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