Updated
July 9th, 2019

HER-Vaxx Cancer Vaccine Reports Positive Results

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

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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.

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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.

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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; [email protected].

For further information contact Leslie Chong at 614-580-0433 or [email protected].