Ann: Prestigious Research Journal Publish HER-Vaxx Phase 1B Data, page-39

  1. 1,068 Posts.
    lightbulb Created with Sketch. 356
    For those interested, here is the published Abstract. It gives you a bit more detail:
    AbstractBackground: HER2/neu is overexpressed in up to 30% of gastroesophageal adenocarcinomas (GEA) and linked to poor prognosis. Recombinant mAbs to treat HER2/neu-overexpressing cancers are effective with limitations, including resistance and toxicity. Therefore, we developed a therapeutic B-cell epitope vaccine (IMU-131/HER-Vaxx) consisting of 3 fused B-cell epitopes from the HER2/neu extracellular domain coupled to CRM197 and adjuvanted with Montanide. This Phase 1b study aimed to evaluate the optimal/safe dose leading to immunogenicity and clinical responses.

    Patients & Methods: 14 patients with HER2/neu-overexpressing GEA were enrolled and dose escalation (10, 30, 50μg) was performed in 3 cohorts (C). Immunogenicity was evaluated by HER2-specific Abs and cellular responses, clinical responses by CT scans according to RECISTv1.1.

    Results: IMU-131 was safe without vaccine-related significant local/systemic reactions or SAEs. 11/14 patients were evaluable for changes in tumor size and vaccine-specific immune responses. One patient showed complete, 5 partial responses and 4 stable diseases as their best response. HER2-specific IgG levels were dose-dependent. In contrast to patients in C1 and C2, all patients in C3 mounted substantial HER2-specific Ab levels. Additionally, cellular vaccine responses such as Th1-biased cytokine ratios and reduced Treg numbers were generated. Progression free survival was prolonged in C3, correlating with the vaccine-specific humoral and cellular responses.

    Conclusions: IMU-131 was well tolerated and safe. The induced HER2-specific Abs and cellular responses were dose-dependent and correlated with clinical responses. The highest dose (50 µg) was recommended for further evaluation in a Phase II trial, with chemotherapy +IMU-131 or chemotherapy alone, which is currently ongoing.

    So the higher dose C3 50μg showed the important parameter of Progression Free Survival (PFS) being prolonged and therefore 50μg will be the dose evaluated further in the Phase II trial. The other important news was that it was well tolerated and safe which puts it in front of alternative immunological methods.
    Last edited by vein1: 29/04/21
 
Add to My Watchlist
What is My Watchlist?
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)
Last
1.3¢
Change
0.002(18.2%)
Mkt cap ! $97.07M
Open High Low Value Volume
1.2¢ 1.4¢ 1.1¢ $625.7K 50.56M

Buyers (Bids)

No. Vol. Price($)
20 5795292 1.2¢
 

Sellers (Offers)

Price($) Vol. No.
1.3¢ 3258567 9
View Market Depth
Last trade - 16.10pm 27/06/2025 (20 minute delay) ?
IMU (ASX) Chart
arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.