HER-Vaxx Cancer Vaccine

Anti-Cancer Vaccine Presented Positive Phase 1 Results

Don Hackett — Thu, 03 Oct 2019 13:18:53 +0000

Reviewer:

An Australian immuno-oncology company announced comprehensive clinical data results from the Phase Ib clinical study of its HER-Vaxx anti-cancer vaccine, in gastric cancer patients overexpressing the Human Epidermal Growth Factor Receptor 2 (HER2) target protein.

Imugene Limited's HER-Vaxx is a B-cell peptide cancer vaccine designed to treat tumors that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

This small study’s data in 68 patients showed a 100 percent objective response rate in 3 patients who received the optimal dose of 50 micrograms.

And, in 5 of 11 patients evaluable for tumor responses, tumor reduction was associated with high HER2-specific antibody levels which showed a capacity to inhibit HER2-phosphorylation.

This is important since the inhibition of HER2- phosphorylation is a key mechanism of successful HER2-targeting drugs that inhibit cancer cell growth.

The HER2 gene makes HER2 proteins, which are receptors on breast cells, says BreastCancer.org.

Normally, HER2 receptors help control how a healthy breast cell grows, divides, and repairs itself.

But in about 25 percent of breast cancers, the HER2 gene doesn't work correctly and makes too many copies of itself, which is known as HER2 gene amplification.

All of these extra HER2 genes tell breast cells to make too many HER2 receptors. This makes breast cells grow and divide in an uncontrolled way.

Imugene’s Managing Director and Chief Executive Officer Leslie Chong said in an October 1, 2019, press release, “Together with our dedicated investigators and research teams we are building an impressive library of evidence to support the clinical potential our unique B-cell cancer vaccine pipeline and clinical development strategy.”

There are 4 breast cancer tests available:

IHC test (ImmunoHistoChemistry),
FISH test (Fluorescence In Situ Hybridization),
SPoT-Light HER2 CISH test (Subtraction Probe Technology Chromogenic In Situ Hybridization),
Inform HER2 Dual ISH test (Inform Dual In Situ Hybridization).

Imugene’s poster, abstract number 1212P, is entitled ‘Comprehensive results of a Phase Ib study with a HER2/neu B-cell peptide vaccine administered with cisplatin and 5-fluorouracil or capecitabine chemotherapy show safety, immunogenicity and clinical response in patients with HER2/neu overexpressing advanced gastric cancer’. The poster presentation is available on the Imugene website.

Imugene aims to complete this phase 1 study in 2020.

Imugene is a clinical-stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumors.

Cancer Vaccine information published by Precision Vaccinations

Sub Title:

HER-Vaxx is a B-cell peptide cancer vaccine candidate designed to treat tumors that over-express the HER-2/neu receptor

Reference:

Comprehensive Phase 1b HER-Vaxx Cancer Vaccine Results Presented at the European Society of Medical Oncology (ESMO) Congress

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HER-Vaxx Cancer Vaccine Published New Clinical Data

Don Hackett — Mon, 08 Jul 2019 14:30:19 +0000

Reviewer:

Robert Carlson, MD

John Paul Sanchez, PharmD

An Australian clinical stage immuno-oncology company announced new clinical data from the Phase Ib study of its HER-Vaxx (IMU-131) cancer vaccine candidate, plus chemotherapy.

Imugene’s HER-Vaxx is a B-cell peptide cancer vaccine designed to treat tumors that over-express the HER-2/neu receptor, such as gastric cancer.

This new clinical study data is showing HER-Vaxx’s cancer-fighting antibody and clinical response rates continue to be positive in the patients receiving the optimal biological dose of vaccine.

On July 8, 2019, Imugene Limited said in a press release that ‘patients have maintained strong and high levels of HER-2 targeting antibodies indicating a durable response is present, with no resistance developed.’

In this small study, the cohort 3 patients who received the optimal biological dose, and selected Phase 2 dose, have realized positive trends.

One patient has seen a total tumor reduction of almost 80 percent from baseline CT scan, with 1 out of 4 of their lesions becoming unmeasurable by RESIST criteria, on Day 266.

The Phase 1b HER-Vaxx study in metastatic gastric cancer patients overexpressing the HER-2 protein completed enrollment in late 2018 and reported no safety or toxicity issues. All evaluable patients showed increased antibody responses.

This study is important since gastric cancer is the 5th most frequently diagnosed cancer.

HER-2/neu is overexpressed in 15 to 25 percent of patients with gastric cancer and associated with a poor prognosis, and death, says the National Cancer Insitute.

Imugene Managing Director and CEO Leslie Chong said in a press release, “This presentation from the HER-Vaxx Phase 1b study further reinforces the very good early results and ongoing interest among the international oncology community in our potentially promising B-cell platform cancer vaccine and clinical development strategy.”

The Phase 2 study began enrollment in March 2019 and is scheduled to complete in 2020.

Recent cancer vaccine news:

The positive new data was presented to international delegates at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer, in Spain.

The oral presentation was delivered by Dr. Marina Maglakelidze from the Research Institute of Clinical Medicine in Tbilisi, Georgia.

The presentation is titled: ‘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.’

Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumors.

For further information please contact: Leslie Chong Managing Director and Chief Executive Officer T: +61 458 040 433 E: Leslie.Chong@Imugene.com

Sub Title:

Imugene Limited HER-Vaxx (IMU-131) is a B-cell peptide cancer vaccine designed to treat tumors that over-express the HER-2/neu receptor

References:

New HER-Vaxx Cancer Vaccine trial data presented at the European Society of Medical Oncology World Congress on Gastrointestinal

A phase Ib/II open label study of IMU-131 HER2/Neu peptide vaccine plus cisplatin and either 5-fluorouracil or capecitabine chem

A phase Ib study of IMU-131 HER2/neu peptide vaccine plus chemotherapy in patients with HER2/neu overexpressing metastatic

Stomach (Gastric) Cancer

HER-Vaxx Cancer Vaccine Reports Positive Results

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HER-Vaxx Cancer Vaccine Reports Positive Results

Don Hackett — Wed, 05 Jun 2019 12:29:14 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

John Paul Sanchez, PharmD

A clinical stage immuno-oncology company based in Australia announced positive data from the Phase Ib study of its HER-Vaxx cancer vaccine candidate.

Imugene’s HER-Vaxx is a B-cell peptide cancer vaccine designed to treat tumors that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER-2/neu.

The Phase 1b HER-Vaxx study which completed the enrollment of 36 participants in 2018, met all its primary endpoints, according to a presentation given at the ASCO annual meeting on June 4, 2019.

The study is ongoing with patients continuing to receive HER-Vaxx every 3 months to maintain high levels of cancer targeting antibodies.

The ASCO presentation details the continued progress being made by patients who received the highest dose of HER-Vaxx.

By day 182 of the trial, their tumors have either shrunk further or stabilized.

In one patient, their tumor has shrunk more than 70 percent since joining the trial.

A Phase 2 study was initiated in March 2019 dosing patients at the highest Phase 1b dose. These results will be presented in an oral presentation at ESMO GI in Barcelona on 3-6 July 2019.

>>> Enroll in a clinical trial for free <<<

According to Cancer.gov, HER-2-positive B-cell peptide antigen IMU-131 is a cancer vaccine consisting of a fusion peptide, composed of three peptides derived from the extracellular domain (ECD) of the HER2 peptide antigen found on B-cells (P4, P6 and P7; P467), conjugated to the carrier protein DT-CRM197, a non-toxic, mutated form of diphtheria toxin (DT), and combined with the immunoadjuvant montanide ISA 51, with potential immunostimulatory and antineoplastic activities.

Imugene Chief Executive Officer Leslie Chong said in a press release, “There is continued interest in the positive data from our Phase Ib trial which supports our B-cell platform cancer vaccine strategy for treating HER-2 positive gastric cancer.”

Gastric cancer is the 5th most frequently diagnosed cancer and the 3rd leading cause of cancer deaths. HER2/neu is overexpressed in 15 to 25 percent of patients with gastric cancer and associated with a poor prognosis, says Cancer.gov.

The Principal Investigator is Pravin Kaumaya, Ph.D., Ohio State University, Columbus, Ohio; 614-292-7028; Pravin.Kaumaya@osumc.edu.

For further information contact Leslie Chong at 614-580-0433 or Leslie.Chong@Imugene.com.

Sub Title:

Imugene’s IMU-131 HER-Vaxx is a B-cell peptide cancer vaccine candidate in phase 2 study

References:

A PHASE 1B STUDY OF IMU-131 HER2/NEU PEPTIDE VACCINE PLUS CHEMOTHERAPY IN PATIENTS WITH HER2/NEU OVEREXPRESSING METASTATIC

Vaccine Therapy in Treating Patients With Metastatic Solid Tumors

A Study of IMU-131(HER-Vaxx) and Chemotherapy Compared to Chemotherapy Only in Patients With HER2 Positive Advanced Gastric Canc

Breast Cancer Vaccine Moves into Phase 2 Clinical Trial

HER2 Vaccine Candidate Met Phase 1b Study Endpoints

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