HER-2/neu peptide vaccine / National Cancer Institute - Bethesda - LARVOL DELTA

VADIS: Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer (clinicaltrials.gov) - P2 | N=43 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Mar 2024 ➔ May 2023

Trial completion • Trial completion date • Breast Cancer • Oncology • Solid Tumor

Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab (clinicaltrials.gov) - P1/2 | N=22 | Completed | Sponsor: University of Washington | Active, not recruiting ➔ Completed

Metastases • Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • HER-2 • IFNG

VADIS: Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer (clinicaltrials.gov) - P2 | N=43 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | N=13 ➔ 43

Enrollment change • Breast Cancer • Oncology • Solid Tumor • HER-2

Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab (clinicaltrials.gov) - P1/2 | N=22 | Active, not recruiting | Sponsor: University of Washington | Trial completion date: Sep 2023 ➔ May 2023

Preclinical • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • HER-2 • IFNG

A phase Ib/II open label study of IMU-131 HER2/Neu peptide vaccine plus cisplatin and either 5-fluorouracil or capecitabine chemotherapy in patients with HER2/Neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction. (ASCO-GI 2019) - P1b/2; "No conclusions can be drawn at this time."

Clinical • P1/2 data

A Phase Ibstudy of IMU-131 HER2/neu peptide vaccine pluschemotherapy in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction. (ASCO 2019) - P1b/2; "Each patient received IMU-131 on Days 0, 14, and 35, accompanied by cisplatin and 5-fluorouracil or capecitabine every 21 days. IMU-131 is a promising B-Cell vaccine against HER2. Further work in a controlled phase 2 trial is ongoing. Clinical trial information: NCT02795988"

Clinical

A phase 1b study of IMU-131 her2/neu peptide vaccine plus chemotherapy in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction (ESMO-GI 2019) - "Each patient received IMU-131 on Days 0, 14, and 35, accompanied by cisplatin and 5-fluorouracil or capecitabine every 21 days.   IMU-131 is a promising B-Cell vaccine against HER2. Further work in a controlled phase 2 trial is ongoing."

Clinical • P1 data

A Phase Ib open label multicenter study with a HER2/neu peptide vaccine administered with cisplatin and 5-fluorouracil or capecitabine chemotherapy shows safety, immunogenicity and clinical response in patients with HER2/Neu overexpressing advanced cancer of the stomach (AACR 2019) - "The vaccine was well tolerated and safe with antibody responses at the highest dose (50 µg) showing a strong correlation with clinical responses. Thus, a dose of 50 µg was recommended for further evaluation in Phase II, featuring two arms of either IMU 131 plus CT or CT alone. We propose that this vaccine might be of significant medical benefit and further trials are warranted."

Clinical • P1 data

A phase Ib/II open label study of IMU-131 HER2/Neu peptide vaccine plus cisplatin and either 5-fluorouracil or capecitabine chemotherapy in patients with HER2/Neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction. (ASCO-GI 2019) - P1b/2; "No conclusions can be drawn at this time."

Clinical • P1/2 data

Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer (clinicaltrials.gov) - P2; N=10; Recruiting; Sponsor: University of Washington

Clinical • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Male Breast Cancer • Oncology • Solid Tumor • HER-2

Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer (clinicaltrials.gov) - P2; N=3; Terminated; Sponsor: University of Washington; N=10 ➔ 3; Recruiting ➔ Terminated; Trial primary completion date: Nov 2015 ➔ Jun 2013; Study ended early due to slow enrollment

Clinical • Enrollment change • Trial primary completion date • Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Male Breast Cancer • Oncology • Solid Tumor • HER-2

Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer (clinicaltrials.gov) - P2; N=10; Recruiting; Sponsor: University of Washington; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Male Breast Cancer • Oncology • Solid Tumor • HER-2

Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer (clinicaltrials.gov) - P2; N=10; Recruiting; Sponsor: University of Washington; N=20 ➔ 10

Clinical • Enrollment change • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Male Breast Cancer • Oncology • Solid Tumor • HER-2

Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab (clinicaltrials.gov) - P1/2; N=26; Active, not recruiting; Sponsor: University of Washington; Trial completion date: Sep 2020 ➔ Sep 2023; Trial primary completion date: Sep 2020 ➔ Mar 2021

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • HER-2

VADIS: Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer (clinicaltrials.gov) - P2; N=108; Recruiting; Sponsor: National Cancer Institute (NCI); Suspended ➔ Recruiting

Enrollment open • Biosimilar • Breast Cancer • Oncology

Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab (clinicaltrials.gov) - P1/2; N=20; Enrolling by invitation; Sponsor: University of Washington; Trial primary completion date: May 2018 ➔ Nov 2018

Trial primary completion date • Biosimilar • Breast Cancer • Gynecologic Cancers • HER2 Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor

Intraoperative imaging of positron emission tomographic radiotracers using cerenkov luminescence emissions -

Target-specific uptake of 89Zr-DFO-trastuzumab in BT-474 (HER2/neu positive) vs MDA-MB-468 (HER2/neu negative) was revealed in xenografts in the same mice; Competitive inhibition (blocking) studies followed by CLI also confirmed the in vivo immunoreactivity & specificity of 89Zr-DFO-trastuzumab for HER2/neu;

Imaging data • Oncology

Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab (clinicaltrials.gov) - P1/2; N=26; Active, not recruiting; Sponsor: University of Washington; Trial completion date: Mar 2020 ➔ Sep 2020; Trial primary completion date: Mar 2020 ➔ Sep 2020

Clinical • Trial completion date • Trial primary completion date • HER-2

Vaccine Therapy in Combination With Rintatolimod and/or Sargramostim in Treating Patients With Stage II-IV HER2-Positive Breast Cancer (clinicaltrials.gov) - P1/2; N=50; Completed; Sponsor: University of Washington; Active, not recruiting ➔ Completed

Clinical • Combination therapy • Trial completion • HER-2

Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer (clinicaltrials.gov) - P2; N=13; Active, not recruiting; Sponsor: National Cancer Institute (NCI); N=108 ➔ 13

Clinical • Enrollment change

Vaccine Therapy in Treating Patients With Previously Treated Stage II or Stage III Breast Cancer (clinicaltrials.gov) - P1; N=45; Completed; Sponsor: Mayo Clinic; Phase classification: P=N/A ➔ P1

Clinical • Phase classification

Vaccine Therapy in Treating Patients With Previously Treated Stage II or Stage III Breast Cancer (clinicaltrials.gov) - P=N/A; N=45; Completed; Sponsor: Mayo Clinic; Active, not recruiting ➔ Completed

Clinical • Trial completion

Vaccine Therapy in Treating Patients With Previously Treated Stage II or Stage III Breast Cancer (clinicaltrials.gov) - P=N/A; N=45; Active, not recruiting; Sponsor: Mayo Clinic; Trial primary completion date: May 2017 ➔ May 2018

Clinical • Trial primary completion date

Vaccine Therapy in Treating Patients With Previously Treated Stage II or Stage III Breast Cancer (clinicaltrials.gov) - P=N/A; N=45; Active, not recruiting; Sponsor: Mayo Clinic; Trial primary completion date: May 2016 ➔ May 2017

Clinical • Trial primary completion date

Vaccine Therapy in Treating Patients With Previously Treated Stage II or Stage III Breast Cancer (clinicaltrials.gov) - P=N/A; N=45; Active, not recruiting; Sponsor: Mayo Clinic; Trial primary completion date: May 2015 ➔ May 2016

Clinical • Trial primary completion date