15pm today to learn more…  #IndaptusTherapeutics #BeiGene #CancerResearch #Immunotherapy #ClinicalTrials #Biotech https://lnkd.in/ehH9vU6g

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Fixed dose of Semaglutide/Cagrilintide vs Tirzepatide The markets are overreacting to the topline news from the REDEFINE 1 phase 3 trial investigating CagriSema. The first problem is that Novo Nordisk overpromised the efficacy of CagriSema saying it would achieve 25% weight loss. The second problem is that we only have topline results from the SURMOUNT-5 and REDEFINE 1 trials. We really need the full results, not just topline. However, comparing the tirzepatide and semaglutide topline results from the two trials leads to the conclusion that CagriSema is at least as good as tirzepatide and probably better – although not as good as Novo Nordisk had promised investors. REDEFINE 1 Trial Topline results from REDEFINE 1, a 68-week efficacy and safety phase 3 trial investigating CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to the individual components showed CagriSema achieved a superior weight loss of 22.7% after 68 weeks compared to a reduction of 11.8% with cagrilintide 2.4 mg, 16.1% with semaglutide 2.4 mg and 2.3% with placebo alone. In addition, 40.4% of patients who received CagriSema reached a weight loss of 25% or more after 68 weeks, compared to 6.0% with cagrilintide 2.4 mg, 16.2% with semaglutide 2.4 mg, and 0.9% with placebo. https://lnkd.in/eQiNXdh2 SURMOUNT-5 Trial Topline results from the SURMOUNT-5 phase 3b open-label randomized clinical trial. On average, Zepbound led to a superior weight loss of 20.2% compared to 13.7% with Wegovy. In addition, in a key secondary endpoint, 31.6% of people taking Zepbound achieved at least 25% body weight loss compared to 16.1% of those taking Wegovy. https://lnkd.in/efVB9P4F

Among China-made PD-1 inhibitors at ASCO 2024 and status within late-stage pipeline it is of note that Henlius | 复宏汉霖 will have update on #Serplulimab (also known as HLX10). https://lnkd.in/gDVGccAx https://lnkd.in/g_hKMjti We are set to hear results of the Ph2/3 ASTRUM-015 trial of #Serplulimab in Combination With Bevacizumab (HLX04) and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab (HLX04) and Chemotherapy (XELOX) in first-line treatment of patients with metastatic colorectal cancer (mCRC). This report is the only other indication beyond SCLC (where it already holds FDA Orphan Drug Status) to present late stage Ph3 outcome and it is a part of numerous portfolio of chemo-combos with this PD-1 inhibitor across indications that is certain to bring many updates beyond mCRC. According to announcement by Henlius the abstract will be released on 2024/5/23, at 5:00 PM EDT on ASCO.org. The poster will be displayed on-site on 2024/6/1, 1:30 PM-4:30 PM CDT. #PD-1 inhibitor #China Biotech #mCRC #ASCO2024